0930037,01/08/2021,GA,64.0,64,,F,,"No injection site issue from elbow to wrist swallen red fevered area hand was difficult to be used for 12-24 hours to subside . Very large arm left 2 - inches red a swallen 12-24 hours welts all over body three to five inches. Continuing every day . 120 dexitrun Cycles 16th day woke up intergestion roof of mounth Employee health hospialize Adverse event allergiest umulize hopital, clarifein, swelling",,,,,,,,,N,12/17/2020,12/17/2020,0,01/02/2021,PVT,,Rosuvastatin 10 mg Multi viatium Vitiaum D D3 Osto Byflex,No,Heart disease Heart Stint,,vsafe,2,01/08/2021,,,Y,No 0934944,01/11/2021,CA,50.0,,,M,,"The subject experienced acute pericarditis on 27Dec2020; Other vaccine same date vaccine date= 23Dec2020; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The facility type vaccine was hospital. None medical history. The patient's concomitant medications were not reported. Other vaccine same date vaccine date on 23Dec2020. The patient experienced acute pericarditis on 27dec2020 with outcome of recovered. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received for the adverse event. The event was reported as non-serious. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.",,,,,,,,,Y,12/23/2020,12/23/2020,0,,PVT,,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,USPFIZER INC2021008311,2,01/10/2021,,Y,, 0941566,01/13/2021,TN,30.0,30,,F,,12/29 vaccination 12/31 woke with HA; lasted 1 week. don't know if was related to pregnancy or the vaccine. 1st pregnancy; 6/17/21,,,,,,,,,Y,12/29/2020,12/31/2020,2,n/a,PUB,,"Phenergan, Pepcid, nexium, B6, unisom, prenatal",n/a,n/a,,VSAFE,2,01/13/2021,,,,n/a 0974343,01/26/2021,MI,51.0,51,,F,,about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.,,,,,,,,,Y,12/31/2020,12/31/2020,0,none,WRK,,Lexipro,None,Crohn's Disease although stable and not on any medications or treatments,,,2,01/26/2021,,Y,,"Vicodin, Sulfa , Iron Infusions" 0995477,02/02/2021,NY,42.0,42,,F,,"lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness",,,,,Y,,,,U,01/23/2021,01/30/2021,7,n/a,PVT,,n/a,n/a,n/a,"12/26 covid, moderna, rashes on both arms, vomiting, low grade fever",,2,02/02/2021,,,,"strawberries, morphine, naproxen, shellfish" 1017724,02/09/2021,MI,75.0,75,,F,,Acute pericarditis complicated by atrial flutter,,,,,Y,2,,,N,01/15/2021,01/16/2021,1,"CT aorta with smal pericardial effusion TTE with small pericardial effusion, normal EF 68% ESR 48, CRP21,3, BNP 216",UNK,,"cholecalciferol, diclofenac gel, MVI, omeprazole, rosuvastatin, Tylenol PRN",,"Osteoarthritis, gastric sleeve 2011, GERD, HLD",,,2,02/09/2021,,Y,Y,None 1025660,02/12/2021,MN,32.0,32,,F,,"Pt received second dose of Pfizer vaccination at 0910. At 0925, pt notified staff of intermittent feelings of shortness of breath and lightheadedness. Pt verbalized she had no intake for the morning was given apple juice and animal crackers. At 1015, pt reported to staff of continuing intermittent feelings of lightheadedness, shortness of breath and itching on the legs. Pt was transported to private area for further assessment via wheelchair and assisted to lie down on massage table. A provider on duty assessed pt at 1015 and administered Epipen at 1020 for potential allergic reaction. Pt reported to have taken Lorazepam (dose unknown) prior to appointment at 0905. Symptoms were discussed with pt and agreed to have EMS transport to ED for further monitoring. EMS was called and they transported pt to WW ED. 0925 Vitals: BP-108/64, P-64, O2-97%, Resp-20 1015 Vitals-BP-104/60, P-78, O2-100%, Resp-20 1035 Vitals-BP-124/68, P-80, O2-100%, Resp-20 Admin: Epinephrine (EPIPEN) 0.3mg/0.3 mL injection R thigh transported to ED next to clinic. ED COURSE & MEDICAL DECISION MAKING: 11:10 AM I met with the patient, obtained history, performed an initial exam, and discussed options and plan for treatment here in the ED. I was wearing PPE including N95 mask and face shield. 11:19 AM Paged allergist. 11:40 AM I discussed the patient with allergist from Fairview. He does not recommend any additional labs or treatment for the patient. 2:12 PM I rechecked on the patient and she is feeling better. We discussed the plan for discharge and the patient is agreeable. Reviewed supportive cares, symptomatic treatment, outpatient follow up, and reasons to return to the Emergency Department. Patient to be discharged by ED RN. Pertinent Labs & Imaging studies reviewed. (See chart for details) 32 y.o. adult presents to the Emergency Department for evaluation of allergic reaction. Had onset of symptoms within a few minutes of receiving her second Pfizer COVID-19 vaccination today. Symptoms seem consistent with allergic reaction including itching, hives, feeling lightheaded, nausea, and some abdominal cramping. She was given an EpiPen prior to arrival and brought here by EMS. There she was also given Benadryl, Solu-Medrol, and Pepcid. Other than some mild itching, did not have any return of other symptoms. Given prescriptions to continue with Claritin, Pepcid and prednisone. Also prescriptions for EpiPen was provided. Did briefly discuss with the allergist on call. No additional recommendations at this time. I do recommend that she follow-up with an allergist sometime the next few weeks. She was advised to return to the emergency department for any new or worsening symptoms or other concerns. At the conclusion of the encounter I discussed the results of all of the tests and the disposition. The questions were answered. The patient or family acknowledged understanding and was agreeable with the care plan. MEDICATIONS GIVEN IN THE EMERGENCY: Medications methylPREDNISolone sod suc(PF) injection 125 mg (Solu-MEDROL) (125 mg Intravenous Given 2/10/21 1135) diphenhydrAMINE injection 25 mg (BENADRYL) (25 mg Intravenous Given 2/10/21 1137) famotidine 20 mg injection (20 mg Intravenous Given 2/10/21 1138) Transported to ED by EMS. Symptoms seem comsistent with allergis reaction including itching, hives, feeling lightheaded, nausea, and some abdominal cramping. Given Benadryl, Solu-Medrol and Pepcid. Other than mild itching, did not have any return of other symptoms. Given prescriptions to continue with Claritin, Pepcid and prednisone. ALso given prescription for EpiPen. Did briefly discuss with allergist on call. No additional recommendations at this time. I do recommend that she follow-up with an allergist sometime the next few weeks. Pt returned to ED later in the evening reporting throat tightness and itching. Normal vitals and no objective signs of anaphylaxis. DC'd to home.",,,,,,,,,Y,02/10/2021,02/10/2021,0,N/A,PVT,,"Lorazepam, dosage unknown, prior to vaccination.","Patient was seen by PCP on 2/3/2021 for a routine general medical evaluation. In the notes, patient reported feeling anxious, lightheaded and reported SOB after leaving the vaccination facility (completed the 15 minute observation time). Patient has a hx of anxiety. Pt did not report these symptoms r/t previous vaccination to the vaccination team when she came in for her 2nd dose.","ETOH Abuse, Anxiety, Borderline Personality Disorder, PTSD, Panic Disorder w/ Agoraphobia, Adjustment Disorder with Depressed Mood, Episode of Major Recurrent Depressive Disorder, Psychological Factors Affecting Medical Condition, Stress.",,,2,02/12/2021,,,,NKA 1052127,02/24/2021,IL,34.0,34,,F,,"Received the vaccine, and was in the monitoring area. Within ~5 minutes, I felt my throat was thickening. I asked for water to see if that would help the sensation. The sensation of thickness increased to a tightening and thickness and a very mild itchiness on the roof of my mouth. I continued to feel a strong need to drink water and became extremely cold. At about 20 minutes, my voice became hoarse. I was given benadryl at approximately 40 minutes post injection, however the staff were communicating with people at the ER and was told that I needed an Epipen and to be transported immediately to the ER given signs of analphylaxis with the vocal change. I received the epipen about 45 minutes after injection, and a few minutes after receiving the shot, my throat felt looser. My voice continued to be hoarse. They had a very difficult time finding a vein in my arm for an IV (an I am typically very veiny). I was transported to the ER, and given steriods and monitored. At approximately 4 hrs post vaccine, I started to have worsening voice again, in which they gave me additional benadryl. I continued to be monitored in the ER until 7 hrs post vaccine. My voice continued to have moments where it was better and then it would go away again. They offered to keep me for observation, however I declined and was discharged to home. At home, later that night, I developed entire body itchiness, particularly over my face, and trunk. This lasted for several days, with decreasing intensity. My face was also very flushed looking lasting for 2 days after the reaction. My voice returned to normal after 3 days.",,,,,,,,,Y,12/23/2020,12/23/2020,0,Blood test in ER on 12/23/20,PVT,,"LoEstrin FE, Midodrine 5 mg, Adderall 10 mg ER, Emgality (taken 36 hrs prior to vaccination), topamax 5 mg, magnesium, multivitamin, vitamin B12, vitamin D3","Had taken Emgality 36 hr prior to receiving the vaccine. This causes a localized hive reaction for approximately 48-72 hrs in area of injection (on my leg), and also this time (3rd time taking the medication) caused me to wake up in early morning of 12/23 with itchiness over my entire trunk. It resolved once getting out of bed and I didn't think anything more of it.","POTS, chronic headaches.",,,2,02/24/2021,,Y,Y,"Choloprep 1 step, Bactrim." 1065720,03/02/2021,VA,77.0,77,,M,,"Poor PO intake, fevers at night, body aches, excessive somnolence/sleeping, and a progressive exquisitely tender erythematous maculopapular rash. The patient acquired a Stevens-Johnson like syndrome which required a three day inpatient stay and the consultation of Infectious Disease and Dermatologic consultants. Per his SCORTEN score, he had roughly a 3% chance of mortality from the event. He was closely monitored for signs of decompensation but did not have excessive desquamation or duskiness after treatment was initiated. With IV steroids and IV rehydration, the patient improved over the hospitalization course and labs were essentially back to normal a week later on follow up.",,,Y,,Y,3,,,Y,02/11/2021,02/12/2021,1,"CBC 2/17: WBC normal, but with eosinophil and neutrophil predominance (7.03 and 0.74, respectively). By 2/23, pt had leukocytosis 13.7, but was notably on steroids. He still had neutrophil predominance with Neuts absolute 9.6. BMP 2/17: Normal with exception of Creatinine 1.5, Sodium 130, and Chloride 92. All back to WNL by 2/20. LFT 2/17: AST 304, ALT 248, alk phos 161. These uptrended to a max of AST 486, ALT 634, and alkphos 219 on 2/20. On 2/23, they had improved (AST was 47, ALT 270, and alk phos 166). Inflammatory Markers 2/17: ESR 34. CRP 12.9. On 2/19, CRP was 4.2 CK 2/17: 9,901. Down trended to normal (148) by 2/23. Troponin 2/17: negative UA 2/17: 100 protein, small bili, and large blood.",PVT,,ASPIRIN 325 MG EC TABLET Take 325 mg by mouth daily. M- ATORVASTATIN (LIPITOR) 40 MG TABLET Take 40 mg by mouth daily. M- EZETIMIBE (ZETIA) 10 MG TABLET Take 10 mg by mouth daily. M- FAMOTIDINE (PEPCID) 40 MG TABLET Take 40 mg by mou,None,"CAD, HTN, HLD, OA",,,2,03/02/2021,,,,Tetanus toxoid (unspecified reaction and severity) Horse derived products (anaphylaxis) 1069001,03/03/2021,NC,73.0,73,,F,,"Fatigue, chills, aches and headaches all from time to time and in various intensity that have declined but still present",,,,,,,,,N,02/05/2021,02/12/2021,7,None- was still advised by primary physician to take second dose of Moderna,PUB,,Thyroid medication Multi-Vitamin Prescription eye drops for glaucoma,,,Shinges two shot doses 2019,,2,03/03/2021,,Y,,sulfar drugs 1069296,03/03/2021,NJ,72.0,72,,F,,"Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Mild",,,,,,,,,N,02/20/2021,02/20/2021,0,,PHM,,,,,,,2,03/03/2021,,,Y, 1077251,03/05/2021,MN,67.0,67,,F,,"Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium",,,,,Y,1,,,Y,03/01/2021,03/02/2021,1,,PHM,,,,,,,2,03/05/2021,,,, 1080339,03/08/2021,SC,60.0,,,F,,"gross hematuria/blood in urine; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9265) via intramuscularly in left arm on 01Feb2021 17:15 as single dose for COVID-19 immunization, at hospital. Medical history included hypertension. Concomitant medication included naproxen, fluoxetine hydrochloride (PROZAC), amlodipine besilate, benazepril hydrochloride (LOTREL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination includes Lotrel, Naproxen, Prozac. On 4Feb2021 18:00 patient had gross hematurea it was not from rectum or vagina. It was visible blood in urine (urine analysis). The patient did not receive any treatment. Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the event was not recovered.",,,,,,,,,N,02/01/2021,02/04/2021,3,"Test Date: 20210204; Test Name: Urine analysis; Result Unstructured Data: Test Result:It is visible bloos in urine; Comments: It is visible blood in urine,",PVT,,NAPROXEN; PROZAC; LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE],,Medical History/Concurrent Conditions: Hypertension,,USPFIZER INC2021116821,2,03/06/2021,,,, 1080341,03/08/2021,,20.0,20,,F,,"benign PVCs; felt funny; heart pounding on/off for a good number of days after the episode; Ideopathic peripheral nueropathy; Initial information received in courtesy from Pfizer on 24-Feb-2021 regarding an unsolicited valid non-serious case from other health professional. This case involves a 20 years old female patient (62.5 cm and 112 kg) who experienced idiopathic peripheral neuropathy (neuropathy peripheral), benign PVCs (Premature ventricular contractions) (ventricular extrasystoles), felt funny (feeling abnormal) and heart pounding on/off for a good number of days after the episode (palpitations), after receiving DIPHTHERIA AND TETANUS TOXOIDS, HEPATITIS B IMMUNE GLOBULIN, YELLOW FEVER VACCINE and ORAL POLIO VACCINE. The patient's medical history included seasonal, animal and food allergies; adverse reactions to multiple medicines-some severe. Past medical treatment(s), vaccination(s), family history and concomitant medication(s) were not provided. On an unknown date in Aug-1988, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer), HEPATITIS B IMMUNE GLOBULIN, YELLOW FEVER VACCINE and ORAL POLIO VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination ahead of travel. Because patient had so many at once, was asked to remain for a little while ; within a very short time, patient told the clinician that she felt funny (feeling abnormal, non-serious, same day latency) and heart pounding on/off for a good number of days after the episode (palpitations, non-serious, unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS, ORAL POLIO VACCINE, YELLOW FEVER VACCINE and HEPATITIS B IMMUNE GLOBULIN. Patient reported that clinician checked her and said didn't like what she was seeing and administered EPINEPHRINE (all of this was recorded on her yellow card) and have not had any vaccines then. Patient rather assumed the lasting effect was from the epi-pen, but now, not so certain. On an unknown date in Jul-2014, the patient developed a serious idiopathic peripheral nueropathy (neuropathy peripheral) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS, ORAL POLIO VACCINE, YELLOW FEVER VACCINE and HEPATITIS B IMMUNE GLOBULIN. This event was assessed as medically significant. it was reported that it came on suddenly, progressed quicky over a matter of weeks, then leveled off and subsided over the years , no cause was identified, though doctors felt likely result of a virus (unspecified). On an unknown date , (roughly 7-8 years ago from the administration of COVID-coronavirus vaccine) the patient developed a non-serious benign PVCs (Premature ventricular contractions) (ventricular extrasystoles) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS, ORAL POLIO VACCINE, YELLOW FEVER VACCINE and HEPATITIS B IMMUNE GLOBULIN. (Also reported 5-6 years ago- likely result of hormonal changes and eventually subsided and patient had not felt them in years). No laboratory data was reported. No clear family history relevant to the adverse events that patient experience, other than many relatives with multiple and sever allergies. The patient recovered from the events neuropathy peripheral and ventricular extrasystoles, while was unknown for the other two events. Information on the batch number to be requested. Additionally reported, at the age of 53 the patient received COVID-19 (coronavirus disease 2019, BNT162B2, first dose, ENS318, difficult to read handwriting, so if lot males non sense, try EN5318) vaccine (Pfizer) on 26-Jan-2021. Also, roughly after 7 minutes after receiving the COVID-19 vaccine, she experienced a dramatic jump in pulse rate (tachycardia -pulse rate 152). She requested assistance and the doctor and nurses at the vaccination site took her to an area, where they found her blood pressure had also jumped (blood pressure spiked to 159/98 and 169/92) and she was having irregular beats (irregular rhythm). They asked if her breathing was ok and if her throat felt ok. Her mouth was dry, and she felt a tightness in her chest, but otherwise no rashes or other clear sign of anaphylaxis. They monitored her for roughly 1.5 hours, requesting help from the EMT (Emergency medical technician) stationed there, who did a brief EKG (Electrocardiography), which showed tachycardia but did not picked up the irregular beats. Upon hearing they had heard and seen irregular beats on the blood pressure monitor, she explained that she had a history of benign PVCs (Premature ventricular contractions), but not experienced them in years and was not medicated for them. Eventually the doctor let her go when the blood pressure came down to 138/89 with a resting pulse rate of 112-114 (still significantly higher than normal). He advised her to follow up with her doctor right away, preferably that same day. Her blood pressure and pulse rate eventually returned to her normal levels 11 hours after the administration of the vaccine. As the tachycardia subsided, she could feel frequent irregular beats. The next day she continued to experience the irregular beats on/off all day long and also experienced a crushing fatigue t7o the point where she needed to take day off from work, something she rarely do. The fatigue subsided by the end of the week, but the irregular heartbeats continued for roughly 10 days before they subsided to the point of not being as noticeable. Patient was on cyanocobalamin (B-12) tablet .That evening and over a next few days, she followed up with her primary care physician, her allergies and ultimately the cardiologist, who ordered a 2 week holter monitor results were still pending. Weighing the risk of COVID, the benefits of the vaccine, history of patient's allergies and reaction to her first dose (particularly the irregular beats which h continued past the initial day of the vaccine). Her allergist and cardiologist suggested to hold on the second vaccine until they can better assess her status and why reaction occurred. A follow up with another allergist who specialized in the vaccine reactions also suggested that she have a cardiac stress test prior to considering a second dose.; Sender's Comments: This case involves a 20 years old female patient who presented with peripheral neuropathy, ventricular extrasystoles, feeling abnormal and palpitations, after vaccinations with DIPHTHERIA AND TETANUS TOXOIDS, HEPATITIS B IMMUNE GLOBULIN, YELLOW FEVER VACCINE and ORAL POLIO VACCINE. Time to onset was compatible with the events feeling abnormal and palpitations, while it was too long to consider for the other two events. The patient's medical history included seasonal, animal and food allergies; adverse reactions to multiple medicines-some severe. However, other relevant patient's medical condition at the time of vaccination, immune status, history of similar episodes with previous vaccinations and lab tests were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.",,,,,,,,,Y,08/01/1988,07/01/2014,9465,,UNK,,,Allergy to animal (since child); Food allergy (since child); Seasonal allergy (since child),,,USSA2021SA069238,2,03/06/2021,,,, 1084326,03/09/2021,ND,73.0,73,,F,,"Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies. Lumbar puncture performed showing elevated cell count, elevated protein and low glucose.",,,,,Y,6,,Y,N,01/01/2021,02/26/2021,56,"Infectious Disease work up (viral, treponemal, fungal parasitic) work up negative Metagenomics from CSF in process Auto-immune panel from CSF in progress",PVT,,Melatonin Diltiazem enoxaparin Hydroxyzine Levothyroxin,Cephalexin Gluten Penicillin Sulfa,HTN HLD Factor V Leiden deficiency c/b PE Hashimoto's thyroiditis,,,2,03/09/2021,,,, 1092603,03/11/2021,MN,32.0,32,,F,,"Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.",,,,,,,,,Y,02/10/2021,02/10/2021,0,,PVT,,-Venlafaxine -busPIRone HCl -Propanolol -mirtazapine -Gabapentin -Emgality -Metronidazole,Bacterial Infection,PTSD MDD OCD,,,2,03/11/2021,,Y,Y,Never had an allergic reaction to medication or vaccine prior to this one. 1106182,03/16/2021,TX,,,,F,,"Right side body & arm tingling; Swelling of hands and feet (angioedema); Full-body Hives; Hot flashes; Burning sensation on her back; A spontaneous report was received from a consumer who was also a female patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced full body hives, hot flashes, burning sensation on back, swelling of hands and feet/ angioedema, and right side of body tingling/ paresthesia. The patient's medical history was not reported. The concomitant medications were no reported. On 03-MAR 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch- lot number- 029A21A) intramuscularly in the right arm for the prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient stated she had an allergic reaction while driving home. She broke out in hives with hot flashes, burning sensation on her back, swelling of the hands and feet. The patient went to her doctor's office and received a corticosteroid injection. On 04 Mar 2021, she had full body hives and angioedema in hands and feet. The right side of her body and arm were tingling like it was asleep. No problems with breathing reported. Treatment for the events also included Benadryl 300mg, Xyzal (levocetirizine), montelukast, prednisone, Pepcid AC, and Zyrtec. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events were considered unknown.",,,,,,,,,U,03/03/2021,03/03/2021,0,,UNK,,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,"USMODERNATX, INC.MOD20210",2,03/15/2021,,Y,, 1119858,03/21/2021,,,,,F,,"Pfizer's vaccine ""failed.""/confirmed non-responder; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history included multiple sclerosis and immunocompromised patient. Concomitant medication included Anti-B cell therapy. Physician said that when they tested the patient for antibodies, the result showed that it was immeasurable. The reporter also mentioned that the antibody testing was done more than 2 weeks after receiving the 2nd dose of the vaccine. He wanted to know if there was anything that they could do for the patient, and if they needed to revaccinate the patient because he said the vaccine failed. The patient was a confirmed non-responder to BNT162b2 vaccine with no cellular or humoral immunity to the vaccine. The outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a causal relationship between event vaccination failure and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.",,,,,,,,,U,,,,Test Name: antibody test; Result Unstructured Data: Test Result:Immeasurable; Test Name: immunity; Result Unstructured Data: Test Result:no cellular or humoral immunity to the vaccine,UNK,,,,Medical History/Concurrent Conditions: Immunocompromised; Multiple sclerosis,,USPFIZER INC2021116984,2,03/18/2021,,,, 1126551,03/23/2021,,,,,M,,"Viral infection; A spontaneous report was received from a male consumer who developed viral infection after receiving Moderna's COVID-19 vaccine (mRNA-1273). Medical history or concomitant product use was not reported. On an unknown date, the patient received planned dose of mRNA-1273 (batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. Later he developed viral infection which was prevalent since 14 days and it made him feel very weak. He went to the emergency room three times since and was admitted eventually. His symptoms were aggressive and then backed off. His oxygen saturation was 96 but ranged roughly between 97-100 (98.6 or 97) and his blood pressure fluctuated between extremely high and low. He also reported he had rapid decline of temperature which then reached to 103.7 DF and his heart rate was 90-100. It was reported that he might go home with oxygen. Action taken with mRNA-1273 in the response to the event viral infection was not reported. The outcome of the event viral infection was unknown. The causal relationship between mRNA-1273 and the event viral infection was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the patient's medical history is lacking and the exact viral infection was not specified. Further information has been requested.",,,,,Y,,,,N,,,,Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: High; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Low; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: rapid decline then rose to 103.7 F; Comments: rapid decline then rose to 103.7 F; Test Date: 2021; Test Name: Heart Rate; Result Unstructured Data: 90; Test Date: 2021; Test Name: Heart Rate; Result Unstructured Data: 100; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: 96; Comments: ranged from 97-100; was somewhere around 98.6-97.; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: 97,UNK,,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,"USMODERNATX, INC.MOD20210",2,03/22/2021,,,Y, 1128124,03/23/2021,CA,59.0,59,,M,,Patient without prior otologic history noted to have onset of sudden hearing loss on the right ear. He also noted dizziness. This was noted approximately 6 days after 1st dose of vaccine. Currently treated with oral and intertympanic steroid injections.,,,,,,,,,U,02/17/2021,03/01/2021,12,Serial audiograms,UNK,,,,,,,2,03/23/2021,,Y,, 1129100,03/24/2021,MO,67.0,67,,F,,The evening of 23 Dec 2020 I developed sudden shortness of breath with exertion and was unable to walk to my car in a hospital parking lot without stopping twice. SOB progressed over next few weeks and I sought medical attention.,,,Y,,Y,1,,,U,12/22/2020,12/23/2020,1,"1. Stress echo, 04 Feb 2021: Ejection Fraction: 73%, PHTN with estimated PASP 40mmHg+RAp, poor performance terminated due to SOB 2. CT of Chest 18 Feb 2021: 1. Bilateral segmental pulmonary emboli involving multiple segments with CT evidence of mild right heart strain. 2. Indeterminate sub-5 mm pulmonary nodules and enlarged bilateral hilar lymph nodes which may be reactive but are indeterminate. Recommend follow up of the Incidental pulmonary nodules and hilar lymphadenopathy Additional Imaging in 3 Months or as clinically indicated with chest CT. 3. Venous Duplex of upper and lower extremities, 19 Feb 2021: no evidence of DVT",PVT,,None,none,Uveitis Osteoarthritis,,,2,03/24/2021,,Y,,Theophylline Pine nuts 1132802,03/25/2021,KY,30.0,30,,F,,"Patient reported mild itching of arms at the time of injection. Was monitored for 30-45 minutes at the clinic and patient contacted MD via phone. MD advised patient to take Zyrtec and report to ER if symptoms worsened/difficulty breathing or swelling of throat/lips/face. Patient reports that approximately one hour after the injection, she began having a rash, throat tightness and shortness of breath. Arrived at ER and was treated with at steroid. Was advised by MD to abstain from receiving dose #2 of the Moderna Vaccine.",,,,,,,,,Y,03/01/2021,03/01/2021,0,Unknown - was evaluated by ER.,PUB,,None listed,None reported,None,,,2,03/25/2021,,,Y,Benadryl allergy 1134488,03/25/2021,MI,75.0,75,,F,,"She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better. About 12 hours later she had a headache and took some Aleve. She woke up the next morning with a severe headache and chest pain that was excruciating. Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis. They sent her home with steroids and Colchicine. They did not want to put her on NSAIDS due to possible ulcers. She all the COVID symptoms, and had severe pain still. Her daughter 3 weeks later took her to the cardiologist. She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine. She was then sent to the ER again, and went there twice. He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues. They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter. She is now back in sinus rhythm. She was advised not to get the 2nd vaccine due to the reactions from the first one. She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.",,,,,Y,10,,,N,01/15/2021,01/16/2021,1,Multiple.,OTH,,None.,None.,None.,,,2,03/25/2021,,,,None. 1136884,03/26/2021,FL,63.0,63,,M,,Chest and torso cramping the day after the injection. The chest cramping continued into the second day until I went to the emergency room.,,,Y,,Y,2,,,N,03/11/2021,03/12/2021,1,"On 3/13/2021, blood pressure was 212/130; blood enzymes showed heart was under stress. Received 2 cardiac stents on 3/14/2021.",OTH,,Duloxetine 90mg once a day Meloxicam 10mg once a day Amlodipine besylate 10mg once a day Carvedilol 25mg twice a day Losartan 100mg once a day.,None,"Hypertension, depression",,,2,03/26/2021,,,Y,None 1137058,03/26/2021,FL,67.0,67,,F,,"Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave breathing tx, 02 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to hospital. Diagnosed with transient global amnesia and hypercapnia. Client was transported to medical center for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o memory loss, confusion, and h'a are becoming less severe. Client states that senrory processing is slowed.",,,,,Y,2,,,N,02/11/2021,02/13/2021,2,"CT and MRI were negative, unsure of labwork",UNK,,Medoprazole and a Statin ( name?),none,"Fx C%, mitral valve prolapse, osteoarthritis, and cataract implant",,,2,02/13/2021,,,,"PCN (hives), contrast dye (unsure reaction), benedryl" 1142065,03/28/2021,TX,40.0,40,,F,,"Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.",,,,,Y,1,,Y,N,01/05/2021,01/06/2021,1,"1/6/2021: Monocyte% 10.4%, Neutrophil 75.9%, Lymphocyte 12% 1/7/2021: Red Blood Cell Count: 4.16 m/uL, White Blood Cell Count 4.42k/uL, Neutrophil 86.5%, Lymphocyte 9.5% 1/19/2021: Neutrophil 69.6%, Lymphocyte 18.45 1/28/2021: D-Dimer 1.76, Chest X-Ray and CT Angiogram negative for Pulmonary Embolism, EKG showed change in QRS Axis: T wave amplitude has increased in inferior leads Livedo Reticularis confirmed by biopsy on 2/18/2021 Halter Monitor worn on 3/25/2021-03/27/2021, awaiting results as of now",PVT,,"Zoloft, Lysine, Zyrtec, Vitamin D, Adzenys, Vitamin C, Evekeo",none,none,,,2,03/28/2021,,Y,Y,none 1142725,03/29/2021,,57.0,57,,M,,Chest pain. Difficulty breathing. Admiited to hospial emergemcy room. Released after 7 hours. Conclusion was that there was no heart attack But the chest pain has continued for almost a month since the vaccination.,,,,,Y,1,,,N,03/02/2021,03/02/2021,0,,PUB,,None,None,None,,,2,03/29/2021,,,Y,None 1143380,03/29/2021,MI,85.0,85,,F,,Heart rate dangerously high and in atrial fibrillation Still feeling cold all the time and not feeling well in general. can?t catch breath at times and nearly lost consciousness several times,,,Y,,,,,Y,N,02/25/2021,03/11/2021,14,"03/15/2021 129 BPM Heart Rate BP 155/111 Emergency room visit Diagnosis atrial fib, irregular heartbeat IV brought heart rate down briefly, then prescription for blood thinner and heart meds 03/25/2021 Heart shock procedure 03/27/2021 Emergency room visit 128 BPM Heart Rate BP 183/101 Did an iv Cardizem Three shocks didn't work. So they increased the beta blocker more",UNK,,,,,,,2,03/29/2021,,Y,Y, 1143424,03/29/2021,MD,73.0,73,,M,,"Patient presented and was admitted through ED for generalized weakness x2 days.The patient also complaints of nausea and vomiting x 2 days and fever this morning. The patient was recently discharged from the hospital on in December 2020 and was treated for covid pneumonia, he also had a small PE and started on warfarin. pertinent lab on admission - leukocytosis of 14.6, calcium very low at 5.1. Per the EUC, hospitalizations are to be reported irrespective of attribution to vaccine.",,,,,Y,,,,,03/16/2021,03/23/2021,7,,PVT,,,,"A. Fib, rheumatoid arthritis (on methotrexate qweekly), hx of lumbar spine injury s/p surgery, DM, CAD s/p 4 stent placement",,,2,03/29/2021,,,, 1144366,03/29/2021,MD,31.0,31,,F,,"Approx 5 minutes after receiving shot my heart started racing, I began to shake, hives spread across my chest, neck and back. I was given a shot of epinephrine via an Epi-pen by a medical provider at the vaccine site and was then transferred to ER.",,,Y,,,,,,Y,03/03/2021,03/03/2021,0,,OTH,,Allegra Pepcid Cromolyn Sodium,None.,MCAS,,,2,03/29/2021,,,Y,"Nsaids, albuterol, opiods" 1145075,03/29/2021,WA,44.0,44,,F,,"3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.",,,Y,,,,,,N,03/25/2021,03/25/2021,0,EKG 3/25/21 EKG 3/26/21 blood work 3/26/21 Chest XRAY 3/26/21,OTH,,"Benadryl, Lexapro, lorazepam, vitamin B12, D3, gabapentin 100mg,",no,"EDS, POTS, MCAS",,,2,03/29/2021,,Y,Y,"cipro, buspirone," 1145205,03/29/2021,,64.0,64,,F,,"Vertigo, left side of tongue swollen progressing to complete tongue swelling. Went to the ED. ENT consulted with concern for threatened airway. Given Steroids, Benadryl, Famtodine and FFP with improvement in symptoms. No need for intubation or tracheostomy.",,,Y,,Y,1,,,,03/27/2021,03/28/2021,1,,UNK,,,,"Diabetes type 1, Sjogren's",,,2,03/29/2021,,,Y,PCN 1145469,03/29/2021,CO,77.0,77,,F,,"Morning after receiving 1st dose of COVID-19 Vaccine, patient experienced headache, difficulty finding words, stammering speech. Pt presented to ED at healthcare facility for evaluation. CT & MRI & TTE of brain were all negative for stroke. Patient had no contra-indications and was given TPA as a precautionary measure due to presumptive diagnosis of occlusive stroke. Symptoms began resolving "" shortly after"" administration of TPA although no specific timeline is given in the record. Patient was advised to check with OP healthcare facility for follow-up care.",,,,,Y,2,,,Y,01/15/2021,01/16/2021,1,"Complete Metabolic Panel, Hepatic function tests, lipid profile, CBC, urinalysis, EKG, Echocardiogram, all of which were negative for pathological findings.",PVT,,"Primidone, duloxetine, prednisone, patoprazole, propranolol",N/A,"Polymyalgia rheumatica, HTN, essential tremor, Hx of TIA",,,2,03/26/2021,,,Y,"Egg, latex, sulfa, erythromycin, PCN, metronidazole" 1145925,03/29/2021,NJ,52.0,52,,F,,Patient had fever after vaccine then later in the day suffered a cardiac arrest,,,Y,,Y,6,,,N,03/23/2021,03/23/2021,0,"CBC, CMP, lactic acid, troponin, CT head, Ct chest (All test done on 03/23/2021) - the date of admission",PVT,,"Acetaminophen, Albuterol, Dulera, ferrous sulfate, folic acid, Lansoprazole, MVI, polyethylene glycol","anxiety, right hip surgery",Alcoholic cirrhosis with portal htn,,,2,03/29/2021,,,Y,NKDA 1145999,03/29/2021,NM,37.0,37,,F,,"Left pinky finger began to get itchy at about 13 minutes. A couple minutes later my scalp was itchy. I alerted staff then. Then my chest and back became itchy. At about 18 minutes after the shot I started having trouble breathing, my throat felt like it was closing and I had a terrible cough. Given two Epi shots about 10 minutes apart, ER gave me breathing treatments and other meds via an IV and shots (I don't know what, I was a little out of it).",,,,,Y,2,,,U,02/06/2021,02/06/2021,0,"Chest xray, blood tests both on Feb. 6 and 7",OTH,,"Protonix, Prozac, daily multi-vitamin, spiriva, qvar, flonase sensimist",none,"Lung disease from burn pits, GERD",,,2,03/29/2021,,,Y,"Penicillin (anaphylaxis), Benadryl, Dilauded, Trazadone, Rythmol" 1147348,03/30/2021,NY,29.0,29,,M,,Developed bruising and petechiae day after vaccine. Found to have platelets of 9. Concern for ITP,,,,,Y,,,,N,03/23/2021,03/24/2021,1,CBC with plt of 9 on 3/29/2021,UNK,,none,none,none,,,2,03/30/2021,,,,none 1150364,03/31/2021,CA,,,,M,,"covid antibody test which came back positive; This is a spontaneous report from a contactable consumer (patient) and via Pfizer-sponsored program Support. A male patient (34, unknow unit) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number and Expiration Date unknown) via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient received the first dose of Pfizer vaccine and experienced a bad adverse reaction. His allergist ordered a covid antibody test which came back positive on 26Feb2021. His allergy doctor wants to confirm if this is because of our vaccine. Patient wanted information on specifically what antigen was being tested on the antibody test he took. The outcome of event was unknown. Information about the Lot/batch number has been requested.",,,,,,,,,U,02/02/2021,02/26/2021,24,Test Date: 20210226; Test Name: covid antibody test; Test Result: Positive,UNK,,,,,,USPFIZER INC2021246792,2,03/19/2021,,,, 1152342,03/31/2021,OH,59.0,59,,F,,"Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21. Diagnosed with ITP at Hospital on 03/25/21. Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21. Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21. Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21. Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.",,,Y,,Y,3,,,U,03/12/2021,03/24/2021,12,All tests and lab results with dates available at hospital.,PVT,,"Coreg, Entresto, Digoxin, Torsemide, Potassium Citrate, Atorvastatin, Humalog U-500, Keflex, Diclofenac, COQ-10, B-12, Calcium w/D-3, Omeprazole, Probiotic supplement.",Peripartum Dilated Cardiomyopathy - Age 34 Diabetes Type II - Age 36 GERD - Age 52,See Item #11,,,2,03/31/2021,,,,Penicillin 1152536,03/31/2021,TX,51.0,51,,M,,"After 3 days he developed 2 new seizures according to him. Document pending since he was admitted in the hospital. Neurology consult placed. He was placed on keppra, atorvastatin and baby aspirin during the admission.",,,Y,,Y,1,,Y,N,03/22/2021,03/25/2021,3,N/A,PVT,,None,None,"Alcoholism, lymphoma",,,2,03/31/2021,,Y,Y,NKDA 1153401,03/31/2021,MS,57.0,57,,M,,"Moderna Covid-19 Vaccine EUA - 3/6/2021 Went to hospital at 4pm because I was coughing up blood and having a hard time breathing. Air lifted to second hospital, admitted 19:00 hrs. Chest X-rays 2 sets, CT Scan, Ultrasound, Bloodwork and 2 Covid-19 test. I was told i had pnuemonia followin first chest x-ray on 03/06/2021. on 03/07/2021 after CT Scan and 2nd chest x-ray I was told I did not have pnuemonia or Bronchitus. I was dischrged on 03/08/2021. I have shortness of breath with little to no energy. I am not retired. I own a business and have not been sick until 03/06/2021",,,Y,,Y,3,,Y,N,03/05/2021,03/06/2021,1,"Chest X-rays, CT Scan, Ultra Sound, Blood work",PVT,,"Pravastatin, Lisinopril,Amplodipine Besylate, Omega 3 Krill oi",none,Aortic Aneurysm Repair,,,2,03/11/2021,,,Y,"Contrast Dye media, grass,tree and weed pollen" 1154522,04/01/2021,OH,38.0,38,,F,,Appendectomy / Appendicitis Received Moderna at 3:40pm on 3/18 Pain developed within 9 hours in stomach and by the next morning the pain progressively worsened. Constant vomiting. Brought to ER on 3/19 and CT scan confirmed appendicitis and needed emergency surgery to remove the appendix. My husband received the vaccine together with me at the same facility and same vaccine lot and he ALSO developed stomach pain and had an emergency appendectomy on 3/29.,,,,,Y,1,,,U,03/18/2021,03/19/2021,1,3/19 CT scan 3/19 Blood results showed WBC very high.,PUB,,Levothyroxine.,None.,None. Very healthy.,,,2,04/01/2021,,,Y,None. 1154565,03/31/2021,NJ,42.0,42,,F,,Previously reported as Bell?s palsy. Diagnosed as Ramsay Hunt Syndrome ( shingles ),,,,,,,,Y,N,02/01/2021,03/25/2021,52,Brain CT Scan 3/25 Sonogram 3/26 ENT exam and audiometry test 3/29 Brain MRI 3/31,OTH,,None,None,POTS,,,2,03/31/2021,,Y,Y,Levaquin allergy 1156482,04/01/2021,,65.0,65,,M,,stroke like symptoms,,,,,Y,,,,,03/03/2021,03/15/2021,12,,UNK,,,,,,,2,04/01/2021,,,Y, 1157505,04/01/2021,FL,,,,U,,"VACCINE GIVEN THROUGH IV; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose was not reported, once a total administered on 24-MAR-2021 14:00 for prophylactic vaccination. The patient was vaccinated at unknown site. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021 14:00, the patient experienced vaccine given through IV. On 24-MAR-2021 14:00, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine given through IV was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s-Off label use and inappropriate route of vaccination. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS",,,,,,,,,U,,03/24/2021,,,OTH,,,,Comments: Unknown,,USJNJFOC20210347370,2,03/30/2021,,,, 1157885,04/01/2021,FL,55.0,55,,F,,"Note: This VAERS report is associated with the patient self-reported VAERS # 348989 submitted 3/11/2021. I, as the Medical Director of Occupational Health at Hospital (patient's employer)submitting this VAERS on behalf of the patient since none of the other involved HCPs to her knowledge have submitted a VAERS. On February 27,2021 about 36 hours after the vaccine administration, patient noted some speech difficulty, but no other symptoms were present at the time. She went to sleep that night. She woke up the next morning February 28 at 6:30 am and noted slurred speech, lack of strength and coordination on her right arm and some asymmetry in her face.She was taken to the emergency room where a CT brain was performed and came back with no anomalies found. She was transferred to the hospital where she lives. She was hospitalized Feb 28th - March 3rd during which time extensive diagnostic workup was done and she was discharged with a diagnosis of ischemic stroke.",,,,,Y,4,,,N,02/26/2021,02/27/2021,1,"CTA Head/Neck (02/28/21): No carotid stenosis; normal angiographic evidence of anterior and posterior cerebral circulation. XR Chest (02/28/21): No acute pulmonary disease. US Carotid Duplex Bilateral (02/28/21): No stenosis involving either ICA. CT Head w/o contrast (02/28/21): No acute intracranial abnormality. MRI Brain w/o contrast (03/01/21): No mass effect; age-appropriate brain atrophy; Age-appropriate brain atrophy, and Nonspecific white matter disease which likely is chronic ischemic white matter disease but an identical appearance can occur with diabetes, demyelination, hypertension, migraine or vasculitis. MRI Spine Cervical w/ + w/o contrast (03/02/2021): Normal cervical cord.",OTH,,Synthyroid 88 mg Q day,No,Hypothyroidism well-controlled on Synthyroid,,,2,04/01/2021,,,Y,Ibuprofen 1158779,04/02/2021,NY,64.0,64,,M,,"Stroke. 48 hours after second vaccination. Because we thought his symptoms were just a result of the vaccine (extreme weakness in his legs, slurring of his words) we did not rush him to the ER as we should have. He is home from the hospital now. We are lining up physical and occupational therapy.",,,Y,,Y,2,,,N,03/13/2021,03/15/2021,2,"CT scan, MRI, Sonogram Left brain infarct",OTH,,"Simvistatin, multivitamin, fish oil",,,,,2,04/02/2021,,,Y, 1159133,04/02/2021,MD,73.0,73,,M,,"3/29/21: Patient presented and was admitted through ED for generalized weakness, nausea, vomiting, fever, multiple joint pains, fell on knee joints and right elbow area. In patient diagnosis - UTI, xrays were c/w severe OA. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.",,,,,Y,,,,,03/16/2021,,,,PVT,,,,"PMH of HTN DMT2, HLD, DVT, P.E, AFib, Rheumatoid Arthritis, CAD, MI s/p PTCA stent placement",,,2,04/02/2021,,,, 1160137,04/02/2021,MN,35.0,35,,F,,"It started with 103 for 48 hours with extreme pain in lower extremities after loss sensation in both legs and arms. I went to ER on 1/14 stayed for 2 weeks and followed up with the Neurological. I went to the Clinic (they did a very good job identifying my diagnosis) diagnosed with post vaccine neurologic deficit in lower extremities and assist with me walking again, IVIG 5 days of infusion and physical therapy. I'm a physician was out of work for 6 weeks and still experiencing left side balance issues/weaknesses of both feet numbness of 4/2.",,,,,Y,14,,,N,01/08/2021,01/08/2021,0,"Lumbar puncture, Brain MRI, Physical therapy, IVIG (5 days infusion)",PVT,,No,No,No,,vsafe,2,04/02/2021,,Y,Y,No 1162016,04/02/2021,CT,57.0,57,,M,,"Died/death; Cerebral hemmorage; Vomited a huge amount in the late morning; Woke up with a back ache; A spontaneous report was received from a nurse, concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced back pain, vomiting and died probably due to and cerebral hemorrhage. The patient's medical history included malignant hypertension and has been hospitalized six weeks prior to the events. Products known to have been used by the patient, within two weeks prior to the event were not provided by the reporter. On 17 Mar 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) for prophylaxis of COVID-19 infection. On 19 Mar 2021, the patient experienced back ache, vomited a huge amount in the late morning. On 19 Mar 2021, the patient was found in fetal position in his bed with vomit all over him by a neighbor. The patient has undergone cardiopulmonary resuscitation (CPR), was intubated and was transported to local hospital. The patient was air lifted to hospital but died probably due to and cerebral hemorrhage at 09.40 pm at 19 Mar 2021. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events is not applicable; Reporter's Comments: This is a case of death in a 57-year-old male subject with a medical history of malignant hypertension, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Y,03/19/2021,,,Y,,,,N,03/17/2021,03/19/2021,2,,UNK,,,Malignant hypertension (Was hospitalized six weeks prior to events.),,,"USMODERNATX, INC.MOD20210",2,03/31/2021,,,, 1162133,04/02/2021,GA,38.0,,,F,,"blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs. On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",,,Y,,Y,4,,,N,02/03/2021,02/03/2021,0,"Test Date: 20210226; Test Name: platelet count; Result Unstructured Data: Test Result:73,000; Comments: platelet count 73,000; Test Date: 20210303; Test Name: platelet count; Result Unstructured Data: Test Result:33,000; Comments: platelet count 33,000 (results received on March 5); Test Date: 20210305; Test Name: platelet count; Result Unstructured Data: Test Result:29,000; Comments: hospitalized with 29,000 platelet count",WRK,,GABAPENTIN,,Medical History/Concurrent Conditions: Blood group O; Drug allergy; Graves' disease; Lupus erythematosus; Rh-negative,,USPFIZER INC2021335672,2,04/01/2021,,Y,Y, 1162857,04/02/2021,NY,72.0,72,,F,,"First day 102 degree fever, aches & pains, digestive distress, inability to eat; third day: sharp transient electric-like pains in left leg with vascular formation (congenital); sore painful leg; heat emanating from leg, which turned surface blood vessels BLUE! Digestive issues including gas; Until today: ongoing pain in left leg; extreme soreness and pain. Saw Dr. for the first time in several years. Got MRI for left leg and pelvis. Results suggest ongoing deterioration of vascular malformation! I have tolerated without problems flu shots for years; first shingles vaccine; pneumonia vaccines. This completely different. More like the response I had to infertility treatments more than 30 years ago. I am really suffering from the unexpected results of this vaccine. My leg is still getting very hot and is causing terrible pain, especially at the top back of my left leg so that sitting is painful. I am very unhappy to have had no warning that this vaccine would be so dangerous for me. It has changed the quality of my life. I don't know what to do! I am awaiting explanation from Dr. Got initial report from my internist. I now have varicose veins in my pelvis. I imagine that this response is similar to the blood clots caused by Astra Zineca's vaccine. The Moderna has certainly had a very negative effect on me.",,,,,,,,Y,N,02/14/2021,02/15/2021,1,"MRI of left leg and pelvis on March 31, 2021.",OTH,,none,,hsahimotos,,,2,04/02/2021,,Y,,"sulfa, penicillin, codein, gluten" 1166742,04/04/2021,MA,75.0,75,,M,,"I suffer from a mild tinnitus. On March 26 (Moderna vaccinations 2/10/2021 & 3/10/2021) I awoke to a very loud ringing in both ears. I noticed a feeling of pressure moving back & forth between ears. When the pressure sensation was present, my hearing was very much impaired in that ear; bordered on deaf. This movement back and forth between ears continued. I contacted a doctor who is a tinnitus specialist (referred by my ENT doc). Saw him April 2, 2021. He took a history and ordered another hearing test (I had had a hearing test on March 4, 2021 by ENT doctor) The 4/2/21 test confirmed that on my hearing was degraded between the two tests. When I drove home April 2 the tinnitus ""noise"" abated a lot, and the deafness was almost gone. When I awoke April 3, the tinnitus in my left ear had quiet buzz, no pressure, hearing was fine. The noise in my right ear was severe, the sense of pressure was present, and my hearing was very much impaired. It has continued through this April 3rd day.",,,,,,,,Y,N,03/10/2021,03/26/2021,16,"Hearing test, March 4. Hearing test, April 2. Extensive history taken by Tinnitus Specialist. Doctor ordered a Rx of Prednisone. I am aware that this was a ""shot in the dark.""",OTH,,"Generic Crestor, Centrum Silver (or Generic equivalent), Vitamin D3, Fish oil, Metamucil capsules, Losartan, Carvedilol, Cialis 5 mg, Nortriptyline, Sumatriptan, Ondansetron, Diclofenac Sodium gel & topical solution.",Tinnitus,"Migraines, Blood pressure elevated, blood lipids",,,2,04/04/2021,,Y,,None 1167195,04/04/2021,MD,29.0,29,,M,,"2/25/2021 0900hrs- Vaccine Administered 0905hrs-difficulty swallowing, increased heart rate, hypotension, swelling tongue and throat. Hives found on chest. 0907hrs- 1st round of adrenaline administered, 50mg of Benadryl administered, and 4mg of zulfran. 0930-began transport to E.D. and felt my throat was beginning to swell again. During transport a second round of epinephrine administered, hypotension and chest pain noted. 0945hrs- Arrival at E.D.and solumedrol administered. Additional Benadryl and Pepcid administered. Fluid bolus started. IV potassium administered for low potassium levels detected via blood work. Throughout the course of the day 4 additional rounds of adrenaline administered. 1730hrs-Admitted to ICU for monitoring. Spent one full day in ICU 1900hrs- began to feel that i had the chills and my face became flushed. No fever detected via thermometer. 02/26/2021 1200hrs- seen by speech language pathologist for difficulty swallowing 1230hrs- increased heart rate to 140 beats/minute while eating lunch. No edema noted. Was informed that I would be staying an additional night in the hospital for further monitoring and testing because of the unexplained increase in heart rate. 1600hrs- Transferred to a step down room and monitored throughout the night. 2/27/2021- 1200hrs- discharged from E.D with prednisone prescription and told to follow up with primary care doctor and allergist.",,,Y,,Y,2,,,Y,02/25/2021,02/25/2021,0,Blood testing revealed low potassium levels. Chest X-ray 12 lead EKG.,OTH,,None,None,None,,,2,04/04/2021,,Y,Y,None 1167394,04/05/2021,,20.0,20,,M,,Patient developed chest pain and shortness of breath 24 hours after receiving the 2nd dose of the Moderna vaccine. He was hospitalized for myocarditis and discharged in stable condition on 03Apr.,,,,,Y,8,,,Y,03/24/2021,03/25/2021,1,EKG demonstrated ST depression in septal leads and elevation in others. Troponin I was elevated to 1.58. He was emergently transported to the local hospital for admission and treatment by cardiology.,MIL,,,,,,,2,04/05/2021,,,, 1167973,04/05/2021,MO,53.0,53,,M,,"History of Present Illness: This is a 53-year-old male with significant past medical history of cerebral palsy, mental retardation, decubitus ulcer, recent left loculated pleural effusion with empyema status post catheterization line placement by IR at outside hospital. Patient is A&O times 2-3 at baseline. This patient presents with recent fall associated with right shoulder pain, decreased range of movement and minor bruise to forehead. Per report from nursing home patient was also altered and slightly confused. Due to concern for intracranial process patient was transferred to the ED for further workup. In the ED, vitals were remarkable for mild tachycardia. Patient was noted to be hypoxic on room air an Additional information for Item 18: Patient was noted to be hypoxic on room air and placed on 3 L oxygen via nasal cannula. Initial labs show leukocytosis 28.6. For concern for sepsis blood cultures obtained patient initiated on antibiotics vanc and Zosyn. Status post 2 L IV fluid bolus. Inflammatory markers elevated patient tested for COVID-19 infection. CT brain negative for fracture. CT abdomen showed nonspecific thickening of the colonic wall may represent colitis in appropriate clinical setting.",,,,,Y,,,,N,02/12/2021,03/25/2021,41,COVID PCR (+) 3/25/2021,PHM,,"Tylenol, hydroxyzine, lexapro, zofran, propranolol, ferrous su Additional information for Item 9: ferrous sulfate, colace, miralax, midodrine, nexium, pepcid",Recent left loculated pleural effusion with empyema,"CP, mental retardation, decubitus ulcers,",,,2,,,,,cephalosporins 1167979,04/05/2021,MO,71.0,71,,M,,"a 71 year old male with a PMH significant for COPD, Hep C, HTN, and PE presents for worsening sob since last wed. He reports that he received his Covid vaccination last week but does not think that the two are causally related. He denies fevers but reports chills. No loss of taste or smell but decreased appetite. No diarrhea. He does have a history of COPD but no reported home oxygen use. Slightly hypoxic in ED.",,,,,Y,,,,N,03/25/2021,03/31/2021,6,COVID PCR (+) 4/1/2021,PUB,,"aspirin, albuterol, symbicort, spiriva, valtrex, flonase, mult; Additional information for Item 9: multivitamin, fish oil",,"COPD, Hepatitis C, HTN, PE",,,2,,,,,NKA 1168061,04/05/2021,IL,71.0,71,,F,,"The patient states that on 3/28, she received the COVID-19 vaccine. Following this vaccine, she was told to wait 30 minutes in case she had any reactions. She had already started feeling abdominal pain, but did not tell anyone. She went home, drank coffee, and was reading the newspaper when she began to experience several episodes of hematemesis. She vomited several times and she started to feel dizzy and was falling at home. Her daughter called EMS and she was immediately brought to the ED. Patient was found to have a significant GI bleed which required intubation for protection of airway, blood transfusion, left gastric artery coil embolization, and endoscopic injection of epinephrine and cautery to treat.",,,Y,,Y,,,,,03/28/2021,03/28/2021,0,,PUB,,Lasix 20mg daily; multi-vitamin daily; paroxetine 30mg oral tablet daily; Plavix 75mg oral tablet daily; TriCor 145mg oral tablet daily; Tylenol extra strength 500mg 2 tablets as needed; Ventolin HFA 90 mcg/inh inhalation aerosol 1 puff Q 4,,"CAD, CABG x 4 vessels in 1996, cardiac stent, COPD, obstructive sleep apnea with use of CPAP, history of gastric ulcers in 2014",,,2,04/05/2021,,,Y,Penicillins-causes hives 1168298,04/05/2021,MI,75.0,75,,M,,"Patient presented to the emergency department on 4/2/21 with complains of headache, fever, difficulty walking, and increased right-sided weakness. Of note, patient has baseline right-sided weakness due to history of stroke. Upon admission patient had temperature of 100.9 F and was tachypneic. Blood cultures were obtained and patient was given one dose of Rocephin for possible meningitis which was then discontinued due to low suspicion. Patient's fever resolved and was discharged from ED on 4/3/21 with instructions of possible return to ED pending blood cultures (which are NGTD as of this report).",,,,,Y,2,,,Y,04/01/2021,04/02/2021,1,"Temperature 100.9 (4/2/21 1434), (Blood cultures x2 (4/2/21 1540 and 4/2/21 1545)",OTH,,"Aspirin, Atorvastatin, Fenofibrate, Glipizide, Hydrocodone/Acetaminophen, Ibuprofen, Levetiracetam, Linagliptin, Losartan, Metformin, Metoprolol Tartrate, Tamsulosin",N/A,"BPH, Coronary Artery Disease, Cataracts, Diabetes Mellitus Type II, Hyperlipidemia, Hypertension, Memory Loss, Seizures, Sleep Apnea, Stroke, Visual Impairment",,,2,04/05/2021,,,Y,Codeine 1168694,04/05/2021,OR,72.0,72,,M,,"went outside to mow. Started having shortness of breath, loss of consciousness, disoriented, nausea, uncontrollable vomitting. Wife reports pt possibly aspirated on the vomit. Wife reports he is in the step down unit.",,,,,Y,2,,,U,03/31/2021,04/01/2021,1,"chest xray, EKG, blood draws, antibiotics.",PUB,,"Metformin, prilosec",NONE,Diabetes,,,2,04/02/2021,,,,NKA 1169523,04/05/2021,TX,21.0,21,,M,,"Fever beginning 12 hours after 1st vaccine dose on 3/26/21 and all-day next day.. By Sunday 3/28/21 morning temp was 103.7 and went to ER. For the record, I tested positive for Covid in September 2020. Upon arrival at the ER at Hospital, white cell count was 14.3 and creatinine levels were at a level that the doctors were not comfortable with. Diagnose with Acute Kidney Injury. Tested negative for Covid. Admitted and started on fluids and antibiotics for an unknown infection. Clear chest ex-ray and given blood thinners as a precaution. By Sunday night in the hospital fever was at 104. By Monday midday, fever was finally lower at 100.9 and received another blood thinner shot. White cell count was 11 at this point. Doctors wanted me fever free for 24 hours before being discharged. Blood work still showed an infection and white cell count was still not where they wanted, an infectious diseases doctor was called on Monday. On Tuesday, March 30, temp was finally within a normal range, kidney function was improved and the infectious diseases doctor finally examined me and determined that this was a very rare reaction to the first dose of Moderna vaccine due to previous positive Covid in September 2020 .",,,,,Y,3,,,Y,03/26/2021,03/26/2021,0,"Blood Culture 1&2 3/28, 3/30, Chest Exray, 3/28 Acute Kidney Injury 3/29",PVT,,None,None,None,,,2,04/05/2021,,Y,Y,None Binary file data-files/2021/2021VAERSDATA.csv matches 1169981,04/05/2021,,59.0,59,,F,,"Received vaccine at 14:30 and started feeling itching on her tongue. Took Bendaryl 50mg @ 15:15. Facial swelling, SOB, and difficulty swallowing upon arrival. Received Solu-Medrol, Benadryl, and Pepcid. Epinephrine 0.3mg Twinject IM x 4. Admitted to ICU.",,,,,Y,5,,,,04/01/2021,04/01/2021,0,,MIL,,CHLORTHALIDONE,N/A,HTN,H1N1 VACCINATION,,2,04/01/2021,,,Y,"TREE NUTS, PEACHES, APRICOTS, PLUMS" 1170073,04/05/2021,WA,79.0,79,,F,,"Hives Swollen - Left side of face Swollen Tongue She took Benadryl and felt better. It took couple of days for swelling to go down. The two weeks later, patient had symptoms again. Ambulance came and took her to ER. Then a month later she had symptoms again with a stroke and heart attack. March 30th - Shingles",,,Y,,Y,10,,Y,U,01/15/2021,01/15/2021,0,Treatment for heart attack and stroke. Treatment for Shingles.,WRK,,Vitamin D / B12 Pregabalin Aspirin Amlodipine Jardiance Pregabalin Tylenol Metoprolol,,Diabetic High Blood Pressure,,,2,04/05/2021,,Y,Y,Sulfa Cephalosporins Amoxicillin Cephalexin Amitriptyline Ibuprofen Lisinopril Metformin 1171203,04/06/2021,ME,71.0,71,,F,,PATIENT HOSPITALIZED THE FOLLOWING DAY WITH RIGHT CVA,,,,,Y,,,,U,02/25/2021,02/26/2021,1,,PHM,,UNKNOWN,,,,,2,04/06/2021,,,, 1172544,04/06/2021,IL,18.0,18,,F,,seizure occurred within 1 hour of vaccine administration,,,,,Y,2,,,Y,04/05/2021,04/05/2021,0,,PVT,,"? arginine HCl (L-arginine) tablet 4,000 mg ? atenolol (TENORMIN) tablet 25 mg ? bisacodyl (DULCOLAX) EC tablet 10 mg ? brivaracetam (BRIVIACT) tablet 150 mg ? cannabidiol (EPIDIOLEX) solution 440 mg ? citrulline capsule 3,600 mg ? c",none,"Mitochondrial encephalopathy, lactic acidosis and stroke-like episodes (MELAS) intractable focal epilepsy Hypertension IgA nephropathy",,,2,04/06/2021,,,Y,"Tylenol [acetaminophen], Aminoglycosides, Erythromycin base, Linezolid, Metformin, Other (see comments), Statins-hmg-coa reductase inhibitors, Valproic acid, and Vancomycin" 1172782,04/06/2021,CT,60.0,60,,F,,"Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted 4 days follow by burning and painfully legs especially, in calf area made walking painful. As of this report legs still painful.",,,Y,,Y,2,,,U,03/31/2021,03/31/2021,0,"test done on 3-31-4-01-21, CT head w/o contrast-neg ECG 12 leads normal MRI Brain w/o contrast XR Chest 1 view-Portable urine for drugs - neg",PVT,,"Levothyroxine, Pantoprazole, Calcium, Vit-D3, B-complex, B-12, Loratadine Adair only when needed",none,"allergies,",,,2,04/06/2021,,Y,Y,"provigib: mold-foods and environmental, Penicillin, Geodon, Sulfanilamide (SULFA) sulfathiazole or surfer related drugs, doxycline Hyclate (Morgidu) , Talwin, contact latex, Dairy (protein) and Glueton" 1172806,04/06/2021,MN,51.0,51,,M,,"developed dysarthria, facial droop, spontaneously resolved over several days. symptoms developed about 11 days after receipt of vaccination",,,,,Y,6,,,Y,02/16/2021,02/26/2021,10,"3/1 Brain MRI"" Multiple nonenhancing subcortical and periventricular/pericallosal lesions; the differential diagnosis includes tumefactive multiple sclerosis and metastatic disease."" CT angio head no vessel occlusions. LP 12 WBC 74% lymphocytes, 26% mononuclear cells. glucose 63, protein 45, 4 oligoclonal bands, flow cytometry negative for lymphoma. developed lymphocytosis in blood that resolved. bone marrow no malignancy. Component Latest Ref Rng & Units 3/1/2021 3/2/2021 3/2/2021 3/3/2021 3/3/2021 8:16 PM 8:16 PM 5:42 AM 9:20 PM WBC 3.2 - 11.0 10*9/L 13.5 (H) 21.7 (H) 22.2 (H) 13.8 (H) 12.6 (H) Component Latest Ref Rng & Units 3/4/2021 3/4/2021 5:32 AM 5:32 AM WBC 3.2 - 11.0 10*9/L 9.6 9.4 Component Latest Ref Rng & Units 3/2/2021 3/3/2021 3/4/2021 3/5/2021 NEUTROPHIL % % 68 56 46.2 56.5 LYMPHOCYTE % % 26 33 39.1 29.1 MONOCYTE % % 4 10 10.8 10.2 EOSINOPHIL % % 2 1 1.8 2.1 NEUTROPHIL ABS 1.5 - 7.6 10*9/L 14.8 (H) 7.7 (H) 4.4 5.7 LYMPHOCYTE ABS 0.8 - 3.3 10*9/L 5.6 (H) 4.6 (H) 3.7 (H) 3.0 MONOCYTE ABS 0.2 - 0.9 10*9/L 0.9 1.4 (H) 1.0 (H) 1.0 (H)",PVT,,none,none,"Heart disease, status post bare metal stents 2010",,,2,04/06/2021,,,,none 1172922,04/06/2021,NJ,61.0,61,,F,,"Pt stated that a short time after receiving the Covid-19 vaccination her throat felt like it was closing and she dosed herself with 50 mg of PO Benadryl. The paramedics took the pt to ER. She was given an epi pen en route to ER. Pt received epinephrine, benadryl & steroids in the ER as well as potassium. Pt felt better the following day but the her symptoms returned and she was managing herself at home with benadryl, prednisone & epi pens at home. Pt's primary doctor was aware, according to pt. On 4/1, pr felt as if she couldn't manage her symptoms at home and was very short of breath. In the ED, she was given solumedrol, Benadryl & epinephrine. Pt was in ICU, then PCU then",,,,,Y,6,,,Y,03/27/2021,03/27/2021,0,Ultrasound of lower extremities due to swelling 3/27 - WNL,OTH,,"Tylenol 3,Xanax,Astelin,QVAR INHL, Valium,Benadryl,Lomotil,Epi",,"osteoprorosis, asthma, bradycardia. concussion, hard to intubate, migraines, scoliosis, shortness of breath, stroke, v",,,2,04/06/2021,,,Y,"Betadine, dihydroergocristine,haldol, shellfish derived,tuberc" 1173603,04/06/2021,FL,,,,F,,"Her granddaughter friend grandmother had a stroke after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Her granddaughter friend grandmother had a stroke after receiving Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Her granddaughter friend grandmother had a stroke after receiving Moderna vaccine) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Her granddaughter friend grandmother had a stroke after receiving Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested. This case was linked to (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",,,,,,,,,U,,,,,UNK,,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,"USMODERNATX, INC.MOD20210",2,04/06/2021,,,, 1173685,04/06/2021,NY,27.0,27,,M,,"Moderna COVID-19 Vaccine EUA Vaccine administered 3/11/21 at public health pop-up clinic. Sore arm from night of vaccine through day 5. Beginning on day two, extreme muscle twitching, spasms, and involuntary movements. This lasted until day 8. Starting on day 3, daily persistent cranial pressure, right eye pressure, and ear pressure. This persists today (day 26). On day 4, heart rate noticeable heart rate increases, palpitations, and chest tightness. This persists today (day 26). On day 7, I woke up early AM and upon trying to fall back asleep, had what felt like 4-5 seizures before finally falling back to sleep. Upon waking up, right side of body was weak, tingling; right eye vision was blurry and right ear was muffled. Decided to go to ER after 2-3 hours of consistent symptoms. Admitted for observation, routine labs completed, normal. Brain CT w/o contrast, unremarkable. Symptoms persisted into next day, brain MRI WWC performed, unremarkable. ER docs and specialists (neurologist/cardiologist) implied that it could be related to vaccine, as no history of any such symptoms or disease and the temporal association with vaccine administer. Was discharged and told to follow up with PCP, neurologist, cardiologist. Have since been in and out of doctors appointments(PCP, neurologist, cardiologist), labs drawn weekly, and several follow up imaging/labs. No doctor so far can figure out a clinical problem, but several symptoms persist or worsen as time goes on. As of now, right side weakness/tingling considered RESOLVED. Cranial/ear/eye pressure considered UNRESOLVED. Chest tightness, heart rate increases considered UNRESOLVED.",,,,,Y,2,,,N,03/11/2021,03/12/2021,1,"In ER: Routine Labs including: CBC, Metabolic, TSH, Covid-19 test, Influenza test, Sed Rate, Urinalysis -3/18/21 & 3/19/21 UNREMARKABLE Brain CT w/o Contrast - 3/18/21 UNREMARKABLE Brain MRI WWC - 3/19/21 UNREMARKABLE Outpatient: Routine chems, ANA, D-Dimer, metabolic, CBC, all UNREMARKABLE Echocardiogram - UNREMARKABLE Stress Test- UNREMARKABLE Heart Halter Monitor - UNREMARKABLE",PUB,,"Turmeric, Vitamin D, Elderberry, Prostate Support",N/A,N/A,,,2,04/06/2021,,Y,Y,N/A 1173952,04/06/2021,WA,63.0,63,,F,,"AFTER PT LEFT THE PHARMACY AFTER WAITING 15 MINUTES SHE NOTICED HER FACE WAS RED AND HER ARMS HAD A RASH, AS SHE DROVE AWAY SHE DECIDED TO DFRIVE TO THE MEDICAL FACILITY ACROSS THE STREET FROM US WHERE SHE WAS TREATED WITH AN EPIPEN AND BENADRYL AND WAS TAKEN BY AMBULENCE TO A HOSPITAL (UNSURE WHICH) WERE SHE WAS MONITORED AND RECEIVED A COURSE OF STEROIDS AND LEFT WITH A RX OF STEROIDS AND BENADRYL. SHE CONTACTED OUR PHARMACY ON 4/6 TO INFORM US OF THE EVENT AND STILL HAD A RASH AND ITCHING AT THAT TIME",,,,,Y,1,,,N,04/03/2021,04/03/2021,0,UNSURE,PHM,,NONE,NONE,UNKNOWN,,,2,04/06/2021,,Y,Y,SULFA DRUGS AND ACE INHIBITORS AND NOW COVID VACCINE 1174190,04/06/2021,KS,33.0,33,,F,,"Pt developed disabling vertigo and ear pressure the following day. Several days later she developed double vision, she was unable to work or drive. Pt was treated with prednisone taper and meclizine with no improvement",,,,,,,,Y,N,01/15/2021,01/16/2021,1,MRI brain with contrast and CT brain both normal. Labs normal,PUB,,Juice Plus Fibre,None,None,,,2,04/06/2021,,Y,Y,None 1174319,04/07/2021,IL,83.0,,,F,,"Wound up with shortness of breath; Oxygen levels dropped below standard; Chest X-ray showed signs of Covid like characteristics; Chest X-ray showed signs of Covid like characteristics; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 83-years, administered in arm left on 03Mar2021 13:00 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Wound up with shortness of breath and taken to hospital on 18Mar2021 0:00. Chest X-ray showed signs of Covid like characteristics. Oxygen levels dropped below standard. This was 2 weeks after the first dose. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization. No days hospitalization: 3. Treatment included Oxygen, chest X-rays, medicine was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination via Nasal Swab with Hospital Administered on 23Mar2021, Covid test result was Negative; Covid test post vaccination via Nasal Swab on 24Mar2021, Covid test result was Negative. There is no known allergies to medications, food, or other products. Other medical history was known by hospital. The outcome of the events was resolving. Information on the lot/batch number has been requested.",,,,,Y,3,,,N,03/03/2021,03/18/2021,15,Test Date: 20210318; Test Name: Chest X-rays; Result Unstructured Data: Test Result:Covid like characteristics; Test Date: 20210318; Test Name: oxygen saturation; Result Unstructured Data: Test Result:oxygen levels dropped below standard was coded as; Test Date: 20210323; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210324; Test Name: Nasal Swab; Test Result: Negative,PHM,,,,,,USPFIZER INC2021334604,2,04/05/2021,,Y,Y, 1177197,04/07/2021,,92.0,92,,F,,Patient was hospitalized within 60 days of receiving a COVID vaccine,,,,,Y,4,,,,01/25/2021,02/16/2021,22,,SEN,,,,,,,2,04/07/2021,,,, 1177522,04/07/2021,TX,69.0,69,,M,,"Initial symptom was difficulty urinating, then developed a fever and weakness. Fell in the bathroom. Went to ER; they ran labs, did EKG, chest X-ray, covid test (negative). Their conclusion was unspecified virus. The next day he had slight fever and body aches, with pins and needles pain in arms and back. Still having difficulty urinating. Next morning still unable to urinate and having severe pain in abdomen. Very weak and unable to walk. We called 911 and had him transported to ER. They inserted catheter and drained his bladder, attached bag to his leg. Their diagnosis was inflamed prostate. They did not address his weakness and inability to stand. He was instructed to see his primary physician and a urologist after the weekend. As that day progressed, he became unable to control his left leg. By the next morning, he couldn't move either leg. Called 911 and he was transported back to ER. They attempted to do an MRI but the machine broke down. He was transferred to a medical center that evening, where he had an MRI and was admitted. The initial diagnosis was inflamed spine, but the 2nd day the neurologist told us he had a spinal stroke.",,,,,Y,6,,Y,N,03/09/2021,03/24/2021,15,"MRI, CT, lumbar puncture, blood cultures",PVT,,"Doxycycline, multi vitamin",none,Rosacea,,,2,04/07/2021,,,,none 1177961,04/07/2021,,,,,M,,"SKIN PEELED OFF; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for infusion, route of admin) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced skin peeled off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin peeled off was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.",,,,,,,,,U,,,,,OTH,,,,Comments: Unknown,,USJNJFOC20210401426,2,04/02/2021,,,, 1178192,04/07/2021,TX,38.0,38,,M,,"after 10 minutes after vaccination patient said he felt flushing in the forehead, dizzy, had a unsusual taste in mouth, tightness in throat. Patient was given 10 ml of beandryl oral liquid 12.5mg/5ml , monitored . After 5 minutes of oral benadryl administration patient said he was feeling better , his throat was getting better and dizziness was gone. patient was monitored was additional 30 minutes before he left.",,,,,,,,,U,04/07/2021,04/07/2021,0,,PHM,,,,,,,2,04/07/2021,,,, 1178213,04/07/2021,TN,64.0,64,,F,,"Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot. Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours. Was discharged on 50 mg Prednisone X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.",,,Y,,,,,,Y,02/23/2021,02/23/2021,0,All test done were in ED on 2/23/2021 - I don't have record of these yet.,PUB,,"Levoxyl, Amitriptyline, ASA 81mgs, Vit C, D",NONE,"Hypertension, Hashimoto's Thyroiditis",,,2,04/07/2021,,Y,Y,CORN and ALL derivatives/food stuff made or distilled from Corn. Darvon Ducosate sodium 1178419,04/07/2021,NY,57.0,57,,M,,"4/3/21 30 seconds after 2nd dose - developed hot flashes, lightheadedness, and dizziness, 1 min later developed tachycardia, felt presyncopal, then crushing chest tightness, dyspnea. Given Epi at the site - symptoms plateaued immediately. Better within 30 mins. EMS - Benadryl 50mg. In ER - Solumedrol. Sent to ER - monitored for 4-6 hrs. D/c'ed home on Prednisone. 4/7/21 Now feeling some chest/abdominal bloating and tightness. Today feeling better. Full body aching.",,,Y,,,,,,Y,04/03/2021,04/03/2021,0,Tryptase level drawn at local ER Results still pending.,PHM,,Dupixent,None,Severe Atopic Dermatitis Asthma,Mild lightheadness with flu vaccines in the past - has received yearly.,,2,04/07/2021,,Y,Y,Propylene glycol 1178633,04/07/2021,TN,44.0,44,,F,,"Patient received Moderna vaccine on 3/3/21. Symptoms started 3/4/21. Left arm muscle weakness, muscle wasting and atrophy left arm, intentional tremor left arm/hand with limited range of motion. Disability is not known whether to be permanent or temporary prognosis pending evaluation per Neurologist.",,,,,,,,Y,N,03/03/2021,03/04/2021,1,"4-7-21-MRI with and without contrast-left upper extremity pending, Physical Therapy referral-left arm weakness, Referral to Neurologist for left arm weakness.",PVT,,,None,,,,2,04/07/2021,,,,None 1179218,04/08/2021,,,,,F,,"Caller states that she was recently exposed to someone who tested positive for COVID-19 and is asymptomatic, and would like to know if she herself is still okay to get her second dose of the vaccine; Caller states that she was recently exposed to someone who tested positive for COVID-19 and is asymptomatic, and would like to know if she herself is still okay to get her second dose of the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included sars-cov-2 test positive from Oct2020 to an unknown date tested positive for COVID-19 last October. The patient's concomitant medications were not reported. Caller stated the patient experienced that she was recently exposed to someone who tested positive for covid-19 and was asymptomatic and would like to know if she herself was still okay to get her second dose of the vaccine (covid-19). The outcome of event was unknown.",,,,,,,,,U,01/28/2021,,,Test Date: 202010; Test Name: Covid-19 Test; Result Unstructured Data: Test Result:positive,UNK,,,,Medical History/Concurrent Conditions: COVID-19 virus test positive (tested positive for COVID-19 last October),,USPFIZER INC2021166901,2,04/07/2021,,,, 1179668,04/08/2021,,55.0,55,,F,,Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient complained uncomfortable numbness tingling in her arms and legs on 4/3. Was admitted to medical center on 4/5.,,,,,Y,2,,,,03/29/2021,04/03/2021,5,,UNK,,,,"breast cancer, s/p double mastectomy, chemotherapy and radiation therapy as well as BPPV presents",,,2,04/08/2021,,,,NKDA 1179790,04/08/2021,NJ,55.0,55,,F,,"Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started about 24 hours after receiving the vaccine. These symptoms resolved by day three. However, she started developing parasthesias in her feet and pain in left hip. Patient came to hospital on 4/5 after symptoms worsened. In hospital, patient received an LP and GBS was ruled out and was discharged with patient still complaining of burning of her feet and hands.",,,,,Y,1,,,N,03/29/2021,04/01/2021,3,,PVT,,Percocet,,breast cancer,,,2,04/08/2021,,,,N/A 1180193,04/08/2021,IL,74.0,74,,M,,Seizure,,,,,Y,1,,,Y,03/08/2021,03/09/2021,1,101 fever in route to E.R.,OTH,,"Vitamin D-3 1000 units/day, Vitamin C: 1000 mg/day, Multi-Vitamin, Choline 300 mg/day, Metamucil, Align Pro-Biotic",Asthma (inactive),Tendency to Kidney/bladder stones,,,2,04/08/2021,,,Y,None 1182219,04/08/2021,WI,60.0,60,,F,,"I recently retired after 37 years and now stay and provide significant weekly care for my elderly parents. Because I am a primary caregiver for my parents, and have been throughout the months of the pandemic, I explored various potential paths to ethically and appropriately get in line for a vaccination. When I took my mother in for her second vaccination at the Health Department in late in March I was able, while my mother was waiting, to converse with a county public health care worker about options and avenues for me to obtain the vaccine as well. She could see, clearly, that I was a caregiver for my mother, so she took down my name and number, and she called me the next day to say that I could, as a caregiver, proceed to sign up for their next clinic vaccination day that would be happening on Thursday, April 1st. I arrived for my noon vaccination time at the Health Department before 12 on Thursday, April 1st. I proceeded through the check in line and screening questions, and arrived at vaccination site #1 at 12:05 where I was promptly given the Moderna vaccine (lot #026B21A). Within seconds of the injection, I knew that I was having a reaction. My heart immediately began pounding, my tongue swelled and the room disintegrated into swirling flashes of color. I looked into the kind eyes of my vaccinator and remember distinctly saying to her in those first few post-injection seconds that, I was, ??sorry, but I think that I am having a reaction.? The vaccinator then took me over to the nursing site coordinator who proceeded to check and record my vitals. I do not have that sheet with the vitals that she recorded, but I do remember that my heart rate and blood pressure measures were high. I sat as she continued to monitor me. After 20-30 minutes, as best I can recall, my vitals were not improving, but remained elevated and even seemed to be trending higher. Also, the swelling and tingling in my tongue was worsening and seemed to be spreading to my lips and face, and down to the base of my neck. I began to feel dizzy, like I was going to faint, so she had me lay on the floor with my legs elevated. Additionally, it was becoming more difficult to breath because of the pressure in my neck. She had earlier and initially offered me Benadryl for the symptoms I was experiencing but I did not previously have good luck with Benadyrl the one time I took it, and also was unsure if I would have been able to swallow it. At 12:40 she thus gave me an injection of epinephrine (3mL) in my thigh and an ambulance was called. I was transported to the ER at the hospital. (Please note that the nursing site coordinator provided top-notch, high quality care through-out my entire emergency medical reaction experience, and I am very grateful and appreciative of her professional and caring response.) In ER they monitored my blood pressure and pulse, and other aspects of my heart rhythm, as well as the swelling and tingling that continued in my tongue, lips, face and forehead. I met with the Dr., and worked with RNs during my time there where they continued to monitor me for a number of hours. By about 4:30, when my vitals had returned to normal and stabilized for over an hour, they released me from the hospital. Since my release from the hospital, late in the afternoon on Thursday, April 1, I have noted only a few, relatively minor persisting symptoms which have included tongue, lip and face numbness and tingling. Also, I have noted, from time to time, some periods of continued heart rate elevation, though wonder if it is more of an almost ?PTSD? type of reaction than a pure physiological response, since, for example, just retelling this story right now is causing my heart rate to rise as I recall what happened. Needless to say, this vaccination induced medical event, explained above, made for a surreal and frightening day unlike anything I have ever experienced. Processing of it, and grappling with its implications, from concrete to existential, is seeming equally daunting, and it is here where I have a range of questions for which I am seeking assistance and perspective from the CDC: The most concrete types of vaccination questions first: They indicated I should not try to obtain the second dose of the Moderna vaccine but that I should consult and maybe it could be given to me in a hospital setting? I welcome thoughts and feedback on how to proceed to become ?fully vaccinated.? What about another vaccine? What about the additional boosters now being discussed for the new variants? Will I need to consider a ?cave dwelling? of some type for myself in the future since I will not have the vaccination card that is being discussed as ?the ticket to travel? in the future? Will there be special cards for folks like me who tried but for whatever strange immunological reason was not able to take the vaccine? Increasingly complex, bigger picture questions next: Would any type of ?reach-out? to Moderna be in order? Or, do you, at the CDC, reach out to Moderna for me as a result of this VAER? Are they studying people like me? My sense, from what little reading I have done, is that what happened to me, though severe, is rare, though definitely want the producers of the vaccine to know about my experience. Bordering on existential questions: What does this mean for me and my life going forward? Should I meet with Moderna, or some type of allergy specialist to better understand what may have happened, and what I will need to watch out for in the future? As everyone begins sharing vaccination cards and experiences, what should I say? I don?t want to scare others away from doing what is needed to save lives by sharing my experience, and don?t want to fuel the ?anti-vaxers.? What about the lingering disquiet and unease that something I sought to help and protect me seems like it might have/nearly killed me? The pandemic has already shaken and taken so much in so many of our lives. Immunization seemed to promise to give back some of what the pandemic has taken, yet, feeling now that ?normal? is not only more distant but possibly will not be achievable for folks like me, rare though we seem to be?",,,,,Y,1,,,Y,04/01/2021,04/01/2021,0,"Monitoring of vitals including blood pressure, heart rate and at the hospital, an EKG.",PUB,,I daily take only Vitamin C and Vitamin D.,None,"None. I do not have any chronic or long-standing health conditions and had never, before my adverse reaction to the Moderna vaccine, been hospitalized.",,,2,04/08/2021,,Y,Y,"I have no (known) allergies to any medications, food or other products. The only mild allergic reactions that I have had took place in the few years of my life to a couple of bee stings sustained in the summer of 2017 and another in the summer of 2020." 1182731,04/08/2021,MA,27.0,,,F,,"Cold sores lip; Swollen Left Arm; Seizures; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration administered in arm left on 19Mar2021 12:15 (Batch/Lot Number: ER2613) at age of 27 years old as single dose for covid-19 immunisation (To not die from Covid). Medical history included functional neurological disorder from Nov2019 and ongoing. There was not any history of all previous immunization with the Pfizer vaccine considered as suspect. There were no vaccines administered on same date of the Pfizer suspect. There were not any prior vaccinations within 4 weeks. There were no adverse events following prior vaccinations (she did not have any vaccines since she got the seizure disorder). The patient's concomitant medications were not reported. The vaccination was given: 12:15, kept 30 minutes because of disorder (24 hour clock). The patient experienced seizures from 19Mar2021 to 24Mar2021, swollen left arm from 20Mar2021 to 23Mar2021, Cold sores lip from 21Mar2021 and ongoing. Cold sores lip was reported as worsened. The patient stated that she had a seizure disorder and a lot of people online were saying that they had questions about seizures and the vaccine on the epilepsy site, but there wasn't much information. She had seizures for four days after her first dose. She did not have epilepsy, she had functional neurological disorder. She normally had seizures that cause her to freeze or fall or have a kick. She stated that this time though, she had the ones that most people get, falling on the floor and convulsing. She would be getting the second one but she wanted to let us know. She stated she got that Covid weight. She had seven seizures over four days. She was back to her normal with her disorder and she was not losing consciousness. She also reported a swollen left arm. She reported getting 2 cold sores. She got them when her immune system struggling. She had two on lip and that had never happened. She stated they were really inflamed and it looked like someone punched her in the lip. She usually had them for a week. She got them once a year if she was really sick, had a fever or the flu. The patient Took 2 Ativan as treatment. She stated that it kind of helped but not really. She took it on 20Mar2021. She also took alcohol because it usually lowered the seizure threshold and she won't get any but it wasn't helping. The patient was having an increase and change in type of seizures after receiving the first Covid vaccine. She had an increase in her normal seizures. They were normally 3-4 minutes and she medicates them away. Those started around 16:00. She stated they then got too powerful and too many for too long around 18:00. At 20:00 she had seizures where she would lose consciousness and fall to the ground. She had 6-7 of those. She stated that each day they were getting weaker and weaker. She stated the one at 20:00 was 10/10 painful and scary and people thought she was dying but she was not. The events did not require a visit to emergency room or physician office. She stateds that they were in a different state, they went to an island and decided if she had second one that night then would go but she didn't. She stated that she was not supposed to go [to the emergency room] unless they last 5 minutes or longer and hers lasted 3 minutes. The outcome of event seizures was recovered on 24Mar2021. The outcome of event swollen left arm was recovered on 23Mar2021. The outcome of event Cold sores lip was not recovered. Follow up attempts are needed. Further information has been requested.",,,,,,,,,N,03/19/2021,03/19/2021,0,,UNK,,,Neurological disorder NOS (Verbatim: Functional Neurological Disorder),,,USPFIZER INC2021328360,2,04/06/2021,,,, 1183404,04/08/2021,CA,78.0,78,,M,,1. Acute/subacute ischimec CVA involving right basal ganglia 2. Hyperlipidemia 3.HTM,,,Y,,Y,3,,,N,04/01/2021,04/02/2021,1,CT 4/3/21 MRI 4/5/21 Heartscan Arteriscan,PVT,,N/A,NONE,NONE,,,2,04/08/2021,,Y,Y,NONE 1183571,04/09/2021,NY,42.0,42,,F,,"Adverse reaction to second dose 013L20A 1/23/2021 Rashes on both Arms Itching all over the body , threw up before 7:30 right arm and leg start moving really fast and was very cold and shivering.",,,,,Y,4,,Y,N,01/23/2021,01/23/2021,0,"When sent downstairs in my job at the hospital, they had the cocktail of medicine for me steroid IM , Pepcid and iv fluids. I?ve never been to an Allergist , Dermatologist, Infectious disease doctors or the CCU from 1/30/2021 to 2/2/2021 as relapse from adverse reaction with throwing up, rash , left side face drooping, left left and arm weak and numb. PCP came to the CCU all labs and diagnostic testing was done as well as TPA just in case it was as stroke. Yet when I was realize it was put in my allergies list Modena vaccine. Also all allergy testing was all negative for environmental allergies, food allergies and PEG. I also had a normal CBC , CMP . Was tested negative for cancer and lime disease and I have all the lab results on paper to prove this from the lab. Also I never had Covid 19, never tested positive for Covid while working with Covid Patients since April, and I was tested for IGM for Covid was negative, then tested for IgG was tested for antibodies after the vaccine compromised my autoimmune system as per Dr. I am out of work since 3/10/2021 and unable to go back to work as of yet as per Dr and Dermatology Dr. As dermatology goes post adverse reaction to moderna 2nd dose I also have a condition called dermotographism which I never had in my life. Please help me if you can Moderna will not return my phone calls.",OTH,,Paxil 20 MG Alpralazam 0.25 mg,None,2 cervical spine surgeries and fully fused no issues,,,2,04/09/2021,,Y,Y,No allergies confirmed only assumed since childhood and has not seen an allergist until after the adverse reaction to the Moderna Vaccine on 1/23/2021 and I am on workers compensation since 3/10/2021 due to the vaccine. 1183853,04/09/2021,,,,,F,,"Caller also had patients who received the first dose, contracted covid; Caller also had patients who received the first dose, contracted covid; This is an initial spontaneous report from a contactable Physician. A 94-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 28Jan2021 at single dose for covid-19 immunisation. It was reported that, patient who received the second dose of the Pfizer covid vaccine (first dose was given on 28Jan). One week after the second dose, the patient tested positive for covid and since she is at a very high risk and came back with abnormal xray results, she was given ""bamlanomab"". Her question is if the monoclonal antibody may potentially neutralize the vaccine and would this necessitate a repeat of the second dose. The patient underwent lab tests and procedures which included covid: patient tested positive for covid and x-ray: abnormal x-ray results on an unspecified date. The events were considered as serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",,,,,,,,,U,,,,,UNK,,,,,,USPFIZER INC2021189087,2,04/08/2021,,,, 1185118,04/09/2021,GA,43.0,43,,F,,"Severe burning sensation when injected. Extremely sore arm once injection removed. Directed to park car for to be monitored for 15 minutes. Parked the car. Car was in park but still running. Attendant at the clinic instructed me to move my car forward. I put the car in ?Drive? and as I moved forward I lost consciousness. Completely blacked out. Foot released off brake and unconscious in the car, the car rolled for some distance and crashed in a parked car. I was revived once someone tried to wake me up. I was white and delirious and had no idea what had happened. Presently have no smell and have been very tired with the chills. I was sweating in my sleep, shivering and woke up in a wet bed from all my sweat. The next day my arm is extremely sore and I am running low grade fever. If the car attendant did not tell me to move my car I would have blacked out in a stationary car and not cause damage to someone else?s car. This has caused nearly $7000 in damages to my car not to mention the other car.",,,,,,,,,N,04/08/2021,04/08/2021,0,,PUB,,none,none,none,,,2,04/09/2021,,,,iodine 1186082,04/09/2021,KS,33.0,33,,F,,nystagmus and vertigo began the day after vaccination. oral steroids were given for 10 days. Double vision began 6 weeks after vaccination. Blood work and MRI all normal,,,,,,,,Y,N,01/15/2021,01/16/2021,1,,UNK,,,,,,,2,04/09/2021,,Y,Y, 1186147,04/09/2021,NV,47.0,47,,F,,"03/25 - day after shot, developed calf tightness, weakness, chills, shortness of breath, and headache. discomfort continued for several days. 04/05 - SOB continues to increase, patient experienced lightheadedness and passed out without losing consciousness. 04/06 - continues to have increasing SOB, fainted and lost consciousness. 04/08 - ultrasound done to leg, found DVT, sent to ER",,,,,Y,,,,U,03/24/2021,03/25/2021,1,04/08 ultrasound done to lower extremity. CTA of chest with contrast done with extensive bilateral pulmonary emboli.,PVT,,"vitamin d, vitamin c, b complex, melatonin, ibuprofen as needed",none,none,,,2,04/09/2021,,,,none 1187988,04/09/2021,WV,43.0,43,,F,,"No issues during the 15 minutes at pharmacy, went back to work and about 45 min later went into anaphylaxis. Called 911 and went to emergency room",,,,,Y,1,,,Y,03/20/2021,03/20/2021,0,na,PHM,,na,no,no,,,2,04/09/2021,,Y,Y,shell fish 1189963,04/10/2021,VA,46.0,46,,F,,"Pt developed decreased sensation in bilateral lower extremities, worsening March 4 in which she presented to ED. March 8 she presented again and was admitted because she was having difficulty walking, decreased sensation except deep touch from chest and down, as well as no temperature sensation from chest and down. Initial work up concern for neuromyelitis optica but all testing was negative. No infection was noted. Ultimately neurology was consulted and patient was diagnosed with transverse myelitis, possibly secondary to COVID 19 vaccination. She went to rehab floor where I was consulted (internal medicine) and took care of her while she underwent PT and OT under physiatry services. She was started on steroid taper, made some improvements in ability to walk and use the bathroom and was discharged from inpatient rehab March 22. Sensation remains altered per pt as of 4/9. Completing steroid taper, follow up appt with neurology pending.",,,,,Y,14,,,U,02/25/2021,03/04/2021,7,"MRI completed 3/9 revealed a C6-T2 non-enhancing lesion, initial concern for neuromyelitis optica. IGG only 956 (March 8) , Anti MOG was negative (March 15 ), MMA normal at 167 (March 17 ), Lyme negative (March 8 ), HIV negative (March 15), CSF not suspicious for infection (March 8) ,low B 12 at 245 (March 8), COVID negative (March 13).",PUB,,"famotidine 10mg as needed, buspar 5mg TID, daily B12 supplement",Anxiety,Anxiety,,,2,04/10/2021,,,Y,None 1190379,04/10/2021,NY,29.0,29,,M,,"Severe thrombocytopenia immediately following the vaccine. Platelet count fell to 5, which caused bruising and petechiae on the body and blood blisters in my mouth.",,,Y,,Y,2,,,U,03/23/2021,03/24/2021,1,CBC revealed a platelet count of 5.,PVT,,None,None,None,,,2,04/10/2021,,,Y,None 1191783,04/10/2021,NY,55.0,,,F,,"in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown. Information on the lot/batch number has been provided. Other information has been requested.",,,,,,,,,U,03/24/2021,03/24/2021,0,,OTH,,HUMALOG; PRAVASTATIN +PHARMA; ZYRTEC ALLERGY,,Medical History/Concurrent Conditions: Allergy; Shellfish allergy; Type 1 diabetes mellitus,,USPFIZER INC2021336010,2,04/08/2021,,Y,Y, 1191796,04/10/2021,AR,45.0,,,M,,"nausea; Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome; Swelling of ear; pain intensified; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6199 and expiration date: Not available), via an unspecified route of administration in the left arm on 08Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had possible Sulfa's allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. No COVID-19 test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 10Mar2021 at 14:00, the patient experienced pain in ear began two days after vaccine. Swelling of ear, pain intensified, facial paralysis occurred within 6 days from vaccine. Vertigo and nausea set in 7 days after vaccine. Zoster (shingles) infection of the ear causing the facial paralysis and vertigo was diagnosed, also known as Ramsay Hunt Syndrome. 19 days post vaccine and no improvement. The patient still continuing treatment with prescribed medications. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The clinical outcome of events was not recovered.",,,,,,,,Y,N,03/08/2021,03/10/2021,2,,PVT,,,,Medical History/Concurrent Conditions: COVID-19; Sulfonamide allergy,,USPFIZER INC2021336821,2,04/09/2021,,Y,Y, 1194900,04/11/2021,NJ,34.0,34,,F,,"Radiating pain on the arm to the face; decrease facial sensation to the left; tongue deviates to the right; numbness on the left side; face, eyebrows, mouth all are drooping; left side weakness",,,,,,,,Y,N,04/07/2021,04/07/2021,0,Went to Urgent Care on Apr 7 (Day of vaccination)- Tested for two point discrimination on face and arm and failed the test; strength of left extremity is very weak; recommended to visit Emergency Room right away. Went to Emergency Room on Apr 7 after Urgent Care - Blood test done and no one attended because the doctors and nurses were unavailable Went to Neurologist on Apr 9 (2 data after vaccination)- Confirmed that the vaccination caused some damage to the nerve; recommended Nerve Test and MRI but no appointment available for at least a week.,PVT,,N/A,N/A,N/A,,,2,04/11/2021,,Y,Y,N/A 1195524,04/12/2021,WI,51.0,51,,F,,"Anaphylaxis reaction which began immediately upon injection at 2:45Pm (roughly) into arm with wide spread hives covering the entire right arm and spread to left arm right leg. Head and neck, face became numb and I felt like I was going to pass out. Neck numbness/swelling moved to front of neck within five minutes. Itching of left leg. Was able to maintain consciousness but was very out of it. Possibly from lack of oxygen when neck and head swelled. Began to lose ability to recite address or remember address by the time was placed in paramedic van. Paramedic put IV in hand. Paramedics administered ephedrine, Benadryl, prednisone and reaction subsided. Was taken directly to hospital arrived there for monitoring by 3:15 Pm . Felt much better at hospital. Had one wave/head rush where it felt like the reaction was starting again and may pass out but that subsided and they continued to monitor. Had a few waves of nausea which did not last long. The IV placed in hand by paramedic was infiltrated so attempts at giving fluids failed and it was never corrected at hospital. After 2 hours of monitoring I was told to go home and given a prescription for steroids. I was asked to monitor for the remainder of the night for any trouble breathing. Night sleep was not good waking often with one occasion of wheezing which subsided after taking Benadryl. Continue to monitor.",,,,,,,,,U,04/10/2021,04/10/2021,0,EKG showed ok heart rhythm. All vitals were at normal ranges upon being discharged.,UNK,,Benedryl,asthma,no,,,2,04/12/2021,,,Y,Penicillin 1196323,04/12/2021,CO,32.0,32,,M,,"Patient symptoms of chills, headache, and body aches began on Sunday 3/28, 6 days after vaccination. One day later, on 3/29, patient started experiencing pain in the right armpit, the same shoulder where the vaccine was received. That pain built up until Wednesday 3/31, when the arm was very swollen, purple, and rapidly loosing sensation. The patient went to the ER. In the ER, via ultrasound, the patient was diagnosed with deep vein thrombosis of the right subclavian and axillary veins. From 4/1 to 4/2 the patient underwent an interventional radiology procedure, thrombo lysis, using tPA directed by catheter to the site of the 12 cm long clot. On 4/2, it was determined that the flow was not restored to the vein, and the radiologist informed the patient that right first rib removal would be necessary. On 4/9, right first rib resection surgery was performed to alleviate pressure on the subclavian vein. Patient is currently recovering on the blood thinner Eliquis. Additional procedures for thrombo ectomy and angioplasty will follow in approximately two weeks to clear the subclavian and axillary veins.",,,Y,,Y,5,,Y,N,03/22/2021,03/28/2021,6,"Ultrasound in the ER, many XRays taken in the interventional radiology department.",PHM,,Multivitamins,None,Back pain,,,2,04/12/2021,,Y,Y,None 1197820,04/12/2021,MD,58.0,58,,F,,"No symptoms after first vaccine, but day after second dose of vaccine, began experiencing fatigue and dyspnea on exertion. Initial workup at primary care notable for anemia below baseline. Over next week, developed thrombocytopenia and neutropenia with 2 hospitalizations. Began experiencing recurrent fever 20 days after second dose of vaccine. Approx a month after second dose of vaccine, was hospitalized for pancytopenia.",,,,,Y,5,,,N,03/12/2021,03/13/2021,1,,SCH,,"Viread (tenofovir disoproxil fumarate) 300 mg daily Vit B12 5000 mcg daily Vit C, unknown dose daily Folic acid 800 mcg daily Ferrous sulfate 325 mg daily",N/A,"Chronic hepatitis B, undetectable viral load on viread",,,2,04/12/2021,,Y,Y,No known allergies 1198108,04/12/2021,MS,60.0,60,,F,,"Pt blew horn and stated ""I can't breathe"". 11:55 am Epi given IM 11:57 A.M Benadryl GIVEN IM; 1156 AMBULANCE CALLED; VS Monitored & recorded; 1211 Ambulance arrived and patient discharged. 1213 Patient's husband notified. spoke with patient 4/12/2020 @ 1345. States she remained in hospital overnight on the day of vaccine. Completely recovered now. Has followed up with MD and he states she is okay and will monitor future if any COVID vaccine.",,,,,Y,1,,,Y,03/26/2021,03/26/2021,0,,PUB,,Blood Pressure Medicine,None,HTN,,MS0942021,2,04/12/2021,,,,NKDA 1198618,04/12/2021,VA,27.0,27,,F,,"Anaphylaxis with difficulty breathing and tongue swelling despite treatment with steroids, benadryl, pepcid and epinephrine. Eventually requiring intubation at 1900 on the day of immunization. Also later had poor perfusion, hypotension and acidosis requiring ICU care. Patient improved and was extubated 4/1/21 at 11:28 am. Discharged from the hospital on 4/2/21.",,,Y,,Y,3,,,Y,03/30/2021,03/30/2021,0,,PUB,,"Levothyroxine 75 mcg daily, Nifedipine ER 30 mg daily, prenatal vitamin","Gestational Diabetes, resolved with delivery 3 weeks prior to vaccination","Polycystic ovarian syndrome, hypothyroid, hypertension",,,2,04/12/2021,,,Y,"Levemir [insulin Detemir]: Hives (Skin erythema: raised 2-4 inch patches of erythema with pruritus and warm to touch) Amoxicillin: Angioedema Apple: Not Specified Coconut Oil: Not Specified Kiwi Extract: Not Specified Mango Flavor: Not Specified Nectarine, cherry: Not Specified Peach: Not Specified Pineapple: Not Specified Sulfa Antibiotics: Hives" 1199254,04/12/2021,MI,45.0,45,,F,,"Within 5-7 minutes First thing I noticed I felt very hot, my skin started burning, then my arms and legs started feeling tingling and numb, I saw black dots, next thing I know I woke up in the Emergency Room.",,,Y,,,,,,Y,03/26/2021,03/26/2021,0,,PVT,,Seroquel Zoloft,None,None,,,2,04/12/2021,,,Y,None 1201403,04/13/2021,NY,19.0,19,,M,,"4/4 headache. lethargic, temp 102.6, chills, hard swollen lymph node right axilla. Symptoms persisted into 4/5 with addition of nausea. 4/6 chest tightness/pain, short of breath. 4/6 to ER, elevated troponin level peaking at 9.6 ER transferred to hospital for direct admission to rule out non STEMI. Admitted to hospital, discharged on 4/9 with diagnosis of myocarditis",,,,,Y,4,,,N,04/03/2021,04/04/2021,1,"multiple lab tests, elevated troponin, elevated CRP. Multiple EKG's showing ST elevation, echocardiogram, cardiac MRI, CT angiogram.",SCH,,none,none,hx of asthma,,,2,04/13/2021,,,,none 1201408,04/13/2021,CA,72.0,72,,M,,Severe drop in platelets and blood clots.,,,Y,,,,,,N,02/25/2021,03/12/2021,15,"CT scans, multiple blood tests, hematologist, rheumatologist",PHM,,,,,,,2,04/13/2021,,Y,Y, 1201717,04/13/2021,WA,74.0,74,,F,,"On Friday April 2 at around 6:00 PM, pt. reported feeling fine. She lives alone. Overnight, between 10:00 PM 4/2 and 3:00 AM, she began to feel loss of motor control in her right leg and arm. She had to drag herself to the bathroom. She tried to call her daughter, but could not use her right hand to find the correct button. She also could not use her mind properly. At 10;30 AM on Sunday 4/3 her daughter texted pt. to check on her, but pt. did not respond. At 2:30 PM on Sunday, daughter FaceTimed pt. and found her mother in bed, unable to speak. Daughter called 911 emergency services.",,,Y,,Y,3,,,U,04/02/2021,04/02/2021,0,"Pt. was taken by ambulance to the hospital. There, the doctors gave pt. a CT scan, and MRI, and a heart ultrasound. Daughter was present Sunday morning (around 10:00 AM) to hear the results of the tests. Pt. heart was found to be fine, but the MRI showed signs of a stroke in the left hemisphere of her brain. The doctor informed pt. she had a stroke and prescribed medications, physical therapy, occupational therapy, and speech therapy.",SEN,,LEVOTHYROXINE 88 MCG TAB,None,None,,,2,04/13/2021,,Y,Y,None 1202539,04/13/2021,PA,45.0,45,,M,,"Symptoms: Headache, tiredness, upper abdomen pain, vomiting, lower abdomen pain Outcome: Mesenteric Thrombosis, found via CT scan w/dye Treatment: Heprin in hospital, xarelto at home",,,Y,,Y,3,,,N,03/26/2021,03/27/2021,1,"April 3, 2021 - CT ABDOMEN PELVIS W CONTRAST Main portal vein, right portal vein, and SMV thrombus. Name Standard Range4/3/21 4/4/21 4/5/21 4/6/21 HCT 36.5 - 49.3 % 45.0 45.7 44.0 44.9 Hemoglobin 12.0 - 17.0 g/dL 15.2 15.3 14.6 14.9 MCH 26.8 - 34.3 pg 30.9 30.7 31.0 30.7 MCHC 31.4 - 37.4 g/dL 33.8 33.5 33.2 33.2 MCV 82 - 98 fL 92 92 93 92 MPV 8.9 - 12.7 fL 8.3 L 8.3 L 8.8 L 8.6 L Platelet Count 149 - 390 Thousands/uL 222 202 193 184 Red Blood Cell Count 3.88 - 5.62 Million/uL 4.92 4.98 4.71 4.86 RDW 11.6 - 15.1 % 11.9 11.8 11.8 11.8 WBC 4.31 - 10.16 Thousand/uL 11.04 H 11.89 H 7.69 7.15 April 3, 2021 test results: Factor V Leiden Result: Negative (no mutation found) Protein C Activity 54.0 % of Normal PROTEIN S ACTIVITY 94 % Protein S Ag, Total 81 % Protein S Ag, Free 117 % Prothrombin Mutation NEGATIVE No mutation identified. BETA 2 GLYCO 1 IGG 1.2 BETA 2 GLYCO 1 IGA 4.4 BETA 2 GLYCO 1 IGM <2.9 PTT 32 seconds Protime 14.9 seconds H INR 1.17",PVT,,None.,None.,None.,,,2,04/13/2021,,,Y,"Seasonal Hay fever, nothing else." 1202766,04/13/2021,NC,17.0,17,,F,,"17yr old patient with documented allergies tree nuts (anaphylaxis), peanuts (anaphylaxis), chocolate (anaphylaxis), and shellfish (abdominal pain) presented to clinic for first dose of COVID-19 Pfizer vaccine. No history of previous reactions to any vaccines. RN administered PFIZER COVID-19 VACCINE (EUA) (LOT # ER8729, exp 7/31/2021) IM to patient's left deltoid on 4/12 at 1529. During observation period, patient complained of throat swelling ~ 1545. Patient with noted hives near administration site and flushing on chest which spread to face. Patient given epinephrine 0.3mg IM at 1553. Upon assessment, BP 139/111, HR 103, 100% RA, lungs clear to auscultation bilaterally. Pharynx not visualized due to tongue. Patien",,,,,Y,,,,U,04/12/2021,04/12/2021,0,UNKNOWN,WRK,,EPI PEN FOR ALLERIGES,UNKNOWN,UNKNOWN,,,2,04/13/2021,,,Y,"TREE NUTS (ANAPHYALXIS), PEANUTS (ANAPHYLAXIS), SHELLFISH (ABD" 1202973,04/13/2021,MI,,,,F,,"CANNOT BREATH; CANNOT MOVE LEG; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered two weeks ago on an unknown date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced could not breathe and mobility decreased and was hospitalized for the same (date unspecified and unspecified days). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot breath and mobility decreased This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210409268-Covid-19 vaccine ad26.cov2.s-CANNOT BREATHE and CANNOT MOVE HER LEG. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).",,,,,Y,,,,N,,,,,OTH,,,,Comments: Unknown,,USJNJFOC20210409268,2,04/13/2021,,,, 1203766,04/13/2021,CO,38.0,38,,F,,"Pt reported abdominal pain beginning 6 days post vaccination, was admitted to the hospital 3/20/2021 with 2 days of abdominal pain. Surgeon reports disseminated intravascular coagulation involving multiple organs",,,,,Y,,,,U,03/07/2021,03/18/2021,11,,PUB,,,,,,,2,04/13/2021,,,, 1204355,04/13/2021,AL,28.0,28,,F,,"Pt reports at time of injection she was unaware she was pregnant. She was confirmed to be pregnant 2 weeks ago and is now 10 weeks pregnant. She had suspected COVID-19 in January of 2020 and has had ongoing fatigue, occasional palpitations, COVID tongue, occasional tinnitus, and fevers. She received her first Moderna dose on March 11th. Listed below are side effects experienced and the duration of the events (reported by patient): ? ""COVID tongue"" swollen/blistering (2hr, 13 days) ? Site soreness/stiffness (5hr, ongoing) ? Exhaustion (24hr, ~7 days) ? Neck stiffness (~24hr, 12 days) ? Tinnitus (~24hr, ongoing) Patient reports since the birth of her first child, her immune system has been very suppressed and in the last year she has had hand, foot, and mouth along with a stomach bug that resulted in hospitalization. After discussion with her OBGYN and pharmacy team, we advised patient to avoid receiving the second Moderna dose for safety concerns.",,,,,,,,Y,N,03/11/2021,03/11/2021,0,,SCH,,,,,,,2,04/13/2021,,Y,,None known to patient 1204823,04/13/2021,IA,27.0,27,,F,,I had 2 blood clots on my vertebral arteries that caused me to have a stroke. This happened on March 22nd which is 2 months after receiving my 2nd dose of Moderna. I am still going through the recovery process.,,,,,Y,2,,,N,01/25/2021,03/22/2021,56,"I had 2 CT scans, an MRI, ECG, and lab work that can be provided.",WRK,,,,,,,2,04/13/2021,,,Y, 1204878,04/13/2021,NC,30.0,30,,F,,Right lower extremity DVT (popliteal vein),,,,,,,,,N,03/31/2021,04/06/2021,6,Ultrasound showed DVT,PVT,,Estradiol Proair levothyroxine zyrtec sumatriptan multivitamin vitamin d3,,endometriosis severe obesity hypothyroidism asthma,localized reaction and fever after flu shot,,2,04/13/2021,,Y,,amoxicillin egg containing vaccines 1205147,04/13/2021,WA,46.0,,,F,,"Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.",,,,,Y,2,,,N,03/25/2021,03/25/2021,0,Test Date: 20210325; Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:Negative,PUB,,METFORMIN; LAMOTRIGINE,,Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension,,USPFIZER INC2021344530,2,04/12/2021,,,Y, 1205160,04/13/2021,TX,43.0,,,M,,"sore arm; left ear ache; headache; sore throat; chills; sweats; fatigue; watery eyes; upper lip swollen; face swollen; tightness of chest; shortness of breathe; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 13Mar2021 14:00 (Lot Number: EN6207) as a single dose for covid-19 immunization. Medical history included penicillin allergies and allergies to baked egg whites. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications received within 2 weeks of vaccination. On 13Mar2021 15:00, the patient experienced sore arm, left earache, headache, sore throat, chills, sweats, fatigue, watery eyes, upper lip swollen, face swollen, tightness of chest and shortness of breathe. The events were considered serious with seriousness criteria of disabling/incapacitating. The adverse events resulted in the patient going to the emergency room/department or urgent care and the patient received treatment for the adverse events which included Benadryl. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Mar2021 with sequelae.",,,,,,,,Y,N,03/13/2021,03/13/2021,0,,UNK,,,,Medical History/Concurrent Conditions: Egg allergy; Penicillin allergy,,USPFIZER INC2021345318,2,04/11/2021,,,Y, 1205166,04/13/2021,LA,63.0,,,F,,"hemorrhages' in my right eye along with tears; Friday, 19Mar i started noticing flashes in my right eye; seeing lines like blood vessels; This is a spontaneous report from a contactable nurse (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 16Mar2021 11:00 (63-years-old) as single dose for COVID-19 immunization. Medical history included GERD. Patient is not pregnant. Patient had no Covid prior vaccination. Patient was not Covid tested post vaccination. Facility type Vaccine: School or Student Health Clinic. Concomitant medications included aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX); omeprazole (PROTONIX); ergocalciferol (VIT D); ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); ascorbic acid (VIT C); cetirizine hydrochloride (ZYRAC). The patient previously took macrobid and experienced allergy. On 19Mar2021 12:00 Friday, the patient started noticing flashes in her right eye and started seeing lines like blood vessels. No pain, still had vision. Flashes on Sat, not so much sun and Monday saw ophthalmologist, saw hemorrhages' in her right eye along with tears. Appointed on Wednesday to see retina specialist. Adverse event start date/time was reported as 19Mar2021 12:00. AE treatment was laser surgery to right eye. The outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, events eye hemorrhage, photopsia and abnormal vision are most likely from intercurrent medical condition not related to the use pf BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",,,,,,,,,N,03/16/2021,03/19/2021,3,,SCH,,B-COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORI; PROTONIX [OMEPRAZOLE]; VIT D; PRESERVISION; VIT C; ZYRAC,,Medical History/Concurrent Conditions: GERD,,USPFIZER INC2021345611,2,04/12/2021,,Y,, 1205171,04/13/2021,FL,,,,M,,"facial paralysis; neck, ear & head pain; neck, ear & head pain; neck, ear & head pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 13Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He experienced neck, ear & head pain on 21March2021. He also reported facial paralysis that started on Wednesday, 24March2021. The patient asked if he should receive the second dose of the Pfizer-BioNTech Covid 19 vaccine. He also asked what protection he has from the Pfizer-BioNTech Covid 19 vaccine. The outcome of the events was unknown. Information about batch/lot number has been requested.",,,,,,,,,U,03/13/2021,03/21/2021,8,,OTH,,,,,,USPFIZER INC2021345756,2,04/12/2021,,,, 1206461,04/14/2021,MD,,,,U,,"SUBSTANCE CONTAMINATION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced substance contamination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of substance contamination was not reported. This report was non-serious.",,,,,,,,,U,,,,,OTH,,,,Comments: Unknown,,USJNJFOC20210416747,2,04/12/2021,,,, 1207817,04/14/2021,NJ,30.0,30,,F,,"3/17/21 - Pt tested positive for COVID-19 3/21/21 - Pt started to experience leg pain 3/23/21 - Pt went to hospital with DVT and multiple bilateral PE 3/26/21 - Pt returned to hospital due to leg swelling and tingling sensation in arm and chest Pt now is required to regularly follow up with hematology, pulmonology and cardiology.",,,,,,,,,,03/07/2021,03/21/2021,14,,PUB,,not applicable,not applicable,not applicable,,,2,04/14/2021,,,Y,not applicable 1208469,04/14/2021,MI,67.0,67,,M,,"Breakthrough COVID infection in fully vaccinated individual. Dates of vaccination: 1/30/21 and 2/20/21. COVID symptom onset on 4/6/21 (fever, stomach ache, chills, nausea, cough, shortness of breath, lightheaded and chest tightness). Patient presented to hospital on 4/7/21 and has been admitted since then on a medical surgical unit.",,,,,Y,8,,,,02/20/2021,04/06/2021,45,COVID positive test result on 4/7/2021 via Nucleic Acid Amplification.,UNK,,,,"Severe peripheral vascular disease, hypertension, Hep C s/p liver transplant on anti rejection medication.",,,2,04/14/2021,,,, 1212513,04/15/2021,NC,56.0,56,,M,,Pt reports after his vaccine he had mild symptoms on 3/24/21 the developed SOB and rapid heartbeat on 4/6/2021 and was admitted to the Hospital for blood clots. Pt was hospitalized from 4/6 to 4/9/21.,,,,,Y,3,,,N,03/22/2021,04/06/2021,15,MRI and ultrasound per pt,PUB,,None per patient,None per patient,None per patient,,,2,04/15/2021,,,,None per patient 1214630,04/15/2021,KS,16.0,16,,F,,"My daughter had her vaccine at 6:15 on 4/7/21. She complained of a horrible soreness in the site of the shot, headache, and fatigue. Those were her only symptoms. I gave her ibuprofen. She stayed home from school and rested. I checked on her, and she said her headache was getting better. She had a seizure at work around 4:15 pm on 4/8/21. Her co-workers called 911, and the ambulance took her to the Medical Center. They did a head CT and ran labs. They were unsure if she had passed out or had a seizure. They gave her ibuprofen for the headache and told us to follow up with our PCP and monitor her for the weekend. She had another seizure on 4/8/21 at 10:30 pm. We called 911, and they took her to the Medical center again. They gave her Keppra and called a hospital to see if they wanted her transferred. The hospital said to provide her with the Keppra, follow up with them on Monday the 4/12/21, plus sent us home with a prescription for Keppra. They sent us home at 2:00 am on 4/9/21. I gave her the Keppra at 10:30 am on 4/9/21. She had another three seizures back to back. The EMT had to provide her with something to stop the seizures because I could tell she was about to have another one. They took her to the hospital, where she continued to have several episodes in the ER. They admitted her and gave her a higher dose of Keppra. They hooked her up to an EEG and determined that the seizure, not epileptic seizures, was brought on by stress. They released her from the hospital on 4/11/21. They told us that we needed to reduce her stress and follow-up with Neurology on 4/12/21. We could give her ibuprofen and Benedryl for the pain. She has several seizures a day, and is having numbness on her left side which they knew before releasing her. Her headache has never gone away. I keep telling them she has a horrible headache and the more seizures she is having the worse they get throughout the day. On 4/11/21, she had 17 episodes total and Monday, 4/12/21, 21 episodes. On 4/13/21, we took her back to the ER but this time took her to a different hospital. They were not able to treat because they wanted her to be seen by a pediatric neurologist. The hospital transferred her to another hospital. Where she was admitted on 4/13/21 and once again ran labs and hooked her up to an EEG. They told us they are not epileptic events and don't worry. They treated her for a chronic migraine. Sent her home telling us to give 3 ibuprophen, 2 Benedryl, and 1 Reglan every six hours until the headache is gone. She still has a severe headache and having seizures.",,,,,Y,6,,,N,04/07/2021,04/08/2021,1,"Head CT, unsure of what labs they ran but all four hospitals ran labs.",PUB,,none,None,NOne,,,2,04/15/2021,,,Y,"She does have an allergy to food, but we are unsure what food. She has been to an allergist, and they haven't been able to figure it out." 1214747,04/15/2021,IL,27.0,27,,M,,"Patient admitted 4/14/2021 with chest pain. Patient had received second Moderna vaccine on Sunday 4/11/2021 Patient had pain underneath both armpits. Patient was woken up around 4AM due to substernal pressure-like chest pain, left sided. Admitted through the ED. Cardiac Cath on 04/14/2021. Non-ST segment elevation myocardial infarction mostly likely secondary to maternal vaccine and acute thrombosis. 4/14/2021 Troponin I High Sens 3288 @ 0735 and 7616 @0930.",,,Y,,Y,,,,,04/11/2021,04/14/2021,3,04/14/2021 Troponin I High Sens 0735 3288 and @0930 7616,PHM,,,None,None,,,2,04/15/2021,,,,None 1218189,04/16/2021,VT,80.0,80,,F,,Sudden profound hearing loss on the right with severe vertigo. Hearing loss did not respond to transtympanic dexamethasone injections times two. Vertigo resolving but not gone.,,,,,,,,Y,N,03/18/2021,03/19/2021,1,Audiometric testing: Profound hearing loss on right. Mild to moderate loss on Left. MRI scan of brain:,PVT,,"Albuterol, Eliquis, Buspar, Famotidine, Breo, Lasix, Glimipiride, Losartan, Methimazole, Metoprolol, Zofran, Potassium, rosuvastatin, zoloft","Anxiety, Arthritis, COPD, Chronic Kidney Dse (stage 3), Type","Anxiety, Arthritis, COPD, Chronic Kidney Dse (stage 3), Type 2 DM, Type 2 DM, HTN, Hypercholesterolemia, Obesity",,,2,04/08/2021,,Y,,"Cefepime, Rifampin, Vancomycin" 1218252,04/16/2021,NY,29.0,29,,F,,"29 year old- year old female with known protein S deficiency with strong family history without prior VTE, presenting after diagnosis of unprovoked RLE DVT and RLL subsegmental PE. She had no known injury, immobility prior to this event, in fact was exercising 6 days/week and working fulltime as an RN. Received the first dose of Pfizer vaccine on 12/23/2020, pain in RLE started 12/26/2020 . Diagnosed with RLE DVT and RLL subsegmental PE. Started Eliquis starter pack. She had some shortness of breath so she was switched back to Lovenox for 5 days. Then placed back on Eliquis. Reports heavy bleeding with period, near syncopal episode. Subsequently, had a syncopal episode and 2/5/2021- MRI brain pituitary- Subcentimeter rounded well-circumscribed T1 hyperintense and hypoenhancing lesion in the pituitary gland measuring 8 x 7 mm with questionable small volume blood layering at its base, may reflect either a hemorrhagic pituitary microadenoma or possibly hemorrhagic Rathke's cleft. Patient's labs were significant for a cortisol of 3 for which she was given hydrocortisone 100mg, as well as a 100mg IV hydrocortisone pre-operatively. Patient underwent a transsphenoidal resection for mass with ENT assistance on 2/8. She is on hydrocortisone 30 mg daily and ELiquis. Seen last on 2/24/2021- protein S - 36,",,,,,Y,5,,,Y,12/23/2020,01/01/2021,9,"1/1/2021-No evidence of right lower extremity deep venous thrombosis. Superficial thrombophlebitis of the right foot. No evidence of right lower extremity deep venous thrombosis. Superficial thrombophlebitis of the right foot. CT chest: Right lower lobe subsegmental pulmonary emboli. 1/4/2021- Right Lower Extremity No Deep Vein Thrombosis. Focal dilatation of one of the gastrocnemius veins with slow flow and possible webbing, could be related to prior thrombosis. Superficial Thrombophlebitis of the right GSV from below the knee to the ankle with associated tenderness to palpation. Superficial thrombophlebitis extends into a dorsal right foot vein. 2/5/2021MRI brain",PVT,,n/a,none,none,,,2,04/16/2021,,Y,Y,"minocycline, naproxen" 1223355,04/17/2021,AL,19.0,19,,M,,"Fever developed about 10 hours after the injection. Average temp throughout the night and first part of the next day was 104.7, also experienced severe headache, chills, and muscle aches and pains. Throughout the day after the injection 4-10-2021 these symptoms improved but did not completely resolve. Overnight from the 10th into the morning of the 11th I developed a cough and felt short of breath. The afternoon of the 11th my oxygen saturation began to drop upon light exertion (walking around inside my home). I checked in to the Emergency Dept. at around 7 p.m. on the 11th of April 2021. I had elevated D-dimer, and abnormal Troponin. I was admitted with a diagnosis of myocarditis.",,,Y,,Y,5,,Y,N,04/09/2021,04/09/2021,0,"Abnormal Labs including D-dimer, Troponin, and CRP, imaging including CT and Cardiac MRI, and multiple EKGs all which had abnormal or elevated values",PVT,,none,none,none,,,2,04/17/2021,,Y,Y,none 1223994,04/17/2021,CA,29.0,29,,F,,"Everything started on January 24th at about 7pm exactly 20 days post first Pfizer vaccine. No other changes or vaccines given since October (flu vaccine) was scheduled for 1/25/21 for second Pfizer dose. It all started when I was working at ER when I started to feel cold like it was in an ice bath and numbness in both feet. I went to discharge my patients when I realized ascending numbness and coldness from the feet was traveling upward. Within 5 hours (around midnight) I went to hospital due to having severe weakness to where I couldn?t walk and loss of bladder control. I was rushed to MRI of brain, cervical, thoracic, and lumbar. I also had blood work done and a lumbar puncture. I was admitted for a couple days to watching the ascending weakness and loss of feeling. My MRIs came back clear from any diseases such as transverse myelitis, MS, etc. My LP showed mild elevated protein at 54 (normal range 15-45), one tube elevated lymphocytes 100% (range 40-80%) and one tube elevated monocytes 50% (range 15-45%). Also CK-MB w/reflex was 352 (range 26-140). I was discharged on 2/26 at 5:30pm with a diagnosis of bilateral leg weakness and numbness. From this point on I was wheelchair bound at home and being cared for 24/7. After discharge some additional random symptoms started such as chills with no fever to where I slept in sweat pants and sweat shirts, leg spasms/ twitches, leg heaviness, severe lower back and hip pain, a loss of sensation while going pee or poo but not incontinent, and things like drop foot with the severe weakness and numbness . On 2/3/22 I started with double vision, blurry vision and pain behind my right eye. I went to ER and had repeat MRIs of brain, cervical, thoracic and lumbar with and without contrast and basic blood work and was sent home to follow up with Dr. on 2/9 and was discharged home. By 2/8 my strength started to get worse to where I couldn?t lift my kids. Finally saw Dr. neurology and MS specialist 2/9, he ran detailed neuro exams from head to toe, looked at both scans from both hospitals, all the blood work and LP results. He reported that I had severe hyper reflexes in both legs and Hoffman?s sign in both hands. My feet were completely numb and cold to where I couldn?t feel them or walk. Literally felt like everyday I was standing in a ice cold bath with no feeling of touch hot or cold sensation or pin pricks. He realized my loss of sensation was from my bra line down and included tingling in my hands and weakness in my arms. I was able to get up for the first time with a walker and take a few steps with assistance at this time. He then sent me to ER to be admitted and see their neuromuscular team to get further treatment. Upon arrival via wheelchair I was brought back to see the ER Doctor and re-did a neuro exam, some blood work and contacted the neurology team to come see me. I was then admitted to the hospital step down ICU under Dr with strict monitoring. On 2/10/21 The neuro team ordered another set of MRI of brain, cervical and thoracic with and without contrast due to a change in condition again since my last visit to hospital. They reviewed and compared studies with no changes. They scheduled me for MRI lumbar on 2/11/21 with and without contrast which came back no changes from previous MRI as well as another LP which everything that was off before was now normal. Everyday I would work with PT, OT and speech. I had no changes in speech and slowly got some strength back, and was able walk using a walker. I was then discharged home on 2/13 mid afternoon and was told I would do home health and follow up with their neurologist and Neuromusclar team once everything was resulted back. On 2/19/21 I saw my primary doctors office (nurse practitioner) where she checked up on the status of me, took me officially off work and on state disability, filled out paperwork for work and a handicapped pass. On 2/25/21 followed up with neurology, and discussed all my imaging and blood work. All CSF fluid came back normal, all labs were fine and wanted me to get an EMG to look for nerve damage. She also wanted a follow up with cardiology as my resting heart rate was 110-120 and would spike to 160s. On 3/1/21 Home health was started for physical therapy for strengthening and working on sensation for both legs. At this point I had almost full strength in my arms, still tingling in my hands and constant numbness and cold feeling in both feet and knees with severe sensitivity to cold, wind or touch on my legs. I had Home health twice a week every week for 2-3 weeks then started outpatient physical therapy which has been twice a week for 1.5 hours. On 3/5 I saw cardiology and was placed on a holt monitor for 48 hour monitoring. On 3/9 I had my EMG with Dr. and had a follow up with Dr. for 35 tubes of blood he had drawn for multiple diseases which both blood work and EMG came back negative. On 3/16 symptoms started to change from numbness to severe hypersensitivity to touch, severe shooting nerve pains, burning sensations, non stop tingling in hands, issues with temperatures either hot or cold, and swelling of both legs. On 3/17 I saw rheumatology that looked into everything said it was not lupus related as none of my inflammatory markers or lupus DNA strands were elevated and no lupus symptoms like rashes, ulcers in the mouth or tongue, hair loss or joint pain. He ordered more blood work and confirmed it was not a lupus flare up. He suggested doing a small nerve fiber biopsies. On 3/19/21 saw spinal orthopedics who reassured it has nothing to do with my spine, prescribed gabapentin for all the nerve pain and told me that neurology is who should be following me. On 3/26 I had an echocardiogram done due to the leg swelling and heart rates which came back negative for any heart problems and was told since the tachycardia is getting better to just continue watching it and was prescribed trazodone 25mg to help with sleep due to severe nerve pains, spasms and severe back and hip pains at night. On 4/1/21 was followed up again with neurology. Ordered small nerve fiber biopsy for may 18th, increased the gabapentin to 300 mg- 3 times a day and had me wean off cymbalta. I am still dealing with tingling, burning hot and cold sensitivities in both legs, still tingling in hands all day but strength is back to full. I am scheduled to hopefully return to work 5/30/2021 after being off since 1/24/2021.",,,,,Y,8,,,N,01/05/2021,01/24/2021,19,see # 18 all comibined,WRK,,"Plaquinel 200mg BID, Vitamin D 50,000 IU weekly, symbicort 180/3.5, albuterol inhailer PRN","Anaphylaxis from mustard pizza 12/20/21 at 10:42 pm. Epi, steriods and benedryl.","Lupus, hasimotos, and asthma","Pneumococcal 23, 12/11/2019- cellulitis, followed by anaphylaxis on 12/14/2019",,2,04/17/2021,,Y,Y,"No medications, foods- mild allergies per skin test to: corn, oats, rye, peanut, brewers yeast, sesame seed, rice, hazelnut, celery, clam, buckwheat, pistachio, almond, and salmon. Deathly allergic to horses and mustard." 1224437,04/18/2021,IL,31.0,,,F,,"Baby was delivered with apgars of 0 and ultimately fetal demise; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and fetus/baby. This is a maternal report. A 31-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 16Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient presented to physician office 2 weeks after covid vaccine, with complaints of decreased fetal movement. Patient was taken to emergency c-section due to decreased fetal heart tones in the office. Baby was delivered with apgars of 0 and ultimately fetal demise. Patient was 34 weeks pregnant and had an otherwise uncomplicated pregnancy. Due to the event, the patient with doctor or other healthcare professional office/clinic visit and was hospitalization for 3 days. The mother was 34 weeks pregnant at the onset of the event. The mother delivered the pregnancy on an unknown date via cesarean delivery. APGAR Score 1 was 0, APGAR Score 2 and APGAR Score 3 was not provided. The fetal outcome is neonatal death. The outcome of the event was unknown.; Sender's Comments: Based on the available information and a temporal association, a causal relationship between the event fetal demise and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021363057 baby case",,,,,Y,3,,,U,03/16/2021,,,,UNK,,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,USPFIZER INC2021359597,2,04/14/2021,,Y,, 1227272,04/18/2021,MD,83.0,,,F,,"massive stroke; massive blood clot in brain next day; This is a spontaneous report from a contactable healthcare professional. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 10:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks and no other medications within two weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. On 09Mar2021 19:00, patient had massive blood clot in brain and stroke. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient died on 13Mar2021 with cause of death: massive stroke. Outcome of the event ""massive blood clot in brain next day"" was unknown. Autopsy was not performed. Treatment received for AEs include anticoagulant. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke and Thrombosis cerebral cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: massive stroke",Y,03/13/2021,Y,,Y,,,,N,03/08/2021,03/09/2021,1,,UNK,,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,USPFIZER INC2021391591,2,04/14/2021,,,Y, 1227280,04/18/2021,NY,46.0,,,F,,"appendicitis; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 27Mar2021 at 16:30 (batch/lot number: ER 870) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unspecified date. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and drospirenone (SLYND); both taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. On 31Mar2021 at 12:00 AM, 4 days after receiving the first Pfizer shot, the patient was hospitalized with severe abdominal pain and diagnosed with appendicitis. A day later, she had surgery to remove her appendix. The woman in the hospital bed next to her had received the same shot on the same day and was hospitalized at the same time as her with the same diagnosis and surgery. The adverse event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for appendicitis from 31Mar2021 to 03Apr2021 for 3 days. No Covid prior to vaccination and was Covid tested post vaccination. Covid test post vaccination included nasal swab on 31Mar2021 with negative result. Therapeutic measures were taken as a result of appendicitis which included appendectomy. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403551 same reporter, drug and event, different patient",,,Y,,Y,3,,,N,03/27/2021,03/31/2021,4,Test Date: 20210331; Test Name: Nasal Swab; Test Result: Negative,PHM,,SYNTHROID; SLYND,,Medical History/Concurrent Conditions: Hypothyroidism,,USPFIZER INC2021401328,2,04/16/2021,,,Y, 1227936,04/19/2021,MN,50.0,,,F,,"BLOOD CLOT; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 19:18 at right arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 at 02.30 patient experienced severe cramping on front and back of right leg; she was unable to stand and had to sit down on the floor. The patient then started feeling the left leg also cramp and was rushed to the hospital. At 02:45 was in the hospital and received intravenous morphine and laboratory tests (hemoglobin and metabolic panel - test results not provided). At 04:24 patient received intravenous Valium. That same day, 10-APR-2021 at 05:07 Sodium Chloride (NaCl 0.9%) was stopped and the patient was released from hospital. On 13-APR-2021 the patient received D-Dimer testing. She stated the levels were 0.95 (units unspecified) ""which was elevated compared to average 0.5"". Her doctor notified her not to fly anywhere and have an ultrasound. On 14-APR-20-21 ultrasound performed. Reports came back with no Deep vein thrombosis (DVT) but still blood clotting was present in unknown location. On 15-APR-20201 patient has requested another D-Dimer test with her physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 50-year-old female patient was rushed to the hospital for severe cramping of right leg 2 days after receiving COVID-19 VACCINE AD26.COV2.S on right arm. Hemoglobin and metaboic panel was awaiting results; D-Dimer was reported to elevated at 0.95; and ultrasound showed no deep vein thrombosis but was told that there was still blood clotting in an unknown location. Additional work up is being done. The patient was treated with Valium and IV fluid and was released from the hospital. Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per the WHO causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism. Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information has been requested for further assessment.",,,,,,,,,U,,04/01/2021,,"Test Date: 20210410; Test Name: Hemoglobin; Result Unstructured Data: not reported; Test Date: 20210410; Test Name: Comprehensive metabolic panel; Result Unstructured Data: not reported; Test Date: 20210413; Test Name: Fibrin D dimer high; Result Unstructured Data: 0.95, Stated her levels were elevated, the average is 0.5; Test Date: 20210414; Test Name: Diagnostic ultrasound; Result Unstructured Data: BLOOD CLOT BUT NO DVT",OTH,,,,Comments: Unknown,,USJNJFOC20210430704,2,04/17/2021,,,Y, 1228440,04/19/2021,,18.0,18,,U,,ED visit and hospitalization within 6 weeks of receiving first dose of COVID vaccination. Second dose not yet received.,,,,,Y,6,,,,03/16/2021,03/23/2021,7,,OTH,,,,,,,2,04/19/2021,,,Y, 1229754,04/19/2021,,70.0,70,,M,,"70YM w chest pain, lower extremity swelling, left arm pain and dyspnea started on 3/27, 2 days after Covid vaccine given on 3/25. Presented to Hospital on 4/7 complaining of shortness of breath and nausea and vomiting with elevated troponin and NSTEMI. Low suspicion that the vaccine caused this man?s heart attack as his hear cath showed severe multi-vessel disease. Pt gave inconsistent history in previous COVID infection: he told some he did have it and others that he did not . CT surgery was consulted, and patient was not felt to have viable targets for CABG. Cardiology discussed risks and benefits of an attempt at a high risk PCI to the LAD, and patient and family opted for medical management. Patiet discharge home on 4/10/21 with medical management for his coronary artery disease and new onset systolic heart failure with an ejection fraction of 15%, including aspirin, clopidogrel, atorvastatin, Coreg, furosemide, Entresto.",,,,,Y,3,,,,03/25/2021,03/27/2021,2,"/7/21 Toponin 31. 4/8/21 ANGIOGRAPHIC FINDINGS: Heart cath on 4/8 with diffuse disease , LAD 100% ostial, LCX-99% distal, RCA- 95% RPL. Vgram- EF < 15%, apical dyskinesis. Echo 4/8: The left ventricular systolic function is severely decreased, estimated LVEF <20%. The left ventricle is moderately increased in size. The left ventricular diastolic function is moderately abnormal (Grade II, pseudonormal). The right ventricular cavity size is normal. Normal right ventricular systolic function. The left atrium is mildly dilated. There is moderate mitral regurgitation. There is moderate tricuspid regurgitation",UNK,,,,"Type 2 diabetes, insulin-dependent Hypertension Hyperlipidemia",,,2,04/19/2021,,,,Lisinopril 1230022,04/19/2021,MN,72.0,72,,M,,"Patient recieved Moderna Vaccine dose 2 on March 18th. He was working in the yard 4/4/21, then developed lumbar pain, numbness in legs, abnormal gait 4/5/21. Flew from hometown to go to another state 4/6/21 to visit daughter. Presented to hospital 4/7/21 with shortness of breath, numbness from knees down on both legs. Denies fall or trauma. Progressive paresthesias o/upper and lower extremity ataxia with CSF analysis with albuminocytogic dissociation concerning for Guillain barre syndrome. GQ1b, GD1a, GD1b, GM1 antibodies negative. MRI brain with very mild small vessel disease, cervical and thoracic without root enhancement on the however cervical spine with severe degenerative disc disease. Completed 5 days IVIG 4/13 with some improvement, but then transferred to ICU 4/14 for worsening wekness and cranial nerve deficits (unable to speak). Neuro recommended restarting IVIG 4/19 x1-2 more days. Remains profoundly weak with limited mobility upper extremities no significant mobility lower extremities, currenlty on BiPAP for respiratory support.",,,Y,,Y,13,,,N,03/18/2021,04/04/2021,17,"COVID negative, Oligoclonal bands (IgG CSF 11.1 mg/dL, albumin CSF 72 mg/dL, albumin index 19.4, CSF IgG synthesis rate 9.1 mg/d), ANCA vasculitis panel neg, C3 complement normal, Rheumatoid factor < 10 U/mL, Aldolast WNL, Ganglioside (Asialo-GM1, GM1, GM2, GD1a, GD1b, and GQ1b) Antibodies WNL, Anti-nuclear antibody negative, Borrelia IgG neg, CRP WNL, Cyclic citrul peptide IgG WNL, HIV RNA PCR neg, MMA/plasma vitamin B12 WNL, sjogrens AB negative, Vitamin B12 level WNL, Syphilis non-reactive, Lyme PCR CSF neg, JC Virus PCR CSF neg, Myelin basic protein CSF WNL, VDRL CSF non reactive, varicella zoster PCR neg, paraneoplastic antibodies reflex panel (Purkinje cell/neuronal nuclear IgG including ANNA-1, ANNA-s, PCCA-1, PCCA-Tr (DNER)) not detected",PVT,,"Biotin 1 tablet PO daily (formulation unknown), Vitamin D3 1000 IU PO daily, docosahexaenoic acid-epa 120-180 mg cap PO daily, sildenafil 20 mg PO daily (pulmonary HTN)","Intermittent scant cough productive of yellow sputum, no fevers/chills, dyspnea upon exertion, flew from out to another state day prior to hospital admission.","Hypertension, obesity (BMI 29), osteoarthritis, prostate cancer metastatic to lymph nodes",,,2,04/19/2021,,,,NKDA 1230592,04/19/2021,NE,27.0,27,,F,,"This is a 27 y.o. female with a PMH of hypothyroidism, obesity, and chronic migraines who presented to Lakeside ED on 4/13/21 for evaluation of chest pain. In the ED, her troponin was elevated at 1.73. EKG showed NSR with nonspecific t-wave abnormality. CTA chest and CXR were negative for acute findings. She was given 325 mg aspirin and cardiology was consulted. HMS was asked to admit for ongoing evaluation and management. Her troponin was trended and peaked at 9.59, trended down to 8.18 on the day of discharge. Echocardiogram showed normal LVEF at 62% and no wall motion abnormalities. Her CRP was elevated at 25.5. Cardiac MRI 4/14 showed evidence of epicardial delayed enhancement consistent with myocarditis, no evidence of myocardial infarction. She was diagnosed with myocarditis, possibly related to recent Pfizer COVID vaccination (vs other viral etiologies). ID was consulted and added on labs to rule out a mild case of MIS-A as well. Labs pending at time of d/c (ferritin, d dimer, CRP/ESR, COVID total AB, and IL-6). Depending on results, PCP may consider outpatient referral to rheumatology. Discussed with her to only have mild to moderate physical activity for the next 12 weeks, avoid or limit alcohol, and limit caffeine intake. F/u with cardiology in 2-3 weeks, and PCP in 1 week.",,,,,Y,3,,,U,04/10/2021,04/13/2021,3,Recent Labs 04/14/21 04/13/21 WBC 6.2 5.9 HGB 13.1 13.8 HCT 38.2 39.9 RBC 4.46 4.66 MCV 86 86 PLT 252 253 LYMPHOPCT -- 30 Recent Labs 04/14/21 04/13/21 GLU 95 99 NA 138 137 K 4.0 3.6* CL 110 108 CO2 24.0 24.0 BUN 12 13 CREATININE 0.74 0.91 CALCIUM 8.6 8.7 PROT -- 6.8 ALBUMIN -- 3.4* ALKPHOS -- 94 AST -- 15 ALT -- 25 BILITOT -- 0.6 Estimated Creatinine Clearance: 179.9 mL/min (based on SCr of 0.74 mg/dL). 04/15/21 04/14/21 04/13/21 04/13/21 04/13/21 TROPONINI 8.18* 9.59* 5.31* 5.08* 1.73* 04/13/21 DDIMERQUANT 1.14 Component Value Date CHLPL 155 04/14/2021 TRIG 170 (H) 04/14/2021 HDLPML 43 04/14/2021 VLDL 34 (H) 04/14/2021 LDLCALC 78 04/14/2021 CHOLHDLRATIO 3.6 04/14/2021 LDLHDL 1.8 04/14/2021 NONHDL 112 04/14/2021 Echo: 1. The calculated biplane ejection fraction is 62%. 2. There is normal left ventricular geometry,UNK,,ibuprofen 200 mg po q6h prn pain. levothyroxine 125 mcg po qam. loratadine 10 mg po daily. tipiramate 100 mg po daily.,,"hypothyroidism, obesity, chronic migraines",,,2,04/19/2021,,,Y,hydrocodone - nausea 1230893,04/19/2021,NY,,,,F,,"DIZZINESS; FLUSHED; FELT WARM; CHILLS; TIREDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included Levaquin, and geographic tongue, and concurrent conditions included drug allergy to steroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced flushed. On 05-APR-2021, the subject experienced felt warm. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 05-APR-2021, and flushed, felt warm, chills, and tiredness on 07-APR-2021. This report was non-serious.",,,,,,,,,Y,,04/05/2021,,,OTH,,,Drug allergy,Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Geographic tongue (Blotches on tongue Treated with ciprofloxacin and discontinuation of levaquin),,USJNJFOC20210427678,2,04/16/2021,,,, 1231039,04/19/2021,WI,27.0,27,,F,,"APPROXIMATELY 2 WEEKS AFTER DOE 1 OF MODERNA COVID VACCINE, PT EXHIBITED WEAKNESS WITHOUT PAIN IN BOTH HIPS WHICH HAS WORSENED. ABOUT 2 WEEKS AFTER DOSE 2 OF THE MODERNA VACCINE, PT EXHIBITED ABNORMAL GAIT. AT HER ER VISIT, PT WAS INCAPABLE OF ADL'S AND UNABLE TO WALK EVEN A FEW STEPS WITHOUT FALLING. CONSTANT PAIN IN BOTH ANKLES. WHERE PRIOR TO RECEIVING THE FIRST DOSE OF MODERNA COVID VACCINE, PT TOOK DOG OUT ON 3 MILE WALKS DAILY AND RAN AROUND THE YARD WITH DOG WITHOUT ANY PAIN/DIFFICULTY.",,,,,Y,,,,U,03/17/2021,03/30/2021,13,"ADMISSION TO HOSPITAL, REQUIRED A NEUROLOGY CONSULT.",SEN,,UNKNOWN TO WRITER,UNKNOWN TO WRITER,UNKNOWN TO WRITER,"BILATERAL HIP WEAKNESS WITHOUT PAIN, 27Y, 2/17/2021 MODERNA COVID VACCINE DOSE #1",,2,04/19/2021,,,Y,NONE LISTED 1231593,04/20/2021,MI,,,,M,,"FLUID IN LUNGS; FLUID AROUND THE HEART; FLUID ON LEGS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, frequency once total for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported. On an unspecified date, the patient experienced fluid on legs, fluid in lungs, and fluid around the heart and was hospitalized (date unspecified) for few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluid on legs, fluid in lungs and fluid around the heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210420342-covid-19 vaccine ad26.cov2.s -Fluid in lungs, Fluid around the heart, Fluid on legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).",,,,,Y,,,,U,,,,,OTH,,,,Comments: Unknown,,USJNJFOC20210420342,2,04/19/2021,,,, 1232358,04/20/2021,OH,65.0,65,,F,,"Diagnosed TGA - started approximately 5:45 pm on 03/17/2021 after I got home from work. Started repeatedly asking my husband the same question over and over again as if I was on a loop. I don't remember anything for the next couple hours. I was taken to the hospital, where several tests were run and nothing showed why. Saw my family doctor, on 03/22/2021 and he had reviewed my tests and diagnosed TGA.",,,,,,,,,Y,03/05/2021,03/17/2021,12,All tests were done on 03/17/2021. MRI and MRI with contrast. I'm not sure of other tests.,OTH,,Lisinipril,None,high blood pressure,,,2,04/20/2021,,Y,Y,None 1235704,04/21/2021,CA,63.0,,,M,,"Peripheral neuropathy; Arthritis in neck hips and shoulders; Arthritis in neck hips and shoulders; Metallic taste on tongue; tingling on tongue; stomach muscle fatigue; itchy head; inability to clear ears; burning sensation in stomach; generalized sore muscles; generalized achy joints; enlarged or swollen lymph nodes; testicular pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730 and expiration date not provided) via an unspecified route of administration, administered in left arm on 22Mar2021 10:45 as a single dose for COVID-19 immunization. Medical history included pinched nerve in neck and allergies to Penicillin. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Mar2021 18:00, the patient experienced peripheral neuropathy, arthritis in neck hips and shoulders, metallic taste on tongue, tingling on tongue, stomach muscle fatigue, itchy head, inability to clear ears, burning sensation in stomach, generalized sore muscles, generalized achy joints, enlarged or swollen lymph nodes, and testicular pain. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. No treatment was given in response to the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 since having the vaccine.",,,,,,,,Y,N,03/22/2021,03/22/2021,0,,UNK,,,,Medical History/Concurrent Conditions: Penicillin allergy; Pinched nerve,,USPFIZER INC2021372250,2,04/18/2021,,Y,, 1249186,04/23/2021,NC,41.0,,,F,,"CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 41 years old white and Not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient experienced rash when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 2 weeks later the vaccination patient gave blood at red cross and found no antibody for COVID-19 (confirmed immunological vaccine failure). In MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) showed Negative antibody. On 11-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) as Negative antibody test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422640-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS",,,,,,,,,U,,,,Test Date: 202103; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative antibody; Test Date: 20210411; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative antibody test,OTH,,,Allergic reaction to antibiotics (Rash),Comments: Unknown,,USJNJFOC20210422640,2,04/23/2021,,,, 1253002,04/24/2021,KS,17.0,,,U,,"ADMINISTERED TO 17YO; OFF LABEL USE; JNJ VACCINE ADMINISTERED TO 17 YEAR OLD; This spontaneous report received from a pharmacist concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced administered to 17yo. On 13-MAR-2021, the subject experienced off label use. On 13-MAR-2021, the subject experienced jnj vaccine administered to 17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered to 17yo, off label use and jnj vaccine administered to 17 year old was not reported. This report was non-serious. Version created to amend previously reported information on 17-Mar-2021: upon review following information was amended: Event (Product administered to patient of inappropriate age), causality, labelling were amended and narrative was updated accordingly.",,,,,,,,,U,,03/13/2021,,,OTH,,,,Comments: The patient had no known allergies,,USJNJFOC20210333461,2,03/26/2021,,,, 1254128,04/24/2021,,,,,F,,"his wife also received the vaccine series and her antibody test was positive; his wife also received the vaccine series and her antibody test was positive; This is a spontaneous report received from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date patient had her antibody test and result was positive (covid19 and drug ineffective). Outcome of events was reported as unknown. Information about the Lot/batch number has been requested.",,,,,,,,,U,,,,Test Name: antibody test; Test Result: Positive ; Comments: Received the vaccine series and her antibody test was positive,UNK,,,,,,USPFIZER INC2021201402,2,04/16/2021,,,, 1254140,04/25/2021,NY,,,,F,,"diagnosed with covid on 01Feb2021 after receiving the shot; diagnosed with covid on 01Feb2021 after receiving the shot;asymptomatic when she got COVID; This is a spontaneous report from a contactable consumer or other non hcp (reported for his wife). A 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose for COVID -19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, thyroid disorder (thyroid removed) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 01feb2021, the patient diagnosed with COVID after receiving the shot. Caller states that her wife received the first dose of the pfizer COVID-19 vaccine and was diagnosed with COVID on 01Feb2021. The second shot was scheduled for 05Feb2021, but she missed this appointment because she was in isolation. Caller wanted to know if and when she should be receiving her second dose. Possible duplicate AE. Caller wanted to know if the monoclonal antibody treatment for COVID will interfere with the COVID 19 vaccine and Stated that the doctor wanted her to have the monoclonal antibody treatment for COVID because she has diabetes, heart issues, high cholesterol and thyroid removed and is high risk and would only get mild symptoms and not any severe symptoms. Wanted an answer if she needs the second dose and the time frame to get it because it was approaching for 3-6 weeks after the first dose to get the second. Stated that no one knows the answer for Pfizer COVID shot. Stated she was asymptomatic when she got COVID. Stated that she was given the shot and was given information to report symptom wise. The patient underwent lab tests and procedures on 01Feb2021 which included sars-cov-2 test: positive, diagnosed with COVID on 01Feb2021. The outcome of the events was unknown. Information about lot/batch number has been requested.",,,,,,,,,U,,02/01/2021,,Test Date: 20210201; Test Name: Covid; Test Result: Positive ; Comments: diagnosed with covid on 01Feb2021,UNK,,,,Medical History/Concurrent Conditions: Diabetes; Heart disorder; High cholesterol; Thyroid disorder,,USPFIZER INC2021205980,2,04/20/2021,,,, 1254169,04/25/2021,GA,33.0,,,F,,"currently 26 weeks pregnant; Covid test result: positive; Covid test result: positive; This is a spontaneous report from a contactable other-HCP (patient herself). A 33-year-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown, via an unspecified route of administration on 20Dec2020 at 9:30 pm for covid-19 immunisation. The patient medical history included Asthama, GERD, Amxiety/Depression. Patients concomitant medications included Prevacid, Cymbalta, Multi Vitamin and Flovent. Patient did not received COVID prior vaccination. Since the vaccination, patient has been tested for COVID-19. On 15Feb2021 at 1:15 pm, a nasal swab test revealed that the patient tested positive for COVID-19 infection over a month after 2nd vaccine dose and has been sick. The patient was 26 weeks pregnant at the time of this report. The patient thought that the easiest way to get the information to Pfizer by enrolling her in research for efficacy during pregnancy/effects on foetus. Patient treatment medications for the event included azithromycin, zinc, steroids and melatonin. The outcome of the events was unknown. Follow-up (19Feb2021): No new significant information received from same contactable consumer.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and the suspect drug.",,,,,,,,,U,12/20/2020,02/15/2021,57,Test Date: 20210215; Test Name: Nasal Swab; Test Result: Positive,WRK,,PREVACID; CYMBALTA; FLOVENT,,Medical History/Concurrent Conditions: Anxiety; Asthma; Depression; GERD,,USPFIZER INC2021211405,2,04/15/2021,,Y,, 1254434,04/25/2021,AR,48.0,,,F,,"anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; massive and dangerous swelling of my tongue; an intense burning on the roof of my mouth; there were bumps forming all over the back of my tongue; blisters forming on the back of my throat; She has been very very sick; This is a spontaneous report from a contactable consumer (patient), other healthcare professional, and a physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (at the age of 48years) as single dose for Covid-19 immunization. Medical history included known allergies: mild allergy to sulfa as a child that resulted in a rash; mild allergy to Crestor that resulted in extreme gas and bloating; other medical history: type 2 diabetic that has been controlled for 8 years with no A1C higher than 7.0. The patient is not pregnant at the time of vaccination. Concomitant medications included metformin, glipizide, bupropion hydrochloride (WELLBUTRIN), lovastatin, and other unspecified medication; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 23Mar2021, she received her vaccine at 4 p.m. and experienced an anaphylactic reaction within 5 minutes, by 4:10 she was taken to the ER (emergency room) attached to the clinic due to her tongue first tingling, then burning all over her tongue, and then massive and dangerous swelling of her tongue and an intense burning on the roof of her mouth. The attending physician noted there were bumps forming all over the back of her tongue and blisters forming on the back of her throat. She was admitted for anaphylactic shock and kept at the ER for 2 hours before being transferred via ambulance to other hospital and she was admitted to the ICU (intensive case unit). She spent the next day in the ICU then 2 days in Cardiac Care, another day back in the ICU, with a 5th and final day back in the Cardiac care. All 5 days were spend trying to get her anaphylactic shock under control. She had numerous doses of EpiPen, steroids, Benadryl, and Pepcid. Her tongue never did completely stop swelling and the burning sensation has never stopped. The patient was hospitalized for 5 days. It was reported further reported that the patient was hospitalized for 6 days (also initially reported as 5 days-pending clarification) and was sent home with medications but was back in the hospital yesterday (unspecified date) because of another big blow up. She has had 2 stays in the ICU, 4 days in cardiac care and is now back in cardiac care again because of yesterday. It has been 2 weeks since she received the vaccine and it is now day 12 but it keeps coming back and she just cannot stop it. She has been very very sick, in a very severe, very rare, extreme, constant state of anaphylactic shock. She has had many Epi (Epinephrine) and is on strong steroids but it has not subsided. She mentioned that their lead pharmacist called last week but never heard any response back. Her doctor told her that they accessed a website from Pfizer which allowed them to search for adverse reactions and they mentioned to her that most of these reactions subside within 24-48 hours. She mentioned that she has no food allergies, no allergies to vaccines, and has only had minor drug reactions. This is the 1st time that this has happened to her and it is getting serious. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. The reporter (consumer) assessed the events as non-serious. Information on lot/batch number was available. Additional information has been requested.",,,Y,,Y,5,,,N,03/23/2021,03/01/2021,,,OTH,,METFORMIN; GLIPIZIDE; WELLBUTRIN; LOVASTATIN,,Medical History/Concurrent Conditions: Sulfonamide allergy (Mild allergy to sulfa as a child that resulted in a rash); Type 2 diabetes mellitus (That has been controlled for 8 years with A1C higher than 7.0),,USPFIZER INC2021366448,2,04/15/2021,,Y,Y, 1254460,04/25/2021,DE,59.0,,,F,,"appendicitis; sweating; 1/2 later developed chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 22Mar2021 14:30 (Lot Number: er8727; expiration date: 31Jul21) as a single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERDs), migraine and unspecified allergies. The patient was not diagnosed with Covid prior vaccination. Concomitant medications included unspecified medication. The patient did not receive other vaccine in four weeks. On 24Mar2021 (36 hours after the shot), the patient developed stomach pains, sweating and nausea, 1/2 later (unspecified) developed chills. The pain and nausea continued for 4 days admitted to hospital (unspecified date) and being treated for appendicitis. The patient was hospitalized for 4 days. The treatment included antibiotics with surgery pending. The patient has not been Covid tested post vaccination. The patient inquired if she should get the second dose. The patient mentioned that her physician stated that you can't get the vaccine for 90 days after having the Covid virus. She inquired about the efficacy after having 1 dose of the vaccine. She further reported that she received her first Covid vaccine dose on 22Mar2021 and on 24Mar2021 she began having stomach pains and later diagnosed with appendicitis. She added that she has been trying to do her own investigation on if she should receive the second dose as her HCP's have been unable to provide guidance. She mentioned that she has been trying to determine if it will be safe to get the second dose given that she experienced appendicitis after the first dose. The events resulted in emergency room visit. The outcome of the event was not recovered.",,,,,Y,4,,,N,03/22/2021,03/24/2021,2,,UNK,,,,Medical History/Concurrent Conditions: Allergy; GERD; Migraine,,USPFIZER INC2021372362,2,04/20/2021,,,Y, 1254555,04/25/2021,NY,51.0,,,F,,"Small intestinal obstruction; vomiting; Indigestion; extreme stomach pain; don't feel well enough; This is a spontaneous case is received from a contactable consumer reported for herself from a Pfizer Sponsored Program. A 51-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955 and Expiry date: 30Jun2021) via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The patient did not have any adverse events prior to vaccination. Patient received the first dose of the Pfizer vaccine and had some adverse events front the first dose. She doesn't feel well enough to receive the second shot of the vaccine. On 18Mar2021 night patient experienced vomiting, indigestion, extreme stomach pain with the outcome unknown. Patient would like to reschedule her second dose if possible because she was hospitalized. On 20Mar2021 she went to the emergency room was diagnosed with small bowel obstructions and had surgery. She spent 10 days in the hospital and is currently recovering after the surgery of small bowel resection at the point of obstruction. She was released from the hospital on 1Apr2021. The patient underwent lab tests and procedures which included blood test: nil, x-ray: nil. Therapeutic measures were taken as a result of small intestinal obstruction (small intestinal obstruction). Additional information has been requested.",,,,,Y,12,,,N,03/18/2021,03/18/2021,0,Test Name: blood tests; Result Unstructured Data: Test Result:Nil; Test Name: x-rays; Result Unstructured Data: Test Result:Nil,UNK,,,,,,USPFIZER INC2021376475,2,04/19/2021,,,Y, 1254798,04/25/2021,OH,43.0,,,M,,"High frequency hearing loss; High pitch ear ringing; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER26L3), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 17:45 as a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies. The patient did not have COVID prior to the vaccination. There were no concomitant medications and the patient did not have other vaccines in four weeks and did not have other medications in two weeks. The patient has not been tested for COVID post vaccination. The patient experienced high frequency hearing loss and high pitch ear ringing on 26Mar2021 at 05:00. The patient did not receive treatment for the events. The outcome of the events was not recovered. The events were reported with a seriousness criteria of disability.",,,,,,,,Y,N,03/24/2021,03/26/2021,2,,PUB,,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other Medical History: None",,USPFIZER INC2021385892,2,04/21/2021,,Y,, 1255461,04/25/2021,IL,,,,F,,"Feeling hot; Feeling bad; Inflammation; Nauseous; Cold; Diarrhea; Cramps of extremities; back discomfort; Injection site itching; discopathy; neck pain; yeast infection; Allergy; Nasal stuffiness; Arthritis; Swelling of legs; Rheumatoid arthritis flare up; Back pain; This is a solicited report from a contactable physician via a non-Pfizer program, FACILITATED COLLECT, based on the information received by Pfizer from Abbvie [Manufacturer control number: 21K-163-3753088-00]. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation; promethazine hydrochloride (PHENERGAN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA), subcutaneous from 2013 (Batch/Lot number was not reported) and ongoing, at unspecified dose for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced back pain in 2018, rheumatoid arthritis flare up on Dec2020, nasal stuffiness and allergy on 04Mar2021, arthritis and swelling on legs on Mar2021; and feeling hot clarified, feeling bad clarified, inflammation clarified, nauseous clarified, cold clarified, diarrhea clarified, cramps of extremities clarified, back discomfort, injection site itching clarified as arm itched real bad after COVID vaccine, discopathy clarified, neck pain clarified, unevaluable event (as reported) clarified, and yeast infection clarified on an unspecified date. The patient underwent lab tests and procedures which included blood uric acid: unknown, pain assessment: 8, vitamin d: unknown on unspecified dates, and x-ray: arthritis on Mar2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for promethazine hydrochloride was unknown while for adalimumab was dose not changed. Therapeutic measures were taken as a result of rheumatoid arthritis flare up, feeling hot, feeling bad, inflammation, nasal stuffiness, nauseous, cold, diarrhea, cramps of extremities, back pain, allergy, arthritis, swelling of legs, back discomfort, injection site itching, discopathy, neck pain, unevaluable event, and yeast infection. Outcome of the events rheumatoid arthritis flare up, feeling bad, cramps of extremities, back pain, allergy, swelling of legs was not recovered. Outcome of the events feeling hot, nasal stuffiness, nauseous, diarrhea, unevaluable event, and yeast infection was recovering. Outcome of the event injection site itching was recovered on an unspecified date. Outcome of inflammation, cold, arthritis, back discomfort, discopathy, and neck pain was unknown. The reporter's causality for the events of got real hot after taking phenergan, feeling bad, inflammation, arthritis, rheumatoid arthritis flare, nauseous, cold, knee cramping, allergy symptoms, one leg swollen, disk in back bothering/bother/woke up with upper back was bothering and cause discomfort unknown onset, disk in back bothering/bother/woke up with upper back was bothering and cause discomfort unknown onset and neck pain was reported as not provided. Causality for nasal stuffiness, diarrhea, back pain, injection site itching, unevaluable event, and yeast infection was also reported as no reasonable possibility. Information on the lot number has been requested.; Sender's Comments: Based on the limited information provided, a possible contributory role of the vaccine administered cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",,,,,,,,,N,,12/01/2020,,Test Name: Uric Acid; Result Unstructured Data: Test Result:Unknown; Test Name: pain scale; Result Unstructured Data: Test Result:8; Test Name: Vitamin D Test; Result Unstructured Data: Test Result:Unknown; Test Date: 202103; Test Name: X-Ray; Result Unstructured Data: Test Result:Arthritis,UNK,,,,,,USPFIZER INC2021403911,2,04/23/2021,,,, 1255632,04/25/2021,MO,,,,F,,"She faced anaphylactic reactions; This is a spontaneous report received from a contactable Pharmacist. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose in for COVID-19 immunisation. Medical history and Concomitant medications were unknown. On unknown date, the patient experienced anaphylactic reaction; the event was considered an important medical event. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The contributory of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported anaphylactic reaction is probable.",,,,,,,,,U,,,,,PVT,,,,,,USPFIZER INC2021417286,2,04/21/2021,,,, 1255743,04/25/2021,MI,,,,M,,"tested positive for Covid after his first dose; tested positive for Covid after his first dose; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored Program (the patient). This reporter reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID after his first dose (04Mar2021) in 2021. He was on quarantine and did not get the second dose (25Mar2021). He was informed that someone will be in contact to give the schedule for the second dose; however, until now, no one was calling them. He also wanted to know if it was true that there should be a 6 weeks gap (for his case) between the first and second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021387274 same drug and event, different patient",,,,,,,,,U,03/04/2021,,,Test Date: 2021; Test Name: COVID; Test Result: Positive,UNK,,,,,,USPFIZER INC2021437813,2,04/20/2021,,,, 1255745,04/25/2021,VA,2.0,,,F,,"she was going to die/dies after vaccine; 2-year-old patient; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A 2-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 2-years-old via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the 2-year-old dies after vaccine on 03Mar2021. Reported on VAERS. Look for the researchers to exclude her from the study, probably claiming her death had nothing to do with the shot, she was going to die that day, five days after vaccination anyway. That's how they roll. The patient died on 03Mar2021. The outcome of the event was fatal. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.; Reported Cause(s) of Death: she was going to die",Y,03/03/2021,,,,,,,N,02/25/2021,02/25/2021,0,,UNK,,,,,,USPFIZER INC2021438454,2,04/23/2021,,,, 1255747,04/25/2021,FL,,,,F,,"she had tested positive for the COVID-19 Virus after having her second dose of COVID-19 Vaccine; she had tested positive for the COVID-19 Virus after having her second dose of COVID-19 Vaccine; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) and on 29Jan2021 (Lot Number: EL9262; Expiration Date: May2021) and 19Feb2021 (Lot Number: EN6200; Expiration Date: Jun2021) both doses via an unspecified route of administration at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, on an unknown date, she had tested positive for the COVID-19 virus after having her second dose of COVID-19 vaccine. The patient reported that she underwent sars-cov-2 test on unknown date after second dose for which she was tested positive. She also reported that she underwent covid-19 PCR test on 15Apr2021 for which the report is negative. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.",,,,,,,,,U,02/19/2021,,,Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: After 2nd dose.; Test Date: 20210415; Test Name: Covid-19 PCR test; Test Result: Negative,UNK,,,,,,USPFIZER INC2021438747,2,04/23/2021,,,, 1255977,04/25/2021,CO,35.0,35,,M,,On 4-20-2021 I felt a deep pain in my lower left leg that increased until I went to the hospital on 4-22-2021. The pain is a deep throbbing pain that has caused swelling to where I cannot feel most of my left foot. I went to the hospital around 3 p.m. and they found I have Deep vein thrombosis of distal end of left lower extremity.,,,,,,,,,N,04/07/2021,04/20/2021,13,"On 4-22-2021 the following tests were conducted. They were CBC, CMP, PT INR, EKG, and US leg duplex venous left. I was prescribed Xarelto afterwards.",PHM,,None,None,None,,,2,04/25/2021,,,Y,None 1261420,04/27/2021,WI,,,,M,,"LOW THERAPEUTIC EFFECT; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced low therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low therapeutic effect was not reported. This report was non-serious.",,,,,,,,,U,,03/12/2021,,,OTH,,,,Comments: Unknown,,USJNJFOC20210446824,2,04/26/2021,,,, 1266056,04/28/2021,NJ,,,,U,,"Anaphylactic reaction; Sign and symptoms like severe migraine and stroke; Sign and symptoms like severe migraine and stroke; Liver enzyme abnormal; Yellowing of the eyes; Pulmonary deficits requiring BiPap Machine; This is a spontaneous report from a contactable Nurse (patient) A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunisation . Medical history included Allergy with Shellfish, dizziness, stroke, vertigo, Osteoporosis in cervical spine and thoracic spine, Chronic basilar migraine, asthma, hysterectomy, Myeloma tumor removal ,microcytic anaemia, Iron deficiency, Cataract removal and Abdominoplasty.Concomitant medication(s) included azelastine (AZELASTINE) Nasal spray 137 micro grams, ""22 per mere"" (not clarified) per day taken for an unspecified indication, start and stop date were not reported; estriol (ESTRIOL) at : 0.5 mg daily taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) at 10 mg daily taken for an unspecified indication, start and stop date were not reported; aceclofenac, paracetamol (ACIMOL [ACECLOFENAC;PARACETAMOL]) at 150 mg once a month taken for an unspecified indication, start and stop date were not reported; ubrogepant (UBRELVY) taken for an unspecified indication, start and stop date were not reported at 50 mg. The patient experienced anaphylactic reaction (hospitalization) on 27Mar2021 with outcome of not recovered , extreme red all over body, red face on 27Mar2021 with outcome of not recovered , shortness of breath; hard time deep breathing on 27Mar2021 with outcome of not recovered , Sign and symptoms like severe migraine and stroke on 27Mar2021 with outcome of unknown , liver enzyme abnormal on 27Mar2021 with outcome of unknown , yellowing of the eyes on 27Mar2021 with outcome of unknown , pulmonary deficits requiring bipap machine on 27Mar2021 with outcome of not recovered. The patient was hospitalized for anaphylactic reaction (anaphylactic reaction) from 27Mar2021 to 31Mar2021. The clinical course was reported as follows: ""When probed for second dose due date, Nurse stated, ""I am not getting the second dose I am still having reactions from the first dose. It started within 5 minutes and I went an anaphylactic, I was brought to Emergency room there at least 8 hours then went home on prednisone and Benadryl it's too ""intestacy me walker"" (not clarified) within 2 days I developed an extreme I was red all over, extreme red face completely body was red, shortness of breath having a hard time deep breathing and rushed back to the Emergence room, again for another anaphylactic reactions which I received ""Pfizer one"" (not clarified) in the Emergency room was put on BiPap Machine and the step down unit I developed severe migraine and I developed sign and symptoms of stroke like ""deficit""(not clarified). Then I was transferred through the rapid response to the intensive care, in the intensive care, my liver enzyme starting failing and I had severe abnormal, liver enzymes goes, yellowing of the eyes and I was having antihistaminic response I regained 15 pounds of fluids also, it's not administered to me my body did it on its own. It's was due to my reaction I still continue to have Pulmonary deficits, that's the breathing goes, requiring BiPap machine and requiring respiratory treatment I was receiving Benadryl 50 mg every 4 hours I.V, I was receiving Solumedrol every 6 hours around the clock and first I received Epinephrine shots I got in the beginning.Nurse stated, ""I was receiving Racine like too the epinephrine dose if it doesn't help, it helps you breath rest all the time by the way I was COVID negative. This is all from the vaccine.""When probed for date of Hospitalization, Nurse stated, ""The first day was 27Mar and then I went back end its 31st when I called my doctor, he told me to come in the evening.""When probed for vaccination date, Nurse stated, ""It's probably 1 o'clock in the morning."".Nurse added, ""I have not even told what happening to me in past two weeks. I have not even told you what happening to me in the past two weeks. I had more reactions heart been affected, liver been affected, eye sight been effected, track of life been affected, every organ of my body. What day I can walk, I can live thing, I want to know is that like to this medication how it is going to stop and nobody has this kind of issues as my body.""The patient underwent lab tests and procedures which included hepatic enzyme: abnormal on unkown date.Treatmente received for some events. Outcome of the events Anaphylactic reaction , extreme red all over body, red face, Shortness of breath; hard time deep breathing , severe migraine and Pulmonary deficits requiring BiPap Machine was not recovered the outcome of the other events was unkown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylactic reaction and the suspect drug BNT162B2. While causality for the other events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",,,,,Y,4,,,N,03/27/2021,03/27/2021,0,Test Name: Liver enzyme; Result Unstructured Data: Test Result:abnormal,UNK,,AZELASTINE; ESTRIOL; SINGULAIR; ACIMOL [ACECLOFENAC;PARACETAMOL]; UBRELVY,,Medical History/Concurrent Conditions: Abdominoplasty; Asthma; Cataract extraction; Chronic migraine; Dizziness; Hysterectomy; Iron deficiency; Microcytic anemia; Osteopetrosis; Shellfish allergy; Stroke; Tumor excision; Vertigo,,USPFIZER INC2021426376,2,04/27/2021,,,Y, 1273220,04/30/2021,CO,48.0,48,,F,,"Right transverse sinus thrombus with b/l subarachnoid hemorrhage. Presented with headache and seizure. Initially treated with heparin gtt 4/27, but changed to bivalirudin gtt 4/28. The patient remains on ICU 4/30 AM on bivalirudin drip and will be transitioned to oral anticoagulants if CT of head today is stable. Patient is recovering. She will require a stay at a rehab/skilled facility at discharge for continued recovery. She remains in hospital as of today (4/30/21)",,,Y,,Y,,,,Y,04/10/2021,04/27/2021,17,"CT Head 4/27/21, CTA head & neck 4/27, MRI brain 4/27/21, MRV bran 4/27/21 Labs: HIT antibody negative, drawn 4/28 Platelets 111 on 4/27/21 (baseline was 280 in November 2020)",PVT,,"clonazepam, co-q 10, Jardiance, Insulin, lacosamide, lamotrigine, lisinopril, lorazepam, MVI, Fycompa, simvastatin,",seizures,"seizure disorder, diabetes, hypertension, hyperlipidemia",,,2,04/30/2021,,,,"Keppra, reaction unknown to patient" 1275527,04/30/2021,CA,60.0,60,,F,,"severe joint and nerve pain in wrists, thumbs, and fingers. Blisters on fingertips (including thumbs). some swelling on bottom of feet. some stiffness in forearms. has lasted over a month from injection date. no such symptoms or problems ever before vaccine.",,,,,,,,,N,03/30/2021,04/03/2021,4,Saw doctor listed on previous page. Doctor said pain would subside. It has not. Date of doctor visit 4/12/2021.,PUB,,None,None,None,,,2,04/30/2021,,Y,,None 1275741,04/30/2021,CA,60.0,60,,F,,Persistent fingertip and toe swelling and erythema for over a month which is significant and persistent,,,,,,,,,N,03/30/2021,03/30/2021,0,NA,PUB,,Na,NA,NA,,,2,04/30/2021,,Y,Y,na 1276250,05/01/2021,MI,53.0,53,,M,,"ADVERSE EVENTS: dizziness ,nausea, vomiting, could'nt move neck, seizure, flat lined, aneurysm, Death. TREATMENT: Hospitilization with hundereds of tests. OUTCOME: DEATH on April 2, 2021",Y,,,,Y,,,,N,03/11/2021,03/24/2021,13,multiple tests were administered,PVT,,,,,,,2,05/01/2021,,,Y, 1276710,05/01/2021,,72.0,,,F,,"bruising on her arms and legs; blisters that bled inside her mouth; thrombocytopenia; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia), CONTUSION (bruising on her arms and legs) and MUCOSA VESICLE (blisters that bled inside her mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2020, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOCYTOPENIA (thrombocytopenia) (seriousness criterion hospitalization). On 19-Jan-2021, the patient experienced CONTUSION (bruising on her arms and legs) (seriousness criterion hospitalization) and MUCOSA VESICLE (blisters that bled inside her mouth) (seriousness criterion hospitalization). The patient was hospitalized from sometime in January 2021 to sometime in 2021 due to CONTUSION, MUCOSA VESICLE and THROMBOCYTOPENIA. At the time of the report, THROMBOCYTOPENIA (thrombocytopenia), CONTUSION (bruising on her arms and legs) and MUCOSA VESICLE (blisters that bled inside her mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Platelet count decreased: zero (abnormal) abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient was ordered by doctors to not leave her bed for over a week due to increased risk of fatal hemorrhage. Treatment included ""platelet treatments."" Patient was not showing signs of improvement after 10 days in the hospital. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",,,,,Y,,,,U,01/18/2021,01/19/2020,,Test Date: 202101; Test Name: platelet count was zero; Result Unstructured Data: abnormal,UNK,,,,,,"USMODERNATX, INC.MOD20210",2,04/28/2021,,,, 1276995,05/01/2021,,,,,M,,"sars-cov-2 test: positive; sars-cov-2 test: positive; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program . A male patient (reporter's father) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 17Feb2021 as single dose for COVID 19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot Number was not reported) via an unspecified route of administration as single dose for covid-19 immunization. On an unspecified date, the patient had a finger prick (at local pharmacy) and it came back positive. Patient blood was drawn at the Doctor office to test for IgG COVID-19 antibodies and was tested negative. The reporter was concerned that the negative antibodies test results could be due to a lack of efficacy and requested information on the vaccine coverage or vaccine efficacy in obesity population. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative and sars-cov-2 test: positive. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported Lack of Efficacy cannot be excluded. However, more information is needed regarding the date on which sars-cov-2 test was conducted. Once the information is received the case can be further reassessed",,,,,,,,,U,02/17/2021,,,Test Name: IgG COVID-19 antibodies; Test Result: Negative ; Test Name: finger prick; Test Result: Positive,UNK,,,,,,USPFIZER INC2021401257,2,04/26/2021,,,, 1284658,05/04/2021,WI,73.0,,,M,,"CLOTS IN LEG; PULMONARY EMBOLISM; FELT WEAK/WEAKNESS; WAS NOT FEELING GOOD; SPORADIC TIREDNESS; SORE ARM; This spontaneous report received from a patient concerned a 73 year old Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included exposure to agent orange with vision, high pressure in eyes, glaucoma, few eye surgeries, high cholesterol, high blood sugar, and pain in knees, and concurrent conditions included non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. Symptoms were started after 15 days of vaccination, the patient took a trip on 01-APR-2021 and was feeling ok. The patient returned on 16-APR-2021 from trip. On 17-APR-2021, the patient experienced fast heart rate and stated that he used to be a long distance runner and he felt like running marathon again but worst. On 17-APR-2021, the patient felt weak and faint, lightheaded. On APR-2021 the patient experienced sore arm. The patient went to hospital and then his wife continued to provide information over call. On 17-APR-2021, the patient was not feeling good and heart started racing. The patient and his wife waited for one day and on 19-APR-2021 patient went to hospital for check-up. The patient had to be released from hospital by 15:00, however by 20:00 the doctor called to patient's wife and told that patient rushed to intensive care unit (ICU) because they discovered one clot that disintegrated and went to both the lungs on 19-APR-2021 as the reason for patient's slow breathing and accelerated heart rate which were occurred on 17-APR-2021. The doctor said there were many other clots still in patient's leg on 19-APR-2021. The patient was prescribed a very strong anticoagulant in hospital and at home on a different anticoagulant. The patient was on very strict regimen with no exercise. On APR-2021, the patient experienced weakness, difficulty breathing and sporadic tiredness. The patient was admitted on 19-APR-2021 for 4 days and discharged on 22-APR-2021. Laboratory data included: Electrocardiogram (EKG) (NR: not provided) Blood clots in both lungs and leg and lots of other test performed at hospital which were unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, and the outcome of sore arm, felt weak/weakness, was not feeling good and sporadic tiredness was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s-1) Pulmonary embolism. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 2)-Clots in legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).",,,Y,,Y,4,,,N,,04/01/2021,,Test Date: 20210419; Test Name: EKG; Result Unstructured Data: Blood clots in both lungs and leg,OTH,,,Abstains from alcohol; Non-smoker,Medical History/Concurrent Conditions: Blood sugar increased; Exposure to toxic agent; Eye operation; Glaucoma; High cholesterol; Increased intraocular pressure; Knee pain; Comments: the patient had no known allergies.,,USJNJFOC20210455700,2,05/03/2021,,,, 1284863,05/04/2021,FL,57.0,,,M,,"anaphylactic allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 13:30 (Batch/Lot Number: ER8736) as SINGLE DOSE for covid-19 immunisation, 57 years old. Medical history included Parkinson's disease, Melanoma Cancer, Small Cell cancer in liver, allergies: Penicillen, and allergies: Peanuts from an unspecified date. Concomitant medications included carbidopa, levodopa (CARBIDOPA LEVODOPA); escitalopram oxalate (LEXAPRO); omeprazole; dutasteride (DUTASTERIDE), taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced allergies. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. No other vaccines in four weeks. On 25Apr2021 13:45 (also reported as after about one minute after injection) patient went into an anaphylactic allergic reaction with symptoms of throat constricted, could not breathe, and Dizziness. The patient was given EPIPEN injection by pharmacy employee and was taken to local ER by ambulance. Patient was given care by ER staff via steroid IV and other medications. Patient had another anaphylactic reaction with same throat closure and EPIPEN was used and taken to local ER on 28Apr2021. Two identical allergic reactions with 4 days was noted. Patient have refilled his two EPIPENs as instructed by his PCP. Event required visit to doctor or other healthcare professional office. Outcome of the event was not recovered. Seriousness criteria was provided as life-threatening.",,,Y,,,,,,N,04/24/2021,04/25/2021,1,,PHM,,CARBIDOPA LEVODOPA; LEXAPRO; OMEPRAZOLE; DUTASTERIDE,,Medical History/Concurrent Conditions: Liver carcinoma; Melanoma; Parkinson's disease; Peanut allergy; Penicillin allergy,,USPFIZER INC2021476772,2,05/03/2021,,Y,Y, 1288451,05/05/2021,FL,51.0,,,F,,"Unknown cause of death; Cataract; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Oct2020 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus-diagnosed 10-15 years ago, ongoing asthma-all her life, Allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), and obesity. The patient's concomitant medications were not reported. The patient had a cataract surgery a couple of weeks prior on an unspecified date and on 21Apr2021, died of unknown cause. The reporter's mother was part of one of the clinical trial groups for the Pfizer COVID vaccine, and she died suddenly and unexpectedly last week. They did blood work with her family physician last week. It was fine. They didn't believe it was something she had going on. There were no indicators for why she died. She had lost a lot of weight, but she was trying to lose weight - she had been trying the past 3-4 years. Her blood work at the doctor before she died was the best her blood work had been in years. She had a physical, the week previous with our family doctors and the doctor had no reason to suspect that anything was about to happen. Medical examiner basis, they say because there is no drug overdose, they declined to do autopsy, but she has been part of trial and just dying suddenly unexpectedly. The family doctor doesn't know what to put on the death certificate. There were no drugs and no foul play involved so they won't do an autopsy. She was in the Pfizer clinical trial group. The doctor's office is supposed to report through CDC. His father reached out yesterday to the clinic group, but they haven't heard anything back. He is unsure of the exact dates she was given the vaccine. He thinks the first one was Sep2020, and the last one was Oct2020. Later on, she did receive paperwork that she did receive the vaccine, and not the placebo. It told her she got the vaccine and didn't need to be revaccinated. He is wondering if Pfizer will do an autopsy to see why she passed. His mom wanted to be cremated so once that happens, there won't be much information at that point. They are trying to hold off to see if Pfizer wants to do an autopsy. The doctor has no clue what happened. The doctor doesn't know what to put on the death certificate. At 2:45, 2:50, and 3:06 her fit bit just stopped. She has been at the funeral home since Wednesday. He is sure the funeral home would like to get started with something. They can't move forward with cremation until they know for sure. Therapeutic measures were taken as a result of cataract. The outcome of the event cataract was unknown. The patient died on 21Apr2021. Autopsy was not performed. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Unknown cause of death",Y,04/21/2021,,,,,,,N,10/01/2020,,,"Test Date: 20210421; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Comments: 430 on 21Apr2021 already past at that point.; Test Name: weight; Result Unstructured Data: Test Result:Lost; Comments: She had lost a lot of weight, but she was trying to lose weight. She had been trying the past 3-4 years.",OTH,,,Asthma (all her life); Diabetes (diagnosed 10-15 years ago),Medical History/Concurrent Conditions: Allergy; Chromosome disorder; Endocrine disorder (including diabetes); Immune system disorder; Obesity; Respiratory disorder,,USPFIZER INC2021482196,2,05/04/2021,,,, 1288831,05/05/2021,MT,70.0,70,,M,,The pharmacy was contacted by the local health department and this is what was relayed: Patient started having leg pain and swelling on 5/1 and was concerned that it may be a blood clot. Patient then reported to the urgent care and saw. I spoke with this provider and she said that a DVT in that leg was confirmed via ultrasound and the patient was discharged with xarelto.,,,,,,,,,U,04/11/2021,05/01/2021,20,Please contact provider at the contact info provided to verify test results and patient diagnosis.,PHM,,None reported to pharmacy. does not fill his meds here,None reported. Primary care physician that saw him for the DVT states he has a history of PE and has a cardiac stent.,Provider that saw patient for reaction stated history of PE and cardiac bypass surgery with stent,,,2,05/05/2021,,,Y,No allergies reported on intake form when he received his vaccine 1294684,05/07/2021,MI,22.0,,,F,,"face and neck swells; face and neck swells; Tachycardia; feels like she is having an asthma attack.; blotch; blood counts continue to become worse; asthma worse; White blood cell counts are all elevated; A lot of bone pain; some trouble breathing; chest pain; dark purple on face; Ginormous welts/Rash or welt 1.5 inches by 1 inch on cheek; Itching in back of throat; anaphylactic reaction; anaphylactic shock; ginormous rash on her daughter's face that comes and goes and then it will be on her chest , face, neck and shoulders and migrates wherever; throat feels tight; This is a spontaneous report from a contactable consumer (patient's mother) and consumer (patient) via a Pfizer-Sponsored Program, . A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 17Apr2021 at 09:10 (at the age of 22-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included penicillin allergy from an unspecified date and unspecified if ongoing, asthma from an unspecified date (diagnosed at 4 years old and it is usually controlled with medications) and ongoing and Ehlers-Danlos syndrome from 2019 and ongoing. Concomitant medications were reported as none. The patient did not receive any additional vaccines on the same date as the COVID-19 vaccination and did not receive any vaccinations within 4 weeks prior to the COVID-19 vaccination. The patient previously received the flu shot on an unspecified date for immunization and experienced allergic to flu shot preservative and the patient previously received Biaxin on an unspecified date for an unspecified indication and experienced allergy. On 17Apr2021 at 09:12 the patient experienced anaphylactic reaction and anaphylactic shock; on 17Apr2021 the patient experienced throat feels tight, ginormous rash on her daughter's face that comes and goes and then it will be on her chest , face, neck and shoulders and migrates wherever; on 18Apr2021 the patient experienced ginormous welts/rash or welt 1.5 inches by 1 inch on cheek, itching in back of throat; on 20Apr2021 the patient experienced dark purple on face; on 24Apr2021 the patient experienced some trouble breathing and chest pain; on 25Apr2021 the patient experienced a lot of bone pain; on 26Apr2021 the patient experienced white blood cell counts are all elevated and on unspecified dates the patient experienced face and neck swells, tachycardia, feels like she is having an asthma attack, blotch, blood counts continue to become worse and asthma worse. The reporter called to report that her daughter received the first dose of the COVID-19 vaccine on 17Apr2021 and that her side effects started two minutes later (also reported as 4 minutes later). The patient experienced anaphylaxis and anaphylactic shock. She stated that her daughter continued to have anaphylactic reactions and had to go to the hospital every day since then. The clinical course was reported as follows: her daughter and her husband went to get the vaccine together on 17Apr2021. They went to a facility giving the Pfizer vaccine, and the reporter stated that her daughter was asked, and she did tell them, that she could not receive the flu vaccine that had the additives in it because she was allergic to it. The reporter stated that her daughter was not taking the flu shot for years. She stated that her daughter was allergic to Biaxin but could take Zithromax because of the different additives. They had no idea what the preservative was, but it was obviously in the flu shot so they stopped getting the flu shot until they stopped putting the preservative in the vaccine. The reporter stated that her daughter received the COVID-19 vaccine and within two minutes her daughter told her dad that she was having a hard time breathing. Her daughter walked over to the city EMS who were on site and told them that she was having a hard time breathing. They treated her and then took her to hospital via ambulance. She was treated at the hospital and they were hesitant to discharge her because they were worried about her bounce back. This was exactly what has happened. Every night since the vaccine she has had to take her daughter into the hospital. Every day was a nightmare of either EpiPen injections, Tagamet, Benadryl or prednisone and ended up in the ER every day, where they give her IV Benadryl and send her home. The caller stated that her daughter's symptoms start with ginormous welts and then an itching to the back of the throat. She had seen a ginormous rash on her daughter's face that came and went and then it would be on her chest, face, neck and shoulders and migrated wherever. She saw dark purple on her daughter's face yesterday before she went to the ER. Her skin will blotch, and she will say that her throat feels tight like when she had a reaction to penicillin. She stated that her daughter used to get this when she they would give her penicillin; she would have that reaction every time she got penicillin and they finally said she was allergic to it. The caller states that after those symptoms started, she called EMS and they took her to a hospital. The caller stated she took her daughter to another hospital and they medicated her with IV Benadryl and fluids. Her primary care doctor told the emergency room staff to discharge the patient and that he would give her specific medications to go home with. He called in the medications, but they did not work. He gave her specific medication that did not work, half of her face was turning purple. The purple face was then replaced by an area approximately 1 inch wide on cheek between temple and the jaw. It was 1.5 inches long and was red and looked like a rash or welt. The patient would take an inhaler when she started to have breathing difficulties. That was when the reporter was like ""here she goes again"". It felt like it almost made her asthma worse and had to treat that as well. There was a little oddity when they did blood work on her daughter and her white blood count was high and was probably her body reacting to the COVID-19 vaccine. So, she went back to the hospital. The nurses said there was nothing they could do for her, and she needed to find an allergist. The reporter stated that she was tired of the ER visits and wanted her daughter to get better. She stated that she doubled the dose of her daughter's Tagamet. She stated that the patient's face and neck swells and she would get tachycardia. The reporter stated that she would not take her daughter to the hospital anymore. The hospital did not think it could be related to the vaccine, but she had not done anything else. The reporter wanted to report this event because she did not think people were taking this seriously. She stated that no one believed it was related to the vaccine, so they were not getting help. She wanted to know if this was a side effect and what could she do about it. She also inquired on whether her daughter should get the second shot. She stated that her daughter would not get the second shot. She had heard that if you had any reaction to the vaccine, then you should not receive the second dose. Her daughter's doctors have told her to receive the second vaccine. The reporter also stated that she wondered if this was some mast cell activation due to Ehlers-Danlos syndrome. The reporter also asked if Pizer made a preservative free vaccine. Upon follow-up received on 27Apr2021, the patient called to report that she was still experiencing side effects from the anaphylactic reaction and it had been 10 days since administration. She was told it would last about 4-10 days and then be gone, but it had continued, and it had been over 10 days. She had no new symptoms, other than a lot of bone pain. The bone pain made it feel like her bones were shattering. She went to the ER yesterday where they did blood work and said that all of her white blood cell counts were elevated. The anaphylaxis lasted from 17Apr2021 and subsided in that sense on 24Apr2021. Since then she still had the chest pain, some trouble breathing, and felt like she was having an asthma attack. She had been back and forth to the ER several times since 17Apr2021. The ER kept ruling her symptoms as a reaction to the vaccine. She had been using epinephrine as needed. The patient stated that she was not planning on receiving the second dose due to her reaction. She wanted to know where she should go from here. She wanted to know if this would last forever and how much longer could her symptoms last. The clinical outcomes of the events ginormous welts/rash or welt 1.5 inches by 1 inch on cheek, itching in back of throat and a lot of bone pain were not recovered/not resolved; dark purple on face was recovered/resolved on 21Apr2021; outcomes of all other events were unknown.",,,,,,,,,N,04/17/2021,04/17/2021,0,Test Name: Height; Result Unstructured Data: Test Result:155cm; Test Date: 20210426; Test Name: Blood work; Result Unstructured Data: Test Result:Elevated; Comments: All White Blood Cell Counts Elevated,UNK,,,Asthma (Diagnosed at 4 years old and it is usually controlled with medications.); Ehlers-Danlos syndrome,Medical History/Concurrent Conditions: Penicillin allergy,,USPFIZER INC2021444126,2,05/06/2021,,Y,Y, 1299107,05/08/2021,OH,45.0,,,F,,"Allergic swelling of young and throat; Allergic swelling of young and throat; Shakes; Numbness on right side of face; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies to gluten and dairy, covid prior vaccination and Mthfr. There were no concomitant medications. The patient has no other vaccine in four weeks and no other medications in two weeks. The patient experienced shakes, numbness on right side of face and allergic swelling of ""young"" (as reported) and throat on 20Apr2021 at 22:00. The events were treated with Benadryl. The patient was not tested for covid-19 post vaccination. The outcome of the events was recovered with sequel on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",,,,,,,,,N,04/20/2021,04/20/2021,0,,PVT,,,,Medical History/Concurrent Conditions: COVID-19; Gluten sensitivity (allergies: Gluten. Dairy); Milk allergy (allergies: Gluten. Dairy); MTHFR gene mutation,,USPFIZER INC2021448930,2,05/06/2021,,,, 1299334,05/08/2021,OH,36.0,,,F,,"blood clots and I suffered a pulmonary embolism.; blood clots and I suffered a pulmonary embolism.; pain; Maternal exposure during pregnancy, third trimester; other vaccine same date: Pfizer, Er8732, 03/Mar/2021, dose number 2; This is a spontaneous report from a contactable consumer (patient). A 36-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:15 (Batch/Lot Number: En6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: Er8732) as single dose for covid-19 immunization. Medical history included ITP as a kid. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received Synthroid 100mg and Prenatal Vitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. Her Last menstrual date was 21Jul2020 and delivered on 16Apr2021. Gestational period was 38 weeks. Since the vaccination, the patient has been tested for COVID-19. On 12Apr2021, the patient had tested Oral swab which was Negative and on 23Apr2021, Nasal Swab was tested and result was Negative. On Friday 23Apr2021 21.00, the patient was rushed to ER by ambulance, where they found blood clots and she suffered a pulmonary embolism. She was admired critical and later sent home to manage pain in blood thinners. With zero history of blood clots. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3 days. The patient was treated with Hephrin and blood thinners for at least 3 months. The patient was recovered with lasting effects. Outcome of events thrombosis, pulmonary embolism, pain was recovered with sequelae and other events were unknown. No follow-up attempts are needed. No further information is expected.",,,Y,,Y,3,,,N,03/03/2021,03/03/2021,0,Test Date: 20210423; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210412; Test Name: Oral swab; Test Result: Negative,OTH,,SYNTHROID,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19.); Idiopathic thrombocytopenic purpura",,USPFIZER INC2021487244,2,05/05/2021,,,Y, 1301802,05/10/2021,PA,36.0,36,,F,,"Patient received Pfizer COVID-19 vaccine on 12/27/2021 and 01/17/2021. Previously checked for COVID-19 infection 12/13/2020, 01/23/2021 and 04/06/2021 and was negative on each test. On 01/18/2021, patient states she had low-grade fever, fatigue, myalgia. Took Tylenol. Patient contacted office on 01/22/2021 stating the night prior (1/21/2021)her heart rate was up to 209 and had numbness and tingling in both upper extremities. Also with sharp pain down her legs and her hands were very cold. Patient had started taking a Kelp supplement on 01/21/2021 which was recommended by a provider. Reported later reported that she ""felt like a truck hit her."" She also noted onset of chest pain. She went to urgent care for evaluation 1/22/2021. Patient felt lightheaded while in urgent care as she was about to have her blood pressure taken and passed out for approximately 2-3 minutes. Ammonia inhalant was used and patient woke up. During evaluation by physician, patient had another few seconds of loss of consciousness. No tonic clonic movements. No tongue biting. Patient was seen at urgent care and had syncope times 4 episodes. Patient was not postictal. No evidence of seizure-like activity. No urinary incontinence or tongue biting. She felt like she was going to pass out and mention to the urgent care staff . Patient was transferred to the ED for further evaluation. Was admitted under observation. It was felt that the initial episodes of syncope may have had a psychogenic component due to history of pseudoseizures/convulsive syncope. Cardiac enzymes were negative. Ultrasound negative for DVT. D-dimer negative. Chest pain was reportedly reproducible on admission. Was given diagnosis of costochondritis. Received Toradol, tramadol, Ativan. Orthostatics were performed in the morning after admission for observation and she passed out while standing. Was given 1 L IV fluids with resolution of orthostasis and blood pressure subsequently remained stable. There was report of tachycardia. It was felt that the tachycardia was due to reflex tachycardia in the setting of vasovagal syncope. Patient discharged on ibuprofen and Tylenol p.r.n. COVID-19 test negative at that time. Patient also admitted to Hospital 01/31/2021 through 02/01/2021 due to chest pain. Also had seizure-like activity in CT scan. Seen by Neurology. Patient was able to remember what she thought to be ?seizure?. She was asked to raise her arms while getting her CT and when she did she feel that her ?arms got frozen?. And that she could not talk while she was still hearing people around. She said ""everything went south"". She remembered the attending and her getting back to normal immediately afterwards. When patient seen by nurse on the medical floor nurse has described her to be alert oriented x3. CT brain: No acute abnormalities Driver's license has been suspended for at least 6 months through 08/2021. On follow-up visit via video visit 02/18/2021, patient reported ongoing shortness of breath at at rest as well as chest pain also with palpitations. Also noted lightheadedness with ambulation. Patient seen by Cardiology 03/12/2021. Holter monitor 03/16/2021 with few isolated PACs. Pharmacologic stress test 03/2021 negative for ischemia with EF 70%. 2D echo (03/16/2021) with normal EF. No significant valvular abnormalities found. Suggested chest pain may be due to costochondritis. Seen in the office on follow-up 04/01/2021. Noted coldness of hands and feet since 01/22/2021. Ultrasound bilateral lower extremities negative for DVT 01/2021. Onset of discoloration of feet 03/26/2021. Also noted occasional muscle spasms and cramping of the right lower extremity below the knee. Noted particularly metatarsals and lateral surface of right lower extremity. Referred for lower extremity PVR ( 4/7/2021) showed elevated arterial pressures throughout both lower extremities suggesting non-compressibility. ABIs therefore unreliable. Strong pulsatile waveforms are maintained metatarsal region bilaterally suggesting no evidence of a arterial insufficiency at rest. Flat line digital waveforms suggest small vessel occlusive disease or vasospasm. X-rays of the toes negative for significant abnormality. Patient referred to vascular surgery for urgent evaluation. patient also refer to Rheumatology on 04/07/2021. On follow-up 04/07/2021 patient continue to note ongoing chest pain as well as shortness of breath. Patient started on aspirin 81 mg p.o. Daily on 03/25/2021. Shortness of breath is constant, unable to walk prolonged distances. Distal 2nd digits bilateral feet are deeper purple in color compared with prior visit 04/01/2021. Noted paresthesias of entire body from head to toes. Noted cold intolerance for few weeks intermittently. Notes discoloration hands from wrist to fingers and below knees to toes. States her extremities are ?freezing.? Was using a heating pad. States when she washes her hand in warm water the discoloration improved. During hospitalization CTA chest ( 01/31/2021) was negative for PE. Showed nonspecific, bilateral axillary subcentimeter lymph nodes. Minimal right breast calcification. Patient states she had mammogram performed 01/2021 and no significant abnormalities found. Patient followed at doctors. Hematology/Oncology aware of CT chest findings. Notably patient received COVID-19 vaccination prior to CT chest. Repeat CT chest requested by insurance however denied by insurance company. Left axillary ultrasound 04/26/2021 showed small axillary lymph nodes which have a relatively benign morphology. The largest node is actually decreased mildly in size when compared to 01/31/2021. Right axillary ultrasound 04/26/2021 showed small axillary lymph nodes as seen previously with 1 top normal size round lymph node with an indeterminate morphology but unchanged in size when compared to 01/31/2021. Patient has not been able to work since 04/01/2021 due to overall symptoms. Previously was working from home. Also works as an MA but discontinued in 02/2021 with onset of symptoms in 01/2021. On evaluation 04/07/2021 patient noted to have tenderness palpation along left lower quadrant. Initial CT abdomen and pelvis was denied by insurance company. Abdominal ultrasound 04/13/2021 unremarkable. Patient seen by vascular surgery on 04/12/2021 and recommended patient to start applying nitroglycerin to toes as well as initiation of a Plavix 75 mg daily. Also agreed with referral to Rheumatology. Patient has not yet received an appointment. Information was faxed to Rheumatology however referral was also placed by vascular surgery to rheumatology group. On evaluation in office 04/28/2021, patient reported chest pain all night where she ""felt like something sitting on her chest"" with associated shortness of breath. Radiated to neck. Also noted intermittent palpitations which can last for 5 minutes with associated chest pain. Notes left groin pain for the last 2 days. Symptoms lasted 2 hours, from 11:00 p.m. to approximately 1:00 a.m. and patient subsequently fell asleep. On awakening patient continues to notes chest tightness but less. Patient feels weak today. While patient was being examined on the examination table patient appeared weak and stated that she felt like she was going to pass out. Then noted left arm numbness. When asked to raise arms, left arm elevation less compared with right. However subsequently patient had difficulty elevating both arms. Patient also not moving both lower extremities to command. With cranial nerve testing, cranial nerves 2-12 intact except patient was unable to smile on command however while patient was crying facial muscles appeared symmetric. Repeat BP 120/78 with heart rate 75 and O2 sats 99% on room air. Blood pressure repeated another 5 minutes was 115/75 with heart rate of 76. patient referred to the ER for immediate evaluation by ambulance. Patient has been admitted to the hospital since 04/28/2021. On 4/28/2021, patient noted bruising along right brachial area, right upper extremity distally as well as left medial thigh. Noted dry patch along dorsum of left foot with associated redness for the last 3 days. Purplish discoloration of 2nd left digit and 2nd right digit had subsided since this weekend prior to visit 4/28/2021 and area is now scaly on both toes. Has been using nitroglycerin b.i.d. to toes since 04/12/2021 at recommendation of vascular surgery. States per patient's coloration of feet bilaterally improves with exposure to warm water. Also has been elevating the lower extremities. Noted significant constipation for which patient was seen by GI. Has been using Metamucil and MiraLax. States constipation persists. States she has to use a step stool to elevate her legs when trying to have a bowel movement. States she spent a long time in the bathroom when she has to have a bowel movement. Also notes bright red blood per rectum with each BM with wiping as well as on the stool. States she did not have bright red blood per rectum at time of recent GI evaluation. EGD/colonoscopy was initially scheduled for 05/14/2021 prior to admission to hospital.",,,,,Y,13,,,N,01/17/2021,01/21/2021,4,See item 18.,PVT,,"Kelp supplement, Naprosyn 550 mg p.r.n., Imitrex 100 mg p.r.n., Topamax 100 mg p.o. q.a.m. and Topamax 150 mg p.o. Q p.m..","On 12/11/2020 patient contacted office in reported intermittent left-sided and midsternal chest pain x4 days. emesis daily. Intermittent shortness of breath with and without chest pain. Noted when she takes a deep breath she feels ""like I was punched."" Total body muscle aches especially in shoulders and chest. Patient evaluated in urgent care 12/13/2020 due to above symptoms. Patient noted body aches, cough, runny nose, abd pain, vomiting, looser stools, generalized abdominal pain. COVID-19 test ( 12/13/2020) negative. Patient diagnosed with viral syndrome.","Migraines, seizure disorder, pseudoseizures/convulsive syncope ( 10/2015, 04/2018, 6018 and possibly 01/2021), white matter abnormality on MRI brain with negative spinal tap 02/2019, followed by Neurology, anxiety/depression, bipolar disorder",,,2,05/10/2021,,,,Gadolinium containing contrast media 1303282,05/10/2021,MI,61.0,61,,F,,"On approximately April 9, 2021 I came down with severe abdominal pain, as I had no prior experience with this pain, I felt it would pass. The pain was predominately at night while laying down and would occur between 3-4 am . The pain did not pass. I went to the emergency room on April 15, where i told them I had the J& J vaccine and was now experiencing the abdominal pain which was in the time frame for the side effects of the J& J vaccine. They did a CT scan, it showed diverticulitis with an abscess. I had no previous issue with diverticulitis until this time, my diet had not changed either. I was admitted to the hospital for treatment",,,,,,,,,U,03/20/2021,04/09/2021,20,"April 15, 2021 CT scan of abdomen and pelvis as well as blood work. Blood work continues to this date.",PHM,,"B Stress complex, Vit. D, Folic Acid, Krill oil, Vitamin C,",None,Anemic,,,2,05/10/2021,,,,"Xylocaine, Novacaine" 1303430,05/10/2021,NH,31.0,31,,F,,"It started on my birthday - I started having contractions - I was only 23 weeks pregnant. I was admitted to the hospital for pre-term labor on - March 6, 2021; (date of delivery removed). Pregnancy history - 2nd pregnancy - first - abortion - four years ago. Estimated due date - June 29, 2021 . I was re-admitted to the hospital two days later for a delayed post delivery hemorrhage - after that I had a pretty typical recovery, I think.",,,,,Y,5,,,N,02/26/2021,02/28/2021,2,Hospital - blood cultures - were taken - I have not been able to seen the results of these. Some test I don't have access to because they are not giving me my son's medical records. They are waiting for documentation - and there seems to be a lot of red tape.,OTH,,Wellbutrin; Prenatal vitamins,no,no,,vsafe,2,05/10/2021,,Y,,no 1305488,05/11/2021,TX,37.0,37,,M,,"I am still having severe headaches, sensitivity to light, fatigue, hypersomnia. Report #498529. I am unable to sleep well. I have till now been to work or been able to drive since 4/13/21. I visited ophthalmologist om5/7 and he stated I have optic nerve inflammation and could be a number of concerning etiology, but definitely something wrong. Recommended lumbar puncture and MRV with contrast. Visited neurology 5/10/21 and after test he recommended lumbar puncture and MRV. MRV taken same day",,,,,,,,Y,N,04/12/2021,04/13/2021,1,"Meds, iv, blood work twice, toradol for pain, Neurology visit twice, ophthalmologist visit, MRI and MRV.",PHM,,Trintellix,,,,,2,05/11/2021,,Y,, 1306208,05/11/2021,NC,63.0,,,F,,"On the floor in the store; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is spontaneous report from contactable consumer. A 63 years old female patient reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9269) on 05Feb2021 12:30 at right arm for COVID-19 immunization. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed in 2019 and ongoing asthma diagnosed in 2019. Family history included some heart problems and cancer. Concomitant drugs were not provided. She says she waited the 15 minutes after the vaccine and felt fine. She then went to the store. She ended up on the floor at the store, her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She was freezing and could not get warm. They put warming blankets on her. She had to be taken out of the withheld by ambulance; she thought she was having a stroke. All of her tests at the hospital were negative. They did a MRI and a CT Scan and everything was fine. The time she got her vaccine to the time they had to call the ambulance was about an hour. They symptoms lasted a couple of hours, then they were gone. She states that at that time Pfizer was saying to wait two weeks between the first and second vaccine; because of her event she was told to wait three weeks. States that she missed that vaccine because her son passed away. She didn't know if she has to start over again with the first vaccine; or if she can just go get the second vaccine that she missed. Her experience with the first one was scary; but her tests were all negative. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. The patient stated that the Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The Emergency Room doctor told her that he wouldn't get it if he had a reaction like hers. The outcome of the events was recovered on 05Feb2021. No follow-up attempts are needed. No further information is expected.",,,,,,,,,Y,02/05/2021,02/05/2021,0,Test Date: 20210205; Test Name: CT scan; Test Result: Negative ; Test Date: 20210205; Test Name: test; Test Result: Negative ; Test Date: 20210205; Test Name: MRI; Test Result: Negative,OTH,,,Asthma; COPD,Medical History/Concurrent Conditions: Cancer; Cardiac disorder,,USPFIZER INC2021489084,2,05/10/2021,,,Y, 1306632,05/11/2021,MN,49.0,49,,F,,Patient presented to the ED with bowel obstruction and was subsequently hospitalized within 6 weeks of receiving COVID vaccination.,,,,,Y,2,,,,01/27/2021,02/23/2021,27,,WRK,,,,,,,2,05/11/2021,,,Y, 1307083,05/11/2021,,62.0,62,,M,,"Facial droop, CVA (cerebral vascular accident); Facial weakness ALTERED MENTAL STATUS DIZZINESS HEADACHE",,,,,Y,,,,,04/21/2021,04/29/2021,8,,PVT,,,,,,,2,05/11/2021,,,Y, 1307098,05/11/2021,,90.0,90,,F,,"Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Thrombocytopenia, unspecified Hyponatremia AKI (acute kidney injury) ABDOMINAL PAIN",,,,,Y,,,,,03/25/2021,04/13/2021,19,,PVT,,,,,,,2,05/11/2021,,,Y, 1307218,05/11/2021,NY,59.0,59,,M,,"Pt experienced severe generalized pain day after getting vaccine, symptoms worsened with additional symptoms of chest pain, shortness of breath, painful inspiration over the 7 days following vaccine. Sent to ER from office day 8 and was admitted with diagnosis of sepsis, pneumonia, ground glass appearance on cxr, cardiomegaly, delirium, new onset atrial fibrillation, acute renal failure.",,,Y,,Y,7,,Y,N,04/14/2021,04/15/2021,1,"04/22/2021 CXR with cardiomegaly, Pneumpnia, Ground glass appearance on cxr. EKG rapid atrial fibrillation after few hours in ER. Became delirious few hours after admission and required intubation for several days",PVT,,none,HTN,HTN,,,2,05/11/2021,,Y,Y,none 1308272,05/11/2021,PA,79.0,79,,M,,"WHEEZING, FATIGUE, COPD, PNEUMONIA,COUGH",,,,,Y,10,,,N,01/25/2021,02/04/2021,10,"Probable COVID-19 (Resolved) Specimen information: Swab / Nares Added: 2/4/2021 by POCT COVID-19 Antigen (Collected 02/04/21) Onset date: 2/4/2021 Resolved: 2/18/2021 (Expired) ED to Hosp-Admission Discharged 3/23/2021 - 3/26/2021 (3 days) Hospital Last attending ? Treatment team Pneumonia Principal problem Discharge Summary (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 3/23/2021 Length of Stay: 2 Days Discharge Date: 3/26/2021 HPI: Patient is an 79 y.o. male with past medical history of hypertension, orthostatic hypotension, multiple syncopal episodes in the past, history of hyperlipidemia, COPD, history of aspiration pneumonia, history of cancer of the tongue and throat status post surgery as well as currently on a PEG tube feeding comes to the ER at this time with feeling weak and tired and as per the wife patient is a pneumonia which was diagnosed 2 weeks back has not cleared yet. Chest x-ray also showed worsening of the infiltrates on the right lower lobe followed by which patient has been given Levaquin and we have been called for further evaluation management. Seems that just before previous admission patient was diagnosed with COVID-19 along with rest of the family and was treated with monoclonal antibodies. X-ray shows a worsening of the right basilar infiltrate, as well as leukocytosis of 12.5, and mild hyponatremia. He is also anemic from 10.3 on last discharge 11 March to 8.8 today. Hospital Course: 70-year-old male with past medical history of hypertension history of orthostatic hypotension dyslipidemia COPD history of PEG tube placement history of recurrent aspiration pneumonia presented with weakness. Please review H&P done by admitting hospitalist for details. Patient admitted for aspiration pneumonia dehydration, patient seen by ID, recommended IV antibiotics with Levaquin for 5 days, patient will be discharged on p.o. Levaquin for 3 more days, oxygen was weaned off currently on room air since yesterday. Patient has issues with aspiration pneumonia , patient was advised to get a tracheostomy last year, patient need to follow with ENT outpatient basis. ED to Hosp-Admission Discharged 4/27/2021 - 4/30/2021 (3 days) Hospital Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Hospital Course HPI: Patient is an 79 y.o. male with past medical history of orthostatic hypotension, aspiration pneumonias, malignancy of the tongue and throat status post surgery currently on PEG tube feeding presented to the ER with shortness of breath, generalized weakness, and cough. He was recently just discharged on 3/26/2021 for aspiration pneumonia at that time. He was on Levaquin. He was advised to get a tracheostomy last year and was told to follow-up with ENT as an outpatient. Denies any significant sputum production. SOB with rest, worse with exertion. Denies any fevers, chills. He did have Covid a few months ago. Denies recent weight loss or weight gain. Seen by ENT and had a scope showing no significant mucus. Led them to believe he isn't having further aspiration episodes. Patient states has a very dry mouth. Hospital Course: Patient was admitted to medical floor initially for cough and shortness of breath. Initial CT chest revealed right lung mass. Pulmonary was consulted, pulmonary was on the impression that the mass looked more like an abscess. Surgery was consulted as well as IR. On April 29 patient patient was taken to IR for abscess drainage versus possible mass biopsy, IR was able to drain 17 mL of purulent fluid from the abscess, cultures were sent out and results are still pending. Pigtail was left in abscess but nothing more is draining out. Patient returned from procedure yesterday on room air, his breathing improved but patient was struggling with pain in the area. Late evening yesterday however patient became more short of breath and was requiring more oxygen. Chest x-ray stat revealed mild congestion and bilateral pleural effusion right greater than left. By this afternoon patient is now requiring high flow oxygen 35 L FiO2 70% patient is only maintaining saturation of 92% on current high flow settings. Repeat stat chest x-ray showed worsening of right pleural effusion. Pulmonary and surgery are both aware of situation, surgeon recommended getting patient transferred to tertiary facility. Family requested a different Medical Center specifically because patient is known to their facility. I have spoken with thoracic surgeon at tertiary hospital, anesthesia/SICU attending Dr, and medical ICU Dr, initial concern was for hemothorax. However we had repeated CBC and patient had elevated WBC at 22,000, hemoglobin actually increased to 9.9 instead of decreasing. Due to patient's medical complexity and rapid worsening of his condition, patient was accepted to the medical ICU whenever a bed becomes available. Accepting physician is Dr. but medical ICU patient may overflow to ICU. Hospital specialists recommended for patient to be stabilized here at this hospital with having surgeon place a chest tube to relieve the pleural effusion while patient is awaiting transfer. Update at 6:39 PM: Medical Center had called us back, both Dr. are now unable to accept patient due to lack of ICU bed and to at least tomorrow if not longer, especially patient's critical condition. I have called another hospital and spoke with medical ICU attending Dr. in ICU does have beds available, patient is excepted for transfer to different hospital after 8 PM this evening. Surgery is in with patient now putting in chest tube. Wt Readings from Last 1 Encounters: 04/30/21 85.2 kg (187 lb 13.3 oz) Physical Exam Vitals reviewed. Constitutional: General: He is awake. He is in acute distress. Appearance: He is normal weight. He is ill-appearing and toxic-appearing. Interventions: Nasal cannula in place. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds, S1 normal and S2 normal. No murmur heard. Pulmonary: Effort: Tachypnea and respiratory distress present. Breath sounds: Examination of the right-middle field reveals decreased breath sounds. Examination of the right-lower field reveals decreased breath sounds. Decreased breath sounds and rhonchi present. Abdominal: General: Abdomen is flat. Bowel sounds are normal. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Comments: PEG tube Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Neurological: Mental Status: He is alert and oriented to person, place, and time. Mental status is at baseline. Psychiatric: Cognition and Memory: Cognition normal. Memory is impaired. Judgment: Judgment normal. Admission Current 5/1/2021 - present Hospital Last attending ? Treatment team Empyema of right pleural space",PVT,,ADVAIR DISKUS 500-50 mcg/dose diskus inhaler buPROPion (WELLBUTRIN) 100 mg tablet dextroamphetamine-amphetamine (AdderalL) 10 mg tablet dextroamphetamine-amphetamine (AdderalL) 10 mg tablet dextroamphetamine-amphetamine (ADDERALL) 20 mg tab,,"Hiatal hernia Insomnia Fracture of mandible (CMS/HCC) Hyponatremia Hypotension Attention deficit hyperactivity disorder (ADHD), other type Abnormal CXR Shortness of breath",,,2,05/11/2021,,Y,Y,BuspironeRash Zosyn [Piperacillin-tazobactam]Hives / Urticaria 1309244,05/12/2021,GA,,,,U,,"Cerebral venous sinus thrombosis; COVID-19 PNEUMONIA; This spontaneous report was received from literature: This report concerned a patient of unspecified age and sex. The patient's height, weight, past medical history and concurrent conditions were not reported. No concomitant medications were reported. On an unspecified date, the patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number was not reported) dose and anatomical site not provided. On an unspecified date, the patient experienced COVID-19 pneumonia and was hospitalized post vaccination with COVID-19 vaccine Ad26.COV2.S followed by a hospitalization with cerebral venous sinus thrombosis (CVST) and pneumonia (hospitalization dates unspecified). Treatment details were unspecified. The author(s) reported that this case was not included because thrombosis was a known complication of COVID-19. The action taken with COVID-19 Vaccine Ad26.COV2.s was not applicable. The outcome of the cerebral venous sinus thrombosis, and COVID-19 pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This literature report describes a patient of unspecified age, sex, and race/ethnicity who was hospitalized for Covid-9 pneumonia and cerebral venous sinus thrombosis an unspecified period of time after receiving the Janssen Covid-19 vaccine. The literature article described a series of cases identified in VAERS which reported cerebral venous sinus thrombosis with thrombocytopenia after vaccination with COVID-19 vaccine Ad26.COV2.S. The authors stated that this patient was not included because thrombosis is a known complication of Covid-19 infection. The article did not state whether this patient experienced thrombocytopenia. Considering the plausible alternative explanation of Covid-19 infection requiring hospitalization provided by the authors and no plausible biological mechanism for the vaccine to cause Covid-19, the relationship of the events to vaccination is assessed to be inconsistent. Of note, due to lack of patient identifiers, it is unknown if this case could represent a duplicate of a case already present in the Janssen safety database. Additional information will be requested of the authors.",,,,,Y,,,,U,,,,,OTH,,,,Comments: Unknown,,USJNJFOC20210516953,2,05/11/2021,,,, 1309601,05/12/2021,MD,0.25,,,F,,"anaphylactic shock; my throat was getting tight again and pressure/throat was closing up; lips were tingling; Not feeling well; started getting tired again; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736, Expiration date: Jul2021), via an unspecified route of administration on left arm on 24Apr2021 09:55 as single dose for covid-19 immunisation. Medical history included Asthma (Asthma was diagnosed when she was a baby or a child), Irregular heart rate, Allergy multiple (Patient allergies were diagnosed as being seasonal, she doesn't know exactly when. She says she recently had an anaphylactic reaction after eating sushi. She said she also has environmental allergies), right ear hearing impairment and Mild cerebral palsy (diagnosed since she was a baby, it correlates with her mild cerebral palsy). Concomitant medications included unspecified flu shot given on 24Mar2021. The patient reported, she received the first dose of Pfizer vaccine and was monitored for 30 minutes because of my history of allergies. The doctor and paramedic gave medication, Benadryl. 3-4 hours later, the medicine wore off and again was feeling the effects again she was getting tired, her throat was getting tight again and pressure, throat was closing up and her lips were tingling. She went to urgent care they said it was in anaphylactic shock on 24Apr2021 and gave a bunch of medications, steroids and epi-pen and Benadryl they monitored me for 3 - 4 hours, sent her home. Next day, Sunday not feeling any better went to the emergency room, was admitted for anaphylactic shock, they gave same medications, Benadryl, steroids, and epi-pen, they kept 2 nights, overnight for observation. Beta blockers were given for her heart, which she had never had to be on those before but she has a history of an irregular heart. They also gave her saline IV fluids. She says they gave her a steroid, Prednisone 20mg, to take twice a day by mouth (discard date:27Apr2022), Famotidine 20mg, to take twice a day by mouth (discard date: 27Apr2022) and Fexofenadine (discard date: 27Apr2022). She was discharged Tuesday night. Reporter seriousness was assessed as serious as the patient went to emergency room; admitted me into the hospital for 3 days. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.",,,,,Y,,,,U,04/24/2021,04/24/2021,0,,UNK,,,,"Medical History/Concurrent Conditions: Allergy multiple (Patients allergies were diagnosed as being seasonal, she doesn't know exactly when. She says she recently had an anaphylactic reaction after eating sushi. She said she also has environmental allergies.); Asthma (patient reported that Asthma was diagnosed when she was a baby or a child.); Cerebral palsy (It has been diagnosed since she was a baby, it correlates with her mild cerebral palsy.); Hearing impairment aggravated (Patient reported she was diagnosed when she was a baby.); Heart rate irregular",,USPFIZER INC2021481285,2,05/10/2021,,,Y, 1312888,05/13/2021,CA,,,,F,,"Part of right toe amputated; Missed her scheduled 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TOE AMPUTATION (Part of right toe amputated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced TOE AMPUTATION (Part of right toe amputated) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her scheduled 2nd dose). The patient was hospitalized on 24-Apr-2021 due to TOE AMPUTATION. At the time of the report, TOE AMPUTATION (Part of right toe amputated) and PRODUCT DOSE OMISSION ISSUE (Missed her scheduled 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's friend would like to know if the patient should repeat the 2nd dose series considering she missed the dose. Concomitant medications have not been reported. Event treatment: Not specified. Company Comment: This report refers to a case of (Product Omission Issue- missed scheduled 2nd dose) for mRNA-1273, lot # n/a with no associated AEs. Very limited information regarding this event Toe Amputation (Part of right toe amputated) has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of (Product Omission Issue- missed scheduled 2nd dose) for mRNA-1273, lot # n/a with no associated AEs. Very limited information regarding this event Toe Amputation (Part of right toe amputated) has been provided at this time. Further information has been requested.",,,,,Y,,,,U,,04/24/2021,,,UNK,,,Diabetes mellitus,,,"USMODERNATX, INC.MOD20211",2,05/12/2021,,,, 1313035,05/13/2021,,,,,U,,"have swelling of the heart muscle after getting vaccinated.; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced have swelling of the heart muscle after getting vaccinated on an unspecified date with outcome of unknown. Reported as: ""Question: Have there been Reported Cases of Heart Muscle Inflammation in Recipients of the COVID-19 Vaccine? I know one person who did have swelling of the heart muscle after getting vaccinated."" Follow-up attempts are needed. Further information is expected. Information on the lot/batch number has been requested.",,,,,,,,,U,,,,,UNK,,,,,,USPFIZER INC2021475747,2,05/11/2021,,,, 1313241,05/13/2021,,,,,U,,"CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose 0.5 ml, frequency once total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date, after a month of receiving vaccine the patient performed an spike of antibody test and its result was very low (30). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Very low (30). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the PQC evaluation/investigation performed. This case was associated with a product quality complaint number 90000178884. Additional live follow up information was received from consumer on 10-MAY-2021.; Sender's Comments: V0: 20210516999-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.",,,,,,,,,U,,,,Test Name: Antibody test; Result Unstructured Data: Very low (30),OTH,,,,Comments: Unknown,,USJNJFOC20210516999,2,05/13/2021,,,, 1313571,05/13/2021,,58.0,58,,F,,K43.9 - Ventral hernia without obstruction or gangrene R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC),Y,05/12/2021,,,Y,,,,,04/21/2021,04/24/2021,3,,PVT,,,,,,,2,05/13/2021,,,Y, 1315775,05/13/2021,,,,,F,,"CEREBRAL VEIN THROMBOSIS-SAGGITAL SINUS; THROMBOCYTOPENIA; SUBARACHNOID HEMORRHAGE; This spontaneous report received from a health care professional via a Regulatory Authority concerned a Black or African American and not Hispanic or Latino 48 year old female. The patient's height, and weight were not reported. The patient was not pregnant. The patient's concurrent conditions included urinary tract infection, diabetes mellitus, cerebrovascular accident, seizure, and vagus nerve stimulator. The patient experienced drug allergy when treated with levetiracetam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 10-APR-2021 for product use for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included clonazepam, empagliflozin, insulin glargine, insulin lispro, lacosamide, lamotrigine, lorazepam, perampanel, semaglutide, and simvastatin. The patient visited the emergency room on an unspecified date. On 26-APR-2021, the patient experienced cerebral vein thrombosis of the sagittal sinus, right sigmoid sinus and transverse sinus, extending to the right jugular vein; thrombocytopenia; and subarachnoid hemorrhage (bilateral frontal sulci). The patient was hospitalized on an unspecified date. Laboratory data (dates, normal values and results unspecified) included: Angiography, CT scan of head, and complete blood count. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral vein thrombosis, thrombocytopenia, and subarachnoid hemorrhage. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: This case received via VAERS concerns a 48-year-old black female who experienced cerebral venous thrombosis, thrombocytopenia, and subarachnoid hemorrhage 16 days after receiving the Janssen COVID-19 vaccine. The patient has a history of diabetes mellitus, cerebrovascular accident, seizure with vagus nerve stimulator, and urinary tract infection. Concomitant medications included clonazepam, empagliflozin, insulin glargine, insulin lispro, lacosamide, lamotrigine, lorazepam, perampanel, semaglutide, and simvastatin. Sixteen days after receiving the Janssen COVID-19 vaccine, the patient was found to have thrombosis of the sagittal sinus, right sigmoid sinus, transverse sinus, and right jugular vein, thrombocytopenia, and subarachnoid hemorrhage. Treatment was not reported; the patient has not recovered. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination.",,,,,Y,,,,N,,04/26/2021,,Test Name: CT scan; Result Unstructured Data: Unspecified(Head); Test Name: Complete blood count; Result Unstructured Data: UNSPECIFIED; Test Name: Angiography; Result Unstructured Data: UNSPECIFIED,OTH,,OZEMPIC; LAMICTAL; LORAZEPAM; JARDIANCE; SIMVASTATIN; TOUJEO; HUMALOG; VIMPAT; FYCOMPA; CLONAZEPAM,Cerebrovascular accident; Diabetes mellitus; Urinary tract infection,Medical History/Concurrent Conditions: Seizure; Vagal nerve stimulator implantation; Comments: Unknown,,USJNJFOC20210522710,2,05/13/2021,,,Y, 1316212,05/14/2021,NC,87.0,,,F,,"left side weakness; Elevated troponin levels but no sign of heart attack; patient became so weak that she could not stand or walk , even with assistance; transient ischemic attack; gallstones; Endometrial cancer; headache; migraine; goiter; hypothyroidism; high blood pressure; Slurred speech; This is a spontaneous report from a contactable consumer (Patient's daughter). An 88-year-female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Right on 09Feb2021 17:00 as 2nd dose, single for covid-19 immunisation. Medical history included Type 2 diabetes from 08Jan2016 to an unknown date (diabetic retinopathy). Concomitant medications included latanoprostene bunod (VYZULTA) from an unspecified start date and ongoing. The patient previously took dose 1 of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, Lot no Lot number : EL3247), anatomical location was left arm for Covid Immunization on 16Jan2021(Age at the time of vaccination was 87years 10 months). On 10Feb2021 at 19:00, Patient felt unwell, fainted and could not stand due to weakness. Elevated troponin levels but no sign of heart attack, 08Mar2021at 19:00, she had transient ischemic attack resulting in left side weakness and slurred speech. Endometrial cancer, gallstones, headache, migraine, goiter hypothyroidism and high blood pressure. On 10Feb2021. Patient became so weal that she could not stand or walk even with assistance and received treatment for these events. She was incapable of even holding her head up properly before hospitalization, she was basically dead weight and as treatment had IV fluids, shot to prevent blood clotting. In hindsight, patient probably experienced a transient ischemic attack on 10Feb2021. She wasn't taken to the hospital until 12 hours after the weakness started. and ER physician didn't check to see it she was weak on one side of her body. AE required to visit to emergency room. Patient was hospitalized 1st time from 10feb2021 to until 18Feb2021 and 2nd time from 09Mar2021 until to 16mar2021. The outcome for the event transient ischemic attack, slurred speech, left side weakness, gallstones, endometrial cancer, headache, migraine, goiter, hypothyroidism, high blood pressure was unknown and for the event patient became so weak that she could not stand or walk, even with assistance and elevated troponin levels but no sign of heart attack was recovered. Additional information is requested.",,,,,Y,9,,,Y,02/09/2021,02/10/2021,1,Test Date: 20210308; Test Name: blood pressure; Result Unstructured Data: Test Result:high blood pressure,UNK,,VYZULTA,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus (Diabetic retinopathy),,USPFIZER INC2021494330,2,05/11/2021,,,Y,