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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1423069
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: broke her my wrist; swelling; Pain; Sore arm; Inflammation in her wrist; This is a spontaneous report from a consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 15Mar2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received her first dose of the Pfizer vaccine and then then broke her wrist the following day (unspecified date in Mar2021) and got her stitches removed on 16Mar2021. The doctor told her to take Aleve 3 of them three times a day for swelling and pain and to start physical therapy. She was also instructed to take Aleve three times a day for inflammation in her wrist. Patient stated she heard Aleve and the vaccine were not supposed to be taken. My second dose was on 5Apr2021. She questioned that, are we not allowed to have Mammograms, magnetic resonance imaging (MRI) and X-rays. She had no reaction only a sore arm for a day but nothing else happened. She only took 2 Aleve because she did not want it to interfere with the vaccine. Patient visited Physician office due to events broke her wrist and inflammation in her wrist. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1423070
Sex: M
Age:
State: IL

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Tested positive for Covid ten days later; Sick; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 05Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the Pfizer vaccine on 05Feb2021. He became sick and tested positive for Covid ten days later (on an unspecified date in Feb2021). He was prescribed Bamlanivimab infusion the next day and was told by nurses not to get the second dose of the vaccine until ninety days later. He reached his principal doctor from the assistant and was told he should wait only forty-five days to get the second shot. He was calling to get an opinion on the matter, whether he should wait forty-five or ninety days before getting the second dose. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1423071
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Myocarditis; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 18Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer (Patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and had abnormal side effects. On an unspecified date the patient experienced myocarditis. She mentioned that she was 76-year-old woman not a teenager or 30-year-old man. She stated that she had to run around and spend like 20minutes going through all these menus and was not helpful. Patient doctor wants to call and report that they think patient have Myocarditis. Patient wanted to connect to the medical department so that she can talk to the nurse to know if her problem was the result of the vaccine. The outcome of the event myocarditis is unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1423072
Sex: F
Age:
State: AZ

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Was tested positive for the Covid Virus.; Next day felt like "crap" was on couch all day. Coughing, and did not feel well.; Next day felt like "crap" was on couch all day. Coughing, and did not feel well.; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 01:15 AM (at the age of 75-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported and had no known allergies. Concomitant medications included amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN + CLAVULANIC ACID) 875 mg Tablets, fish oil D, monascus purpureus (RED YEAST RICE) taken for an unspecified indication, start and stop date were unknown. No other vaccines were received in four weeks. It was reported that the next day the patient felt like "crap" was on couch all day. On 13Mar2021 at 05:00 AM the patient experienced coughing and did not feel well. By Friday went to Urgent care. Was tested positive for the Covid Virus on 19Mar2021. Advised to quarantine for 10 days. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of events coughing, and did not feel well, tested positive for the covid virus. Patient was prescribed with Dexamethasone, 6 mg, Vit D-1000/day, Vit c 2000/day, Zinc 90/day, Asprin 325/day (large dose of vitamins). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Mar2021. The patient had no Covid prior vaccination and not tested post vaccination. The outcome of the events was recovering. No follow up attempts are completed. No further information is expected.

Other Meds: AMOXICILLIN + CLAVULANIC ACID; FISH OIL; RED YEAST RICE

Current Illness:

ID: 1423073
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/23/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Bell's Palsy Type Sensory Reaction; 4 day she developed the shingles; She was so sick; she developed Spots on her chin and cheek leftover from the shingles; This is a spontaneous report from a contactable consumer (patients mother) or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, the patient underwent quantitative antibody lab tests included sars-cov-2 antibody after the first shot and the count results were 77.74 milliliters. Patient mother wanted to know how safe her daughter was because she could not get a second one as her doctors had told her she could not take the second dose. Patient never had Covid which reporter thanked God. Reporter stated that somebody had to have some data. 132 needed to donate convalescent plasma. On 23Jan2021, the patient experienced Bell's Palsy Type Sensory Reaction (always serious event) and 4 day she developed Spots on her chin and cheek leftover from the shingles. The events were considered as medically significant events. Reporter stated that she had an appt today with the dermatologist. They gave her almost like a bleaching thing and something for the itch. Patient mother stated that she had such a horrible, horrible reaction. The shingles and the way she reacted reporter thought she should have good antibodies. She was so sick the first 3 days and the 4 day she developed the shingles, bells palsy type reaction. Reporter got a table of all the companies that do the IGG testing and had gone to 7 doctors, 3 MRIs, 2 neurologists, her brain, cervical trigeminal nerve infectious disease and ophthalmologist. She further stated that there were other people getting these bells palsy type reactions. It was reported that they are all 27 (Patient) came out of it and patient left with spots on her face and her mother was grateful that she did not had nerve paralysis. Further reported that patient never had chickenpox. She was the first age group that got Varicella before kindergarten. She never got chicken pox so to get shingles and never had chicken pox, only 22% of the population gets that. 78% of the people that get the vaccine did not get shingles. But yet her antibodies for the varicella zoster was off the roof after the vaccine. IT was over 3000 and her face was proof of it. The outcome of Bell's Palsy Type Sensory Reaction was recovered on unspecified date and rest events was reported as unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1423074
Sex: U
Age:
State: IN

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Bloody stool; Diarrhea; Dehydration; This is a spontaneous report from a contactable consumer. An 80-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Deltoid Left on 01Feb2021 12:40 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from 01Jan1990 and ongoing, PE from Jan2001, Hypocholesteremia from 01Jan2000 and ongoing, cardiac disorder Cardiac health, GERD. Concomitant medications included asa (ASA) taken for Cardiac health; atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for hypocholesterolaemia; losartan (LOSARTAN) taken for HTN; famotidine (PEPCID [FAMOTIDINE]) taken for GERD. The patient previously took bnt162b2 for covid-19 immunisation. On 01Feb2021 18:40, the patient experienced bloody stool, diarrhea, and Dehydration. The outcome of the event bloody stool, and dehydration was unknown, for the event diarrhea was recovered on 04Feb2021.

Other Meds: ASA; LIPITOR [ATORVASTATIN CALCIUM]; LOSARTAN; PEPCID [FAMOTIDINE]

Current Illness: Hypertension (Verbatim: Hypertension); Hypocholesteremia

ID: 1423075
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Caller received both covid vaccines. She is still covid positive; Caller received both covid vaccines. She is still covid positive; This is a spontaneous report from a contactable consumer or other non hcp (patient) via a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunization. The patient reported that she had received both covid vaccines. She was still covid positive. The patient underwent lab test and procedures which included Sars-cov-2 test which showed covid Positive. The case was assessed as medically significant. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1423076
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: tested positive for the virus; tested positive for the virus; This is a spontaneous report from a Pfizer sponsored program. A non-contactable Male consumer reported for himself that or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The patient tested positive for the virus (sars-cov-2 test positive) on an unspecified date. INT-# Swap from (Name)- first time caller received his first covid vaccine and then tested positive for the virus. He was suppose to get his second covid vaccine and was now wondering if he should still get it. Upon collecting his information (only got his name) for transfer he stated his work was calling for conference call and he had to get off the phone. Provided him medical information to call later. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1423077
Sex: F
Age:
State: PA

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: she tested positive to COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 09Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got tested positive for Sars-CoV-2 and the patient is scheduled to have second dose and is just completing her isolation. The patient's doctor has recommended her to wait 2 weeks before getting the second dose, but she also heard opposite recommendations. The outcome of the events was reported as unknown at the time of report. No follow-up attempts are possible. No information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1423078
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: he tested positive for covid after the first dose; he tested positive for covid after the first dose; This is spontaneous report from a contactable pharmacist. A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported) via an unspecified route of administration on unspecified date as a 1st dose single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient was due to take the second shot of the covid vaccine today but he tested positive for covid after the first dose. Reporter wanted to know should she still give the second dose to patient. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded.

Other Meds:

Current Illness:

ID: 1423079
Sex: F
Age:
State: MD

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: broke her ankle; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: not reported) dose 1 via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant was not reported. It was reported that patient broke her ankle, and she could not make it on 02Apr2021 for her second dose schedule. She wanted to reschedule. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1423080
Sex: M
Age:
State: SC

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: tested positive for COVID-19; tested positive for COVID-19; dizziness; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9264), dose 1 intramuscular, administered in right arm on 30Jan2021 as single dose for COVID-19 immunisation. Medical history included COPD. The patient's concomitant medications were not reported. The patient was tested negative for COVID-19 several times before getting the first dose of the vaccine. On an unspecified date he tested positive and went to rehab centre in Feb2021, prior to received his second dose of the product. In Feb2021, patient had dizziness had been ongoing for might be about 2 to 3 weeks. The patient underwent lab tests and procedures which included COVID-19 test: positive in Feb2021. On an unspecified date, the patient was discharged from rehab centre. he outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1423081
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Do not take the second dose; I will not be able to be fully covered; Started shaking specially my hands; I started to feel very giddy; My tongue started to swell up badly; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 76-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. She had many vaccines in her lifetime. The Pox vaccine to live in abroad when she was young. Then vaccine to live abroad to work. Then another country and then in another country. She had so many but she never had any reaction to anything. On 22Mar2021, the patient had started shaking specially her hands and then within the first 15 minutes then it was okay and then she started to feel very giddy like she had several glasses of champagne and then her tongue started to swell up badly. The events were considered serious as medically significant events. Patient received Benadryl as treatment for the events. On an unknown date, patient stated that she definitely do not take the second dose. So, she will not be able to be fully covered. It was reported that patients doctor send her to an allergist to see if she should take the second dose. She told that she had even get a the green pass and who knows if she could take anymore vaccine that are created for the mutant strains of this virus. Further, this was a very severe reaction, and she was on the first one not even the second one and its not acceptable. Patient stated that there are people that did not have allergic reaction to anything before in their life. These things nothing, scorpion bite nothing and this was a huge surprise. They need to know this kind of things all this other stuff. It was reported that patient was not experiencing the problem or symptoms. At the time of report, patient was recovering from the events shaking specially my hands, started to feel very giddy and tongue started to swell up badly without hospitalization. The outcome of the event Do not take the second dose; I will not be able to be fully covered was unknown and for other events was recovering. Information about batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1423082
Sex: M
Age:
State: FL

Vax Date: 01/27/2021
Onset Date: 02/25/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Mouth and face shingles; This is a spontaneous report from a contactable physician. A 89-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection) intramuscularly in right deltoid on 27Jan2021 as single dose for COVID-19 immunization. Medical history reported was hyperlipidemia, osteoporosis, chronic ischemic cardiovascular disease (CICD III), stroke prevent, all ongoing. Concomitant medications reported was atorvastatin (LIPITOR) for hyperlipidemia, acetylsalicylic acid (ASPIRIN) for stroke prevent, all ongoing and via orally route. Patient previously received first dose of BNT162B2 (lot: EH9899) in right deltoid on 06Jan2021 for covid-19 immunization. The patient experienced mouth and face shingles on 25Feb2021. Patient was hospitalized from 28Feb2021 to 03Mar2021. Treatment was received as tramadol for and Gabapentin for shingles. Outcome of the event was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.; 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 event Herpes zoster 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.

Other Meds: LIPITOR [ATORVASTATIN]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Chronic ischaemic heart disease, unspecified; Hyperlipidemia; Osteoporosis; Stroke

ID: 1423083
Sex: F
Age:
State: FL

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; My lymph nodes swelled up and that lasted a few days; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:15 (Age at time of vaccination 38-years-old ) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history, concomitant medications was not reported. The patient previously taken historic vaccine first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: ER8730) administered in Arm Left on 24Mar2021 01:45 pm for covid-19 immunization. The patient did not administer other vaccine in four week and no other medication in two week. The patient was not covid vaccination prior and post vaccination. On 04Apr2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative Covid test type: Nasal swab Covid test name: PCR Covid test result: Negative. On an unspecified date the patient experienced when i got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed, my lymph nodes swelled up and that lasted a few days. The outcome of events was recovered with sequelae. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1423084
Sex: F
Age:
State: IL

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Tightness in throat; Coughing; Dizziness; Legs tingling; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and hypertension, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included losartan potassium 100 mg, and diltiazem hydrochloride 240 mg, both from unknown dates for unknown indications. The patient previously received sodium benzoate from an unknown date for an unknown indication and experienced drug allergy, hydrochlorothiazide from an unknown date for an unknown indication and experienced drug allergy, unspecified angiotensin converting enzyme (ACE) inhibitors from unknown dates for unknown indications and experienced drug allergy; cefazolin from an unknown date for an unknown indication and experienced drug allergy; and hydrocodone-acetaminophen from an unknown date for an unknown indication and experienced drug allergy. On 03Mar2021 at 10:45, the patient experienced tightness in throat, coughing, dizziness, and leg tingling. The events required a physician office visit and emergency department visit. The patient was treated with intravenous diphenhydramine hydrochloride (BENADRYL) and steroids. The clinical outcomes of tightness in throat, coughing, dizziness, and leg tingling were recovered on unspecified dates in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19.

Other Meds: LOSARTAN POTASSIUM; DILTIAZEM HCL

Current Illness:

ID: 1423085
Sex: M
Age:
State:

Vax Date: 05/20/2021
Onset Date: 05/24/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: he is still feeling very very tired; This is the spontaneous report from a contactable consumer (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24May2021, the patient was still feeling very very tired. He wanted to know if this was normal. The outcome of very very tired was unknown. No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.

Other Meds:

Current Illness:

ID: 1423086
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: could not talk because of her swollen tonsils/tonsillitis; fatigue; burning legs and toes; arm pain; swollen lymph nodes; could not talk because of her swollen tonsils; This is a spontaneous report from a contactable consumer (patient's father). A 20-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Three to four days after receiving the vaccine, the patient experienced fatigue, burning legs and toes, arm pain, swollen lymph nodes, and swollen tonsils. She could not talk because of her swollen tonsils and was diagnosed with tonsillitis. The patient received treatment with steroids and antibiotics. The outcomes of fatigue, burning legs and toes, arm pain, swollen lymph nodes, swollen tonsils, could not talk, and tonsillitis were unknown.

Other Meds:

Current Illness:

ID: 1423087
Sex: F
Age:
State: GA

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: I believe it triggered a pretty bad case of arthritis in both knees, and it is still a daily struggle; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 14:00 (Batch/Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included obesity from an unknown date and while the knees were not in perfect health prior to the shot, patient was able to walk and hike, that patient had not been able to do at the time of report. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine and fluoxetine hydrochloride (PROZAC); both taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received first dose of BNT162B2 (Lot number: EL9264) via unspecified route on the left arm at age 37 years on 02Mar2021 at 08:30 AM for COVID-19 immunisation. On 24Mar2021 19:00, the patient experienced significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving. The doctor recommended Advil and electrolytes. It got a little bit better for a short time, but the pain is still there- I believe it triggered a pretty bad case of arthritis in both knees, and it is still a daily struggle. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the adverse event included cortisone shots so far, physical therapy, naproxen. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a Public Health Clinic. The outcome of the event was not recovered. Further information has been requested.

Other Meds: LEVOTHYROXINE; PROZAC

Current Illness:

ID: 1423088
Sex: M
Age:
State: VA

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: I suffered from acute Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 10:00 (Batch/Lot Number: EW0177) (at age of 34 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was none. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other concomitant medications the patient received within 2 weeks of vaccination included vitamin C gummies. The patient suffered from acute idiopathic thrombocytopenic purpura on 18May2021 19:00. At the end of the 18th, patient noticed spots on arms and legs, about the size of the average mole. Later, gums bled and patient had blood blisters in mouth, from 1 to 3 after rinsing with listerine. The next day, he noticed more spots on feet and lower legs, similar to freckles. By the end of the day, his gums were bleeding unprovoked and he had hematuria. The bleeding continued and he went to the ER the following day and was informed that his platelet count dropped to 0. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Number of days of hospitalization was 3 days. Treatment received for the adverse events included Intravenous Immunoglobulin and steroids. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information on Lot/Batch number is available; Further information has been requested.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1423089
Sex: M
Age:
State: CA

Vax Date: 05/22/2021
Onset Date: 05/24/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: double vision whenever he moved his head; vision was disrupted when he would move his head; equilibrium was totally off; Head felt wobbly, head was in a fog type haze; The felling was scary; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 54-year-old via an unspecified route of administration in the left arm on 22May2021 16:00 (Lot Number: EWO179) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Nov2020 to Nov2020 prior to vaccination. The patient has no known allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both indications, start and stop date were not reported. The patient received the most recent COVID-19 vaccine in a public health clinic or facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days after the vaccination (24May2021 08:00), the patient's vision was disrupted when he would move his head. He saw almost what you would call double vision whenever he moved his head, like while driving or looking from one side to the other. He couldn't drive for about 3 days because the movement of one car would look like 2 cars. This didn't happen when head was still and looking straight. His equilibrium was totally off, his head felt wobbly, his head was in a fog type haze for about 2 weeks. The feeling was scary. He mentioned that he did have covid Nov2020. He added that he made phone call to his doctor and they said to give it 2 weeks before coming in which is exactly when symptoms started to subside but still feel a little off. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: CYMBALTA; XANAX

Current Illness:

ID: 1423090
Sex: M
Age:
State: WA

Vax Date: 06/07/2021
Onset Date: 06/08/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: tummy was weird; fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: En6203), dose 2 via an unspecified route of administration, administered in arm right on 07Jun2021 15:30 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 17May2021 15:45 (lot number: En203) for COVID-19 immunization. On 08Jun2021 05:15, patent experienced fainted morning after vaccine, and was lightheaded, tummy was weird too. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1423091
Sex: M
Age:
State: DE

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: get in to the hospital due to my heart, AFib; Shortly after, his heart rate went up/Heart beat jumped so fast, sudden rapid heartbeat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 48-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 13:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. Patient received the first dose on 14Mar2021 at the age of 47years old. The patient medical history was not reported. The patient's concomitant medications were not reported. Shortly (about an hour) after vaccination, his heart rate went up to 190 bpm and into atrial fibrillation. Heart beat jumped so fast, sudden rapid heartbeat. Caller sought medical care via emergency department, and went to doctor couple of times specially to heart doctor to make sure things are good. Patient was hospitalization for event Atrial fibrillation. Patient had Echocardiogram and PET scan on unknown date with result unknown. Outcome of events was unknown. Follow up needed, further information was requested.

Other Meds:

Current Illness:

Date Died: 05/27/2021

ID: 1423092
Sex: F
Age:
State: VA

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung infection; some lesions on her liver; a small mass in her lung,which they said were suspicious for cancer; a small mass in her lung,which they said were suspicious for cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II diabetes mellitus (DM2). Concomitant medications included regular prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post vaccination in May2021 was negative. The patient had no acute issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and poor appetite to the point of hardly being able to walk. The patient saw her primary doctor who ran some blood work and noticed she was dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The patient started having some SOB and scans done indicated possible lung infection. The patient was switched to IV meropenem which did not help. The doctors also noted some lesions on her liver and a small mass in her lung (no biopsy was done cause she declined) which they said were suspicious for cancer. The patient then suffered a large ischemic stroke and she passed about a week later. The patient was feeling well before her vaccine and everything started to go downhill after her vaccine. AEs result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test: negative in May2021. The outcome of events weakness, decreased appetite, unable to walk, dehydration, elevated liver enzymes, white blood cell count increased, short of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported suspicion on malignancy and BNT162B2 use is unrelated while the causal relationship between the remaining events and the use of BNT162B2 cannot be fully excluded. There is limited information available which precludes a more meaningful assessment. However, the underlying conditions and the age of the patient maybe risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug 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: ischemic stroke; infection

Other Meds:

Current Illness:

ID: 1423093
Sex: F
Age:
State: NJ

Vax Date: 05/15/2021
Onset Date: 05/16/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Fainted the morning following the vaccine; Weakness; dizziness/feeling of almost fainting/second time of feeling faint; "out of body" feeling; brain foggy; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old female patient received bnt162b2 (BNT162B2; brand: Pfizer), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:15 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE dose for covid-19 immunization, at the age at vaccination date of 36 years old. Patient was not pregnant. The patient medical history was not reported. No known allergies. Historical vaccine included first dose of BNT162B2 (brand: Pfizer; lot number: EW0161; vaccine location: Left arm) on 24Apr2021 14:15 (24hr) for covid-19 immunization. Concomitant medication included oral contraceptive taken for an unspecified indication, start and stop date were not reported. Events reported as: Fainted the morning following the vaccine. Weakness, dizziness, "out of body" feeling, brain foggy, feeling of almost fainting continued for a full weeks after the second dose. Went to emergency room on second time of feeling faint. Referred patient to a cardiologist. Echocardiogram was performed and heart monitor worn. Somewhere in the middle of the second week, the weird feelings gradually became less and less, but didn't completely stop until 2+ weeks after second dose. Echocardiogram, blood pressure, blood tests, all normal. Doctors weren't sure why patient was feeling this way, but it clearly started after she received the vaccine. All events on 16May2021 09:00 with outcome of recovered. The patient underwent lab tests which included blood pressure: normal, blood test: normal, echocardiogram: normal, all on unknown date. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for events included: Increase hydration with Pedialyte, food, rest. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.

Other Meds: ORAL CONTRACEPTIVE NOS

Current Illness:

ID: 1423094
Sex: M
Age:
State: MI

Vax Date: 04/03/2021
Onset Date: 04/04/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: wasn't feeling good; he feels like he's going to fall out or pass out; he feels like he's going to fall out or pass out; walking like he is intoxicated with a wobble; sluggish all the time; heart rate has been elevated; nauseous; cold chills; severe headache; This is a spontaneous report from a contactable consumer (patient). The 33-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 14:00 (Lot Number: ER8727) as single dose for covid-19 immunization at the age of 33 years old. Medical history included asthma, scoliosis, his scoliosis has never caused him to walk like this before. The report was not related to a study or programme. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication(s) included marijuana. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously received bnt162b2, dose 1via an unspecified route of administration, on 13Mar2021 (Lot Number: EP7534) in right arm as single dose for covid-19 immunization at the age of 33 years old. The patient experienced he feels like he's going to fall out or pass out, walking like he is intoxicated with a wobble, sluggish all the time, heart rate has been elevated in May2021, nauseous, cold chills and severe headache on 04Apr2021, wasn't feeling good on an unspecified date. Reported as: The caller received both doses of the vaccine. He had the second dose of the vaccine on 03Apr2021 and about a month after the second dose (in the beginning of May2021) he noticed that he is walking like he is intoxicated with a wobble, he is sluggish all the time, and he cannot control pretty much how he feels sometimes. Sometimes feels like he is going to fall or pass out and his heart rate has been elevated. That all started about a month ago, which was a month after the vaccine and it is progressively getting worse. His boss is asking him if he has been drinking. He is not intoxicated. He reports the day after he received the second Covid 19 vaccine on 04Apr2021, he went to the emergency room because he wasn't feeling good. When asked to elaborate he says he felt nauseous, he had cold chills, and a severe headache. He was discharged from the emergency room. He had some blood work done and a Covid 19 virus test. His bloodwork was fine and his Covid 19 virus test was negative. The AEs Nauseous, cold chills, severe headache, Feeling unwell required a visit to Emergency Room. The outcome of the events Feeling abnormal, Feeling unwell, Headache, Chills, Nauseous was unknown and not recovered for the rest events.

Other Meds: MARIJUANA

Current Illness:

ID: 1423095
Sex: F
Age:
State: CA

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: couldn't lift arm or lay on it; red hematoma at injection site for weeks; burning from head to toe; Arm hurt; Neuropathy and Small Nerve Fiber Neuropathy; worst headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05May2021(at age of 60 years old) (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Hashimoto's, Fibromyalgia, Small Nerve Fiber Neuropathy, surgeries for defective veins and valves, poor circulation problems and kidney infection 10 years before shortly after undergoing cath lab procedure. The patient's concomitant medications were not reported. Consumer call with questions regarding " I had side effects after the first dose of the vaccine. Should I get the second dose?" Side effects included "worst headache on 05May2021 for 2 days continued for weeks, couldnt lift arm or lay on it, red hematoma at injection site for weeks, burning from head to toe." Caller also reported that her arm hurt after the vaccine. Also reported she had to receive prednisone (her doctor put her on steroids) after first vaccine dose, also reported that her doctor gave her Methylprednisolone, which she took for 6 days, the medication did help somewhat with her symptoms, specifically, the burning from her neuropathy, headache and she couldnt lift her arm, the medication was not a miracle drug, but she did have some relief. She tapered the medication, she had less relief of her symptoms. The symptoms have subsided somewhat and it has taken several weeks. Caller just wanted to ask a medical professional if that ingredient (propyl ethlene glycol as provided and spelled by Caller) contributes to Small Nerve Fiber Neuropathy, Patient reported she went on vacation in January of 2020, after returning home she was very sick but was never diagnosed with Covid-19. Caller reported that she had some type of neuropathy that had come back after she got the first vaccine, she had a splitting headache within 30 minutes of getting the vaccine, and it was really bad, for two days after the vaccine. Caller was concerned to take the second vaccine, because of her previous bad reaction, and her doctor told her to take her second dose and Second dose of vaccine scheduled for 10Jun2021, 36 days after the first dose of vaccine. Outcome for events was recovering. Information regarding the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1423096
Sex: F
Age:
State: NC

Vax Date: 03/22/2021
Onset Date: 03/25/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: AFib; heart attack; low platelets; GI bleed; This is a spontaneous report from a contactable consumer (patient). The 64-years-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:00 (Lot Number: ER8730) as single dose for covid-19 immunization at the age of 64 years old; avatrombopag maleate (DOPTELET), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for an unspecified indication. Medical history included ITP from 1987 and ongoing. The report was not related to a study or programme. No Investigation Assessment. The patient's concomitant medications were none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient experienced gi bleed on 25Mar2021, afib, heart attack, low platelets on an unspecified date. The patient was hospitalized for gi bleed from 25Mar2021 to 27Mar2021 and hospitalization details for the rest events were not speicifed. Reported as: Caller states she has ITP, so this means she makes antibodies that destroys her own platelets, her doctors told her to go ahead and get the Pfizer Covid vaccines, states she got the first dose of the Pfizer Covid vaccine on 22Mar2021, states three days later on 25Mar2021, hospitalized with a GI bleed and low platelets, states after that she was hospitalized three more times. States the first three were low platelets, states during second hospitalization she went into Afib and during the fourth hospitalization she had a heart attack due to the Afib. Caller states she was treated with immunosuppressants, IVIG, rituximab, an anti rejection medication called Cellcept to get her ITP under control. States the medication she was taking didn't seem to be working anymore. Medication was Doptelet, was on this prior to vaccine, does not seem to be controlling her ITP anymore after receiving the vaccine. States she is not completely recovered but is on the mend now. The AEs require a visit to Emergency Room. Caller confirms she did not receive the second dose of the vaccine. The action taken in response to the event for avatrombopag maleate was unknown. The outcome of the event gi bleed was recovering and was unknown for the rest events.

Other Meds:

Current Illness: Immune thrombocytopenic purpura (Verbatim: ITP)

ID: 1423097
Sex: F
Age:
State: CA

Vax Date: 03/22/2021
Onset Date: 04/10/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: massive pulmonary embolism; This is a spontaneous report received from a contactable physician. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (at age of 48 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included asthma and menorrhagia. No past drug. Concomitant medication(s) the patient received within 2 weeks of vaccination included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, start and stop date were not reported. The patient experienced massive pulmonary embolism on 10Apr2021 with outcome of recovering. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for massive pulmonary embolism for 30 days. catheter-directed thrombolysis received for event. The patient was not diagnosed with COVID-19 prior to vaccination, and 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship. However, the concomitant medication of ethinylestradiol, norgestimate may have contributed to the development of the PE. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including VQ scan, pulmonary angiogram results and coagulation panel, and concomitant medications. This case will be reassessed once additional information is 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.

Other Meds: SPRINTEC

Current Illness:

ID: 1423099
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: rapid heart rate; anxiety; This is a spontaneous report from a contactable nurse reported for nephew from a Pfizer-sponsored program. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received by the Pfizer Covid vaccine and was now complaining of rapid heart rate. He had never had anything like this happen before. The patient had been transported to the hospital 5 times as a result of his symptoms and all cardiac workup tests had resulted negative for cardia issues. The doctor said its anxiety but it is not anxiety. They put the patient on a blood pressure medicine for his high heart rate. Reporter was concerned that the patient was being treated for anxiety rather than treating this a symptom due to lack of knowledge about the side effects of the Pfizer covid vaccine. The patient was in the hospital right now. 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 reported events cannot be excluded based on temporal relationship. The information available in this report is limited. Of note, medical history and concomitant medications were not provided. Case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1423100
Sex: F
Age:
State: HI

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: inner ear not able to find my balance feeling; off balance; numbness turned into pins and needles; my numb legs began twitching uncontrollable; I was not able to walk or lift my legs; my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks; my tongue became heavy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 14:15 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old. Medical history included Congenital deafness/hard of hearing. Sensory processing disorder and allergic to Septra (co-timoxazole). There were no concomitant medications. The consumer reported about 10 minutes after the shot, my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks, and my tongue became heavy. About 25 minutes after the shot, I was not able to walk or lift my legs. This was extremely scary. About 40 minutes after the shot, my numb legs began twitching uncontrollable. The twitching lasted about 10 minutes. About 2 hours after my shot I was able to walk again and the numbness turned into pins and needles. At about 7 hours after the shot the pins and needles subsided. The next morning I felt like I was on a ship. It was not a dizzy feeling, but more of an inner ear not able to find my balance feeling. I am still off balance. The pins and needles comes and goes. The events resulted in doctor or other healthcare professional office/clinic visit and prolonged hospitalization. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. Follow-up attempts are needed. Further information is requested.

Other Meds:

Current Illness:

ID: 1423101
Sex: M
Age:
State: PA

Vax Date: 04/10/2021
Onset Date: 04/15/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: blood clots in greater saphenous vein; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 08:00 at single dose in left arm (at the age of 55-year-old) for COVID-19 immunization. Medical history included covid-19. Concomitant medication included iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 15Apr2021, the patient experienced blood clots in greater saphenous vein. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Eliquis. The outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds: IODINE

Current Illness:

ID: 1423102
Sex: F
Age:
State: CA

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Bottom lip is numb. Feels like when you get that anesthetic on your gum at the dentist; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), dose 1 via an unspecified route of administration, administered in arm left on 08Jun2021 as dose 1, singe for covid-19 immunisation. Medical history included blood pressure measurement (BP). Concomitant medication included metoprolol. The patient previously received flu shots and experienced allergies. The patient stated, "Bottom lip is numb. Feels like when you get that anesthetic on your gum at the dentist (on 08Jun2021 11:45)." The patient received treatment for AE included Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was resolving.; Sender's Comments: Based on the close temporal relationship, the association between the event "bottom lip is numb" with BNT162b2 can not 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: METOPROLOL

Current Illness:

ID: 1423103
Sex: F
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Also she got COVID and she was pretty sick; Also she got COVID and she was pretty sick; Losing hair; Having an itchy and dry scalp; Having an itchy and dry scalp; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and was losing a lot of hair and also, she got COVID and she was pretty sick. The patient also had itchy and dry scalp. Outcome of the events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1423105
Sex: M
Age:
State: NM

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 18May2021 12:00 at the age of 59-years-old (Batch/Lot Number: EW0176) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included hypertension (HTN), overactive bladder, benign prostatic hyperplasia (BPH). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered on 22Apr2021 at the age of 59-years-old (Batch/Lot Number: ew0164) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine, lisinopril, oxybutynin, tamsulosin, hydroxyzine. The patient experienced syncope, psychosis/encephalopathy within 2 hours at 18May2021 14:00. Duration of hospitalization was 2. AE treatment included antipsychotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is 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 RAs, Ethics Committees, and investigators, as appropriate.

Other Meds: AMLODIPINE; LISINOPRIL; OXYBUTYNIN; TAMSULOSIN; HYDROXYZINE

Current Illness:

ID: 1423106
Sex: M
Age:
State: FL

Vax Date: 06/04/2021
Onset Date: 06/05/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: blood clot; he woke up with a numb hip up to his calf and his foot has been tingling; he woke up with a numb hip up to his calf and his foot has been tingling; chills and fever; chills and fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 04Jun2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history not reported. Concomitant medications included ongoing apixaban (ELIQUIS) as blood thinner. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14May2021 for COVID-19 immunisation. The caller (name withheld) said that she and her husband received the Pfizer Covid-19 Vaccine 1st dose on 14May2021 and 2nd dose on 04Jun2021. Last Saturday (on 05Jun2021), her husband (name withheld) started to experience side effects like chills and fever. Yesterday (on 07Jun2021), he woke up with a numb hip up to his calf and his foot had been tingling. She also mentioned that her husband was taking a blood thinner called apixaban and they thought he had a blood clot. They were asking if they should go to the hospital. The outcome of all events was unknown. Information about batch/lot number has been requested.

Other Meds: ELIQUIS

Current Illness:

ID: 1423107
Sex: F
Age:
State: MT

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: fluid in my inner ear; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; My ear still was feeling pressure; vertigo; vomitting; dizziness; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 15Apr2021 11:30 at the age of 56-years-old (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Mar2021 09:15 AM (Lot Number: EN6205) as single dose for COVID-19 immunization. The patient previously took pencillin and experienced known_allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol, estriol (BI EST). It was reported: After first dose of the vaccine I felt fine but had the feeling that my right ear had a bit of pressure in it. After my 2nd shot on a Thurs. I experienced similar side effects as some do. I had extreme aches, chills, and severe headaches. I am a teacher and called in sick the next day. I still passed it on as no big deal until my headache didn't go away. By Monday my headache was severe but I tried going back to work. My ear still was feeling pressure. My Tues. morning I woke up with a headache and vertigo to the point I was vomitting. Went to doctor It was probably fluid in my inner ear. Woke up 2nd day with Vertigo again, went doctor and was given a migrain shot to control my headache. Vertigo subsided. Missed 2 more of work. One month later Vertigo returned with a severe headache. Went to the doctor and she prescribed vestibular therapy. They tested for crystals but ruled it out. They are now trying to treat nerve/tissue damage in my inner ear. Battling dizziness." All adverse events start date was 15Apr2021 07:30 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Vestibular Therapy and Migraine Shot. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021671886 Same patient and vaccine, different dose and events

Other Meds: BI EST

Current Illness:

ID: 1423108
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Stevens-Johnson syndrome; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Pharmacist stated that she had a patient who received the 1st dose of Pfizer vaccine and developed Stevens-Johnson syndrome. The patient wanted to receive moderna vaccine. Pharmacist wanted to know can the patient receive the moderna vaccine and does the moderna also can cause the same side effect, if causes what is the percentage. Pharmacist did not have the patient details. Outcome of the event was unknown. Information about lot/batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Stevens-Johnson syndrome due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: 1423109
Sex: F
Age:
State: GA

Vax Date: 05/29/2021
Onset Date: 05/29/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Nausea and vomiting; Nausea and vomiting; eyes started swelling and almost shut the left; Eyes and face swollen up; there was a big old sore like staph like someone had poured acid on her/ sores on scalp; she doesn't have any taste; rash forehead/ the side of her forehead was red, like fire red, but it was "kicking"/ rash on nose/ rash all over the place; She was very warm that day/ she started feeling hot; she started burning on left side of her head; pain on top of the forehead/ pain at top of head shooting left side of face; This is a spontaneous report from a contactable nurse (patient; retired nurse). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on the left arm on 29May2021 11:45 (at the age of 82-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included sensitive skin. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. No other vaccines administered on the same date of the Pfizer suspect. The patient had no other prior vaccinations within 4 weeks. Family medical history relevant to adverse events was reported as none. There were no relevant tests done. On 29May2021, the patient received the first dose of BNT162B2. She had the worse reaction and didn't know what to do as she hedn't read about it and now she was reading it and added that she was not taking another one. She should have gone to the emergency room, but she was afraid they would admit her. She had read this paper on what she should, and she had almost every time. She went to her physician on 25May2021, and that they were giving the vaccine at his office and that it would be on the Friday (28May2021). Her physician had said that she needed to take the virus shot, but Friday (28May2021), it would be like to 12 o'clock and she had been there on Tuesday for a physical. She said that they wanted her to make sure if she wasn't coming and reschedule. She said that she went to store on the following Saturday on 29May2021. After she got the shot, she sat there for 15 minutes and read a brochure and then stated that she had been there for 30 minutes. She was very warm that day and she went and did her little shopping and it was very hot. After she did all of the shopping that day (29May2021), she went somewhere else and when she did, she started feeling hot and it was hot outside and she thought she had better get out of the heat. She got home about 17:30. She got to feeling heat so bad and she sat on her porch which she always did before she goes in the house. She said later that day (29May2021), she started burning on left side of her head. Started burning like her head was on fire on left side of her forehead and it kept on. She had a sensitive skin, so she couldn't understand why it was burning so. She then stated that it was burning so bad she went to mirror to see what it was doing and added that the side of her forehead was red, like fire red, but it was "kicking". Her son told her to put some cold compresses on it. She stated that she had been putting warm and that it had helped. The patient had rash forehead and she had put warm compresses on it and laid down because it was feeling so bad and she went back and looked in mirror and it had turned into fire and rash all across left side of forehead. She said she thought she must be having reaction to this shot. The patient stated that she loved coffee but hadn't even drank her coffee because she doesn't have any taste on 29May2021. She then looked at the information that was provided and the next day (on 30May2021), there was a big old sore like staph like someone had poured acid on her and for 2 days, she didn't put anything on her head to touch it. The patient considered the events feeling hot as serious and persisting, rash on nose as serious, rash all over the place as disabling, but then commented it was medically significant, nausea and vomiting had improved but was serious, eyes and face swollen up and pain on top of the forehead as very serious (even with her sitting, she could feel the pain arising on the left side), and sores on scalp and head as serious as serious. The patient experienced heat at night and added that it felt like something was hitting her on the side of her head. She tried to get some ease and she got and tried to eat some soup. She then went to the bathroom and threw up (confirmed it was on 01Jun2021). The patient was still having pain on the left side, top of forehead and added that it was "shooting everything now and then". She then mentioned that it was coming back now. The patient then stated that it had been over a week and she was finally getting better. The patient stated that she wasn't going to the emergency room because they would want to admit her. She further stated that "you could to the emergency room with a thumbtack and be put on Intensive Care Unit" and reiterated that she wasn't going. The patient had rash in her hair and didn't want anything touching it as it was just painful and felt like a big old sore, like a scab. After two days on 31May2021, her eyes started swelling and almost shut the left. She applied Cortisone cream to rash on the 2nd day for one day only. Doesn't not have it available. No other treatment sought. The patient then stated that the rash, feeling hot, burning on left side of her head, rash on nose, pain at top of head shooting left side of face occurred later in the afternoon of 29May2021; while not provided for the other events. The events did not require a visit to the emergency room and/or physician office. The outcome of the events erythematous rash, nausea, and vomiting was recovering; for the events feeling hot, burning sensation, loss of taste, pain on top of the forehead/ pain at top of head shooting left side of face was not recovered; while for skin lesion, eyes swollen and swelling of face was unknown. The reporter considered the events to be related to the Pfizer COVID 19 vaccine. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE0 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:

Current Illness:

ID: 1423110
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: a severe allergic reaction; broke out in a rash; This is a spontaneous report from a contactable other HCP (nurse) reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a severe allergic reaction and broke out in a rash on an unspecified date. Reporter stated that she got her first shot and the whole top of body broke out in a rash, should she get the second shot. It was all over the trunk of body. Reporter stated she got a paper here. It says Pfizer biontech covid 19 vaccine. She does know she has a paper and it said that if you have difficulty breathing, swelling of the face and throat or a bad rash all over body that its supposed to be a severe allergic reaction. Outcome of the events was unknown. Information about lot/batch number requested.; Sender's Comments: Considering temporal relationship, the reported severe allergic reaction with rash were likely related to vaccination with BNT162B2. The case will be reassessed should additional information become 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 agencies, as appropriate.

Other Meds:

Current Illness:

ID: 1423111
Sex: M
Age:
State: CA

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: fainted; Hit his head on the floor; pale looking; This is a spontaneous report from a contactable pharmacist. A 12-year-old male patient received first dose of bnt162b2 intramuscularly administered in right arm on 08Jun2021 at 15:00 (Batch/Lot Number: EW0187) at age of 12-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 08Jun2021 at 15: 10, 10 minutes after the shot (also reported on 08Jun2021 at 15: 00), the patient fainted, hit his head on the floor, conscious but pale looking. Patient's weight 160 lbs, vitals normal per grand ma and emt left after having him seat on the chair. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered on Jun2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported event syncope and BNT162B2 vaccine 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:

Current Illness:

Date Died:

ID: 1423112
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: congestive heart failure; Heart problem/heart down; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced congestive heart failure and heart problem/heart down. The patient had a heart problem after the Pfizer Covid vaccine. The patient had congestive heart failure and was 90 years old. The hospital said for the patient to get the second shot and it shut her heart down and the patient passed away. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: congestive heart failure; Heart problem/heart down

Other Meds:

Current Illness:

ID: 1423113
Sex: U
Age:
State: NJ

Vax Date: 04/24/2021
Onset Date: 04/26/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: diagnosed with a stage 4 non alcoholic cirrhosis of the liver and they were just about they put patient on a transplant and now that all sudden is now the stage 2; diagnosed with a stage 4 non alcoholic cirrhosis of the liver and they were just about they put patient on a transplant and now that all sudden is now the stage 2; sugar started running lower and lower and lower/the second shot it went to the 50; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Apr2021 (Lot Number: EW0161) at the age of 52-year-old, as dose 2, single for covid-19 immunisation. Medical history included diabetic, stage 4 non alcoholic cirrhosis of the liver. Historical Vaccine included first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 (Lot Number: ES8737) at the age of 52-year-old, for covid-19 immunisation and patient experienced blood glucose decreased. Concomitant medications included dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication, start and stop date were not reported; semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient reported the vaccine on April 3rd was patient's first one and April 24th was patient's second one. The patient have from a last 3 years patient became very brittle diabetic they have been trying all the medication on patient, prior to taking the first vaccine patient had been stable and was on to medication. After patient took the first shot, patient's sugar started running a little bit lower but not dangerous, after patient took the second shot on the 24th, starting on 26th, Monday is 26th patient's sugar started running lower and lower and lower. So by May 1st patient was off all the medications for diabetes (Further clarification unknown, suspect captured as Unspecified medication) and patient's sugar is running in hundreds like 99, 98 or 105 with the whole month, now unfortunately now patient is just back with the medication by end of May but obviously something in a vaccine there is something that helped patient with sugar because it's more then just patient's sugar. The patient was diagnosed with a stage 4 non alcoholic cirrhosis of the liver and they were just about they put patient on a transplant and now that all sudden is now the stage 2. The patient stated in 50's so patient had couple of medication and then it almost of May at least for 4 good weeks of May patient had no liver issues what so ever no liver symptoms and no sugar patient was having and no medication and patient's sugars were running normal 98,100. Before patient had the vaccine the sugars were very out control they were 200, and they had patient a medications maintaining like 150 all the time. So patient got the first shot it further gone down into the 110 which is where the warning and patient kept going okay taking medicine working better but then the second shot it went to the 50, so patient become which was fine it was wonderful thing but patient would like to know what was in that which maybe that can help diabetic saving more. The outcome of event was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: FARXIGA; OZEMPIC

Current Illness:

ID: 1423114
Sex: M
Age:
State: FL

Vax Date: 03/12/2021
Onset Date: 05/17/2021
Rec V Date: 06/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Stroke; hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk; tired; sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a 65-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 12Mar2021, dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, fish oil and vitamins (unspecified). The patient did not have prior vaccinations within 4 weeks from the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 on 19Feb2021 AT 16:00 in the right arm. The patient experienced a stroke on 17May2021. It was after his second dose of the Covid vaccine. The reporter said that the most worrying thing is through all of the tests they can't find anything that attributed to the stroke. The patient plays tennis one level below pro and played 4 times that week, he played golf that Saturday, cut the grass on Sunday and there is nothing to attribute to the stroke. The patient has hemiparalysis on the left side and a long road back. The patient can talk but his left arm and left foot are paralyzed and he can't walk, he is in a wheel chair and undergoing intense Physical Therapy. The patient was also tired and he had a sore arm. The patient was hospitalized from 17May2021 to 04Jun2021 due to the events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk. The patient visited the physician's office on 08Jun2021. The events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk were recovering while the events tired and sore arm have recovered on an unknown date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1423115
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: died because of the vaccine; This is a spontaneous report from a Non-contactable consumer (patient's grandson). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died because of the vaccine on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died because of the vaccine

Other Meds:

Current Illness:

ID: 1423116
Sex: M
Age:
State: AR

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: diagnosed with ITP; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN1185), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient relays he had COVID vaccine in March, then subsequently was diagnosed with ITP on Mar2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1423118
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Bells Palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on an unspecified date as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies and did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior and since the vaccination the patient was not diagnosed with COVID-19. The patient previously took BNT162B2(Batch/Lot Number: EN6207) via an unspecified route of administration, administered in Arm Left on 17Mar2021. On 01May2021 the patient experienced bells palsy left side of face. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with Steroid and antibiotic. The outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1423119
Sex: F
Age:
State:

Vax Date: 11/01/2020
Onset Date: 03/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: staph infection in eye; ulcer in eye; This is a solicited report by a non-contactable consumer (patient) from the facilitated collect received by Pfizer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Mar2021 (Lot Number: ER8733) at the age of 63-year-old as single dose for COVID-19 vaccination; upadacitinib (RINVOQ, tablet), orally from Nov2020 (Lot Number: 1139128) and ongoing at 15 mg, 1x/day for moderate to severe rheumatoid arthritis. Medical history included alcohol use from 1975, tobacco use three cigarette sticks per week, left shoulder replacement, right knee replacement, left hand and knuckles joint replacement, problems with eye, both ankles and feet replacement, eye dryness, dryness in mouth, migraine, heart burn/indigestion, rheumatoid arthritis and arthritis. Patient mentioned that she started smoking when she was 19 to 20 years old and quit 40 years ago when she gave birth to her child. She quit drinking alcohol years ago because it was causing migraines. She had a lot of titanium metals placed due to surgeries and replacements. She did not have any history of illicit drug use, immunosuppressive disorders, latent tuberculosis, and diabetes mellitus. Concomitant medication included methotrexate taken for rheumatoid arthritis; lifitegrast (XIIDRA) taken for eye dryness; cevimeline taken for dryness in mouth; folic acid; topiramate taken for migraine; omeprazole taken for heart burn/indigestion; paracetamol (TYLENOL) taken for arthritis. The patient previously oxycodone hydrochloride;paracetamol (PERCOCET) and experienced allergy manifested by throat closing up and rash; oxycodone and experienced allergy manifested by throat closing up and rash; pethidine hydrochloride (DEMEROL) and experienced allergy manifested by throwing up. In Mar2021, the patient experienced ulcer in eye and staph infection in eye with COVID-19 shot. In Apr2021, the ulcer in eye and staph infection in eye with COVID-19 shot resolved. Pfizer-BioNTech COVID-19 Vaccine (TOZINAMERAN) was also considered suspect. The patient had ulcer and it turned into staff in eye. She took an unknown antibiotic for the staph infection in eye and for the ulcer in eye. She had problems with the eye and it developed into ulcer in eye then she got her first Covid-19 shot. The physician told her it was a staph infection but she stated that it was just their speculation. She did not have any blood work done for the reported adverse events. The alternative etiology reported for event ulcer in eye was rheumatoid arthritis. The alternative etiology reported for event staph infection in eye was covid-19 shot. Primary reporter did not have the lot number information of the second dose of Covid-19 vaccine because it was not written on the vaccination card. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 26Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. On 16Apr2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included swab culture: eye Staph infection in eye on Apr2021. The action taken in response to the events for upadacitinib was dose not changed. Causality for upadacitinib: The reporter's causality for the events of ulcer in eye and staph infection in eye with covid-19 shot with upadacitinib was no reasonable possibility. Manufacturer's opinion was that there was a reasonable possibility that the events of ulcer in eye and staph infection in eye with covid-19 shot were related to upadacitinib. Causality for BNT162B2: The reporter's causality for the event of ulcer in eye with BNT162B2 was no reasonable possibility. The reporter's causality for the event of staph infection in eye with BNT162B2 was probable. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, there was not a reasonable possibility that the reported events of ulcer in eye and staph infection in eye were related to BNT162B2 vaccine. The events are attributed to intercurrent medical conditions. 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: METHOTREXATE; XIIDRA; CEVIMELINE; FOLIC ACID; TOPIRAMATE; OMEPRAZOLE; TYLENOL

Current Illness:

ID: 1423120
Sex: F
Age:
State: TN

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: paralyzed 13 hours later; daughter does not have full strength in her legs; left arm goes numb; has shortness of breath; always feels cold; chest pain; cannot feel hot or cold; She reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 14Apr2021 (33-years-old at the time of vaccination) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient was paralyzed 13 hours later, she reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), daughter does not have full strength in her legs, left arm goes numb, cannot feel hot or cold, has shortness of breath, always feels cold, chest pain. She states her daughter has been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection. She reports a cardiologist saw "something" on an EKG and that her daughter has also seen a neurologist and several other doctors. On an unspecified date, the patient underwent lab tests and procedures which included electrocardiogram. The outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1423121
Sex: M
Age:
State: CA

Vax Date: 04/25/2021
Onset Date: 06/07/2021
Rec V Date: 06/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Infected with Covid-19; Infected with Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 09:15 (Batch/Lot Number: EW0176) as single dose, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included Testicular Cancer from 1999 to an unknown date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient infected with Covid-19 on 07Jun2021 09:30. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jun2021 Nasal Swab, sars-cov-2 test: positive on 12Jun2021 Nasal Swab. Event occurred in a country different from that of the reporter. No treatment was received for the adverse events. The patient was not diagnosed with Covid prior vaccination and has been tested via Nasal Swab for Covid post vaccination. The outcome of the events was not resolved. Batch and lot number was obtained. Further information has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm