VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1076890
Sex: F
Age: 35
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
Hospital: Y

Vax Type:
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Lab Data:

Allergies: Sulfa, PCN, Flagyl, Sulfide

Symptom List:

Symptoms: Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 97 RR 26 O2 98% BGM 129 at 1430. At 1440 146/95 HR 93 RR 18 O2 95%. EMT did not administer any medications, EKG Normal sinus. Fire department recommended patient to hospital as she was alone and driving herself. Fire department escorted patient to hospital via ambulance as a precaution at 1456.

Other Meds: Zoloft, Birth control, gout medication, RA medication

Current Illness: n/a

ID: 1076891
Sex: F
Age: 34
State: TX

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 03/05/2021
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Allergies: None

Symptom List:

Symptoms: Seconds after receiving vaccine my finger tips began to tingle and then body became hot, flushed, and heart palpitations with elevated BP. My head was pounding with heart beat. I began to see ?stars? and feeling lightheaded. Lasted 30min. They had me lay down and bend my knees. Then felt nausea. Drank water. After leaving I had intense shaking that eventually went away after about 30min.

Other Meds: None

Current Illness: None

ID: 1076892
Sex: F
Age: 21
State: NY

Vax Date: 02/25/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
Hospital:

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Lab Data:

Allergies: sulfur

Symptom List:

Symptoms: 4 inch by 3.5 inch swelling at injection site, extremely itchy

Other Meds: none

Current Illness: none

ID: 1076893
Sex: F
Age: 29
State: MT

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 03/05/2021
Hospital:

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Lab Data:

Allergies: Penicillin; Sulfa; Bee Stings; Dandelions

Symptom List:

Symptoms: Patient has been nauseated every day since receiving her Moderna vaccine. It will happen 1-2 times per day, and lasts for several hours. It comes and goes, has vomited only once last week. Eating fine, denies diarrhea or constipation; is not pregnant and did do pregnancy tests and were negative. A week after vaccination she said there was a huge red ring around the site of her injection; was hot, and swollen and hard. She said the next morning it was gone. Ginger ale and Tums help her tummy. She is due on March 10th for her 2nd dose, but she is not sure if she should get the second one.

Other Meds: Prednisone 5mg QID since August 2020. Albuterol Inhaler as needed.

Current Illness: No

ID: 1076894
Sex: M
Age:
State:

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 03/05/2021
Hospital: Y

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Symptoms: multiple pulmonary emboli; This is a spontaneous report from a non-contactable consumer (patient's wife) via Medical Information team. A 72-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 19Jan2021 and experienced gradually being short of breath, which was further described as "he would walk for 50 yards and he would be huffing and puffing." The patient's medical history and concomitant medications were not reported. It was further reported that about 8 days after the first one, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing, which was unusual, because he could walk a lot. It gradually got worse and then after the second one, it continued to get worse and he finally ended up in the hospital for 3 days with multiple pulmonary emboli on an unspecified date. The reporter was asking if this had been reported with the vaccine. The patient was hospitalized for the event multiple pulmonary emboli on an unspecified date for 3 days. The outcome of the event was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1076895
Sex: M
Age: 67
State: MN

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
Hospital:

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Allergies: None

Symptom List:

Symptoms: I was briefly hospitalized for covid19 in early December of 2020. Vaccine side effects included ALL of the symptoms of the real thing. Fatigue, head ache, muscle and joint pain, slight nausea, fever of 100 degrees. I would like to know if the second vaccination is necessary.

Other Meds: Prozac

Current Illness: None

ID: 1076896
Sex: M
Age: 43
State: GA

Vax Date: 02/23/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
Hospital:

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Symptoms: Bullseye rash, itching

Other Meds:

Current Illness:

ID: 1076897
Sex: M
Age: 42
State: UT

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 03/05/2021
Hospital:

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Lab Data:

Allergies: No known allergies

Symptom List:

Symptoms: When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity

Other Meds: None

Current Illness: No illness

ID: 1076898
Sex: F
Age: 72
State: GA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/05/2021
Hospital:

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Allergies: CECLOR, PENCILLIN, CODINE Mushrooms, pork, cola, white potatoes, rice

Symptom List:

Symptoms: Turned VERY red and hot. Knot, a lot of Swelling. Spread to 6x5 inches, hurt, sore and lasted 5 weeks.

Other Meds: Aspirin, Sertraline, Hydrochlorothinzide, Metoprolol, Simvastatin, Eliquis, Lyrica. CoQ10, D-3, EB-N3, Evening Primrose Oil, Muti. Vit.

Current Illness: 3 heart stents, A fib, high blood pressure (under control)

ID: 1076899
Sex: F
Age: 20
State: NJ

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 03/05/2021
Hospital:

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Allergies: NKDA

Symptom List:

Symptoms: Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed throat closing, angioedema, and perioral cyanosis. They were treated by EMS on site with epinephrine, diphenhydramine, methylprednisolone, ondansetron, and normal saline fluids. They were transported to emergency department. During reexamination, the patient?s symptoms improved and they were discharged to home.

Other Meds:

Current Illness:

ID: 1076900
Sex: M
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 03/05/2021
Hospital: Y

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Symptoms: Brain bleed; This is a spontaneous report from a contactable consumer (patient himself). An elderly male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 6201), via an unspecified route of administration at Right arm on 17Feb2021 13:30 (at unknown age) at single dose for Covid-19 immunization. Medical history included Hydrocephalus. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. Other vaccine same date product was None. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) on 26Jan2021 04:30 P.M at Right arm, for COVID-19 immunization. The patient experienced Brain bleed on 18Feb2021 16:00. AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 4 days. The patient underwent lab tests and procedures which included CT scan (computerised tomogram): unknown results on Feb2021. Treatment reported as CT scan/observation. The outcome of the event was Recovering.

Other Meds:

Current Illness:

ID: 1076901
Sex: F
Age:
State: GA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 03/05/2021
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Symptoms: Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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.

Other Meds: SERTRALINE; ADDERALL

Current Illness:

ID: 1076902
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 03/05/2021
Hospital: Y

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Symptoms: COVID myelopathy; felt that her walking was off; feeling numbness of her right leg going up to her upper abdomen/ decreased sensation on her right side up to a mid-thoracic sensory level; COVID myelopathy/ leftsided cervical myelopathy; left arm pain and discomfort; left arm pain and discomfort; tingling sensation in her third, fourth, and fifth digits on her left hand; This is a spontaneous report from a non-contactable Pharmacist. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration on 21Jan2021 at unspecified age at single dose for COVID-19 immunisation. Patient was not pregnant at the time of events onset and at time of vaccination. Medical history included mitral valve atresia (MVA) and back pain. Patient has known allergies penicillin. The patient presented to office on 25Feb2021 with left arm pain and discomfort that started three weeks ago on 21Jan2021 and had resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago in Feb2021 she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that had stabilized in the past several days. She also felt that her walking was off but cannot quite describe how or when it started. Exam notable for leftsided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. COVID-19 biofire came back positive. In light of this, COVID myelopathy was (missing information). Adverse event COVID myelopathy start date was reported as 21Jan2021. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, hospitalization. It was unknown if there was COVID prior vaccination. COVID was tested post vaccination. Outcome of event left arm pain and discomfort was recovered with sequel, of the other events was unknown. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on a temporal association, the causal association between the reported events and the suspect drug cannot be totally excluded. Patient's risk factor (family history of multiple sclerosis) can also be assessed as possibly contributory to the events. Case to be reassessed if follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.

Other Meds:

Current Illness:

ID: 1076903
Sex: F
Age:
State: SC

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 03/05/2021
Hospital:

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Symptoms: It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications ("No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry."). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, "My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?" The date when adverse event started was reported as "Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started." The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: "They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time." The outcome of the event "felt like I was going to pass out" and felt unwell was recovering, and "it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking" was not recovered.

Other Meds: LYRICA

Current Illness:

ID: 1076904
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 03/05/2021
Hospital:

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Symptoms: My sight started to go; started getting blurry and I can't see my phone to find number and it lasted about an hour my sight came back; sudden my sight started to go; blurry; ever since then my smell has been back; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E9262), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included high blood pressure, over weight, lost my sense of smell, border line diabetic and a heart condition that is hereditary it has to deal with the elasticity of the vessels; all from unspecified date and unknown if ongoing. The patient was administered first dose of BNT162B2 (lot number: EH9899) on unspecified date for COVID-19 immunization and experienced the regular signs, a little bit of a headache, little dizziness in the morning, and cognitively was little not there for about an hour. Concomitant medication included lisinopril, metformin hydrochloride (ROBUSTIN) and vitamins. The patient stated, "for the second shot the 2nd day I was at school letting kids out and all of a sudden my sight started to go. It started getting blurry and I got back into the building and my Principal said let's just call the doctors, I said I can't see my phone to get, find his number. They took care of that for me and it lasted about an hour and hour and half and my sight came back. That's was the only negative and the positive thing happened, I have lost my sense of smell 10 years ago from taking a prescription for high blood pressure I mean diabetes (unspecified medication). Within a month I lost complete smell of everything, for 10 years I have not been able to smell a thing. The day I lost my lost my sight for little while, that day on the way home I was driving pass a restaurant with my windows up and I could smell barbeque sauce, pass an Italian restaurant and I could smell Italian food, and ever since then my smell has been back. I don't know I am not complaining at all, I am just telling something that, the doctors says I haven't heard of that, so that I thought you should know." The patient had bloodwork done with unknown results on unspecified date. The outcome of the events was unknown.

Other Meds: LISINOPRIL; ROBUSTIN; VITAMINS NOS

Current Illness:

ID: 1076905
Sex: F
Age:
State: GA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/05/2021
Hospital:

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Symptoms: stools have been weird looking and smelly, like yeast; stools have been weird looking and smelly, like yeast; coffee (which is what has been tasting weird), tasted so gross; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 37-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3302, Expiry date: unknown), at 37 years of age via an unspecified route of administration on Left arm on 01Feb2021 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included multivitamin (unspecified) and estradiol (ESTROGEN) as a supplement within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (Lot number: EJ1685, Expiry date: unknown) on 07Jan2021 at 09:30 AM on left arm for COVID-19 immunisation and experienced Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell. Things tasted a little funny, but I mostly noticed it with coffee. Patient also had known allergies to clindamycin and Sulfa. The patient stated that, things tasted a little funny, but I mostly noticed it with coffee. I didn't think about the COVID shot, I just thought maybe I had a cold. Then exactly two weeks after the second, my coffee (which is what has been tasting weird), tasted so gross I had to throw it out in Feb2021. That's when I put it all together that it is probably from the vaccine. Then the more I research that sweet garlic is actually yeast I am smelling. Then I realized since all this has started by in Feb2021 stools have been weird looking and smelly, like yeast and sure enough I googled it and it looks similar. My co-worker is having a yeast infection also, but it is only in her mouth. The patient received treatment for the events with diflucan 150mg a 20-week cycle. The reporter considered the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.; Sender's Comments: Based on temporal relationship, the causality between the suspect 'BNT162B2' and the reported 'stools have been weird looking and smelly, like yeast' 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.

Other Meds: ESTROGEN

Current Illness:

ID: 1076906
Sex: F
Age:
State: CT

Vax Date: 02/17/2021
Onset Date: 02/20/2021
Rec V Date: 03/05/2021
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Symptoms: Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 57-year-old female patient received first dose of bnt162b2 (BNT162B2,COVID 19, brand: Pfizer BioNTech, lot number: EL3247), via an unspecified route of administration on 17Feb2021 15:45 on Left arm at single dose for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, zinc, ascorbic acid (VITAMINS C), ergocalciferol (VIT D), fish oil and Occuv. The patient experienced unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing (medically significant) on 20Feb2021 11:45AM with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown. She is not pregnant. Facility type vaccine was workplace clinic. No other vaccine in four weeks. Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Known allergies was none.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported auditory hallucinations cannot be 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.

Other Meds: ROSUVASTATIN; ZINC; VITAMINS C; VIT D; FISH OIL

Current Illness:

ID: 1076909
Sex: M
Age:
State: FL

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 03/05/2021
Hospital: Y

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Symptom List:

Symptoms: Blood pressure would drop and then go back up; feeling passed; he is not thinking well; he is not talking as clear or loud; sick; Very hot, flushed; Everything started spinning; Headache; Mind not clear/It is like he is kind of in a fog. It is not clear; Not being as focused with is eyes; Breathing difficulty/breathing harder; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9262 and expiry date: 21May2021) solution for injection, via an unspecified route of administration in arm on 17Feb2021 15:00 at a single dose for Covid-19 immunization. Medical history included muscle relaxer/pain therapy, accident at work (stated he taught college for many years. However, he was in (enforcement type) for the office of (County Name). He worked as an admin assistant for the state attorney. He was injured on the job because someone did not like him. He was injured real bad and taking these medications for pain. Concomitant medications included ongoing gabapentin (NEURONTIN) for pain, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for pain, ongoing tizanidine (TIZANIDINE) as muscle relaxer/for pain, and unspecified medications for pain. The first dose was administered on 27Jan2021 (Lot Number: EL1283, Expiry Date: 30Apr2021), in Left arm. The patient reported breathing difficulty/breathing harder, mind not clear/it was like he was kind of in a fog. It was not clear, not being as focused with his eyes, all on 18Feb2021. On 19Feb2021, the patient reported his blood pressure would drop and then go back up, very hot, flushed, everything started spinning, and had headache and was sick. The patient reported feeling passed, he was not thinking well, he was not talking as clear or loud on an unspecified date. On Friday around 1'clock he got very hot, flushed. He took off his shirt. He was washing dishes. He needed to cool down a bit. He went to the bathroom to shave and brush his teeth. However, things were getting out of focus. He sat down on the toilet for about 3-4 minutes and then the feeling passed. He got back up and walked into the family room. He made it in there and had to sit down. All of a sudden he felt like everything was started to spin. Everything was really spinning. He was standing and had to sit down for a few minutes. While sitting he felt all of a sudden a super wave of feeling bad. He was sick. Everything was spinning. He could not stand it for another minute. The patient was hospitalized from 19Feb2021 to 21Feb2021 due to blood pressure would drop and then go back up. The fire department came and one of the things they did was check his blood pressure. Initially stated it was low and then it jumped up 20points when he stood up. They then threw him in the ambulance to take to the ER. He was going to the hospital because they thought he was having a stroke. He was seen by two different neurologist and other hospital doctors. The patient underwent lab tests and procedures which included blood pressure abnormal: it was low and then it jumped up 20points (Initially stated it was low and then it jumped up 20points when he stood up), blood pressure abnormal: believes it was like 140 was the high (he was unable to provide a true blood pressure reading at the time event occurred. Stated he was messed up in the head. He believes it was like 140 was the high. His was usually lower than that to begin with. Then it would go to 110. It would bounce from 110 to 140. It would change from sitting to standing), chest X-ray and electrocardiogram: test came back negative (He was in the ER and had a Chest -X Ray. He had an electrocardiogram, EKG, he had a scan that was dry without contrast and second one with contrast/iodine. He had an MRI of the brain to check for brain bleed. They thought he was in the process of having a stroke. They could not find anything. He had two CTs. Test came back negative. Neurologist determined it was not a stroke. Decided it must be inner ear situation), computerised tomogram: test came back negative (he was in the ER and had a Chest -X Ray. He had an electrocardiogram , EKG, he had a scan that was dry without contrast and second one with contrast/iodine. He had an MRI of the brain to check for brain bleed. They thought he was in the process of having a stroke. They could not find anything. He had two CTs. Test came back negative. Neurologist determined it was not a stroke. Decided it must be inner ear situation); test done on his heart, MRI of the brain, and two different scans: everything was negative (he had all kinds of test done on his heart, two different scans, MRI of the brain to see if had a brain bleed all that stuff. He was in the hospital for three days. Yesterday he was sent home. They found nothing wrong. Everything was negative. Therefore, he was sent home. Outcome of the event Blood pressure would drop and then go back up, Breathing difficulty/breathing harder, Mind not clear/It is like he is kind of in a fog/It was not clear was recovering; everything started spinning was recovered 20Feb2021; not being as focused with his eyes, feeling passed, he was not thinking well, he was not talking as clear or loud, and sick was unknown; headache was not recovered. No follow-up activities are needed. No further information is expected. Information about lot/batch number has been obtained.

Other Meds: NEURONTIN; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]; TIZANIDINE

Current Illness:

ID: 1076910
Sex: F
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Symptoms: anaphylactic reaction from Covid vaccine; nausea; This is a spontaneous report from a contactable Other Health Professional (HCP). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown) on an unspecified date (unknown age at the time of vaccination), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received pegvisomant (SOMAVERT) and experienced nausea. Patient reported the following: pegvisomant 30 mg daily; five missed does due to anaphylactic reaction from Covid vaccine and missed doses (amount missed or dates unknown) due to nausea. MD aware. The outcome of the event was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available and the known product safety profile, a causal association between the reported event 'anaphylactic reaction' and the suspect product 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.

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Current Illness:

Date Died: 02/12/2021

ID: 1076911
Sex: F
Age:
State: CA

Vax Date: 02/08/2021
Onset Date: 02/12/2021
Rec V Date: 03/05/2021
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Symptoms: passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine

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Date Died:

ID: 1076912
Sex: U
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Symptoms: died from COVID after receiving the two doses of the vaccine; COVID; This is a spontaneous report from a contactable consumer report for a friend. A patient of unspecified age and gender received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) both via an unspecified route of administration on unspecified dates at single doses for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer mentioned her friend died from COVID after receiving the two doses of the vaccine. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died from COVID after receiving the two doses of the vaccine

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Current Illness:

ID: 1076913
Sex: M
Age:
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Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 03/05/2021
Hospital: Y

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Symptoms: Pain in arm/sore arm; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another company (MFR. Control No.: 20K-163-3447228-00). A 35-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: e10142, expiry date: Mar2021), intramuscular on 11Jan2021 at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from Sep2019 to an unspecified date, 10Jun2020 to Jun2020 and 24Jun2020 and ongoing at 40 mg (40 mg, 1 in 1 wk) for Moderate to Severe Hidradenitis Suppurativa. Medical history included hyperlipidaemia, high cholesterol, depression, hypothyroidism, sleep apnea from an unknown date and unknown if ongoing, Down syndrome from 31Jan1985 to an unknown date, pneumonia from 1986 to 1986, open heart surgery in May1988, May1994 and Jul2012, acute respiratory distress syndrome from 08Dec2002 to 04Apr2003, aspiration pneumonia from 08Apr2003 to 15Apr2003 and clinical trial participant in 11Jan2021. Concomitant medication included atorvastatin at 20 mg for high cholesterol and hyperlipidemia, fluoxetine at 40 mg for depression, levothyroxine at 0.75 mg, 1 in 2 D for hypothyroidism and sleep apnea, colecalciferol (VITAMIN D3 1000) for supplement. The patient previously took Reglan and experienced vomiting, confusion and disorientation, Percocet and experienced vomiting and disorientation, Toradol and Zofran and experienced vomiting, confusion and disorientation; Humira for moderate to severe hidradenitis suppurativa in Sep2019 and experienced abdominal hernia on Nov2019 which resolved in 19Jun2020 and hidradenitis suppurativa breakout underarm and in groin area/hidradenitis suppurativa flare in Sep2019 which resolved on an unspecified date. The patient experienced pain in arm/sore arm on 12Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date, ultrasound abdomen: unknown results (Abdominal Hernia that needed surgical repair) on 11Jan2020. The action taken in response to the event for adalimumab was dose not changed. The patient recovered from the event on 13Jan2021. The reporter assessed the event as probable to the drug and vaccine.; Sender's Comments: There is a reasonable possibility that the event pain in arm/sore arm was related to BNT162b2 based on known drug safety profile and close temporal relationship.

Other Meds: ATORVASTATIN; FLUOXETINE; LEVOTHYROXINE; VITAMIN D3 1000

Current Illness:

Date Died: 01/21/2021

ID: 1076915
Sex: F
Age:
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Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 03/05/2021
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Symptoms: (name) is now dead 2 days after receiving a COVID mRN shot; This is a spontaneous report from a non-contactable other non HCP. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is now dead 2 days after receiving a Covid mrn (as reported) shot in Jan2021. She died two days later, according to her mother. 28 year old daughter took the vaccine on a Tuesday (on 19Jan2021) and was dead by Thursday (on 21Jan2021). Outcome of event was fatal. Autopsy shows no other red flags (as reported). The reporter has assured us he will get to the bottom of this vaccine crap. Anything attached should be red flag (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: (name) is now dead 2 days after receiving a COVID mRN shot

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Current Illness:

ID: 1076916
Sex: M
Age:
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Vax Date: 02/21/2021
Onset Date: 02/22/2021
Rec V Date: 03/05/2021
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Symptoms: I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with Bell's Palsy; This is a spontaneous report from a non-contactable consumer (the patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in left arm on 21Feb2021 11:30 a.m. at age of 31-year-old, at single dose for COVID-19 immunisation. The patient had history of frequent ear infections. Concomitant medication included fluticasone which was taken within 2 weeks of vaccination for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported when he woke up the next day after receiving the vaccine (22Feb2021), he found that he was suffering from paralysis and numbness on the left side of his face. He went to the emergency room (ER) and was diagnosed with Bell's Palsy. He had been experiencing some minor pain in his left ear beginning two days before he received the vaccine (i.e., three days before onset of facial paralysis), and this ear pain had continued as he continue to experience the palsy. Since visiting the ER, he had also seen a neurologist. The doctors he had seen do not necessarily think that the palsy resulted from receiving the vaccine. The onset date of the event "I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with bell's palsy" was reported as 22Feb2021 09:00 a.m. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event was non-serious (the event did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect). Oral steroid and antiviral drugs, eye ointment was received to treat the event. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: FLUTICASONE

Current Illness:

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ID: 1076917
Sex: F
Age:
State: PA

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Symptoms: one died after the vaccine; This is a spontaneous report from a Pfizer-sponsored program. This contactable consumer reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained one died after the vaccine on an unspecified date. She explained she had no additional details on the adverse event. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: one died after the vaccine

Other Meds:

Current Illness:

ID: 1076920
Sex: F
Age:
State: CA

Vax Date: 01/10/2021
Onset Date: 02/15/2021
Rec V Date: 03/05/2021
Hospital: Y

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Symptoms: chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. 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.

Other Meds:

Current Illness:

ID: 1076921
Sex: U
Age:
State: NY

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Symptoms: A patient had vaccinated with the wrong diluent for ActHIB and used the diluent used for MMR, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00493679) and transmitted to Sanofi on 25-Feb-2021. This case involves a patient (unknown demographics) who had vaccinated with the wrong diluent for and HIB (PRP/T) VACCINE [ACT-HIB] and used the diluent used MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (not produced by Sanofi Pasteur) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (Product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The doctor stated that she had patients waiting so this is all the information she provided at the time of her call but she indicated that safety could follow up with her in terms of a phone call or something in writing. This was a case of actual medication error due to inappropriate dilution of medication (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on batch number for this case.

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ID: 1076922
Sex: F
Age:
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Vax Date: 09/04/2020
Onset Date: 09/04/2020
Rec V Date: 03/05/2021
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Symptoms: Delivery at 36,7 weeks of gestation; Vaccine exposure during pregnancy; Bacterial vaginosis; This observational study case, initially received on 30-Nov-2020 from other health professional and concerned a 33-year-old, female, pregnant subject of body weight: 148 lbs, height: 62 inches and body mass index (BMI): 27.1, enrolled in, a prospective observational study. The subject's concurrent condition included body mass index high. The subject's past medical history included bacterial vaginosis. The subject's concomitant medications included OB complete one (fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide, and cupric sulfate capsule, liquid filled) for healthy pregnancy. The subject's past medications included Metrogel (metronidazole) and terconazole, both used for bacterial vaginosis. The subject's obstetrical history included two previous pregnancies with one full term live birth, and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was on 13-Apr-2020. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 18-Jan-2021 and corrected estimated date of delivery (CEDD) was not reported. On 06-Jul-2020, first trimester screen revealed no MCMs. On 27-Jul-2020, second trimester screen revealed increased risk of Down syndrome, but no MCM was noted. On 06-Aug-2020, amniocentesis revealed no MCMs. On 07-Aug-2020, amniocentesis revealed no MCMs. The whole genome chromosome single-nucleotide polymorphism (SNP) microarray analysis was normal. No significant deoxyribonucleic acid (DNA) copy number changes or copy neutral regions within the 2.695 million region specific SNP. On 04-Sep-2020, at approximately of 20 weeks of gestational age (calculated per LMP), the subject was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV) (influenza vaccine, dose, route of administration, anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. The batch number reported was P100239705. On an unknown date in 2020, unknown amount of time after receiving Afluria Quadrivalent, the subject developed bacterial vaginosis. On 02-Oct-2020, the subject started therapy with Metrogel 0.75 % cream (metronidazole), once at night, vaginally for bacterial vaginosis. On 07-Oct-2020, the subject stopped treatment with Metrogel. At gestational age of 36.7 weeks (as reported), the subject vaginally delivered, live birth female neonate. The characteristics of the neonate included birth weight of 2745 grams, head circumference was 33.5 centimeters (cm) and length 47.6 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores at one and five minutes was 9. APGAR score for ten minutes was not reported. No MCM was identified at birth. The outcome of events was not reported. The reporter did not provide a causality assessment. The event of 'premature delivery' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. This case is linked with 202101525 (the corresponding baby case). Additional information received on 11-Dec-2020 from other health professional: Amniocentesis test results were provided. The narrative was amended accordingly. Additional information received on 15-Jan-2021 from other health professional: The subject was enrolled in study upon data query resolution. Report type was changed. Subject's age was changed from 34 to 33 years. New amniocentesis test added in laboratory data. The narrative was amended accordingly. Additional information received on 25-Feb-2021 from other health professional: Pregnancy outcome received, and pregnancy information updated. Stop date added and outcome changed from not reported to resolved for the event of 'vaccine exposure during pregnancy'. Premature delivery added as a new event and therefore, the case was upgraded from non-serious to serious. Link for baby case added. Narrative was amended accordingly. Company comment: Premature delivery in a 33-year-old female subject was reported after vaccine exposure during pregnancy to the suspect product Afluria Quadrivalent. Vaccine was administered at approximately 20 weeks of gestational age, while the neonate was delivered at gestational age of 36.7 weeks. On an unknown date in 2020, the patient developed bacterial vaginosis. The patient's past medical history included bacterial vaginosis. The subject's obstetrical history included two previous pregnancies with one full term live birth, and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions. Bacterial vaginosis is assessed as not related due to biological implausibility and strong confounder (medical history). Causality for the event premature delivery is assessed as not related due to presence of significant confounding factor (bacterial vaginosis).; Sender's Comments: Premature delivery in a 33-year-old female subject was reported after vaccine exposure during pregnancy to the suspect product Afluria Quadrivalent. Vaccine was administered at approximately 20 weeks of gestational age, while the neonate was delivered at gestational age of 36.7 weeks. On an unknown date in 2020, the patient developed bacterial vaginosis. The patient's past medical history included bacterial vaginosis. The subject's obstetrical history included two previous pregnancies with one full term live birth, and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions. Bacterial vaginosis is assessed as not related due to biological implausibility and strong confounder (medical history). Causality for the event premature delivery is assessed as not related due to presence of significant confounding factor (bacterial vaginosis).

Other Meds:

Current Illness: Body mass index increased

ID: 1076923
Sex: F
Age: 52
State: KY

Vax Date: 11/13/2020
Onset Date: 11/13/2020
Rec V Date: 03/05/2021
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Symptoms: Extreme dizziness; Vomiting; Nausea; Feeling sick; Felt like falling off her bed; This spontaneous case was received on 25-Feb-2021 from other non-health professional (consumer) via Med Communication (reference number: SEQW21-00811) and concerned a 52-year-old, female patient. The patient's concurrent condition included that the patient was diabetic. The patient's concomitant medication included unspecified medication for diabetes. On 13-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was P100271298 and expiry date was reported as 13-Nov-2020 (matched to expiry date of 30-Jun-2021). The patient stated that she was given the vaccine that was going to expire. The pharmacy stated that the consumer had refused the vaccine at the time, but consumer stated that she had received it. On the same date, after receiving Afluria Quadrivalent, the patient was feeling sick and felt extreme dizziness. The patient experienced nausea, vomiting and felt 'like falling off her bed'. The outcome of the events was not reported. The reporter did not provide a causality assessment. Company comment: All events are assessed as related to Afluria Quadrivalent.; Sender's Comments: All events are assessed as related to Afluria Quadrivalent.

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Current Illness: Diabetic

ID: 1076924
Sex: F
Age:
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Vax Date: 09/25/2020
Onset Date: 09/25/2020
Rec V Date: 03/05/2021
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Symptom List:

Symptoms: GERD; Delivery at 36.7 weeks of gestation; Vaccine exposure during pregnancy; This observational study case was received on 25-Feb-2021 from other health professional and concerned a 30-year-old, pregnant female subject of body weight: 147 lbs, height: 64 inches and body mass index (BMI): 25.2, enrolled, a prospective observational safety study. The subject's concurrent conditions included body mass index high and nausea. The subject's concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for healthy pregnancy and Zofran (ondansetron) for nausea. The subject's obstetrical history included three previous pregnancies with one full term live birth and two elective abortions. The subject had no history offspring with major congenital malformations MCMs) and maternal or paternal history with MCMs. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 08-May-2020, the estimated delivery date (EDD) was reported as 21-Feb-2021, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. On 28-Aug-2020, maternal serum alpha 1 fetoprotein (MSAFT) revealed no MCM. On 25-Sep-2020, at gestation age of 20 weeks (calculated per LMP), the subject was administered with Alfuria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly considered as 'Vaccine exposure during pregnancy') for influenza immunisation. The batch number reported was P100239705. On an unspecified date, unknown amount of time after receiving Afluria QIV, the subject developed gastroesophageal reflux disease (GERD). On 08-Jan-2021, the subject commenced treatment with Pepcid Ac (famotidine), 20 mg three times a day, via oral route of administration for GERD. At gestational age of 36.7 weeks (as reported), the subject vaginally delivered premature, live male neonate. The birth weight of the neonate was 2727 g, head circumference 33.5 cm and length 50.2 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and at ten minutes was not reported. No pregnancy complications noted. No MCM was identified at birth. On the same day, treatment with Pepcid Ac (famotidine) was stopped. The outcome of 'premature delivery' and GERD was not reported. The reporter did not provide causality assessment. The event of 'premature delivery' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. This case is linked to 202101523 (baby case). Company comment: A 30-year-old subject was administered Afluria QIV at gestational age of 20 weeks. On an unspecified date, unknown amount of time after receiving Afluria QIV, the subject developed gastroesophageal reflux disease (GERD). At gestational age of 36.7 weeks, the subject vaginally delivered premature, live male neonate. Causal role of the suspect vaccine is assessed as not related, due to unsuggestive temporal relationship with premature delivery, biological implausibility and pregnancy as a strong confounder for GERD (reported in up to 80% of pregnancies). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A 30-year-old subject was administered Afluria QIV at gestational age of 20 weeks. On an unspecified date, unknown amount of time after receiving Afluria QIV, the subject developed gastroesophageal reflux disease (GERD). At gestational age of 36.7 weeks, the subject vaginally delivered premature, live male neonate. Causal role of the suspect vaccine is assessed as not related, due to unsuggestive temporal relationship with premature delivery, biological implausibility and pregnancy as a strong confounder for GERD (reported in up to 80% of pregnancies). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZOFRAN [ONDANSETRON]

Current Illness: Body mass index high; Nausea

ID: 1076925
Sex: M
Age:
State:

Vax Date: 09/25/2020
Onset Date: 01/21/2021
Rec V Date: 03/05/2021
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Symptoms: Foetal exposure during pregnancy; Pre-term birth at 36.7 weeks of gestation; This observational study case was received on 25-Feb-2021 from other health professional and concerned a male neonate, whose mother was 30-year-old, pregnant female subject of body weight: 147 lbs, height: 64 inches and body mass index (BMI): 25.2, enrolled, a prospective observational safety study. The maternal concurrent conditions included BMI high and nausea. The maternal concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for healthy pregnancy and Zofran (ondansetron) for nausea. The maternal obstetrical history included three previous pregnancy with one live birth and two elective abortions. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The maternal last menstrual period (LMP) date was 08-May-2020, the estimated delivery date (EDD) was reported as 21-Feb-2021, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. On 28-Aug-2020, maternal serum alpha 1 fetoprotein (MSAFT) revealed no MCM. On 25-Sep-2020, at gestation age of 20 weeks (calculated per LMP), the neonate's mother was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly considered as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100239705. On an unspecified date in Jan-2021, an unknown amount of time after receiving Afluria QIV, the neonate's mother developed gastroesophageal reflux disease (GERD). On 08-Jan-2021, the neonate's mother started treatment with Pepcid Ac (famotidine), at a dose of 20 mg administered three times per day, via oral route for GERD. At gestational age of 36.7 weeks (as reported), the mother vaginally delivered premature, live male neonate. The birth weight of the neonate was 2727 g, head circumference 33.5 centimetres and length 50.2 centimetres. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and at ten minutes was not reported. No pregnancy complications were noted. No MCM was identified at birth. On the same day, treatment with Pepcid Ac (famotidine) was stopped. The outcome of the event 'premature baby' was not reported. The reporter did not provide a causality assessment. The event of 'premature baby' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. This case is linked with the case 202101522, the corresponding mother case. Company comment: A male neonate patient was delivered as premature baby after foetal exposure during pregnancy with the suspect product, Afluria QIV. Vaccine was administered at gestation age of 20 weeks, while the neonate was delivered at gestational age of 36.7 weeks. The maternal obstetrical history included three previous pregnancy with one live birth and two elective abortions which may be a contributing factor. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. Based on provided information, causality for the event premature baby is assessed as not related. Causality for foetal exposure during pregnancy is assessed as not related (as per company specific guidelines).; Sender's Comments: A male neonate patient was delivered as premature baby after foetal exposure during pregnancy with the suspect product, Afluria QIV. Vaccine was administered at gestation age of 20 weeks, while the neonate was delivered at gestational age of 36.7 weeks. The maternal obstetrical history included three previous pregnancy with one live birth and two elective abortions which may be a contributing factor. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. Based on provided information, causality for the event premature baby is assessed as not related. Causality for foetal exposure during pregnancy is assessed as not related (as per company specific guidelines).

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZOFRAN [ONDANSETRON HYDROCHLORIDE]; PEPCID AC

Current Illness:

ID: 1076926
Sex: M
Age:
State:

Vax Date: 09/10/2020
Onset Date: 02/08/2021
Rec V Date: 03/05/2021
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Symptoms: Foetal exposure during pregnancy; Low birth weight of 2410 g; This observational study case was received on 26-Feb-2021 from other health professional and concerned a male neonate, whose mother was 24-year-old, pregnant, female subject of body weight: 198 Ibs, height: 62.3 inches and body mass index (BMI) 35.9, enrolled in, a prospective observational safety study. The mother's concurrent conditions included increased BMI and the mother was group B streptococcus carrier. The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) used for pregnancy. The maternal obstetrical history included two previous pregnancies which included one full-term live birth and one spontaneous abortion. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was reported as 15-May-2020, the estimated delivery date (EDD) was reported as 19-Feb-2021 and corrected estimated date of delivery (CEDD) was reported as 11-Feb-2021 (also reported as 19-Feb-2021). The type of pregnancy was singleton. The paternal age was not reported. On 19-Aug-2020, the ultrasound revealed no MCMs. On 10-Sep-2020, at approximately 16 weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; route of administration, anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation. The batch number reported was P100230203. On the same day, maternal serum alpha-fetoprotein (MSAFP)/serum markers revealed no MCMs. On 09-Oct-2020, the ultrasound revealed no MCMs. At gestational age of 38.4 weeks (as reported), the mother delivered live birth, male neonate via vaginal delivery method. The neonate's birth weight was 2410 g, the head circumference was 30.5 cm and length was 48.3 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 at one minute, 9 at five minutes. APGAR score for ten minutes was not reported. No pregnancy complications and MCMs were noted at delivery. The outcome of the event 'low birth weight' was not reported. The reporter did not provide a causality assessment. The event 'low birth weight' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. The case is linked with the case 202101590 (the corresponding mother case). Company comment: A male neonate experienced foetal exposure to the suspect vaccine Afluria QIV. The neonate's mother was administered Afluria QIV at approximately 16 weeks of gestational age. The mother delivered live birth, male neonate via vaginal delivery method. The neonate's birth weight was 2410 g. The mother's concurrent conditions included increased BMI and the mother was group B streptococcus carrier. The maternal obstetrical history included two previous pregnancies which included one full-term live birth and one spontaneous abortion. With information available, causal role of the suspect vaccine is assessed as not related for both events, due to unsuggestive chronology (five months after vaccination). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A male neonate experienced foetal exposure to the suspect vaccine Afluria QIV. The neonate's mother was administered Afluria QIV at approximately 16 weeks of gestational age. The mother delivered live birth, male neonate via vaginal delivery method. The neonate's birth weight was 2410 g. The mother's concurrent conditions included increased BMI and the mother was group B streptococcus carrier. The maternal obstetrical history included two previous pregnancies which included one full-term live birth and one spontaneous abortion. With information available, causal role of the suspect vaccine is assessed as not related for both events, due to unsuggestive chronology (five months after vaccination). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1076927
Sex: M
Age: 33
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: N/A

Symptom List:

Symptoms: Patient experiencing swelling in palm of hands, patient report being tired. Initial V/S bp 140/80, HR 78, o2 sat 97% room air. Patient was observed for further evaluation, at 4:00 patient felt better and no complaints. Latest V/S is 110/70, o2 sat 97 on room air, P-79. Patient was able to grip on both hands. Health education provided and instructed to call his PCP for further evaluation. Patient left the premises with wife.

Other Meds: N/A

Current Illness: N/A

ID: 1076928
Sex: F
Age: 69
State: PA

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 03/05/2021
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Allergies: ALL fish and shellfish. Eggs. IVP Dyes; Iodine; Colace Stool Softner; Cortisone injections; Prenisone; Morphine; Percocet

Symptom List:

Symptoms: Evening of injection, at the injection site, it felt sore and warm to the touch. Started to turn red. Upon wakening the next morning, the site was warm, red, raised and itchy. It looked like a red hive, about the size of a 50 cent piece and upper arm was slightly swollen. Third day the redness spread across the arm, warm, sore and swollen. The redness was going down into the elbow to wrist area. My arm was quite swollen. I contacted my PCP, and had a video conference that day. I also sent photos of my arm to a chart website. He saw my arm and ordered Prednisone 20 mg for three days; as he felt it was an allergic reaction to the COVID injection. Also was instructed to continue with Benadryl, Tylenol and ice. It took nine days for everything to subside.

Other Meds: Linzess; Estradiol; Chlorthalidone; Kor-Con 10 CL; Mag-Oxide; Vitamin D3; Fexofenadine; Arnica; Restasis; Biotin; Fluticasone; FDgard; IBgard; Diclofenac Sodium Topical Gel

Current Illness: Slight head cold & sinus issues. (Seasonal Allergies to mold, mildew, dust, dirt, trees, grass, pollen etc.)

ID: 1076929
Sex: F
Age: 42
State: CA

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: No

Symptom List:

Symptoms: Body aches, fever, chills, muscle pain, headache, nausseau, fatigue,

Other Meds: Acetaminophen. Tylenol. Tamoxifen. Levothyroxine.

Current Illness: No

ID: 1076930
Sex: F
Age: 71
State: CA

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: Fish

Symptom List:

Symptoms: Bell?s palsy. Left eye will not close and left mouth droopy with muscle weakness left side.

Other Meds: Lisinopril, Levothtyrn, plavix, Lipitor

Current Illness: None

ID: 1076931
Sex: M
Age: 74
State: VA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 03/05/2021
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Symptoms: No adverse events; He had 1st COVID19 (Pfizer) on Jan 27th which was only 7 days apart between two vaccines. CDC recommend separate out at least 14 days.

Other Meds:

Current Illness:

ID: 1076932
Sex: F
Age: 44
State: IA

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 03/05/2021
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Allergies: IV Dye, Iodine contaning morphine seasonal cats dogs

Symptom List:

Symptoms: They started about 2:30 in the morning, I woke up chilled. I had the muscle and body aches and then I had the nausea and fatigue. I had a headache. Initially, I took 600 mg of Advil and seemed to help. But fever spiked 102.5 - symptoms get worse throughout the day. Advil brought down the fever some. Sleeping helped the most. These symptoms lasted about 48 hours. I missed a day and a half of work because of it.

Other Meds: abilify 5 mg daily bupropion ER 150 mg daily citalopram 40 mg daily claritin 10 mg daily gabapentin 600 mg three times per day modafinil 200 mg twice daily

Current Illness: adverse effects of 1st dose of COVID vaccine; no others

ID: 1076933
Sex: M
Age: 89
State: OH

Vax Date: 02/13/2021
Onset Date: 02/18/2021
Rec V Date: 03/05/2021
Hospital: Y

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Allergies: Opioids-intolerance pseudoephedrine-anxiety

Symptom List:

Symptoms: 2/17/21 Pt w/fever, SOB and diarrhea. Positive household exposure to COVID. + for SARS-CoV-2. Was given fluids and no hypoxemia. Discharged to home and set up with monoclonal AB infusion 2/18/21 In am pt received bamlanivumab w/o issue 2/18/21 several hours later pt returned to ED w/fever to 103.1, tachypnea and hypoxemia. Pt was started on steroid and he had rapid improvement. He weaned off oxygen on 2/19. He was discharged 2/20.

Other Meds: apixaban 5mg BID atorvastatin 40mg QD finasteride 5mg QD furosemide 40mg QD latanoprost one gtt OU QHS lisinopril 40mg QD KCl 20mEq QD

Current Illness: none

ID: 1076934
Sex: F
Age: 67
State: FL

Vax Date: 02/10/2021
Onset Date: 02/09/2021
Rec V Date: 03/05/2021
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Allergies: Lisenopril, silicone,

Symptom List:

Symptoms: Hive on left upper arm from elbow to shoulder, itching and swelling

Other Meds: Irbasartin/HZTC 150/12.5 mg, Atorvastatin 80 mg, Metoprolol 100 mg,, Clopidogrel 75 mg, Levothyroxine 75 mcg, Solifenacin 5 mg, Bupropion 150 mg, Risperidone 1mg, Escitalopram 10 mg

Current Illness:

ID: 1076935
Sex: F
Age: 32
State: CA

Vax Date: 01/01/2021
Onset Date: 01/29/2021
Rec V Date: 03/05/2021
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Allergies: Antibiotics cherries and pineapple

Symptom List:

Symptoms: Face sweeping itchy mouth felt horrible headache migraine

Other Meds: Vesicare baclofen Allegra iron Flonase antihistamine elavile singular

Current Illness:

ID: 1076936
Sex: M
Age: 74
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Symptoms: history cancer on chemo, DM2 non insulin dependent 10 min s/p vaccine adminstered pt developed Chest pain associated with shortness of breath. chest pain resolved after nitro SL and asa. pt was evaluated by cardiologist and discharged home. Denies cardiac history similar reaction with 1st COVID vaccine dose

Other Meds:

Current Illness:

ID: 1076937
Sex: F
Age: 46
State: GA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: none

Symptom List:

Symptoms: Pt. c/o funny feeling in chest that started 5-6mins after sitting for post observation, pt. denied any other symptoms, pt stated the sensation in her chest was just a different feeling, not described as chest pain, flutters, palpitation or tightness, hard to describe.

Other Meds: none

Current Illness: none

ID: 1076938
Sex: F
Age: 64
State: WA

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: nkda

Symptom List:

Symptoms: RIght supraclavicular lymphadenopathy

Other Meds:

Current Illness:

ID: 1076939
Sex: F
Age: 67
State: AZ

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 03/05/2021
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Allergies: None

Symptom List:

Symptoms: Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400. I was taking additional insulin to try and bring it down and I wasn?t eating.

Other Meds: Vitamin D 3, vitamin B12, I am a type 1 diabetic and wear the Omni pod insulin pump

Current Illness: None

ID: 1076940
Sex: F
Age: 29
State: NC

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: None

Symptom List:

Symptoms: Elevated heart rate for hours. Around 12:15am I awoke to fever and chills and a rapid heart rate. While laying down it never went below 122 and at one point when I got up, it went to 154. Around 3:30am my fever broke and the heart rate dropped down to the low 100s. Over the course of the day it has consistently stayed at 85-98.

Other Meds: None

Current Illness: None

ID: 1076941
Sex: F
Age: 61
State: MD

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 03/05/2021
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Allergies: none

Symptom List:

Symptoms: This pain is interfering with my daily activities. The pain is from the injection to just above my elbow. I cannot lift my arm or sleep on my arm. Sanofi told me they had never heard of this complaint. This is day 18

Other Meds: AM- metformin, lisinopril, januvia, hctz, loraadine PM- metformin, atorvastin, doxazosin, amlodiine

Current Illness: none

ID: 1076942
Sex: F
Age: 68
State: WA

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: Oysters

Symptom List:

Symptoms: Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.

Other Meds: Otzela, levothyroxine, vitamin D, CoQ10, potassium, metoprolol

Current Illness: Nothing really

ID: 1076943
Sex: F
Age: 64
State: NM

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: NKDA, no other allergies

Symptom List:

Symptoms: Pt reports cough, SOB with coughing and laying flat, congestion, runny nose, sore throat, and sensation that "throat is closing" when laying flat. No lip swelling, throat swelling, or rash. States she did not have symptoms prior to vaccine and noticed them this am, the day after. No other symptoms. Does admit that in the past when she had allergies act up, that she felt similar. She has not tried taking any medications to treat these current symptoms.

Other Meds: Tramadol 50 mg PRN Naproxen 375 mg PRN Lisinopril 20 mg daily Hydrochlorothiazide 25 mg Daily Citalopram 20 mg daily

Current Illness: Denies any recent illness or symptoms, denies known sick contacts

ID: 1076944
Sex: M
Age: 33
State: NJ

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/05/2021
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Allergies: N/a

Symptom List:

Symptoms: the patient, was given the vaccine at roughly 10:15am. At about 10:30am, after waiting 15 minutes after the shot, the patient stood up from his chair in the waiting area. He staggered over to the pharmacy drop off window and stated that he felt like he was going to pass out. His eyes rolled back and he collapsed. Another patient was approaching the counter at the same exact time and was able to catch him on his way down. By the time I ran from behind the pharmacy counter, he was awake, breathing heavy and confused. One of the pharmacy technicians called 911 immediately and started the emergency response. he was able to regain his composure and move himself back the chair. The EMTs arrived and took his vitals, and discussed what happened. They eventually determined that he was ok and was free to go. The patient did not go to the hospital.

Other Meds: We do not have a patient history. He is not one of our regular patients

Current Illness: N/A

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm