VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

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

ID: 1306144
Sex: F
Age:
State: NY

Vax Date: 04/11/2021
Onset Date: 04/01/2021
Rec V Date: 05/11/2021
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Symptoms: 4-5 days later she tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program (patient) reported for herself that: A female patient of unspecified age received first dose of BNT162B2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot number and expiration was not reported) via unspecified route of administration as single for COVID-19 immunization. Medical history and concomitant medication were not provided. It was reported that Caller received 1st dose of Covid vaccine 11Apr and 4-5 days later she tested positive for Covid. Her 2nd dose of the vaccine is supposed to be on Wednesday, and she was wondering if she can take it. Patient underwent lab test and procedure which included SARS-CoV-2 test positive on unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1306145
Sex: F
Age:
State: WI

Vax Date: 04/14/2021
Onset Date: 04/25/2021
Rec V Date: 05/11/2021
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Symptoms: A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient's medical history included ventricular extrasystoles. She has had PVCs in past but no other underlying conditions. The patient's concomitant medications were not reported. The patient experienced vertigo on 25Apr2021. Event took place after use of product. On an unspecified date, the patient experienced slight dizziness, slight headache, and increased number of PVC's, although she normally does get them. The outcome of the events was unknown. No Follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Premature ventricular contractions

ID: 1306146
Sex: M
Age:
State: NY

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: Rhabdomyolysis (CK > 22.000); Elevated LFTs; This is a spontaneous report from a contactable physician. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 21-year-old on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was School or Clinic. Medical history included asthma. Concomitant medication included ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported. The patient experienced rhabdomyolysis (CK > 22.000) (hospitalization) on 24Apr2021, elevated LFTs (hospitalization) on 24Apr2021. The patient underwent lab tests and procedures which included blood creatine phosphokinase: > 22.000 on 24Apr2021, liver function test: elevated on 24Apr2021, SARS-CoV-2 test: negative on 25Apr2021 (Nasal Swab). Therapeutic measures were taken as a result of rhabdomyolysis (CK > 22.000), elevated LFTs. The outcome of events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rhabdomyolysis and Elevated LFTs. 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 Committees, and Investigators, as appropriate.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1306147
Sex: M
Age:
State:

Vax Date: 02/28/2021
Onset Date: 03/04/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: Heart disease; CARDIAC PAIN; Muscle tension/arm stress; ARM NUMBNESS; Increased blood pressure; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 28Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) and ongoing, at 40 mg for crohn's disease. Medical history included blood pressure high, Urine control, High cholesterol, Stomach upset, heart flow, Alcohol user, three to five bottles of beer on weekends (stopped 1986) , tobacco user, two or three cigars a day (Stopped 1986). Concomitant medications included lisinopril taken for blood pressure increased; finasteride taken for urine control; atorvastatin taken for blood cholesterol normal; pantoprazole taken for stomach upset; diltiazem hydrochloride (CARDIZEM) taken for an unspecified indication; acetylsalicylic acid (ASPIRIN (E.C.)) taken for heart flow; vitamin d3 taken for an unspecified indication; ferrous sulfate taken for urine; terazosin taken for urine control; probiotics taken for an unspecified indication. On unknown date, the patient experienced heart disease and arm numbness. on 04Mar2021, the patient experienced arm stress, cardiac pain and increased blood pressure. in Mar2021, the arm stress, cardiac pain and increased blood pressure resolved. COVID-19 VACCINE was also considered suspect. Patient was hospitalized on 04Mar2021 due to heart disease, stress on his arm and pain on his heart. He had arm numbness. The Covid 19 vaccine second shot could have triggered the event. He underwent electrocardiogram and the result was fine. His blood pressure was going up but he could not remember the reading of his blood pressure during that time. Patient was advised to increase the dose of his medicines and was given with his usual medications which were the Lisinopril, Finasteride, Terazosin, Atorvastatin, Vitamin B12, Fer-rous Sulfate and Pantoprazole during his hospitalization. He was discharged on 05 Mar 2021 and he recovered from the events stress in arm, cardiac pain and increased blood pressure a week af-ter his hospital discharge. Blood pressure went back to normal level. Patient could not remember the indication for Cardizem. Patient already received twodoses of CoVid 19 vaccine. The action taken in response to the events for adalimumab was dose not changed. The outcome of events Cardiac pain, Muscle tension, Blood pressure increased was resolved in Mar2021, of event Numbness was recovering, of event Heart disease was unknown. The reporter's causality for the events of heart disease was not provided. the reporter's causality for the events of arm stress, cardiac pain, arm numbness and increased blood pressure with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. There is no reasonable possibility that the events of heart disease, arm stress, cardiac pain, arm numbness and increased blood pressure are related to humira 40mg/0.4ml(adalimumab). The reporter's causality for all the events with Covid-19 vaccine was Not Reported. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LISINOPRIL; FINASTERIDE; ATORVASTATIN; PANTOPRAZOLE; CARDIZEM [DILTIAZEM HYDROCHLORIDE]; ASPIRIN (E.C.); VITAMIN D3; FERROUS SULFATE; TERAZOSIN; PROBIOTICS

Current Illness:

ID: 1306148
Sex: F
Age:
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Rec V Date: 05/11/2021
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Symptoms: Rash; This is a spontaneous report from a contactable consumer (patient sister). A 56-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number and Dose number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The medical history and concomitant medication were not reported. On an unspecified date, patient experienced rash after developing symptoms. The outcome of the event rash was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306149
Sex: F
Age:
State:

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Rec V Date: 05/11/2021
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Symptoms: rash; This is a spontaneous report from a contactable consumer or other non- healthcare professional (patient's sister). A 55-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced rash. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Reporter (female, aged 57) mentioned that she received second dose on 23Apr2021, then on Monday she developed little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs. Reporter also mentioned that her sister who lived with her aged 56, also developed a similar rash after developing symptoms.

Other Meds:

Current Illness:

ID: 1306150
Sex: M
Age:
State: TN

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Rec V Date: 05/11/2021
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Symptoms: The patient's medical history and concomitant medications were not reported. Caller reporting adverse event with Pfizer Covid vaccine. She was surprised by all of this after the vaccine. Her brother had one and he was six years older than caller and it didn't phase him, only a sore arm. The outcome of the event was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306151
Sex: F
Age:
State:

Vax Date: 04/23/2021
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Rec V Date: 05/11/2021
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Symptoms: tested postive; This is a spontaneous report from contactable consumer (patient's parent) by a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient received 1st vaccine on Friday (23Apr2021) and than tested positive for COVID-19. Outcome of the event was unknown. The patient will have 2nd Dose on May 20th. IInformation on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1306152
Sex: F
Age:
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Rec V Date: 05/11/2021
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Symptoms: Fever; Chills; kind of nauseous like with the name eating; I have been eating things stomach like things stick on stomach; it is swollen under my arm that I got the shot in; headache; Under my arm is lymph node under my arm is very swollen and got bigger; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (reported as past Monday) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, via an unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunization. After patient had a second vaccination of Pfizer shot on Monday (as reported). Patient experienced lots of problem like headache, chills, fever and kind of nauseous like with the name eating and she had been eating things stick on stomach and she had swollen under arm that she got the shot in. Under her arm was lymph node swollen and got bigger. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1306153
Sex: M
Age:
State: CA

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Rec V Date: 05/11/2021
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Symptoms: Severe joints pain; Got fever a 100 and 101; Headache; Severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0170) via unspecified route of administration on an unknown date in left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication (Other medications: Consumer stated I am taking something for prostate and Lipitor I think) was not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8737) via unspecified route of administration on an unknown date in left arm as a single dose for COVID-19 immunization. It was reported that patient received his second shot of COVID vaccine and at around 2:00 had the adverse reaction got fever a 100 and 101, headache, severe joints pain and severe fatigue. The outcome of the events was unknown. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1306154
Sex: F
Age:
State: MS

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/11/2021
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Symptoms: Fever; Chills; This is a spontaneous report from a contactable consumer (patient). This is a cloned case, report 2 of 2. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced fever and chills. Therapeutic measures were taken as a result of fever and chills. The patient stated that they all had certain symptoms but most people have had what they have. The outcome of events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306155
Sex: M
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 05/11/2021
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Symptoms: Too nervous about second dose of Covid-19 vaccine to drive to vaccination facility; A little shaky; This is a spontaneous report received from a contactable consumer (patient's wife). A 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 19Jan2021 10:20 (at 82-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol a long time ago, at least 10 or 15 years, high blood pressure a long time ago, at least 10 or 15 years, high triglycerides a long time ago, at least 10 or 15 years. Concomitant medication(s) included hydrochlorothiazide(HYDROCHLOROTHIAZIDE) taken for high blood pressure from an unspecified start date to Apr2021; eicosapentaenoic acid ethyl ester (VASCEPA) taken for high triglycerides from an unspecified start date to Apr2021; atorvastatin (ATORVASTATIN) taken for high cholesterol from an unspecified start date to Apr2021 and Multi vitamin. Patient underwent laboratory test including a CT scan and MRI, a spinal tap on the patient, and all the tests the medical staff could possibly run to try to find out what the problem was with the patient and the doctors didn't find anything on 2021. On 19Jan2021 patient experienced a little shaky following his first dose of the Covid-19 vaccine and patient was too nervous about second dose of Covid-19 vaccine to drive to vaccination facility on Feb2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds: HYDROCHLOROTHIAZIDE; VASCEPA; ATORVASTATIN

Current Illness:

ID: 1306156
Sex: F
Age:
State: FL

Vax Date: 04/12/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Extreme diarrhea; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported. A 38-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ER8729), intramuscular, administered in Arm Left on 12Apr2021 as single dose for COVID-19 immunisation. Patient had diarrhea as well, after the first dose of the vaccine. Patient knows it came on hard, while patient was driving her car. Reporter states patient does not feel comfortable answering all of these questions for her daughter, states she is only on birth control, no further information required. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1306157
Sex: F
Age:
State: CO

Vax Date: 04/10/2021
Onset Date: 04/25/2021
Rec V Date: 05/11/2021
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Symptoms: Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Allergies; Hot flashes; Nausea waves for two weeks; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0151) as 2ND DOSE, SINGLE for covid-19 immunization, at the Age at Vaccination of 36 years old. The patient medical history was not reported. Patient was not Pregnancy at time of Vaccination. Historical vaccine included first dose of BNT162B2 on 20Mar2021 (Lot number: EP6955; Dose number=1; Vaccine location=Left arm) for covid-19 immunization, reported the first shot she had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Concomitant medications (medications the patient received within 2 weeks of vaccination) included Implanon, Straterra, adderall, multivitamin, ashwa (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient experienced bleeding (medically significant), along with a week and a half of heavy fatigue (non-serious), sneexzing (non-serious), allergies, hot flashes, nausea waves for two weeks (non-serious), heavier menstrual bleeding (non-serious), all on 25Apr2021 with outcome of unknown. Reported as she never have period due to her birth control methods. She got heavier bleeding a few days after her second dose that lasted about a week, along with a week and a half of heavy fatigue, Sneexzing and feeling like she had allergies, with occasional hot flashes and nausea waves for two weeks. And even heavier menstrual bleeding starting 15 days after second shot. No treatment received for events. 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 not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: IMPLANON; ATOMOXETINE; ADDERALL; ASHWAGANDHA; MULTIVITAMIN [ASCORBIC ACID;COLECALCIFEROL;DEXPANTHENOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINO

Current Illness:

ID: 1306158
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Mild flu; Runny nose; Cough; Fever; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for her 70 years mother-in-law. A 70 years old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 23Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 2 weeks after the vaccination, the patient experienced symptoms of a mild flu with runny nose, cough, fever and headache. Patient was tested for COVID-19 because of her symptoms but the result was negative. Clinical outcome of the events was unknown at time of this report. No follow-up attempts are needed, information about lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306159
Sex: M
Age:
State: FL

Vax Date: 04/17/2021
Onset Date: 04/18/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: sepsis; A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO ASSESS THE EFFICACY AND SAFETY OF AD26.COV2.S FOR THE PREVENTION OF SARS-COV-2-MEDIATED COVID-19 IN ADULTS AGED 18 YEARS AND OLDER This is a Non-Pfizer sponsored interventional study report, based on information received by Pfizer from Janssen Vaccines & Prevention B.V. (manufacturer report number USA-U38-US10051-2021-VAC31518COV3009000010 (0)). A 52-year-old male subject received blinded therapy (Ad26.COV2.S /Placebo) on unspecified date. The subject also received Pfizer COVID-19 vaccine (BNT162B2), intramuscularly, first dose on unspecified date and second dose on 17Apr2021. The subject's medical history was not reported. Concomitant medications included alprazolam from 01Jan2015 for anxiety, rosuvastatin from 01Jan2018 for high cholesterol, and lisinopril from 01Jan2018 for high blood pressure. The subject experienced sepsis on 18Apr2021, which was considered as life-threatening event and required hospitalization. Clinical course was as follows: subject's wife called site on 26Apr2021 to report that subject had not been feeling well since 18Apr2021, one day after receiving second dose of Pfizer COVID-19 vaccine. He was having body aches and fatigue. Since symptoms were getting worst, subject decided to go to hospital on 22Apr2021. He was admitted and informed he had sepsis. Subject continued being in the hospital. Sepsis adverse event toxicity was grade 4. Relevant tests were not reported. The action taken in response to the event for blinded therapy and for BNT162B2 was not applicable. The outcome of the event was recovering. The investigator considered there was not a reasonable possibility that the event sepsis was related to blinded therapy; however, the investigator assessment of the causal relationship of the event sepsis with the product BNT162B2 was not provided at the time of this report. Efforts are being made to obtain such final determination. Since no determination has been received, the case is managed as if the investigator's assessment was that a reasonable possibility exists that the event was related to BNT162B2, as a cautionary measure and for reporting purposes.; Sender's Comments: Based on the information currently provided, the company considers there is not a reasonable possibility that the event sepsis is related to Pfizer COVID-19 vaccine (BNT162B2) and Non Pfizer blinded therapy due to the lack of a plausible pathophysiological mechanism. 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: ALPRAZOLAM; ROSUVASTATIN; LISINOPRIL

Current Illness:

ID: 1306160
Sex: F
Age:
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Rec V Date: 05/11/2021
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Symptoms: Calling for her daughter who took 1st dose of Covid vaccine a few weeks ago and developed an intermittent, fine, itchy rash and still had it as of last weekend; This is a spontaneous report from a contactable consumer. A contactable mother reported for her daughter (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving 1st dose of Covid vaccine patient developed an intermittent, fine, itchy rash and still had it as of last weekend. The outcome of the event was unknown. No follow-up attempts are possible: information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306161
Sex: F
Age:
State:

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Rec V Date: 05/11/2021
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Symptoms: Daughter took 2nd dose yesterday and got very sick and skin was hot to the touch; Daughter took 2nd dose yesterday and got very sick and skin was hot to the touch; At 1am the daughter called and was having trouble breathing; Today her rash is gone but now the skin feels raw; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for her daughter (patient) of an unspecified age that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date in 2021 (reported as yesterday) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization a few weeks ago after which the patient developed an intermittent, fine, itchy rash and still had it as of last weekend. The reporter stated that the patient took 2nd dose yesterday and got very sick and skin was hot to the touch. At 1am, the patient called and was having trouble breathing. Today the rash was gone but now the skin feels raw. The patient would like to talk about the side effects with someone. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306162
Sex: F
Age:
State:

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Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Rash after the first dose; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on an unknown date for COVID-19 immunisation. The patient medical history included Polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS). Concomitant medications were not reported. It was reported that the patient experienced rash after the first dose. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306163
Sex: U
Age:
State: CO

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: throbbing of my left arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration, in left arm on 24Mar2021 10:30 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced throbbing of left arm for approximately 24 hours. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1306164
Sex: U
Age:
State: CO

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Soreness at the puncture site; slight fever lasting 1 hour; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender of patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0161) via an unspecified route of administration on 14Apr2021 at 10:30 as a single dose for COVID-19 immunization. Past vaccination includes first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via unspecified route of administration on 24Mar2021 at 10:30 AM as a single dose for COVID-19 immunization and side effect was a throbbing of left arm for approx.24 hours. The patient medical history was not reported. Concomitant medication included arnica montana (ARNICA (PLANTA TOTA) "WELEDA") (MANUFACTURER UNKNOWN). Patient chose to take Arnica on tues prior (with the ok from patient's primary care and RN at the vaccination clinic (withheld). On an unspecified date, that time, patient's symptoms were soreness at the puncture site (only when the patient accidentally touched) and a slight fever lasting 1 hour. On Friday, patient was feeling fine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: ARNICA (PLANTA TOTA) "WELEDA"

Current Illness:

ID: 1306165
Sex: M
Age:
State: OH

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of (Pfizer/BioNTech COVID-19 Vaccine, Solution for injection, and expiry date: not reported) via an unspecified route of administration in the region of left arm on 09APR2021 at single dose for Covid19 immunisation. Medical history of the patient was reported as cataract, which the patient had for over a year and Left eye surgery for cataracts. The patient's concomitant medication was not reported. The patient had cataract surgery in the left eye on 20Apr2021, the outcome of which at the time of observation was reported as recovered. On an unspecified date after the vaccination the patient experienced soreness in the left arm that went away in 4-5 days. The outcome of the event soreness in the left arm was unknown. No follow-up attempts are needed. No further information is expected. .

Other Meds:

Current Illness: Cataract operation (Outcome of reaction/event at the time of last observation: Recovered)

ID: 1306166
Sex: M
Age:
State: MS

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/11/2021
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Symptoms: lump under his armpit on same arm that he got the shot in; lump under his armpit on same arm that he got the shot in; swollen lymph nodes (lymphadenopathy); Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0157), via an unspecified route of administration, on 21Apr2021 at 10:30, administered in Arm Right as single dose for covid-19 immunisation. Patient's first dose of bnt163b2 (BNT162B2, Batch/lot number: ER8733) was administered on 31Mar2021 at 10:30 in left arm. The patient's concomitant medications were not reported. On 21Apr2021 the patient experienced fever (08:00), chills (thinks around 21:00 or 22:00). She says on 21Apr2021, the same day as his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. She does not know the NDC number, lot number, or expiration date of the ibuprofen he took. On 23Apr2021 lump under his armpit on same arm that he got the shot in. On 23Apr2021 swollen lymph nodes. Prior Vaccinations within 4 weeks were none. The patient was not sick at the time of either vaccination. There was no family history. The outcome for events fever and chills were recovered on 22Apr2021 but for event lump under his armpit on same arm that he got the shot in was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1306167
Sex: U
Age:
State: MS

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/11/2021
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Symptoms: Chills; lump under the arm that got injected; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 at 10:30 (Batch/Lot number: EW0157, expiration date: unknown) as single dose for covid-19 immunisation. This is a clone master case, report 1 of 2. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 31Mar2021 at around 10:30 as single dose for covid-19 immunisation. No Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. On 21Apr2021, the patient experienced fever around 21:00 or 22:00 PM, chills around 22:00 PM and lump under his armpit on same arm that he got the shot in injected around on 23Apr2021 08:00 AM. The lump was noticed in morning when he woke up, and thinks it was 8 in the morning. The reported said, that she thought it was about the same. The caller stated that her whole family got vaccine on 21Apr2021. The caller stated that her whole family got vaccine on 21Apr2021. They all had a little bit of symptoms here and one of her oldest son who is 19 has a lump under the arm that got injected She was wondering if this was common, if it'll go away and if she should consult his doctor. The reported said that, patient goes to the clinic and that the doctor there that is their primary care provider is no longer there, so they see whoever is available. The fever started around 9 or 10 at night on 21APR2021, that it must have ended last night on 22Apr2021, because patient was running fever during the day and chills started at 10pm that night, 21Apr2021. On 21Apr2021, the same day of his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. There was no additional vaccines administered on same date of the Pfizer suspect. The patient had not yet visited Emergency Room or physician office, but he probably will. The was not sick at the time of either vaccination. The event fever and chills recovered and outcome of evet lump under the arm that got injected was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306168
Sex: U
Age:
State:

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Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Diagnosed with Covid after receiving first dose of vaccine; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with COVID-19 after receiving first dose of vaccine. The patient wanted to know if patient should receive second dose of vaccine. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306169
Sex: M
Age:
State: FL

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: he tested Positive for Covid; chills; tiredness; This is a Spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that last Monday, he had symptoms; chills and tiredness and it became worse yesterday. He took the COVID Rapid test and he tested positive for COVID. Also took the PCR test but he was still waiting for the results. Asked if this has anything to do with the vaccine. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306170
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: ringing in his ears; Arm left arm is sore. injection site; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date in Apr2021 as a single dose on for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot# EW0158, Expiration date: 31Jul2021) on 08Apr2021 as a single dose for COVID-19 immunization. On an unknown date at 2:45pm the patient got his 2nd shot of Pfizer, 6 am woke up with ringing in his ears, and his arm left arm is sore. injection site. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306171
Sex: M
Age:
State: FL

Vax Date: 03/24/2021
Onset Date: 04/14/2021
Rec V Date: 05/11/2021
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Symptoms: not feeling good; This is a spontaneous report from a contactable consumer, the patient, from Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: UNKNOWN), dose 1 via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient missed his 2nd dose on 14Ap2021 because he has been not feeling good that day. The clinical outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306172
Sex: F
Age:
State:

Vax Date: 04/26/2021
Onset Date: 04/28/2021
Rec V Date: 05/11/2021
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Symptoms: tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) reported for herself that the patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiry date: Unknown) through an unspecified route (age at vaccination:62-year-old) on 26Apr2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medication was not reported. On 28Apr2021, Wednesday, the patient tested positive for Covid-19. The patient enquired what to do about the second dose of the vaccine and did they need to take it or wait. Caller mentioned that she didn't think she got COVID from the vaccine but wasn't sure. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306173
Sex: F
Age:
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: body and muscle aches; body and muscle aches; fever; swelling in the lymph nodes under her left arm; not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient experienced body and muscle aches, fever, and swelling in the lymph nodes under her left arm, which was the same side as the vaccination. She's not feeling well and wanted to know how long the symptoms may last. She had been running a low fever, since her second dose, and wanted to make sure she can't spread it to anyone. She indicated that she was not ill before being vaccinated. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306174
Sex: F
Age:
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: I am feeling nauseated; slight tension headaches; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: not provided), via an unspecified route of administration, on 27Apr2021, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received the second dose on the 27th of the month and then the patient felt nauseated and slight tension headaches, patient ask the question response was given, spoke from attached documents and referred to HCP. The outcome of the events was unknown. Repot received date 30Apr2021 follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306175
Sex: F
Age:
State:

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/11/2021
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Symptoms: numbness on the right side of her face; numbness on the right side of her face; This is a spontaneous report from contactable consumer (patient) via medical information team. A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose at left arm on 21Apr2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient experienced numbness on the right side of her face and the back of her tongue (towards the throat) on 21Apr2021, maybe one hour after the 1st vaccine dose. Patients 2nd Pfizer vaccine dose is scheduled for 12May2021. The outcome of the events was unknown. No follow-up attempts are needed :information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306176
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: redness; itching in arm and leg with tiny red bumps. Also felt itchiness in left cheek but no redness.; itching in arm and leg with tiny red bumps; This is a spontaneous report received from a non-contactable consumer (reporting on herself). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. It was reported that patient never had an allergic reaction before she got second dose of BNT162B2 vaccine on left arm. 10 min after reported redness, itching in arm and leg with tiny red bumps. Also felt itchiness in left cheek but no redness. Next morning still had same symptoms. Only took Tylenol. And was asking anyone else experience this. Patient was asking any % of people who got fully vaccinated and got re infected with covid. Saying that been told she should isolate for 14 days after the dose. Asking if that true and wear a mask. The outcome of the events was un-known. No follow-up attempts are possible. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306177
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/12/2021
Rec V Date: 05/11/2021
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Symptoms: Diagnosed with COVID shortly after; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A female patient of an unspecified age received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0151, Expiration Date: Jul2021) via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient experienced adverse event and diagnosed with COVID-19 shortly. The patient underwent lab tests and procedures which included covid-19: positive on 12Apr2021. The outcome of the events was unknown. The seriousness of the event COVID-19 was reported as non-serious. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1306178
Sex: F
Age:
State: NJ

Vax Date: 04/10/2021
Onset Date: 04/20/2021
Rec V Date: 05/11/2021
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Symptoms: tested positive with Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 20Apr2021 the patient tested positive with covid-19 (covid-19). The clinical outcome of the events was unknown. The patient is asking if she should get the second dose. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306179
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: reporting that he felt feverish; had a blood blister in his mouth; he was really sweaty last night and early this morning; This is a spontaneous report from a contactable consumer. The male consumer (patient) of an unspecified age received dose of (COMIRNATY, solution for injection, Batch/Lot Number: unknown) on an unspecified date via an unspecified route of administration at single dose for COVID-19 immunisation. The medical history and concomitant medication were not reported. Patient reported that on an unspecified date patient felt feverish, had a blood blister in his mouth, and he was really sweaty last night and early this morning. Patient was if there had been reports of a blood blister in the mouth. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306180
Sex: F
Age:
State: NY

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: She had Covid-19 after the 1st dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional via COVAX US support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were unknown. Patient underwent lab test and procedure which tested positive for COVID-19 on unspecified date. On an specified date, patient reported that she had Covid-19 after the 1st dose. She wanted to cancel her 2nd dose scheduled on 28APR2021 and asked if it can be rescheduled. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306181
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Symptoms: weakness; dizziness; fast heart rate; when i felt the weakness was coming my right eye got very warm and felt like it was going to be swollen shut, but it never did, but felt warm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included allergy to animal (to cats and dogs). Concomitant medications were not reported. The patient had the severe reactions that are listed in the fact sheet, it happened within minutes of getting the vaccine, she had weakness, dizziness, fast heart rate, and when she felt the weakness was coming her right eye got very warm and felt like it was going to be swollen shut, but it never did, but felt warm. The events assessed as non-serious. She wants to know if she should not get the second dose. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306182
Sex: F
Age:
State: CA

Vax Date: 04/03/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: she experienced really bad hives on her face and lips.; This is a spontaneous report from a Pfizer sponsored program. The contactable female consumer of unspecified age reported for herself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection) (Lot number& expiry date not reported) via unspecified route of administration on 03, Apr 2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient mentioned that after the 1st dose, she experienced really bad hives on her face and lips. The patient wanted to know if she should continue with the 2nd dose despite what she experienced which she was scheduled on 28, Apr 2021. Outcome of event was unknown. No follow-up attempts are needed; Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306183
Sex: F
Age:
State: MI

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Symptoms: light headed/dizzy; shortness of breath; chest pain; headache; her arm bothered her for couple of days; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Lot Number: EW0172, Expiry date: Unknown) as single dose for COVID-19 immunisation. Medical history included stroke from an unknown date and unknown if ongoing, Cancer; Variant Cancer with Vitamin D from an unknown date and unknown if ongoing, thoracic aortic aneurysm from an unknown date and unknown if ongoing, heart Surgery from an unknown date and unknown if ongoing, seizures from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing, problem with my stomach from an unknown date and unknown if ongoing, lost my gall bladder from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, thyroid cancer from an unknown date and unknown if ongoing. The patient previously took cipro 1a pharma and experienced hypersensitivity before, it stopped her heart, demerol and experienced hypersensitivity, it made her throat close up and Pneumonia vaccine in the past, made her swell up all over her body. Patient had Gastric Bypass before heart surgery. Patient can only take Acetaminophen. Patient cannot take anything with Naproxen in it. So, patient do not know if that matters with this vaccine or not. So, just thought and will let you know. Patient cannot take pain killers because patient raise her grandson. Concomitant medication(s) included topiramate (TOPAMAX) 100 mg taken for seizure, start and stop date were not reported; atenolol (ATENOLOL) 100 mg taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D 3) taken for osteopenia, start and stop date were not reported; cyanocobalamin (B-12) taken for anaemia every 2 months, start and stop date were not reported; benzethonium chloride, ethanol (PENTAL COL) 20 mg 3 times a day for Problem with my stomach, start and stop date were not reported; pepsin (PEPSIN) 20 mg taken for an unspecified indication, start and stop date were not reported; fluorometholone (FLUROMET) do take 1 or 2 Over the Counter pills. I take Fluromet if that is needed when I have migraine, that's not everyday and 2 more over the counter taken for migraine, start and stop date were not reported; diphenhydramine hydrochloride, paracetamol (LEGATRIN PM) taken for restless legs, start and stop date were not reported; rivaroxaban (XARELTO) for Antithrombin 3 blood clotting disorder, start and stop date were not reported; pamabrom, paracetamol (BACKAID) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; hctz (HCTZ) 12.5 mg taken for heart, start and stop date were not reported; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) 60 mg twice a day taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced lightheaded/dizzy, shortness of breath, chest pain, headache and her arm bothered her for couple of days. She states the paramedics made her stay for about 30 minutes to monitor her. Consumer stated, she was going to check with her Cardiologist and if he says that's okay patient was going to take the other shot. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: TOPAMAX; ATENOLOL; CALCIUM WITH VITAMIN D 3; B-12; PENTAL COL; PEPSIN; FLUROMET; LEGATRIN PM; XARELTO; BACKAID; SYNTHROID; HCTZ; CENTRUM SILVER +50; CYMBALTA

Current Illness:

ID: 1306184
Sex: M
Age:
State: MS

Vax Date: 04/12/2021
Onset Date: 04/19/2021
Rec V Date: 05/11/2021
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Symptoms: The caller received his first dose on 12Apr2021. On 19Apr2012 the caller tested positive for covid; This is a spontaneous report received from a contactable consumer (patient, self-reporting). A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 19Apr2021 (7 days post vaccination), the patient tested positive for COVID-19 virus. The patient already completed his 10 days quarantine and had tested back already which shown negative for the virus on 30Apr2021. The patient was scheduled to receive second dose of the vaccine on 03May2021. There was a product complaint The patient just wanted to check if he can safely get the vaccine given that he previously tested positive with COVID19. The outcome of the event was recovered. Follow-up #1 (30Apr2021): This is a spontaneous report received from a contactable consumer. No new significant information was updated. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1306185
Sex: M
Age:
State: CA

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 05/11/2021
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Symptoms: This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus (Diagnosed 1 year and a half or 2 years ago), ongoing hypertension (Diagnosed 1 year and a half or 2 years ago Blood pressure was 130/90 and it used to be a lot higher), ongoing blood cholesterol (Diagnosed 1 year and a half or 2 years ago), He threw his back out (He threw his back out when he worked at a nursery in the 1980s), back pain (He has not missed work due to back pain in 15 years) ongoing Herniated disc, His A1c was 9.3, now it is down to 6.1. Concomitant medication included metformin taken for type 2 diabetes mellitus, chlorthalidone taken for hypertension, rosuvastatin taken for blood cholesterol, hydrocodone taken for an unspecified indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17 Mar 2021 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization and tetracycline and Got knots in his stomach. On Apr 2021, the patient experienced back ache/couple or three days after the vaccine he had pain. it was a gradual pain that got worse/he has to pick up his left leg; if he lifts it on his own it hurts his left lower back, his back was totally wrenched. he feels the vaccine aggravated an old back injury on an unspecified date, his arm was sore for one or two days on Apr 2021, his blood sugar yesterday was 144 on 29Apr2021. Patient visited physician for back pain. Patient stated he has not missed work due to back pain in 15 years. a couple or three days after the vaccine he had pain. It was a gradual pain that got worse until he had to miss work for a couple of days. States this was after the second dose of the vaccine. Says it was back pain. States it took him 10 minutes to get out of bed, his back was totally wrenched. He feels the vaccine aggravated an old back injury. States it wasn't like when he threw his back out because that pain was immediate. States this was a gradual pain that got the point he couldn't work with it. Patient believes the vaccine caused 2 weeks of back ache. The patient underwent lab tests and procedures which included blood glucose: 144 on 29Apr2021. The action taken in response to the event for BNT162B2 was not applicable. Outcome of event His back was totally wrenched. He feels the vaccine aggravated an old back injury, His blood sugar yesterday was 144 was unknown, His arm was sore for one or two days was recovered and for Back ache/Couple or three days after the vaccine he had pain. It was a gradual pain that got worse/He has to pick up his left leg; if he lifts it on his own it hurts his left lower back, His back was totally wrenched. He feels the vaccine aggravated an old back injury it was recovering. No Follow-up attempts are needed. No further information is expected.

Other Meds: METFORMIN; CHLORTHALIDONE; ROSUVASTATIN; HYDROCODONE

Current Illness: Blood pressure high (Diagnosed 1 year and a half or 2 years ago. Blood pressure was 130/90 and it used to be a lot higher.); Cholesterol (Diagnosed 1 year and a half or 2 years ago); Herniated disc; Type 2 diabetes mellitus (Diagnosed 1 year and a half or 2 years ago).

ID: 1306186
Sex: F
Age:
State: MI

Vax Date: 04/17/2021
Onset Date: 04/30/2021
Rec V Date: 05/11/2021
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Symptoms: report positive COVID test and that she had one dose of the COVID Pfizer Vaccine on 17Apr2021.; This is a spontaneous report from a contactable nurse (patient). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 17Apr2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient diagnosed with COVID 19 was unknown. Since the vaccination, the patient had been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that the patient contacted (name) clinic on 30Apr2021 to report positive COVID test and that she had one dose of the COVID Pfizer Vaccine on 17Apr2021. Patient did not receive the vaccine at Pfizer where she works as a contractor. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1306187
Sex: F
Age:
State:

Vax Date: 04/25/2021
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Rec V Date: 05/11/2021
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Symptoms: right after her arm was sore for a little bit; pain in her back.; hears thumping and heart pounding in her head/ears; hears thumping and heart pounding in her head/ears; she did feel numb in her arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, administered in arm right on Sunday 25Apr2021 at 1:00 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer reported that right after her arm was sore for a little bit and she felt out of it. She reported that she did feel numb in her arm and this went away. She reported the next day something happened in her lower back. She stated she was outside weeding for about 10 minutes and had to take three advil that day because of the pain in her back. She stated she was nervous about the shots and does not want to take the second dose. Consumer also reported that when sleeping she hears thumping and heart pounding in her head/ears that wakes her up. She did not know if that was a heartbeat or blood pressure. She stated she did not want to call her HCP until she talked to someone and asked about myocarditis. On an unspecified date, the patient experienced right after her arm was sore for a little bit, pain in her back, hears thumping and heart pounding in her head/ears, she did feel numb in her arm. Therapeutic measures were taken as a result of event pain in her back and included treatment with take three advil. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1306188
Sex: M
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/20/2021
Rec V Date: 05/11/2021
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Symptoms: On 20Mar2021 he had dots form on his body so he went to Urgent Care and he was diagnosed with Shingle; This is a spontaneous report from a contactable reporter (patient). A 68-years-old male patient received bnt162b2 first dose of (Formulation: solution for injection) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 20Mar2021, the patient had dots form on his body so he went to urgent care and he was diagnosed with shingle, patient was told by doctor that not to receive the second dose and to wait for the shingles to clear up. The patient said that, the shingles were gone. The patient was scheduled to receive the second dose on 23Mar2021. The events were considered as non serious. The outcome of the event dots form on his body so he went to urgent care and he was diagnosed with shingle was recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1306189
Sex: M
Age:
State: FL

Vax Date: 04/18/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: he had a COVID-19 test done but the results came back positive for COVID-19 three days later; runny nose; He got the shot without knowing that he had the virus; This is a spontaneous report from a contactable consumer (Caregiver). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Medical history included rhinorrhoea (Verbatim: Runny nose), nasal congestion (Verbatim: Congestion). The patient's concomitant medications were not reported. The patient reported he had a covid-19 test done but the results came back positive for covid-19 three days later, runny nose, he got the shot without knowing that he had the virus on an unspecified date. Patient didn't go to the hospital, had no severe symptoms, only a runny nose, didn't even have a fever or cough". Patient received first dose of Pfizer Covid vaccine on 18Apr2021, that same day in the morning he had a COVID-19 test done but the results came back positive for COVID-19 three days later. patient was originally scheduled to get second dose on 09May2021, however due to the positive COVID-19 test result he was now told he should wait 3 months to receive 2nd dose. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

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Current Illness:

ID: 1306190
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/11/2021
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Symptoms: sore arm; bad headache; felt that bad; This is a spontaneous report from a contactable nurse, other hcp. (Patient mother). A 28-year-06-months old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unknown), via unspecified route on an unspecified date (this past Saturday in Apr 2021) for COVID-19 immunisation. The patient previously received first dose of BNT162b2 vaccine on an unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced a sore arm. Reporter then stated that her son was now complaining of a bad headache and would like to know if it was unusual to experience this side effect 4 days after the vaccine dose. The patient took 2 extra strength Tylenol on morning that did not help, and reporter stated that her son had to ask his professor for an extension on his homework because he felt that bad. Reporter stated that the patient normally do not have headaches but did for a while a couple of months ago, but he cut back on his caffeine consumption which helped. She stated that she has heard on TV and from friends and relatives that this was a common side effect with the vaccine. The clinical outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306191
Sex: F
Age:
State:

Vax Date: 04/26/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: her right arm started feeling heavy with sharp pains in it; her right arm started feeling heavy with sharp pains in it/ her right thumb is "killing me"; her right arm has a tingling sensation and numbness to it; her right arm has a tingling sensation and numbness to it; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in left arm, on 26Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in left arm, on Friday, 26Mar2021, as a single dose for COVID-19 immunization. The patient reported that on Saturday, the patient woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them. She went to her chiropractor for an adjustment, and it appeared to feel a little better, but she reported that her right thumb "was off" feeling numb and with pain. She missed her second dose because her son tested positive for COVID and so she got her second dose on Monday, 26Apr2021. The patient also reported that she was fine but then on Tuesday, her right arm started feeling heavy with sharp pains in it and today she reports that her right thumb was "killing me" and her right arm has a tingling sensation and numbness to it. Outcome of the events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1306192
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date: 04/21/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: afib; 104.7 fever; tired; Third dose on 21Apr, (second dose did not meet requirements of CDC guidelines).; Third dose on 21Apr; This is a spontaneous report from a Pfizer sponsored Program. A contactable other HCP and clinician (as reported) reported that a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown),via an unspecified route of administration on 01Mar2021 as single dose, second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 10Apr2021 to 22Apr2021, at 1 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced afib, 104.7 fever, tired, third dose on 21Apr. Verbatim and Event Description received as, fever, Atrial fibrillation (AFib), hospitalization, tired, and takes the medication as directed. Patient states Vaccination 01Mar2021, 31Mar2021. Called 4/1 wanted me to take the third dose (second dose did not meet requirements of CDC guidelines). Third dose on 21Apr2021, 22Apr2021 had 104.7 fever, AFib, in hospital four days. Stopped 22Apr2021 Inlyta. See oncologist 28Apr2021. Felt good when I was on it. Little bit tired, doing okay. The patient underwent lab tests and procedures which included pyrexia: 104.7 on 22Apr2021. Therapeutic measures were taken as a result of afib, 104.7 fever and tired with the medication as directed. Outcome of the events afib, 104.7 fever and tired was recovered for on an unknown date and remaining events were unknown. Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events of atrial fibrillation and fever cannot be excluded, due to temporal relationship. 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 Committees and Investigators, as appropriate.

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Current Illness:

ID: 1306193
Sex: F
Age:
State: IL

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 05/11/2021
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Symptoms: swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. 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. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: LEVOTHYROXINE; ESTRADIOL; PROGESTERONE; TESTOSTERON

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm