VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1743687
Sex: F
Age:
State: MA

Vax Date: 04/05/2021
Onset Date: 04/09/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210415; Test Name: PCR Covid test/ Nasal swab; Test Result: Negative

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Dizziness; headaches; severe total body aches; nerve pain; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and there were no concomitant medications. There were no other vaccine in four weeks and no other medication in two weeks. The patient had no Covid prior vaccination and was covid tested post vaccination (Nasal Swab: PCR) on 15Apr2021 with Negative result. It was reported that the patient experienced Dizziness, headaches, severe total body aches, nerve pain, nausea, and fatigue on 09Apr2021. The events resulted in: Doctor or other healthcare professional office/ clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The events were treated (also reported as ER visits, PCP visits, and several specialists). The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1743688
Sex: F
Age:
State: NJ

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/29/2021
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: Swollen, red, splotchy left eye; Swollen, red, splotchy left eye; Moderate to severe headache every day; malaise; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 30135BA), via an unspecified route of administration, administered in left arm on 10Sep2021 14:00 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and no known allergies. The patient has not had COVID prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO). On 10Sep2021, the patient experienced Moderate to severe headache every day since day 1, fatigue and malaise. The patient also experienced Swollen, red, splotchy left eye on day 4, on 14Sep2021. No treatment was given in response to the events. The patient was not COVID tested post vaccination. The outcome of the events was not recovered.

Other Meds: LEXAPRO

Current Illness:

ID: 1743689
Sex: F
Age:
State: VA

Vax Date: 08/18/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: states that she is also postpartum and nursing; states that she is also postpartum and nursing; rash on her legs and arms that has turned into severe itching/rash on the torso; severely itchy rash, afraid it will get infected; rash was kind of like hives in the arms and legs.; rash on her legs and arms that has turned into severe itching; bruising on her legs/big bruise on her leg that is now on both arms and legs; This is a spontaneous report from a contactable pharmacist reported information for both mother and fetus/baby. This is the maternal case. Only this case is serious. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in left arm on 18Aug2021 (Batch/Lot Number: FC3182) as dose 2, 0.3 ml single (at the age of 32 years old) for COVID-19 immunisation. Medical history included allergies: seasonal allergy and postpartum disorder from 20Jul2021 to an unknown date. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in left arm on 28Jul2021 around 2:00 or 3:00pm (Batch/Lot Number: FA7485) for COVID-19 immunisationThe patient experienced two weeks later she developed a rash on her legs and arms that has turned into severe itching. She is also experiencing bruising on her legs on 04Sep2021. Severely itchy rash, afraid it will get infected, rash on the torso. The rash was kind of like hives in the arms and legs. Treatment: She took Claritin for allergies and a topical steroid cream, Fluticasone. The patient stated that she is also postpartum (20Jul2021) and nursing. The events worsened and the reported as medically significant. The outcome of rash was kind of like hives in the arms and legs was unknown and other events was not recovered. The reaction was assessed by the primary reporter and global instrospection as related to the vaccine.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101208347 baby case

Other Meds:

Current Illness:

ID: 1743690
Sex: F
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 02/18/2021
Rec V Date: 09/29/2021
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: headaches almost daily; This is a spontaneous report from a contactable other healthcare professional (patient). A non-pregnant 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the right arm on 19Jan2021 at 13:15 (at the age of 35-years-old) at dose 2, single for COVID-19 immunisation. Medical history included endometriosis. The patient had not COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were reported as none. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient received the first dose of BNT162b2 intramuscularly, in the right arm, in Dec2020 at 13:15, at the age of 35-years-old, for COVID-19 immunization. The patient would very rarely get a headache before taking the COVID vaccine. A few months after taking vaccine, since 18Feb2021, she had headaches almost daily. At times had to miss work due to the severeness of headache which was not like her to do at all. No treatment was received for the event. The patient had not recovered from the event. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information in the case, a possible retalitionship between BNT162B2 and the event headache cannot be completely ruled out. 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: 1743691
Sex: F
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210913; Test Name: Fever; Result Unstructured Data: Test Result:High; Comments: High fever for over 24 hrs

Allergies:

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

Symptoms: Passed out; Body pains; Very dizzy; High fever for over 24 hrs; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration in left arm on 13Sep2021 at 13:00 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization in a pharmacy or drug Store. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to COVID vaccination. Prior vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient was not tested for COVID-19. The patient was passed out, felt very dizzy, had body pains and high fever for over 24 hrs on 13Sep2021 at 15:45. It was unknown if the patient received treatment for these events. The outcome of the events was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743692
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital: Y

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: paralyzed; heart condition after the first dose; anxiety; depression; sleeplessness; she has lost several pounds; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021 patient received vaccination and 13 hours later she was transported to a hospital (multiple other hospitals until she ended up in a hospital out of state). She was paralyzed and now she has a heart condition after the first dose. Patient was doing her occupational therapy now. She struggles with anxiety and depression, sleeplessness, she's a wreak, she has lost several pounds and was loosing weight. Patient cannot get the second vaccine and is not going to be able to get a job because of that. The outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1743693
Sex: M
Age:
State: CA

Vax Date: 02/24/2021
Onset Date: 03/08/2021
Rec V Date: 09/29/2021
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: I also spit up blood clots; Nose bleed; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Feb2021 12:00 (at the age of 62-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included diabetic and hypertension. The patient did not have any known allergies. The patient took other medications (unspecified) in two weeks prior to COVID vaccination. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe nose bleed on 08Mar2021 20:00 which lasted over 20 minutes. The patient was transported to nearby hospital for examination. The patient spat up blood clots during transport and at hospital. The patient received anti-blood clot treatment for the events. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1743694
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:Extreme drop of blood pressure; Comments: She had episodes of hypotension to approximately 60-70 systolic over 40, dizziness and extreme drop of blood pressure that lasted for about an hour that was not associated with chest pain or shortness of breath

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Hypotension (extreme drop of blood pressure); Dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician. A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously, on an unspecified date, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, for COVID-19 immunization. On an unspecified date, in Feb2021, the patient experienced hypotension (extreme drop of blood pressure) and dizziness. She had episodes of hypotension to approximately 60-70 systolic over 40, dizziness and extreme drop of blood pressure that lasted for about an hour that was not associated with chest pain or shortness of breath. These hypotensive episodes never happened to her before. Clinical outcome of the adverse events was unknown at time of this report. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hypotension and BNT162B2. 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: 1743695
Sex: F
Age:
State: TX

Vax Date: 05/15/2021
Onset Date: 05/28/2021
Rec V Date: 09/29/2021
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: with blood clotting; I had a late menstrual cycle that lasted almost 2 weeks; very painful; very heavy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 15May2021 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 38-years-old), for Covid-19 immunisation. Medical history included hyperthyroidism, known allergies: shellfish and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included methimazole (METHIMAZOLE) 5mg/daily taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 24Apr2021 (Batch/Lot Number: EW0169) as dose 1, single (at the age of 37-years-old) for Covid-19 immunisation. The patient had no other vaccine in four weeks. It was reported that less than 2 weeks after her second dose on 15May2021, on 28May2021, she had a late menstrual cycle that lasted almost 2 weeks, very painful, very heavy with blood clotting and not normal for her. She historically has very easy, short (3 days), non-painful cycles. After she had that cycle in late May, she has not had a cycle since then. It is nonexistent. She is not pregnant; she recently took a test with her physician in their office. The patient had not tested for Covid post vaccination. No treatment was administered for the events. The patient had not recovered from the events at the time of the report. The events resulted in Physician Office Visit. No follow-up attempts are possible. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743696
Sex: M
Age:
State: AZ

Vax Date: 01/06/2021
Onset Date: 01/19/2021
Rec V Date: 09/29/2021
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: either going into congestive heart failure or acute renal failure; either going into congestive heart failure or acute renal failure; Gained weight; difficulty breathing; significant swelling of feet and lower extremities; continuing large diureses; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek1283), via an unspecified route of administration in left arm on 06Jan2021 (at the age of 59-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, psoriatic arthritis, hereditary pressure point neuropathy, Sulfa allergy, latex allergy, and penicillin allergy. Concomitant medications included omeprazole (PRILOSEC); trazodone hydrochloride (TRAZODON) and ASA. The patient previously took NEURONTIN and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek2730), via an unspecified route of administration in right arm on an unspecified date in Dec2020 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any vaccines within four weeks. The patient experienced either going into congestive heart failure or acute renal failure, gained weight, difficulty breathing, significant swelling of feet and lower extremities and continuing large diuresis on 19Jan2021. It was reported that starting 4 days after inoculation, patient was either going into congestive heart failure or acute renal failure. From symptoms it was probably congestive heart failure. Gained weight despite fluid restriction and Lasix, difficulty breathing and significant swelling of feet and lower extremities. Starting just before two weeks after onset of symptoms, patient experienced a continuing large diuresis and felt much better but have not returned to base line. Patient was treated with Lasix and fluid restriction. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved with sequel.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743697
Sex: F
Age:
State: CT

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: heart monitor; Result Unstructured Data: Test Result:unknown results; Test Date: 20210902; Test Name: Pixel nasal swab; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210907; Test Name: Pixel nasal swab; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: a few heart flutter episodes; After the first vaccine a few heart flutter episodes and shortness of breath each day of the first week; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 34-year-old via an unspecified route of administration in the left arm on 02Aug2021 at 15:00 (Lot Number: EV00181) as dose 1, single for covid-19 immunisation. Medical history included supraventricular tachycardia (SVT) in 2004 and catheter ablation was performed. The patient was patient diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications included valacyclovir [valaciclovir] (VALACYCLOVIR); fish oil; and ascorbic acid, betacarotene, biotin, calcium amino acid chelate, calcium pantothenate, chromium amino acid chelate, copper amino acid chelate, cyanocobalamin, equisetum arvense stem, ferrous fumarate, folic acid, laminaria digitata powder, magnesium oxide, manganese amino acid chelate, nicotinamide, oenothera biennis oil, potassium amino acid chelate, pyridoxine hydrochloride, riboflavin, selenium amino acid chelate, thiamine mononitrate, zinc amino acid chelate (reported as OLLY WOMEN'S MULTI); all indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 at 19:30 after the first vaccine, the patient experienced a few heart flutter episodes and shortness of breath each day of the first week. It was further reported that after the first vaccine, a few heart flutter episodes and shortness of breath each day of the first week but then she wore a heart monitor the week before the second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient considered as the adverse events as non-serious. The events did not result in hospitalization. The patient has been tested for COVID-19 since vaccination. She had Pixel nasal swab on 02Sep2021 and on 07Sep2021 with both having the results of negative. The patient did not received treatment for the adverse events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743698
Sex: F
Age:
State: CA

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210615; Test Name: Fever; Result Unstructured Data: Test Result:99.9; Test Date: 20210908; Test Name: Fever; Result Unstructured Data: Test Result:99.9; Test Date: 20210913; Test Name: Fever; Result Unstructured Data: Test Result:99.9; Test Date: 20210910; Test Name: Covid test; Test Result: Negative ; Test Date: 202108; Test Name: Pap; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: thyroid; Result Unstructured Data: Test Result:little low; Comments: thyroid looks just a little low; Test Date: 20210913; Test Name: thyroid; Result Unstructured Data: Test Result:little low; Comments: Thyroid tests look a little on the low side and might be a little off; Test Date: 2021; Test Name: White blood count; Result Unstructured Data: Test Result:High

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Brain tumor; thyroid looks just a little low; couldn't get out of bed; overly stressed; Nauseated; Neck swelled up; Sore neck; Threw up; The right side was lumpy, like a bump there; Cramping; Shivering/ chills; Fever; Severe headaches; Shoulder pain; Swollen lymph node behind my right ear; Mine hurt really bad when it was given to me; I felt it stab my muscle really bad, like jammed into my muscle. It was just really uncomfortable to begin with; I felt it stab my muscle really bad, like jammed into my muscle. It was just really uncomfortable to begin with; On 14Jul2021 got my period, /I should have gotten it around the 27Jul2021,Then I had a normal period on 27Jul2021; Thyroid is swollen on that side; White blood count looks a little high; Felt weak; Nervous; irregular period bleeding; At first just spotting and when throughout day bleeding started getting heavy like a period; At first just spotting and when throughout day bleeding started getting heavy like a period; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Right on 14Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 38 years) for covid-19 immunisation. Medical history included sensitive to too hot and too cold from an unknown date and unknown if ongoing. There were no concomitant medications. On 14Jun2021, the patient experienced severe headaches, shoulder pain, cramping; On 15Jun2021, shivering/chills and fever. On 08Sep2021, patient felt nauseated, neck swelled up, sore neck, threw up, the right side was lumpy, like a bump there. On 2021 the patient experienced mine hurt really bad when it was given to me, I felt it stab my muscle really bad, like jammed into my muscle. it was just really uncomfortable to begin with, swollen lymph node behind my right ear, "on 14jul2021 got my period, /i should have gotten it around the 27jul2021,then i had a normal period on 27jul2021", thyroid is swollen on that side, white blood count looks a little high. On an unknown date, the patient experienced brain tumor, thyroid looks just a little low, couldn't get out of bed. It was further reported that the patient received first dose Pfizer Covid Vaccine at local Pharmacy on 14Jun2021 . For a few days had chills, fever and felt weak. The chills, fever and feeling weak went away in a few days. About two weeks or a week and a half later, caller had headaches like never experienced before in life. Headaches were so bad, mostly on the right side. The caller also received the first dose Pfizer Covid Vaccine on the right side. The headaches became very severe. Happened to touch back of ear and noticed a very unusual lump: Right around same time because of pain, caller would touch face and head a lot. Thought what was this tiny ball lump behind ear. Another thing that popped up was the lump. Found out the lump was a swollen lymph node behind the ear, diagnosed by doctor. Had headaches like never experienced in life. Basically, got to point where the bad headache wasn't going away and after seeing doctor, doctor told caller to take pain meds, drink water and try to take it easy. Doctor said to keep an eye on swollen lymph node behind ear, monitor it basically and as long as it doesn't grow not really worry too much about it. Caller wanted to get an MRI, caller thought had tumor in head, pain so severe. Stayed in bed, headache so bad couldn't get out of bed. Stayed in bed for almost 3 weeks. Caller has not received second dose Pfizer Covid Vaccine and was not thinking of receiving right now. Headache started about a week and half after first dose on 14Jun2021. Headache became less severe around 14Jul2021. On 14Jul2021 caller got a period. Caller was cramping like how usually would cramp on regular period day. Thought unusual not a stomachache, more like period cramps and started spotting. At first just spotting and when throughout day bleeding started getting heavy like a period. It was very confusing, never in life had caller had unregular periods. Caller was pretty healthy, works out and eats healthy. Really strange. Caller's periods are on 27th of the months and this was way off. Did not think much of it until noticed cramps were on right side, like weird sharp cramps in lower abdominal. Called gynecologist and find out was a few months past due for pap smear, you know done every 3 years. Caused to worry more and make an appointment. Kind of not a regular period, lasted 3 or 4 days, usually periods last 5 or 6 days. Was bleeding quite a lot, more than spotting, but not as heavy as regular period, shorter than a normal period but bleeding the same. The following month, prior to appointment with gynecologists the 14th day in month comes and caller starts bleeding again, bleeding the same as month prior. Caller also getting period on 27th day of month, when caller was supposed to get period. Patient gets two periods within two months. Then Aug comes along and the same bleeding occurs. Also getting a period on 27Aug2021, two periods. After 14Aug2021, when the bleeding stopped caller went to Gynecologist appointment. Caller was quite nervous and overly stressed and though pap smear may come out with somethin wrong, never happened to caller. Relieved to find out the pap smear was completely normal. Caller does not have date of pap smear. Worked out caller had quit bleeding and could receive the pap smear. Had pap smear two days after stopped bleeding and results came a week later and everything was fine. Everything from headache, to lump behind ear or swollen lymph node, then period irregular, caller has gone through more stress after 14Jun2021 then ever gone through in short period of time. Caller states very traumatizing and wants documented. Wants other women to know if experiencing this, they are not the only ones. Also, would like information if been heard or if women called in for the patient's peace of mind. After pap smear was normal, in 27Aug2021, got regular period and kind of calm back to self. Pap smear was normal and Gynecologist said it could be a side effect of the first dose Pfizer Covid Vaccine. Doctor has heard of that possibly happening. Also, caller could be under some stress and women can have irregular periods here and there. Doesn't always mean medical emergency. Can't really target where coming from, pap smear normal most important. Chills: Began 15Jun2021 and went away until just recently. Went away when having irregular periods and headaches and lymph node swelling behind ear and everything else that popped up, no more chills. Lasted the next day and maybe two days. It has been a few days and on 13Sep2021 a better day with no chills. Patient was sensitive to too hot and too cold. No idea what's going on with body. If hot, really hot, if cold get chills, no middle ground, never been like that with AC on. Fever: Began 15Jun2021, not severe temperature like 99.9 and do not think it went higher. Went away until recently. When chills came got another fever of 99.9. Went to Urgent Care and that's how patient knows fever was 99.9. Felt weak: If go back to when basically Aug and now its Sep, so irregular period have been had but was kind of like a little less worried with regular pap smear. Recovered with lasting effects or recovered completely: She has had the same everything for the last two days. Would say that haven't been the same if that makes any sense. When works out doesn't have same energy that had prior to Pfizer Covid Vaccine. Feels weakness not so much effects lifestyle or days, but puts in back of mind and continues with day, not so severe. Had headaches like never experienced before in life: Went away until just recently. The pain during injection went away but patient has shoulder pain in the shoulder bone, area of shoulder where shoulder would connect to right on top of shoulder, where joints are connected. She can actually move arm up to the side up and down and that joint right there makes cracking noises over and over again. Very strange but the shoulder and arm, n

Other Meds:

Current Illness:

ID: 1743699
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
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: Losing vision in right eye; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP7534 and expiration date: not reported), via an unspecified route of administration, in Left Arm on 2021 (as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0151 and expiration date: not reported), via an unspecified route of administration, in Left Arm on 2021, as DOSE 2, SINGLE both for covid-19 immunization in Pharmacy or Drug Store. Medical history included cancer (Cancer survivor), and allergies to many medications (Too many medications to list). Concomitant medications included levothyroxine, buspirone, hydroxyzine and sucralfate. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. It was unknown if the Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced losing vision in right eye on Mar2021.The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the adverse event. The Outcome of the event was not recovered at time of report.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743700
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:107 Fahrenheit; Comments: fever

Allergies:

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

Symptoms: his wife's relative got a fever of 107F after the second dose of the Pfizer COVID-19 vaccine.; This is a spontaneous report from a non-contactable consumer received from a Pfizer-sponsored program via medical information team. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his wife's relative got a fever of 107 F after the second dose of the pfizer COVID-19 vaccine on an unspecified date. The reporter would like to know if Pfizer can provide any guarantee or anything that will say that the Pfizer COVID-19 vaccine is safe for the next 10 years and wanted to know that how long this vaccine immunity last. The reporter also stated that how would he know that the vaccine is not going to cause cancer and how would he know that it will not cause any long term side effects and added if he's going to be dead if he takes the vaccine. The reporter also wanted to know that if it's normal to have a fever of 107 F after receiving the second dose of the Pfizer COVID-19 vaccine and also asked is Pfizer mandating its employees to get the Pfizer COVID-19 vaccine. The reporter also stated that how could they say that the vaccine was safe. They have drugs out there for 10 years on the market and they pull over, change the formula and put it back on the market (referring to ranitidine). The outcome of the event was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743701
Sex: F
Age:
State: TX

Vax Date: 08/23/2021
Onset Date: 09/13/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210822; Test Name: Covid antibody IgH/IgM; Test Result: Negative ; Comments: Blood test

Allergies:

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

Symptoms: severe swelling and muscle ache in left deltoid; Rash on left deltoid; abscess formation; warm; painful; swollen; severe swelling and muscle ache in left deltoid; This is a spontaneous report from a contactable nurse (Patient). A 41-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 23Aug2021 16:00 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 23Aug2021 16: as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy. Concomitant medication include Vitamin d3, folate, zinc, b12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination. The patient experienced rash on left deltoid, severe swelling and muscle ache in left deltoid, abscess formation, warm, painful, and swollen on 13Sep2021 15:00. The patient received treatment in response to the events. The patient underwent lab tests and procedures which included Covid antibody IgH/IgM test, Blood test was negative on 22Aug2021. The outcome of the event as not recovered.

Other Meds: VITAMIN D3; FOLATE; ZINC; B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1743702
Sex: F
Age:
State: GA

Vax Date: 09/12/2021
Onset Date: 09/12/2021
Rec V Date: 09/29/2021
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: RA flare"bonus" period; Inappropriate schedule of vaccine administered; product=COVID 19, lot =EN6202; other_vaccine_same_date_lot =ER8730, other_vaccine_same_date_dose =2; other_vaccine_same_date_lot =FC182, other_vaccine_same_date_dose =1; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FC182 and expiry date not reported), via an unspecified route of administration, on 12Sep2021, as dose 1, single, and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ER8730 and expiry date not reported) via an unspecified route of administration, on 12Sep2021, as dose 2, single and then third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6202 expiry date not reported) via an unspecified route of administration, administered in Arm Left, on 12Sep2021 11:00, as dose 3, single, all for covid-19 immunisation at the age of 51-year-old from Pharmacy or Drug Store. Medical history included ongoing rheumatoid arthritis (RA), penicillin allergy and sulfa allergy. Patient was not pregnant at the time of vaccination. Patient received unspecified medications within 2 weeks of vaccination. 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 had not been tested for COVID-19. The patient was scheduled with inappropriate schedule of vaccine on 12Sep2021 11:00 and had overdose. The patient experienced RA flare "bonus" period on 14Sep2021. Patient received no treatment due to the event. The patient was not recovered from the event.

Other Meds:

Current Illness: RA (RA)

ID: 1743703
Sex: F
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/14/2021
Rec V Date: 09/29/2021
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: Possible hallucinations. Seeing things that are still, moving out of the corner of my eye; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 13Sep2021 10:00 at the age of 27-year-old as dose number unknown, single for covid-19 immunisation. The patient medical history was none and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced possible hallucinations. seeing things that are still, moving out of the corner of my eye on 14Sep2021 12:00. The patient did not receive any treatment in response to the event and patient was not hospitalized. The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743704
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital: Y

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: Low immune system; Feeling very tired; Fever; Vaccine arm was very sore; This is a spontaneous report based on information received by Pfizer from Corporation (Reference ID: NVSC2021US203163) via a non-contactable consumer (patient's daughter). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced low immune system, was feeling very tired, had fever, and vaccine arm was very sore on an unspecified date. The patient was hospitalized for low immune system for 2 days. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1743705
Sex: F
Age:
State: IL

Vax Date: 05/06/2021
Onset Date: 05/17/2021
Rec V Date: 09/29/2021
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: Rash on back of my body and has progressed to arms, breast, neck (front and back), chest and face; itching is very bad; This is a spontaneous report from a contactable consumer (patient). This 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 10:00 AM, at the age of 88 years, as the first single dose, in left arm, for COVID-19 immunization. No other vaccine was administered in four weeks. Medical history included penicillin allergy, sulfa allergy and COVID-19 prior vaccination. The patient was not pregnant. Concomitant medications were not reported. On 17May2021 at 09:00 the patient experienced rash and itching. Rash developed 10 days after the first vaccine on back of her body and had progressed to arms, breast, neck (front and back), chest and face. Itching was very bad. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with cream to put on rash and steroid shot. The patient received the second dose of vaccine on 28May2021. Rash was still on body after 4 months. COVID was not tested after vaccination. The events had not yet resolved. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101210733 same pt/drug, event from diff dose

Other Meds:

Current Illness:

ID: 1743706
Sex: M
Age:
State: VA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Name: Test; Result Unstructured Data: Test Result:Not reported

Allergies:

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

Symptoms: I have developed blood clots in my lungs; I get my first shot that when I developed; I can not get my breath; I started coughing the blood; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, in Feb2021 (reported as 07Feb2021 or 17Feb2021), as dose 1, single, for COVID-19 immunisation. The patient had no medical history and no concomitant medications. After first COVID shot in February, the patient developed blood clots in lungs. The patient could not get breath and started coughing the blood. The patient was hospitalized due to the events. It was reported that, the patient was going through so much problem. Before COVID shot the patient was in real good state. The patient was put on a blood thinner, Eliquis due to blood clot in lungs he was still sick, and a team of doctors got together 2 weeks ago and determined that it was from the Pfizer vaccine. It was also reported that, the patient was given a test in hospital, the result was not reported. The outcome for blood clots in lungs was not recovered while for other events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743707
Sex: F
Age:
State: IL

Vax Date: 05/28/2021
Onset Date:
Rec V Date: 09/29/2021
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: Rash; This is a spontaneous report from a contactable consumer (patient). This 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28May2021, at the age of 88 years, as the second single dose, for COVID-19 immunization. No other vaccine was administered in four weeks. Medical history included penicillin allergy, sulfa allergy and COVID-19 prior vaccination. The patient was not pregnant. The patient received the first dose of BNT162B2 vaccine 06May2021 at 10:00 AM, experiencing rash and itching 10 days after vaccination. Concomitant medications were not reported. The patient received the second dose of vaccine on 28May2021. Rash was still on body after 4 months. COVID was not tested after vaccination. Rash had not yet resolved. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101206952 same pt/drug, event from diff dose

Other Meds:

Current Illness:

ID: 1743708
Sex: F
Age:
State: IN

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: SpO2; Result Unstructured Data: Test Result:73 percent

Allergies:

Symptom List: Unevaluable event

Symptoms: Date of First shot: 14Aug2021, Date of Second shot: 28Aug2021; spO2 was at 73 percent; Pretty severe asthma attacks; Had a very hard time breathing; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC3183; Expiration date was not reported) on the left deltoid on 28Aug2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included an unspecified antidepressant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: FD8448; Expiration date was not reported) on 14Aug2021 (at the age of 28 years old) for COVID-19 immunization, and had And had difficult time breathing, big rash on the back and chest, back was itching and there were like at least a 100 small red bumps covering the entire back migrating towards the spinal area. On 28Aug2021, the patient had received the second dose of vaccination, when the first dose of vaccination was received on 14Aug2021. On an unspecified date in 2021, after the second dose of vaccination, the patient's oxygen saturation (SpO2) was at 73 percent; patient had pretty severe asthma attacks; and had a very hard time breathing. It took the patient "like 15 days" for the breathing to return to normal; breathing was being so compromised. The event, oxygen saturation at 73 percent, was assessed as serious (medically significant). The patient had received albuterol as treatment for the reported events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743709
Sex: M
Age:
State: FL

Vax Date: 04/06/2021
Onset Date: 04/17/2021
Rec V Date: 09/29/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Seeing a round black speck stuck in the center of my right eye's vision; Little white lights that flash and float around when I go out in daylight or look at black surfaces; Hard to see from my right eye; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FP7533; Expiration date was not reported) on the right arm on 06Apr2021 (18:45) as dose 1, single, with route of administration unspecified date, for COVID-19 immunization at the pharmacy/drug store. Medical history included asthma. The patient's concomitant medications were not reported. On 17Apr2021 (22:00), the patient had was seeing a round black speck stuck in the center of the right eye's vision; had little white lights that flashed and floated around when the patient went out in daylight or look at black surfaces; and it was hard to see from the right eye. The events had led to doctor or other healthcare professional office/clinic visit, and were reported to be serious (causing disability or permanent damage). The patient did not receive any treatment for the events. the outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination. The patient had received the second dose of vaccination on 30Apr2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743710
Sex: F
Age:
State: FL

Vax Date: 05/22/2021
Onset Date: 05/24/2021
Rec V Date: 09/29/2021
Hospital:

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: lump under left arm; blood clots during menstrual cycle; late menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 41-years-old ), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 09:45 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-CYCLEN LO) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no known allergies. She did not have covid-19 prior vaccination. She had not been tested with covid post vaccination. The patient experienced lump under left arm, blood clots during menstrual, and cycle late menstrual cycle on 24May2021 with outcome of not recovered. The patient received no treatment for the events. The second dose of the vaccine was given on 12Jun2021 (lot number: ER8730). Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743711
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: A Football player ended up and can't run anymore 7 Miles that he used to; when he walks he is trembling only; he doesn't have his life anymore; This is a spontaneous report from a non-contactable consumer (friend's husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported, via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient was a football player ended up and can't run anymore 7 Miles that he used to, he quit football and he was in bed, when he walks he was trembling only, crippled and he doesn't have his life anymore. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1743712
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital: Y

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: myocarditis; In the Emergency truck she had to get and then connect to restart her heart again.; She didn't even wait for 5 months from Moderna and got another vaccine from Pfizer; She didn't even wait for 5 months from Moderna and got another vaccine from Pfizer; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received MODERNA COVID-19 VACCINE in Apr2021 for COVID-19 immunization. The reporter stated that initially in Apr2021 and the patient was hospitalized and out from Hospital with nursing facility for Apr2021, May2021, Jun2021, Jul2021 because she has been in different Hospital. She didn't even wait for 5 months from Moderna and got another vaccine from Pfizer, she got vaccinated by Pfizer on an unspecified date in 2021 and in that time period she got myocarditis. She ended up in the intensive care unit. In the Emergency truck she had to get and then connect to restart her heart again. She never had myocarditis issue before she was been given multiple tablets of sodium (treatment) by her medical doctor. Doctors were treating with morphine but they were giving her multiple tablets but at the end of the day, so what is the combination of Moderna and then getting the Pfizer vaccine within 2 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743713
Sex: F
Age:
State: TX

Vax Date: 04/07/2021
Onset Date: 04/25/2021
Rec V Date: 09/29/2021
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: Test Date: 202105; Test Name: Depakote level; Result Unstructured Data: Test Result:120; Test Date: 202105; Test Name: Depakote level; Result Unstructured Data: Test Result:70

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: migraines; seizure; seizure; disoriented; Muscle spasms; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration in the left arm on 07Apr2021 12:00 (Batch/Lot Number: EW0151) at the age of 21-years old as dose 1 single for covid-19 immunisation. Medical history included hereditary seizure. Concomitant medication included valproate semisodium (DEPAKOTE) taken for seizure, start and stop date were not reported. On 25Apr2021, the patient experienced seizure; migraines and muscle spasms on unspecified date in May2021. She was disoriented and unable to request an ambulance, someone drove her to the hospital. She was admitted to the hospital 25Apr2021 for observation and discharged 26Apr2021. She reported that her seizures never goes away, it is ongoing but it is improved; she is not having grand mal seizures. The patient was admitted for the second time because she was getting migraines, she was admitted for a day; maybe two weeks after the 25Apr2021 seizure, maybe in May2021, she is unsure of the exact date. Adds the migraines came after the last seizure; every time she has a seizure she has something new and this time it was migraines and muscle spasms. After the first admission they adjusted her mediation levels. At the first admission she was given 1000 mg valproic acid by IV; states it is the same as Depakote; and then she was discharged on 500mg Depakote twice daily. The second admission was because she was getting migraines; at that admission they reduced her daily dose of Depakote to 750mg and added 10mg sumatriptan; and Baclofen muscle spasms. Adds the second admission the valproic acid was pretty much an overdose so her Depakote level was a little high. It had been on average 60 to 70 but it was 120. Adds she thinks that caused the migraine. She has had it re-tested since May2021 and it is now normal at 70. The patient reported that she was scheduled to receive her second dose on 28Apr2021 however she never received it because she had a seizure on 25Apr2021. She reports that before this she has not had a seizure in about 10 years. The patient had to restart her ongoing treatment for seizures. States since she had not had a seizure for ten years she was not going to the doctor; but now she has to see a neurologist and has had to adjust her medications. Adds she has had hereditary seizures all her life. The events seizures, disoriented and migraines required emergency room and physician office visit. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Seizure, Disease recurrence, Disorientation, Migraine, and Muscle spasms and BNT162B2. 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: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743714
Sex: M
Age:
State: CA

Vax Date: 08/26/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: left kidney infarcted; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 26Aug2021 (Lot Number: FC3184) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 on an unknown date prior to vaccination. The patient had no known allergies. Concomitant medications included zinc (manufacturer unknown); vitamin c (manufacturer unknown) and vitamin d (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in 4 weeks. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 02Aug2021 (lot number: FA7485) in the left arm for COVID-19 immunization. The patient was not tested for COVID post vaccination. On 01Sep2021, the patient's left kidney infarcted. The patient spent two days in the hospital from 01Sep2021 to 02Sep2021 and was readmitted on 08Sep2021 to 14Sep2021 as the affected kidney area expanded to damage more of his kidney. The event resulted in an emergency room visit, hospitalization and disability/permanent damage. The patient was hospitalized for a total of 9 days. The patient received heparin, Lovenox and coumadin as treatment for the event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: ZINC; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1743715
Sex: F
Age:
State: FL

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 09/29/2021
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: Test Name: EKG; Result Unstructured Data: Test Result:beating irregular; Test Name: Holters; Result Unstructured Data: Test Result:Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: Losing my breath; My fingers in my left arm (where I got my vaccine) started going numb; Prolonged panic attack; I was shaking profusely; Lost feeling in my fingers and legs; My heartbeat felt really irregular; My body went limp and I fell out of the bed; Unable to swallow; My eyes rolling in the back of my head; Unable to sit up; This is a spontaneous report from a contactable other HCP (patient). This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm at single dose for COVID-19 immunisation on 21Dec2020 at 12:30 (35-year-old at the time of vaccination). The Lot number reported as EH9899, EH1284, EW0153 (pending clarification). Relevant history was unknown. Relevant concomitant drug included fluoxetine hydrochloride (PROZAC). No other vaccine in four weeks. Known allergy was None. The patient was not pregnant. Within 30 minutes after receiving the vaccine on 21Dec2020 at 01:15 PM, her fingers in her left arm (where she got her vaccine) started going numb. Her heartbeat felt really irregular and she started losing her breath. Her husband immediately took her to the emergency department. She was shaking profusely, lost feeling in her fingers and legs, was unable to swallow, unable to sit up, and her eyes rolling in the back of her head. She felt as if she was having a prolonged panic attack but with no feeling in her body and that she could not breathe. She arrived at the hospital, they immediately put her in a bed, her body went limp and she fell out of the bed. They then took an EKG and saw her heart was beating irregular and that she needed medication to calm her heart down. Additional lab tests included Holters and MRI with unknown result. AES resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment therapy was received (not specified). Outcome of events was not resolved. No COVID prior vaccination. No COVID test post vaccination.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the events Dyspnoea, Hypoaesthesia, Panic attack, tremor, sensory loss, heart rate irregular, gait disturbance, dysphagia, eye movement disorder, sitting disability and the suspect drug BNT162B2. 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: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743716
Sex: F
Age:
State: IN

Vax Date: 04/06/2021
Onset Date: 08/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: A1C; Result Unstructured Data: Test Result:6.5; Test Name: A1C; Result Unstructured Data: Test Result:6.7; Test Date: 20210823; Test Name: antigen test; Test Result: Positive ; Test Name: Covid-19 test; Test Result: Negative ; Comments: tested negative for Covid 19 disease four times before getting the Pfizer Covid vaccine 2 dose series; Test Date: 20210822; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptom List: Nausea

Symptoms: does not have any symptoms of elevated BP and she has no signs of diabetes either/haven't had any symptoms of trigeminal neuralgia since having Covid-19 disease; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; couldn't hold pee to make it to the bathroom; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of three reports. A 62-year-old female patient received BNT162B2 (COMIRNATY), 1st dose on 16Mar2021 (lot number EN6208), 2nd dose on 06Apr2021 (lot number ER8737, expiration date 31Jul2021), both at single dose at left shoulder at 62-year-old via an unknown route for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). Medical history included high blood pressure/hypertension since 2010, diabetes since Aug2010, and trigeminal neuralgia. Concomitant drug was not provided. Patient tested negative for Covid 19 disease four times before getting the Pfizer Covid vaccine 2 dose series. She had her first and second shots. Since then she tested positive for Covid after being vaccinated. She did not know the test used the first time but she thought it was a false positive so she paid for an antigen test and that came back positive as well. She said that she had a negative Covid -19 test before family trip to (withheld) and also had a neg Covid-19 test before went to (withheld). On 22Aug2021. She had a Covid 19 test in (withheld) and it was positive, so she paid extra to have the antigen test and it came back positive on 23Aug2021 (also reported as 24Aug2021). She was then quarantined for 2 weeks in (withheld). She stated she felt fine for 2-3 days, but by the 5th-6th day she was "very cold, had a cold head, needed blankets and it felt like my head was open on top." (onset date 28Aug2021). She couldn't eat, had a funny taste like her tongue was coated and "all I could eat was yogurt 3x/day. " She was peeing in a garbage can because she couldn't make it to the bathroom. She was so weak. She just couldn't hold pee to make it to the bathroom. She was so weak couldn't even walk, they took her in a wheelchair to the airport and onto plane. She had trigeminal neuralgia. Her upper teeth were hurting her and the pain was usually the effects of the nerve endings in lower jaw. But since having Covid, she no longer has that conditions. She felt that this was related to the vaccine and Pfizer saved her life. The medicine the neurologist prescribed made her "shaky and unstable" months before trip to (country). So she stopped taking it months ago. She had not had any symptoms of trigeminal neuralgia since having Covid-19 disease. It made it go away and they said she would probably have it the rest of her life. She also had not had any symptoms of elevated BP and she had no signs of diabetes either since her Covid 19 disease. Her A1C was 6.5 6 months ago 6.7 3 months ago (as of 15Sep2021). Outcome of the events was unknown. Investigation result from Product Quality Complaints for lot number ER8737 included: Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101216541 same reporter/vaccine, similar AE, different patient

Other Meds:

Current Illness:

ID: 1743717
Sex: F
Age:
State: GA

Vax Date: 09/04/2021
Onset Date: 09/05/2021
Rec V Date: 09/29/2021
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: hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04Sep2021 12:30 (at the age of 62-year-old) (Batch/Lot Number: FC3184) as dose 2, single for covid-19 immunisation. Medical history included diabetes, high blood pressure, left nephrectomy and known allergies: peanuts. The patient was not pregnant. Concomitant medications included hydralazine, losartan, and metoprolol. The patient previously took Demerol and morphine and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 14Aug2021. On 05Sep2021 08:00, the patient experienced hearing loss in right ear. It was reported that the patient woke up the next morning with hearing loss in right ear. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and assessed as disability or permanent damage. Therapy for the event included prednisone. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.

Other Meds: HYDRALAZINE; LOSARTAN; METOPROLOL

Current Illness:

ID: 1743718
Sex: U
Age:
State: NY

Vax Date: 07/28/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:Rose; Test Date: 2021; Test Name: lost of 15 pounds; Result Unstructured Data: Test Result:15; Comments: lost of 15 pounds in one month

Allergies:

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

Symptoms: Sharp pain to my heart; sharp pains in my head; sensations of squeezing at the sides of my head; needles and pins throughout my body/needles and pins sensations when I move my bowel/needles and pins sensation in my ears; Sharp pains at the bottom of my feet; Sharp pain in my abdomen; Foggy; Burning eyes; Burning lips; blood pressure rose; lost of 15 pounds in one month; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 28Jul2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. As a result of vaccination, the patient suffered greatly from this vaccine and experienced sharp pains in the head, sensations of squeezing at the sides of the head, needles and pins throughout the body, sharp pain to the heart, sharp pains at the bottom of the feet, sharp pain in the abdomen, needles and pins sensations when the patient moves the bowel, foggy, needles and pins sensation in the ears, burning eyes, burning lips, lost of 15 pounds in one month and the blood pressure rose in 2021. The outcome of the events was unknown at the time of report. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1743719
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: IGG antibodies; Result Unstructured Data: Test Result:Neagtive; Comments: patient's IGG antibodies for COVID and the report came back negative

Allergies:

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

Symptoms: hyperthyroidism/hyperthyroid symptoms; Graves' disease; then sub sequentially developed severe graves eye disease; toxic goiter; This is a spontaneous report from a contactable physician. A 69-year-old male patient received second dose of BNT162B2 in Jan2021 (at age of 69-year-old) at single dose for COVID-19 immunization. Medical history included diabetes and doesn't smoke. Concomitant medications were none. Historical vaccine included first dose of BNT162B2 in Jan2021 (at age of 69-year-old) for Covid-19 Immunization. Patient completed his two dose vaccination series in Jan2021. Patient developed hyperthyroidism 2-3 weeks post vaccination (Feb2021) which later progressed to Graves disease. He has been treated with radioactive iodine in Mar2021. He developed graves eye disease which was treated with IV infusion Tapasa and Steroids. Caller reported the therapy seemed to work pretty well. Patient has a medical history of diabetes. Caller wants to know if the patient is eligible to receive the booster of the Pfizer COVID-19 vaccine. Caller is also interested to know if the IgG level will flare up if he gets the third dose of the vaccine. Caller says that he is an endocrinologist and he has been seeing a patient for graves disease. The patient had informed him that he had the Pfizer vaccine in Jan2021 and within 2 to 3 weeks he developed hyperthyroid symptoms and then was diagnosed with graves disease. The caller did a literature search and there are some reports of hyperthyroidism being reported after the COVID vaccination. The patient then sub sequentially developed severe graves eye disease and had a Tepezza infusion for the graves eye disease. It has improved and the patient has been doing better and the graves disease has since been treated. The question came up on whether the patient needs the booster or not. The patient does meet the criteria for it since he is diabetic and over age 65 and so on but the question that the caller has also is if the graves disease was triggered by the COVID vaccine then is it wise to give the patient the booster. To add another complication the caller did check the patient's IGG antibodies for COVID and the report came back negative, which is unexcepted. The caller is calling to see if Pfizer has any thoughts on this case and maybe able to provide some guidance as to what Pfizer recommend him to do for the patient. The story is basically that the patient had the Pfizer COVID vaccine in Jan2021 and then had graves disease within 2 to 3 weeks of getting the 2nd dose. He had developed graves disease and the sub sequentially developed graves eye disease, it is harder to treat both of those conditions. Caller states that these developed within Feb2021 and he confirms that it has been treated since then. The patient initially received radioactive iodine in Mar2021 for his toxic goiter and then for the graves eye disease he was put on steroids and then has also received Tepezza infusions and has responded well to that. History/ Investigations: The only kind of medically relevant event was the COVID vaccine. The patient doesn't smoke and he doesn't have other classic risk factors for graves disease, he is a male. So anyway he would say that the COVID vaccine was the only thing that is medically relevant prior to developing graves disease. The outcome of the events was recovered. The seriousness was reported as medically significant. Relatedness of drug to reaction(s)/event(s): Reaction assessed: developed hyperthyroid symptoms, Graves disease, then sub sequentially developed severe graves eye disease, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Reaction assessed: Graves disease. Causality: In his opinion he thinks that there is strong suspicion that there may be a relationship because the patient really didn't have any other medical reason for this to happen, it just kind of happened to come within 2 to 3 weeks of having the COVID vaccine. He just is reporting to say hey maybe there is something there and he wanted to make Pfizer aware of that timeline. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Hyperthyroidism, Basedow's disease, Endocrine ophthalmopathy,Toxic goitre )and the administration of the 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:

ID: 1743720
Sex: F
Age:
State: VA

Vax Date: 04/30/2021
Onset Date: 05/02/2021
Rec V Date: 09/29/2021
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: tachycardia; Rash, worst on left wrist and hand; Headaches; malaise; fatigue; GI issues; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 61-year-old female patient (not pregnant) received bnt162b2 (Pfizer Covid-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 61 years old (Lot Number: ER8736) as single dose for covid-19 immunization. Facility type vaccine was Health Clinic. Medical history included history of complex injury: cervical spine, Traumatic brain injury (TBI); known allergies: sensitive to gluten, casein, chemicals. The patient didn't have COVID prior vaccination and COVID was not tested post vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient experienced rash, worst on left wrist and hand. Headaches, malaise, fatigue, GI issues, tachycardia. All began 2-3 days after second dose, and took more than 2 weeks to resolve. Adverse events start date was 02May2021. Patient reported that she was still experiencing tachycardia after she got her 2nd dose. She had already reported this experience then, but it persisted until now. She wanted more information since she was having a hard time seeking healthcare in her location. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743721
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Erythema, Pruritus

Symptoms: Blood clots; had strokes; This is a spontaneous report from a Pfizer-sponsored program. This is one of three reports. A non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blood clots and had strokes on an unspecified date after vaccination. The reporter also stated that 3 members of his family experienced the same events after vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211992 Same reporter and drug, different patient;US-PFIZER INC-202101211993 Same reporter and drug, different patient

Other Meds:

Current Illness:

ID: 1743722
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: received the covid vaccine and then developed blood clots; received the covid vaccine and then had strokes; This is a spontaneous report from a non-contactable consumer (family member) from a Pfizer sponsored program regulatory authority. This consumer reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that a member of his family received the Covid vaccine and then developed blood clots and then had strokes. The reporter was wondering about FDA approval and how many deaths happened from the Covid vaccine and also wondering about vaccine shedding. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211991 Different patients, same reporter/drug/events;US-PFIZER INC-202101211993 Different patients, same reporter/drug/events

Other Meds:

Current Illness:

ID: 1743723
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Developed blood clots and then had strokes; Developed blood clots and then had strokes; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. This consumer reported similar events for 3 members of his family. This is the third of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that a member of his family received the Covid vaccine and then developed blood clots and then had strokes. The reporter was wondering about FDA approval and how many deaths happened from the Covid vaccine and also wondering about vaccine shedding. The outcome of the events was unknown at time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211991 Different patients, same reporter/drug/events.;US-PFIZER INC-202101211992 Different patients, same reporter/drug/events.

Other Meds:

Current Illness:

ID: 1743724
Sex: M
Age:
State: PA

Vax Date: 05/14/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210913; Test Name: blood pressure; Result Unstructured Data: Test Result:155/94; Comments: blood pressure was 155/94; Test Name: blood work; Result Unstructured Data: Test Result:unknown result; Comments: They did blood work, EKG and COVID test and then let him drive home.; Test Date: 20210901; Test Name: EKG; Result Unstructured Data: Test Result:normal; Comments: EKG normal; Test Date: 20210905; Test Name: EKG; Result Unstructured Data: Test Result:normal; Comments: EKG normal; Test Date: 20210913; Test Name: EKG; Result Unstructured Data: Test Result:normal; Comments: EKG normal; Test Name: heart rate; Result Unstructured Data: Test Result:50 to 60; Comments: heart rate is 50 to 60; Test Date: 20210913; Test Name: heart rate; Result Unstructured Data: Test Result:80 to140; Comments: heart rate went from 80 to 140; Test Date: 20210913; Test Name: heart rate; Result Unstructured Data: Test Result:140; Comments: heart rate was 140; Test Date: 20210915; Test Name: heart rate; Result Unstructured Data: Test Result:low 80s to upper 70s; Test Date: 20210913; Test Name: oxygen; Result Unstructured Data: Test Result:Fine %; Comments: his oxygen was fine; Test Date: 202109; Test Name: oxygen; Test Result: 98 %; Test Date: 20210901; Test Name: COVID; Result Unstructured Data: Test Result:positive result; Test Name: X-rays; Result Unstructured Data: Test Result:unknown result; Comments: did go to the hospital twice for x-rays.; Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: blood pressure; his heart rate was 140/heart was pounding; cough; feeling really bad; he had sweats; had an accelerated heart rate /rapid heart beat; he received the Pfizer COVID vaccine in Apr and then the second dose in May. Caller reported that he contracted COVID in Sep; he received the Pfizer COVID vaccine in Apr and then the second dose in May. Caller reported that he contracted COVID in Sep; couldn't get his breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 52-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 14May2021 14:00 (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Barrett's esophagus and had the flu vaccine in 2019. Concomitant medication included lansoprazole (PREVACID) taken for Barrett's esophagus from an unspecified start date and ongoing. Patient previously took first dose of bnt162b2 (Lot number: EW0162) administered in left arm on 23Apr2021 at 13:00 (at the age of 52-years-old) for covid-19 immunisation and patient experienced fatigue and sore arm. The patient received the pfizer covid vaccine in apr and then the second dose in may. Patient reported that he contracted covid on 01Sep2021 and had an accelerated heart rate /rapid heart beat on 13Sep2021. On 13Sep2021 20:00, he had sweats, so he took his temperature and it was normal; but his heart was pounding. He put on the pulse ox and his oxygen was fine but heart rate went from 80 to 140. On an unspecified date in Sep2021, he couldn't get his breath. On an unspecified date, blood pressure, his heart rate was 140 and had cough. The beginning of this month he was in the hospital diagnosed with COVID. The first time he went to the hospital he drove himself and was in the ER for observation. The other day he had to call an ambulance because his heart rate was out of control. The ER did give him an EKG and said his heart was fine. He was at the PCP office 31Aug2021, who referred him to the hospital, he thought he had bronchitis, but the doctor said he had no wheezing or rattles in his chest; and his EKG was fine. He sent him to the hospital to take a COVID test. They did blood work, EKG and COVID test and then let him drive home. He was prescribed 50mg prednisone and albuterol inhaler. After two weeks of the steroids was when he got the rapid heart rate. He had no other treatment. His test was positive on 1Sep2021. Then around Labor Day, 5Sep2021 or 6Sep2021 he was feeling really bad and couldn't get his breath and he called his doctor who sent him to the hospital to check his lungs, heart and make sure everything was okay. They did not admit him. They said if he had the vaccine he should be okay and his vitals were good and his oxygen was 98%. They told him the majority of people who are admitted are not vaccinated and have an O2Sat of 80. Then he went by ambulance on 13Sep2021 to the hospital. States his blood pressure was 155/94 and his heart rate was 140. He was evaluated for pneumonia and blood clots, they checked his heart and did a few other things. They released him to go back home. Now, today (on reporting date), he feels he is between persisting and recovered with the COVID. Some days he feels really good and then the next day he couldn't get out of bed. Since Monday he has felt pretty good but today is probably the best he has felt. Adds on average his heart rate is 50 to 60. Today it could be elevated to the 70s due to the steroids and the albuterol but he has not had anymore rapid heart rate; it was in the low 80s to upper 70s today but not going crazy. None of additional Vaccines were Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks, the Pfizer vaccine was the only thing he has had since he had the flu vaccine in 2019. Caller stated in 8 months the immunity was dropping, how much was it dropping each month. Is there a blood test to see how much of the vaccine was running through your body. Caller asked when will the booster dose be offered to everyone. Caller stated he heard on the news that after 8 months of second dose of covid vaccine people will be able to receive the third dose. Caller asked if there is any CDC guidelines on how to clean your home after covid 19 infection, Caller asked how long would a person be contagious after covid 19 infection (reporters question). The patient underwent lab tests and procedures which included blood pressure: 155/94 on 13Sep2021, blood work: unknown result on an unspecified date (they did blood work, EKG and COVID test and then let him drive home), EKG (electrocardiogram): normal on 01Sep2021, electrocardiogram: normal on 05Sep2021, electrocardiogram: normal on 13Sep2021, heart rate: 50 to 60 on an unspecified date, heart rate: 80 to140 on 13Sep2021, heart rate: 140 on 13Sep2021 heart rate was 140, heart rate: low 80s to upper 70s on 15Sep2021, oxygen saturation: fine % on 13Sep2021 (his oxygen was fine), oxygen saturation: 98 % on Sep2021, sars-cov-2 test: positive result on 01Sep2021, x-ray: unknown result on an unspecified date (did go to the hospital twice for x-rays). Therapeutic measures was given for COVID, he was prescribed prednisone and albuterol inhaler. After two weeks of the steroids was when he got the rapid heart rate. He had no other treatment. Outcome of events contracted covid in sep and accelerated heart rate /rapid heart beat was recovered on an unspecified date in 2021. Outcome of events he had sweats, he couldn't get his breath, blood pressure, his heart rate was 140, feeling bad were unknown while cough was not recovered. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8736 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, and the formulated drug product lot EP8585. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Barrett's esophagus

ID: 1743725
Sex: M
Age:
State: WA

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/29/2021
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: Kidney low back pain; Right testicular pain with tinglingness in right testicle; Dizzy spell/Dizziness/He felt like he was going to pass out; Headache; Shortness of breath; Throat swelling; Numbness and tingling to left side of face; Numbness and tingling to left side of face; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program via medical information team. A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) (age at the time of vaccination was 36 years) via an unspecified route of administration administered in arm right, on 10Sep2021 at 16:05 as dose 1, single for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medication was not reported. The consumer clarified as, the first thing was, he stayed there observation after getting the vaccine for 15 minutes (10Sep2021). He was not having much happening then. However, by the time he got home he had throat swelling, numbness, and tingling to the left side of the face. His wife had to give him Benadryl and he took that because he was short of breath as well, but he was able to get through it. He initially stated this lasted an hour or so, but then stated it was also severe the day after the vaccine. He did not know how much Benadryl he took. He also added, the day he got the vaccine had dizziness. The dizziness started by the time he got home and he lives about 5 minutes from where he got the vaccine. He confirmed at this time the dizziness has gone away, but he had another episode of dizziness the day after the vaccine as well. The dizziness was not consistently. The last day he a dizzy spell it was a light spell. He had the spells up until three days. The second day he felt like he was going to pass out. He has not had the dizziness since about three days after the vaccine. The following day he had other symptoms (11Sep2021). The day after the vaccine he started to have kidney low back pain, right testicular pain with tinglingness in right testicle. This feeling had not subsided. However, it was not severe right now. He also had a headache the day he got the vaccine. The headache continued into the day after, and he had a headache all day on 11Sep2021. The most dizziness happened on this day, 11Sep2021, with one episode of him feeling like he will pass out. Therapeutic measures were taken as a result of shortness of breath, throat swelling, numbness and tingling to left side of face, numbness and tingling to left side of face. No Emergency or physician visits due to the events and he had a doctors appointment scheduled. The outcome of the event shortness of breath and dizzy spell/dizziness was recovered on unspecified date of Sep2021. The outcome of event kidney low back pain and right testicular pain with tinglingness in right testicle was recovering. The outcome of the event throat swelling, numbness, tingling to left side of face and headache were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743726
Sex: F
Age:
State: OR

Vax Date: 08/23/2021
Onset Date: 08/27/2021
Rec V Date: 09/29/2021
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: General neuropathy in right arm; Tingling in fingers; numbness; sharp pains; cramping; My hand throbs; This is a spontaneous report from a Contactable Other Healthcare Professional (Patient). A 54-year-old female patient (not pregnant) received bnt162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Aug2021 15:00 at 54 years old (Lot Number: FA6780) as single dose for covid-19 immunization. Facility type vaccine was Doctor's office/urgent care. Medical history included diverticulosis, breast cancer, depression, anxiety; No Known Allergies; no COVID prior vaccination. COVID was not tested post vaccination. Concomitant medications in two weeks included venlafaxine taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported. No other vaccine was administered in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: FA6780) on 02Aug2021 03:00 PM at 53 years old in right arm for covid-19 immunization. The patient experienced general neuropathy in right arm. Tingling in fingers, numbness, sharp pains. Tingling and cramping began in the fingertips and move gradually up her arm to her shoulder. Her hand throbs and she sometimes have stabbing pains while trying to complete daily tasks like holding on to things, writing or driving. Adverse events started from 27Aug2021. No treatment was received for the events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Peripheral Neuropathy and other reported events and the suspect drug BNT162B2 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: VENLAFAXINE; BUSPIRONE

Current Illness:

ID: 1743727
Sex: F
Age:
State: NY

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 09/29/2021
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: muscle aches; extremely nauseous; passed out; broken nose; a huge bump on her forehead; concussion; I felt a little sore in my arm; This is a spontaneous report from a contactable Other Health Professional (patient). A 19-year-old female patient (no pregnant) received the second dose of bnt162b2 on 04May2021 at 14:30 (lot number: unknown) (at the age of 19-years-old) via unknown route of administration in left arm at single dose for COVID-19 immunization. Medical history included Concussions; Tachycardia; anxiety; adhd; known allergies: Sulfa. Concomitant medications included sertraline; amphetamine; dextroamphetamine hydrochloride. Historical vaccine included the first dose of bnt162b2 on unknown date in left arm at single dose for COVID-19 immunization. There was no other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested covid post vaccination. Patient received the second dose of the Pfizer vaccine on 04May2021 around 2:30-3 in the afternoon. She then went home and took some Tylenol just in case she had symptoms and she continued to study for her finals. That night she felt a little sore in her arm but nothing crazy and decided she had to sleep in the next morning so that she would be ready for tests and sleep of the vaccine. Patient woke up the next morning on 05May around 12:30 and went to take a shower feeling normal except for slight muscle aches but nothing flu like; but as she went to turn on the shower she got extremely nauseous so patient sat on the toilet. A few seconds later she woke up in a pile of her own blood with the nose in the bathroom floor. Patient cleaned up the blood and went to call her Roommate and as she was walking to the room she passed out again. Patient then spent the next 12 hours in the ER all with what looked to be a broken nose and a huge bump on her forehead. The doctor 2 days later determined she had a suffered 10th concussion. Patient received treatment including Neurologist, cardiologist, cranial sacrum. The outcome of the events was not recovered. The events resulted in physician office visit, Emergency room visit, Disability. The lot number for [BNT162B2] was not requested and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1743728
Sex: F
Age:
State: MI

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 09/29/2021
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: feeling that her throat was closing up; I had the sensation my throat was getting sore; I couldn't swallow; CVID (Common variable immunodeficiency); I felt like I couldn't swallow or breathe; couldn't move; headache; extreme fatigue; joint pain; muscle ache; I must have had swelling in my throat; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EN6280), via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:45 (age at vaccination 71-Years-old) as dose 2, single for COVID-19 immunisation. Medical history included immunocompromised, little sore in throat, she couldn't swallow and CVID (Common variable immunodeficiency). Concomitant medication included fexofenadine hydrochloride (ALLEGRA) (lot number: 20M610 and expiry date: Apr2023), epinephrine (EPIPEN) (lot number: 1FM339, expiry date: Mar2023) and immunoglobulin human normal (GAMUNEX C) taken for immunodeficiency once weekly dose 1 (batch lot number B3GJE00393, expiry date: 20Jul2023) and dose 2 (batch lot number: B1GGE00133, expiry date: 13Sep2023). she uses 2 separate doses to combine together for her dose, but does not provide the dose amounts. While providing product details stated they have too many zeros. Stated she was to get another infusion in a week. Does not provide any further details. Patient's past drug included Penicillin. It was reported she had about 60,000mg of Penicillin over a 3 day course. She was unable to provide NDC, Lot, or expiry for Penicillin. Caller clarified experience she had at age 30 was prior to any Covid vaccines. No other vaccines given the same day and no problems with vaccines in the past. Patient received historical vaccine bnt162b2 (COMIRNATY, solution for injection, Lot Number: EN6203, expiry date: 01Jun2021), via an unspecified route of administration on 25Feb2021, at 6:45pm, (age at vaccination 71-Years-old) as dose 1, single for COVID-19 immunisation and experienced sore arm. Patient was unable to provide the NDC. On 18Mar2021, around 5pm patient had the sensation of throat was getting sore, but very quickly it went from very sore like couldn't swallow, patient began to feel like she couldn't swallow, the inside of her throat was closed up. She was with her family at the time, so she mentioned to son that she had funny feeling in her throat, but was trying to be brave and be a good example and She didn't make much of it, but if it didn't go away and she felt like she couldn't swallow or breathe she would have him take her to emergency. She knew about all the other symptoms that one could expect but this was not one of them. She was surprised. All that evening, through the night, middle of the night she got the headache and extreme fatigue, joint pain, muscle pain, couldn't move but she expected that so it didn't bother her. she could not get out of bed, but later that night about 5pm it went away. She had 24 hours of the normal reactions, but the throat thing was very scary and didn't want to make a big thing about it then. Her throat was feeling funny but she knew it could have been worse and if so she would not be able to breathe and knows that at that point she would go the hospital. Has an immunocompromised condition and CVID (Common variable immunodeficiency) so she went to see online if the third vaccine came available and she called her Immunologist to sees his recommendation and told him of her experience with the second dose. He responded that, that was a weird reaction regarding her throat and she asked if she should get the third dose since she was able to get through it. Provider recommended her to go ahead and get the third vaccine and to take Allegra. She did some deep breathing, some meditation, by morning it went away, it lifted around 8am. She thought it lifted kind of fast. 1 hour still there, within that hour it was gone. She didn't think about it. It was reported that since she was living outside of her state she went and saw immunologist in. He didn't ask her what symptoms she had and she didn't think to tell him. What he recommended was to go ahead and schedule with local hospital to get the third vaccine. Patient did it without thinking about that, but then thought about it and called him and told him what she just described and he said you already take Allerga. To mitigate symptoms of that, take 2 pills before you go for the vaccine and if you have those symptoms take another 1 or 2. If you get it and it doesn't go away go the emergency. She was almost 72, that's crazy. It's very tough for her to figure out on her own, spent time looking at health agency website last night came across new description about immunocompromised people and if you have a delayed reaction up to 4 hours, swelling anywhere, She must have had swelling in her throat. Now it's beginning to concern her because she went to the health agency website and was researching up to date information due to her being immunocompromised and they actually described what she had and that information was not available back in April and they described that what she was feeling of swelling somewhere that oh my gosh you might not be able to get the vaccine and to contact your doctor to see if there are any alternatives. Which doesn't make any sense because there was no other vaccine available where that symptom may not be present. She thought on her she should have seen this information earlier and she has not called her doctor, but did discuss this with her infusion pharmacy pharmacist who she relies on and it was suggested for her to contact Pfizer whether she should have the third vaccine or not. No further details provided. At the time of this report, the outcome of CVID (Common variable immunodeficiency) was not resolved, I felt like I couldn't swallow or breathe, couldn't move, headache, joint pain, I must have had swelling in my throat was unknown and all other events was resolving.

Other Meds:

Current Illness:

ID: 1743729
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: has been left diplegic in a wheelchair since the Pfizer vaccine was given to him; This is a spontaneous report from a contactable consumer (wife). A male 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 DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient has been left diplegic in a wheelchair since the Pfizer vaccine was given to him. The outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.

Other Meds:

Current Illness:

ID: 1743730
Sex: U
Age:
State:

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Blood count; Result Unstructured Data: Test Result:Going up

Allergies:

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

Symptoms: Blood count was going up; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Pharmaceutical Company (manufacturer control number: US2021AMR058338). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 23Mar2021 (lot number was not reported) as dose 2, single for COVID-19 immunization; belantamab mafodotin via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient reported the blood count was going up on an unspecified date. The patient was doing really well (in regards to COVID-19 antibodies) - as reported. The action taken with belantamab mafodotin in response to the event was unknown. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743731
Sex: M
Age:
State: WA

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: nasal swab; Test Result: Negative

Allergies:

Symptom List: Vomiting

Symptoms: brain inflammation; This is a spontaneous report from a contactable consumer. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:00 (Batch/Lot Number: EN6199) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ER8732) as dose 2, single for COVID-19 immunization. Medical history included COPD and diabetes. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient had other concomitant medications in two weeks. In Mar2021, the patient suffered two episodes of brain inflammation, each occurring within a week of receiving the vaccines which resulted to hospitalization for 51 days, disability, ER and physician visit. The patient had no COVID prior vaccination and has not been tested post vaccination. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab: negative on Aug2021. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1743732
Sex: M
Age:
State: CA

Vax Date: 04/04/2021
Onset Date: 04/04/2021
Rec V Date: 09/29/2021
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: I have noticed significant decrease in libido and inability to maintain an erection; I experienced swelling and pains in my testicles the day after each dose; I experienced swelling and pains in my testicles the day after each dose; I have noticed significant decrease in libido and inability to maintain an erection; Start Date/Time: [Pfizer] 24-MAR-2021 03:00 PM/Start Date/Time: [Pfizer] 4-APR-2021 01:15 PM; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153) via an unspecified route of administration in Left arm on 04Apr2021 13:15 at age of 33-year-old at single dose for COVID-19 immunisation. Medical history included PTSD. No known allergies, no COVID prior vaccination. Concomitant medication (in two weeks) included finasteride taken for an unspecified indication from an unspecified date. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732) on 24Mar2021 03:00pm at age of 33-year-old in Left arm for COVID-19 immunisation and experienced swelling and pains in testicles the day after the dose, significant decrease in libido and inability to maintain an erection. The patient experienced swelling and pains in his testicles the day after the dose (05Apr2021). Since then, he have noticed significant decrease in libido and inability to maintain an erection. No treatment received for the events. No Covid tested post vaccination. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743733
Sex: F
Age:
State: DC

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Shock; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received 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. Unknown if pregnant. The patient's medical history and concomitant medications were not reported. Unknown if received other vaccine in four weeks. Unknown if had COVID prior vaccination and if was COVID tested post vaccination. The patient experienced shock on an unspecified date. Adverse event resulted in Emergency room/department or urgent care and Hospitalization. Outcome of event was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743734
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: left patient diplegic and in a wheelchair; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was left diplegic and in a wheelchair on an unspecified date. The clinical course was as follows: Received call from lady who wanted to know if Comirnaty is supposed to be component BNT162BT. She tried to look in the protein data bank which is how the scientific community speaks to each other. There is nothing on the human expression on that protein. She was left in shock. The only thing she has on the # is the protein expression of this Pfizer MrNA is based on mouse spleen cells. But she is not a mouse. There is an individual with 2 children who was left a diplegic and in a wheelchair. Prior to this, he could run 7 miles in a day. Pfizer left him in a wheelchair. He has been more than 6 months like that. She then started stating something about getting vaccinated with Moderna. The caller kept over talking call handler and would not allow call handler to ask questions or clarify information. The outcome of the event was unknown. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743735
Sex: M
Age:
State: PA

Vax Date: 06/24/2021
Onset Date: 08/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210803; Test Name: COVID-19 PCR test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: uveitis; This is a spontaneous report from a non-contactable consumer (parent) reporting for her son. A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 24Jun2021 (Batch/Lot Number: EW0196) as dose 2, single for COVID-19 immunization at a pharmacy. Medical history included COVID-19 from Jan2021. The patient was never diagnosed with autoimmune issues. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (lot number: EW0202) on an unspecified date in 2021 (also reported as 24Jun2021), dose 1 in the left arm for COVID-19 immunization. No other vaccine in four weeks. On 28Aug2021, it was reported that the patient had uveitis as a result of this vaccine causing disability. The reporter added "this vaccine caused this. My son was sick with COVID in Jan2021 and had no issues. Whatever is in this vaccine caused it as my son's doctor said they are seeing an increase number of people with uveitis issues. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 03Aug2021 (Nasal Swab). Therapeutic measures were taken as a result of uveitis which includes steroid eye drops. The event required emergency room and physician's office visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1743736
Sex: F
Age:
State: FL

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 09/29/2021
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: Angioedema; This is a spontaneous report from a contactable other hcp (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 28Aug2021 16:00 (Lot Number: F08498) at age of 29 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin Allergy in her childhood, she had a rash and hives. There were no concomitant medications. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 28Aug2021 the patient got some grapes, she washed them and ate them and was fine. The patient got the vaccine at 4:00 pm on 28Aug2021 and at 7:00 pm she ate the same grapes and then her face was itchy and her bottom lip was big so she took benadryl the swelling went down. Saturday, 11Sep2021, the patient ate a banana and her top lip got big, swollen, and firm to the touch. The patient took Benadryl and the swelling went down. Yesterday, 14Sep2021, the patient didn't have anything to eat and her lip got really itchy to the touch and her eye had hives and it. The patient took Benadryl and it helped. Her lip was big and her cheek was firm to the touch. She went to urgent care today, 15Sep2021, and they diagnosed her with angioedema and advised her not to get the second dose. The patient has eaten grapes and fruit with no problems before this and the only allergy she has is to Penicillin. 5 minutes after the vaccine (as reported), the patient's lip was swollen and big. The patient's face that was itchy improved in 24 hours. The patient has never had this problem and it has happened three times now. The first flare up was on 28Aug2021, the second flare up was on 11Sep2021 and the third flare up was on 14Sep2021. The team at urgent care gave the patient a steroid shot in her right arm and with the benadryl it has improved within 24 hours. Yesterday, 14Sep2021, the patient had swelling with her bottom lip and 2 hives on her right eyelid. Yesterday was the first time the patient has had hives on her eye with these flare ups. The face swelling and the around her mouth swelling happened the two previous events. She was scheduled for her second dose on 18Sep2021. The outcome was unknown. The causality assessment from primary reporter with Global Introspection assessment method was related.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am