VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1661229
Sex: M
Age:
State: MA

Vax Date: 02/18/2021
Onset Date: 08/13/2021
Rec V Date: 09/01/2021
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: 20210815; Test Name: PCR; Test Result: Positive; Comments: Covid test type post vaccination: Nasal Swab. covid test name post vaccination: PCR covid test date: 15Aug2021 covid test result: Positive

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: This is a spontaneous report from a contactable consumer. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809 and Expiry date was not reported), via intramuscular route of administration on 18Feb2021 (at the age of 65-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9264 and Expiry date was not reported), via Intramuscular route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient received other vaccine in four weeks was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested positive for COVID 19. On 13Aug2021, The patient experienced aches, pains, heavy cold symptoms, brief chills, headache, and loss of smell and taste. On 15Aug2021, the patient experienced positive pcr nasal swab. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 15Aug2021. It was unknown if patient received treatment. The outcome for the events positive pcr nasal swab positive was unknown and for the event aches was recovered in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661230
Sex: M
Age:
State: MA

Vax Date: 02/15/2021
Onset Date: 08/23/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: SARS-COV-2& Influenza A/B PCR molecular test. Nasal Swab Test Positive; Comments: Nasal Swab.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This is a spontaneous report from a contactable nurse. A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), intramuscular, administered in left arm on 15Feb2021 (at the age of 30-years-old) as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), intramuscular, administered in left arm on 25Jan2021 (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced lack of efficacy and tested positive for covid19 with symptoms on 23Aug2021. It was unknown if patient had other vaccine in four weeks or if Covid prior vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 & Influenza A/B PCR molecular test. Nasal swab test positive on 23Aug2021. Treatment for AE was unknown. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) and COVID-19 event cannot be ruled out. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.

Other Meds:

Current Illness:

ID: 1661231
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: shoulder got sore the next day; felt blah; This is a spontaneous report from a contactable consumer (patient's family member). This consumer reported similar events for six patients. This is the third of six reports. A female patient of an unspecified age 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 the patient said her shoulder got sore the next day and felt blah but that was it. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101090541 same reporter/drug, same/similar event, different /patient.

Other Meds:

Current Illness:

ID: 1661232
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: her daughter in law had third dose as well, and experienced itching in both eyes.; her daughter in law had third dose as well, and experienced itching in both eyes.; itching in her eyes; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 as dose 1,single and dose 2, single for covid-19 immunization. Patient experienced itching in both eyes a day after the third dose. She read to put ice on the eyes on internet because other people also experienced the same problem. Patient iced her eyes as well. The outcome of the event itching in her eyes was unknown. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661233
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
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: Allergy test; Test Result: Negative ; Comments: Had allergy testing to see if she could get the covid vaccine and everything came back negative.

Allergies:

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

Symptoms: nerves started firing in her arm; nerves started firing in her arm. It feels like sticking her fingers in a socket; arm muscle being inflamed; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for covid-19 immunisation. Medical history included surgery, she has had multiple surgeries on her arm She clarified that the multiple surgeries and nerve damage was about 10 years ago, nerve injury. There were no concomitant medications. She has had no reaction in 15 years. She had allergy testing to see if she could get the covid vaccine and everything came back negative. Had allergy testing to see if she could get the covid vaccine and everything came back negative. It was Reported that, the patient experienced nerves started firing in her arm on 20Aug2021 with outcome of recovering, arm muscle being inflamed on 2021 with outcome of unknown, nerves started firing in her arm. it feels like sticking her fingers in a socket on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included allergy test: negative on 2021 The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661234
Sex: F
Age:
State: TX

Vax Date: 04/19/2021
Onset Date: 04/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Name: EMG; Result Unstructured Data: Test Result:Normal; Comments: test results were fine; Test Name: MRI of brain and spinal column; Result Unstructured Data: Test Result:showed previous cervical fusion of C4-C5; Comments: showed previous cervical fusion of C4-C5; Test Name: X-ray; Result Unstructured Data: Test Result:Normal; Test Name: X-ray; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: when she turns to her left or right, she falls; equilibrium is off; she now generates heat; paralyzed on her left side; tried to do push ups, but her arms wouldn't push her back up; walking like a child that is just beginning to walk; she has no control over left leg; she was hurting everywhere from being poked for the test; she has no control over left leg; all of her muscles are so tired, she can't do anything anymore; This is a spontaneous report from a contactable consumer. A contactable Nurse reporter different event for two patients. This is 1 of 2 reports. This 66-year-old female Nurse (Patient) reported for herself that: A 66 year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration, administered on right arm on 19Apr2021 (at the age of 61years) at single dose for COVID-19 immunisation. The patient medical history included Diabetes, blood pressure high, high cholesterol and trigeminal neuralgia (Unspecified To: Ongoing). The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced paralyzed on her left side, tried to do push ups, but her arms wouldn't push her back up walking like a child that is just beginning to walk; she has no control over left leg , when she stoops down, she can't get back up, she now generates heat, all of her muscles are so tired, she can't do anything anymore, when she turns to her left or right, she falls, the palms of her hands are itching, and up past her wrists are tingling; she doesn't have control of her hands and she will urinate all over herself. On an unspecified date, patient had laboratory investigation X-Ray, Blood work, EMG and found to be normal. MRI of brain and spinal column and Result showed previous cervical fusion of C4-C5. Patient did not visit to emergency room. 2nd dose on 10May2021 Lot: EW0158 in morning in her Right arm. States that she wanted it in the right side so she could move it around all day. The clinical outcome of the events paralyzed and equilibrium were unknown and all other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Paralysis and the suspect drug. 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: Blood pressure high (Verbatim: Blood pressure high); Diabetes (Verbatim: Diabetes); High cholesterol (Verbatim: High cholesterol); Trigeminal neuralgia (Verbatim: Trigeminal neuralgia)

ID: 1661235
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: 2021; Test Name: Iron; Result Unstructured Data: Test Result:too much iron in her blood; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Her blood levels have gone up

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Hemochromatosis; they throw hers (blood) away because it has too much iron; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hemochromatosis in 2021, they throw hers (blood) away because it has too much iron in 2021. Patient reported, She has hemochromatosis, where she has too much iron in her blood, and having that going on she has been going to the Haematologist twice a month for the last month. You know how you go to donate blood; well, they throw hers (blood) away because it has too much iron. They got it down to a safe level and she went to get the shot. After she got the shot and went to have another blood test, in between this to make sure it's going down. She got the Covid shot and a week later got the blood test because it was time for her to go back for a blood withdraw and the results since the shot have gone up again. Her blood levels have gone up again and now she is scared to get the other shot and does not want the blood level to go up even more. Again, mentions that her condition is called Hemochromatosis. The patient underwent lab tests and procedures which included blood iron was too much iron in her blood in 2021, blood test was done, and her blood levels have gone up on 2021. The outcome of event was unknown. Description of complaint: Declines to provide further report details. Has hemochromatosis and they got her blood levels to a safe level. She got the Covid shot and a week later got the blood test because it was time for her to go back for a blood withdraw and the results since the shot have gone up again. Her blood levels have gone up again and now she is scared to get the other shot and does not want the blood level to go up even more. States she only had the first Covid shot and blood draw was done in between. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661236
Sex: F
Age:
State:

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

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

Lab Data: Test Name: covid-19 test; Result Unstructured Data: Test Result: positive.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID on an unspecified date. Caller also asked if should get the 2nd dose after 42 days from the first dose since they both had COVID. Caller stated that recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1661237
Sex: U
Age:
State: MI

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

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

Lab Data: Test Name: Tested positive after being fully vaccinated; Result Unstructured Data: Test Result: Positive.

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: This is a spontaneous report from a contactable consumer or non-HCP. This consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 second dose of (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received bnt162b2 first dose of (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. On unspecified date, the patient who was fully vaccinated tested positive. Reporter declined to provide details and will give them the number to call. Lab tests and procedures which included sars-cov-2 test positive on unspecified date. At the time of this report, outcome of events was unknown. Follow-up attempts completed. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101095688 same reporter, drug, AE, different patients.

Other Meds:

Current Illness:

ID: 1661238
Sex: M
Age:
State: NY

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

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

Lab Data: Test Name: uric acid level; Result Unstructured Data: Test Result:increases

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: increase in uric acid levels; experienced some of the worst pain; I developed this pain in the right foot, with a little in the left but the right foot; couldn't even walk; pain in my ankle, its like someone took a sledge hammer to my ankle; This is a spontaneous report from a non-contactable consumer(patient) via medical information team. A 70-year-old male patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included gout. Concomitant medications were not reported. Historical vaccine included bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient was asking if his symptoms were a possible side effect from the covid vaccine or if it caused an increase in uric acid levels and if it will go away. The patient received the 2nd dose of the Covid vaccine on the 26th or 27th later clarified it was the 27th, and afterwards he experienced some of the worst pain he has ever experienced with his gout. The patient initially had no symptoms after being vaccinated, but last week, on the 16th or 7th the patient developed pain in the right foot, with a little in the left but the right foot. He could not even walk. The patient had such pain in ankle and it like someone took a sledgehammer to her ankle. Now the patient had gout, but he was watching what he should eat, and did not eat anything on these multiple lists that the doctors provided. The patient not had alcohol in 4 years, which he thought was what used to impact him. The patient stated other than this foot he was feeling fine. The reporter stated that his friends had the shots, some Moderna and Pfizer, and they said that they had chills and all pain, swelling but reported that he didn't have anything initially. The reporter stated that half dozen guys call him that got the shot, 1 guy got Moderna, a double dose, he had a slight rash on his face, he was a 70-year guy, who said his head did not feel right, like he was in the twilight zone. Outcome of the events were 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: 1661239
Sex: F
Age:
State: FL

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

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

Lab Data: Test Name: PCR test; Result Unstructured Data: Test Result: Positive; Comments: had breakthrough COVID case and tested positive with a PCR 8 months after the second vaccine.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable other hcp. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the second vaccine and then had breakthrough COVID-19 case and tested positive with a PCR 8 months after the second vaccine on an unspecified date. The adverse event was considered as serious with seriousness criteria of medically significant. The patient underwent lab tests and procedures which included sars-cov-2 antibody test, positive on an unspecified date. Reporter also wants to know if patient had a heart condition and considered immunocompromised. The outcome of the events was reported as unknown. Information about lot/batch number has been requested. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid-19 and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds:

Current Illness:

ID: 1661240
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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 Name: High antibodies; Result Unstructured Data: Test Result:High; Comments: High; Test Name: blood tests; Result Unstructured Data: Test Result:normal; Comments: they were normal (liver, pancreas, sonogram); Test Name: thyroid; Result Unstructured Data: Test Result:2.3; Test Name: TSH; Result Unstructured Data: Test Result:Normal; Comments: TSH was already normal; Test Name: TSH; Result Unstructured Data: Test Result:TSH didn't go up; Comments: TSH didn't go up; Test Name: sonogram; Result Unstructured Data: Test Result:normal; Comments: normal (liver, pancreas, sonogram); Test Name: weight; Result Unstructured Data: Test Result:15 pounds; Comments: gained 15 pounds; Test Name: weight; Result Unstructured Data: Test Result:112 pounds

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Hashimoto's thyroiditis; States the bloating is not in her hips or waist, and is up to ribs.; has experienced weight gain/has gained 15 pounds; constipated; fluid retention; was just frustrated; this is awful and frustrating; TSH didn't go up; shut down my metabolism; bloating; Does not eat more than 500 calories a day or anything like that; TSH didn't go up; not being able to sleep; This is a spontaneous report from a contactable consumer or other non-health professional (patient reported for self). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration, on an unspecified date as (at the age of 59-years-old) dose 1, single and second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: not reported) as dose 2, single for COVID-19 immunisation. Medical history included blood pressure and underlying thyroid condition from an unspecified date and unknown if ongoing. The concomitant medications were not reported. Past drug history included levothyroxine (SYNTHROID) on an unspecified date for an unspecified indication (she could not tolerate). On an unspecified date, the patient experienced Hashimoto's thyroiditis, states the bloating is not in her hips or waist, and is up to ribs, has experienced weight gain/has gained 15 pounds, constipated, fluid retention, was just frustrated; this is awful and frustrating, TSH didn't go up, shut down my metabolism, bloating, does not eat more than 500 calories a day or anything like that and not being able to sleep. The reporter reported that, she experienced weight gain, she can't eat anything anymore, because every time she eats or drinks anything, she gains weight. Sometimes has a glass of wine to go to sleep at night, and that's like, 120 calories, then mentioned something else she ate yesterday. States repeatedly that most people don't care, and just buy bigger clothes, but this is "really annoying". States her weight does fluctuate, but this is extreme, and she cannot take it off. Reports that she has gained 15 pounds, and nothing is going to fit her this fall, knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds, one about 10. She asked them both if they had underlying thyroid condition, and they said yes. She reports that she has Hashimoto's thyroiditis, and has high antibodies, thyroid was 2.3. This vaccine has completely shut down my metabolism and there's nothing else she can do. States tape measure went down because of exercise, but the scales continue to go up. She states that she wishes more people will report it, as well as that most of them are men. Says repeatedly that none of her clothes fit, but that it is "only 10Aug, so I have some time before fall". Caller reports that she had blood tests a month ago and they were normal (liver, pancreas, sonogram) and comprehensive aside from gynecologist. States the bloating was not in her hips or waist and is up to ribs. Has been exercising and eating better. Was ready to "just never eat again". Did not have exact dates of vaccinations, but said they were 2 months ago. Attempted to gather additional demographic and PCP information, but caller hung up before providing that. Mentions her doctor may increase her water pill. Tried Synthroid, but she could not tolerate that, because TSH was already normal, per patient report. The lab data included blood tests and sonogram they were normal (liver, pancreas, sonogram), thyroid was 2.3 with an unspecified unites, weight was gained 15 pounds and 112 pounds on an unspecified date. 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-202101099308 same reporter/product, different patient / event.;US-PFIZER INC-202101099307 same reporter/product, different patient / event.

Other Meds:

Current Illness:

ID: 1661241
Sex: M
Age:
State: MI

Vax Date: 06/06/2021
Onset Date: 06/10/2021
Rec V Date: 09/01/2021
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 test; Result Unstructured Data: Test Result: Unknown results.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA6780), intramuscular in left arm, on 06Jun2021 at 08:30 AM, as dose 2, single, for COVID-19 immunization. The patient's medical history included polymyalgia rheumatica from 20Sep2018 and ongoing. The patient's concomitant medication included prednisolone for polymyalgia rheumatica. The patient previously took the first dose of BNT162B2 (Lot Number: ER8733) on 19May2021 at 03:30 PM for COVID-19 immunization (intramuscular in left arm). The patient had no prior vaccinations within 4 weeks. The most recent vaccine was administered in a public health clinic or Veterans administration facility. On 10Jun2021, the patient experienced muscle and joint soreness that was considered serious per persistent or significant disability or incapacity. On or about 10Jun2021 (unspecified), the patient had been down to 5 mg prednisolone daily. Soreness (muscle and joint) returned in hands, arms, shoulders, knees, and ankles. Increased prednisolone to 7 mg helped a little for a few days, soreness returned and is increasing. Treatment included increased dosage of prednisolone. The events required visit and blood test (unknown results in 2021) with the physician. The patient had not recovered from the events. Follow-up attempts are completed. No further information is expected.

Other Meds: PREDNISOLONE

Current Illness: Polymyalgia rheumatica

ID: 1661242
Sex: F
Age:
State:

Vax Date: 02/18/2021
Onset Date: 07/15/2021
Rec V Date: 09/01/2021
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:

Allergies:

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

Symptoms: I came down with covid; I came down with covid; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, via an unspecified route of administration on 18Feb2021 (Batch/Lot number and expiration date were not reported) as dose 2, single and dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot number and expiration date were not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she came down with COVID (15Jul2021). What was really concerning about that was she did not know if she was super immune or was not as immune. She experienced Covid brain fog (on an unspecified date in 2021). Exactly 21 days apart she saw Health Care Professional when had COVID. The patient further stated that no one knew if you need another booster, she planned on getting the booster on 18Oct2021, eight months from my last vaccine, she did not know whether to continue to wear the mask, she did not want a cold, did not want anything, she believed the shots kept her out of the hospital, believed it could have been a lot worse. The patient questioned Where she stands on being immune, what should be done if a vaccinated person develops COVID-19? The patient stated that she didn't do a report of adverse reaction. The events I came down with covid were considered as serious (Medically Significant). The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661243
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: contracted Covid about 1 week ago; contracted Covid about 1 week ago; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) the first and second dose, both on unknown date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient is fully vaccinated but contracted Covid about 1 week ago before the time of reporting. Specific covid vaccine that the patient received is unknown, dated of administration are 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: 1661244
Sex: U
Age:
State: SC

Vax Date: 06/01/2021
Onset Date: 08/18/2021
Rec V Date: 09/01/2021
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 Date: 20210818; Test Name: Covid 19; Result Unstructured Data: Test Result:Covid -9; Comments: On Aug 18th the patient was diagoned with Covid-19

Allergies:

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

Symptoms: On 18Aug2021 I was diagoned with Covid 19; I was exposed at my place; This is a spontaneous report received from a contactable consumer or other non HCP (patient) via Epsilon Escalation team. A patient (consumer) of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, and Batch/Lot numbers was not reported), dose 2 via an unspecified route of administration on Jun2021 (age at the time of each vaccination was not provided) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On the patient assistance program, the patient stated received both doses of the vaccine. The first dose was taken in May2021 and the second was taken in Jun2021. On 18Aug2021, the patient was diagnosed with Covid 19. The patient was exposed at the place of employment in 2021. The patient underwent lab tests and procedures which included SARS-COV-2 test, the patient was diagnosed with Covid-19 on 18Aug2021. The outcome of the event was reported as unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661245
Sex: F
Age:
State: FL

Vax Date: 04/28/2021
Onset Date: 08/20/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result: 99.9; Test Date: 20210820; Test Name: COVID; Test Result: Positive; Comments: Nasal Swab.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 28Apr2021 (at the age of 47-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included VYVANSE. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, lot number: ER2613) via an unspecified route of administration, administered in Arm Left on 07Apr2021 (at the age of 47-year-old) as dose 1 for covid-19 immunisation. 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. The patient was not pregnant at the time of vaccination. The patient experienced Symptoms of Covid virus and positive test results on 20Aug2021 and sick for several days with sore throat, slight fever 99.9 for two days, fatigued, headache, and sinus congestion. The patient underwent lab tests which included body temperature: 99.9 and SARS-COV-2 test: positive on 20Aug2021 (Nasal Swab). The patient received treatment for the events with Hydroxychloriquine, Zithromax, and monoclonal infusion. Since the vaccination the patient was tested for COVID-19. Outcome of the events were recovering. Follow-up attempts completed. No further information expected.

Other Meds: VYVANSE

Current Illness:

ID: 1661246
Sex: M
Age:
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Cataracts, could not read; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis going to the lungs from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced cataract, could not read. The reporter stated that the patient had got rheumatoid arthritis that went to his lungs, but the patient was fully vaccinated, after getting was just advised to be careful. The patient has had no problems with the vaccine. The rheumatoid arthritis going to the lungs was all prior to first and second COVID-19 doses. The reporter gave her COVID card to the patient, the patient could not read it and needed to get glasses. The reporter laughed and said they both have cataracts. The clinical outcome for the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cataract and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

Date Died: 03/01/2021

ID: 1661247
Sex: F
Age:
State: NY

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

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

Lab Data: Test Date: 202103; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: foggy brain; atrial fibrillation; facial paralysis; This is a spontaneous report from a contactable Nurse. This contactable 36-year-old female Nurse (patient) reported for herself that: A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (at the age of 36-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included nervous system disorder from an unknown date, hay fever, environmental allergies, known allergies hay fever, environmental allergies. Patient had no concomitant medications. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient had not received any other vaccines within 2 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19On Mar2021 at 15:45, the patient experienced facial paralysis, foggy brain, atrial fibrillation. The patient underwent lab tests and procedures which included Nasal Swab: negative on Mar2021. The patient died on Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Facial paralysis, Feeling abnormal, Atrial fibrillation cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.; Reported Cause(s) of Death: side effect of Covid-19 inoculation

Other Meds:

Current Illness:

ID: 1661248
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: The dose was reached to the client it was realized that the client in question has received vaccine with Pfizer reconstituted 1.8 CC of Moderna. Medical error incident that occurred preparing the vaccine, was inadvertently reconstituted the vial with Moderna instead of sodium chloride; The dose was reached to the client it was realized that the client in question has received vaccine with Pfizer reconstituted 1.8 CC of Moderna. This is a spontaneous report from a contactable Nurse. This nurse reported similar events for 3 patients. This was 2 of 3 reports. An adult patient of an unspecified gender and age was received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: FD7204, Expire Date: 30Nov2021) and co-suspect of covid-19 vaccine mrna (MODERNA COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Medical error incident that occurred, preparing the vaccine, was inadvertently reconstituted the vial with Moderna instead of sodium chloride and the dose was reached to the client it was realized that the client in question has received vaccine with Pfizer reconstituted 1.8 CC of Moderna. Reporter stated, I am not sure I have the right area. Reporter got administered Pfizer COVID-19 Vaccine. And I needed manufacturer consultor. A medical error incident that occurred couple hours ago. So, there are 3 clients in backward. All were to Pfizer, but the person got, was preparing the vaccine, was inadvertently reconstituted the vial with Moderna instead of sodium chloride. After the dose was reached to the client it was realized that the client in question has received vaccine with Pfizer reconstituted 1.8 CC of Moderna (Unspecified Medication). So, reporter was advised by medical officer of health to confirm with the manufacturer for further direction. Reporter was unwilling to share further information. Hence further probing could not be done. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Overdose and suspect drug BNT162B2 cannot be excluded. Linked Report(s): US-PFIZER INC-202101099680 Same reporter, event, different patient. US-PFIZER INC-202101099530 Same reporter, event, different patient.

Other Meds:

Current Illness:

ID: 1661249
Sex: F
Age:
State: MI

Vax Date: 02/02/2021
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
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: Test Date: 20210823; Test Name: COVID test: Nasal Swab; Test Result: Positive; Comments: Post vaccination.

Allergies:

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

Symptoms: This is a spontaneous report received from a contactable other health care professional (HCP). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) first dose via intramuscular administered at right arm on 22Jan2021 13:30 (lot number: EL3248) (at the age of 42-year-old) and second dose via intramuscular administered at left arm on 02Feb2021 13:30 (at the age of 42-year-old) (Lot Number: EL3248) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient known allergies was unknown. Patient was not pregnant at the time of vaccination. It was unknown, if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient has been tested for COVID-19 since the vaccination. The patient had symptoms of cough and nasal congestion since 22Aug2021. The patient was diagnosed with being positive with COVID on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 23Aug2021 Post vaccination. Outcome of events was not recovered. Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the events covid19 and drug ineffective cannot be completely excluded.

Other Meds:

Current Illness:

ID: 1661250
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: pulmonary embolisms with the vaccine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), 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 medical history and concomitant medications were not reported. The patient experienced pulmonary embolism with the vaccine on an unspecified date of 2021. Caller reported having a pulmonary embolism, previously healthy, and the PE was considered unprovoked which she described as having no known cause. Caller said she found information on the VAERS sites regarding pulmonary embolisms, saying that 984 cases were reported, that it has affected 0.47% of people which is 1/200 people. The outcome of event was unknown. Information about lot/batch number cannot be obtained. No further information expected

Other Meds:

Current Illness:

ID: 1661251
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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 Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: Lab test; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: blurry vision on both eyes; This is a spontaneous report from a contactable consumer (Caller reported for grandson) or other non-Healthcare Professional (HCP). A 19-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In two weeks, the patient experienced blurry vision on both eyes on an unspecified date and was hospitalized. It was reported that the patient would be getting the second dose and will be back on campus and they are making him quarantine and get tested every week. He was still having this issue up until today (as reported). They have been to the doctor. The patient underwent lab tests and procedures which included computerised tomogram: unknown results, lab test (investigation): unknown results, magnetic resonance imaging: unknown results. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661252
Sex: U
Age:
State: PA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 09/01/2021
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: developed facial numbness within minutes of getting the second shot.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. The patient was perplexed as to why the patient information on the COVID-19 vaccine stated that adverse neurological effects cannot definitively be associated with the vaccine. The patient developed facial numbness within minutes of getting the second shot and she still had it 7 months out. The outcome of the event was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661253
Sex: M
Age:
State:

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 09/01/2021
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: kicked in his rheumatoid arthritis; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced kicked in his rheumatoid arthritis. It was reported that the patient previously received his first dose of the vaccine on 03Mar2021 which kicked in his rheumatoid arthritis. The patient asked if he should receive the second dose of the vaccine to complete the series. The patient stated that his rheumatologist would be sceptical to receive the second dose, PCP reported of not having enough information to guide him in his decision making. The clinical 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: 1661254
Sex: M
Age:
State: AR

Vax Date: 08/04/2021
Onset Date: 08/10/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210810; Test Name: Covid test; Test Result: Positive ; Comments: for Covid 19

Allergies:

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

Symptoms: Received his 1st Pfizer covid vaccine dose on 04Aug2021 and then was diagnosed with Covid-19 on 10Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0171 and expiration date was not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 14:00 (age 42-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's relevant medical history included blood pressure high and ulcer from an unspecified date and ongoing. The concomitant medications included Hydrochlorothiazide at 25mg once daily from an unspecified date and ongoing for blood pressure high, Amlodipine at 5mg once a day from an unspecified date and ongoing for blood pressure high, Pantoprazole 1 tablet once daily from an unspecified date and ongoing for Ulcer. No prior vaccinations/other vaccinations within four weeks prior to the first administration date of the suspect vaccine was given. The patient stated that people came to his job and gave him the shot of Pfizer Covid 19 vaccine on 04Aug2021, then he got Corona, so he missed his second dose. The received his first Pfizer covid vaccine dose on 04Aug2021 and then was diagnosed with Covid-19 on 10Aug2021. Today, on 25Aug2021, he was supposed to get his second Comirnaty dose and could not be due to quarantine x 14 days plus 3 days extra. The patient asked when he could get it and if he could still get it at his job. He went to his doctor's office, who did the Covid test, which came back positive. No treatment was prescribed, he was just told to quarantine for 14 days, but he had to go an extra 3 days because his daughter got Covid too. The patient declined to provide email address. The patient underwent lab tests and procedures which included sars-cov-2 test which was found to be positive for Covid 19 on 10Aug2021. The outcome of the event was reported as not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE; AMLODIPINE; PANTOPRAZOLE

Current Illness: Blood pressure high; Ulcer

ID: 1661255
Sex: F
Age:
State: NV

Vax Date: 05/07/2021
Onset Date: 08/23/2021
Rec V Date: 09/01/2021
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: Test Date: 20210825; Test Name: Nasal Swab; Test Result: Positive.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0175, Expiry date: Unknown) via an unspecified route of administration on 07May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. Patient tested positive post vaccination. The patient previously received bnt162b2 (lot number: EW0162) as dose 1 on 16Apr2021 for COVID-19 immunisation. The patient was not pregnant. On 23Aug2021, the patient tested positive for covid today aka breakthrough case, headache, fever, loss of smell, and body aches. The adverse event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. It was unknown if therapeutic measures were taken for the events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1661256
Sex: M
Age:
State: MO

Vax Date: 02/05/2021
Onset Date: 03/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Blood Sugar; Result Unstructured Data: Test Result:Nominal; Test Name: Blood pressure; Result Unstructured Data: Test Result:Nominal; Test Date: 202102; Test Name: a1c; Result Unstructured Data: Test Result:5.1; Comments: Before the shot; Test Date: 20210301; Test Name: a1c; Result Unstructured Data: Test Result:9.1; Comments: After the shot

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: The shot been making my a1c going high it, in February my a1c was at 5.1 before the shot and after the shot it jumped to 9.1; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date was not reported), via an unspecified route of administration, in left arm (at the age of 50-years-old), on 05Feb2021 10:00, at dose 1, single for covid-19 immunization from health facility. Medical history included high blood pressure and known allergies to soy oil. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient reported that the vaccine shot making his a1c high. In Feb2021 his a1c was at 5.1 before the shot and it jumped to 9.1 after the shot on 01Mar2021 while his blood sugar and blood pressure were nominal. Therapeutic measures were taken as a result of the events with doctor visit. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1661257
Sex: F
Age:
State: KS

Vax Date: 01/20/2021
Onset Date: 08/23/2021
Rec V Date: 09/01/2021
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: Test Date: 20210823; Test Name: COVID-19 (SARS-COV-2) PCR; Test Result: Positive; Comments: Nasal Swab.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable pharmacist. An 88-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route of administration on 20Jan2021 (lot number: EL1283) (age at vaccination 88-year-old) as dose 2, single for COVID-19 immunisation. The patient had allergies of iodine and diltiazem. The patient medical history included non-obstructive CAD (May2017) and unknown if ongoing, DMT2, dyslipidemia, and PAF from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 30Dec2020 (lot number: EL1283) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had tested positive for COVID-19. The patient had COVID-19 breakthrough infection on 23Aug2021. The patient was hospitalized due to the event for one day. The laboratory investigation included Nasal Swab COVID-19 (SARS-COV-2) PCR and result was found to be positive on 23Aug2021. Treatment was received was unknown. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.

Other Meds:

Current Illness:

ID: 1661258
Sex: U
Age:
State: NJ

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 09/01/2021
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: 2021; Test Name: Covid; Test Result: Positive

Allergies:

Symptom List: Nausea

Symptoms: Fully vaccinated and tested positive for COVID.; Fully vaccinated and tested positive for COVID.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP6955) via an unspecified route of administration on 23Mar2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP6955) via an unspecified route of administration on 13Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced fully vaccinated and tested positive for covid on an unspecified date in 2021. Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date in 2021. The outcome of event COVID-19 was unknown.

Other Meds:

Current Illness:

ID: 1661259
Sex: M
Age:
State:

Vax Date: 04/13/2021
Onset Date: 04/19/2021
Rec V Date: 09/01/2021
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: started to develop bumps on his legs and then it had morphed into basically IGA vasculitis; started to develop bumps on his legs and then it had morphed into basically IGA vasculitis; This is a spontaneous report from a contactable consumer. A 40-year-old male patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Apr2021 (age 40-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient started to develop bumps on his legs and then it had morphed into basically IGA vasculitis on 19Apr2021. The patient said that he was told that when he called, he was supposed to reference a case number, that was opened by his dad. He provided that he did not know how much information was on that original case but basically on 13Apr2021 he had the first dose of the COVID vaccine and then on 19Apr2021 he started to develop bumps on his legs and then it had morphed into basically IGA vasculitis. He asked how long a safety report took and he was just trying to follow up on what his dad had already started. He was hoping that he could just get some information and feedback on the correlation of getting the COVID vaccine and cases of IGA vasculitis. He said if he could be given answers to his question as opposed to going through with a report then he would rather go to that department. The reason for no lot number of COVID vaccine, was that the caller was unwilling to complete the report. The outcome of the events was reported as unknown.

Other Meds:

Current Illness:

ID: 1661260
Sex: F
Age:
State:

Vax Date: 08/02/2021
Onset Date: 08/10/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had the first dose of the Pfizer Vaccine; Came down with Covid; This is a spontaneous report from a Pfizer Sponsored Program. This is the first case out of two cases in which the reporter is reporting for herself. A non-contactable female patient (consumer) of an unspecified age reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 02Aug2021 (Age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, she and her husband had the first dose of the Pfizer Vaccine on 02Aug2021 and they both came down with Covid on 10Aug2021. So, they were out of quarantine on the 22Aug2021 of this month and now they want to go get their second dose, but the doctor told them that they have to wait 90 days. The was transferring because of the adverse event. The patient mentioned "Correct, eight days after she got the Pfizer-BioNTech COVID-19 vaccine and she got Covid. She was no longer on the line now and no phone number was given. The patient hung up the call abruptly before warm transfer in Pfizer Drug Safety. Hence, product details (LOT#, Expiration date, NDC#, UPC#), Pharmacy details and other details could not be probed. Call back could not be done as no contact information was available. Hence, limited information was available over the call. The outcome of the event was reported as unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101105023 Same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1661261
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
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: 20210824; Test Name: Rapid Test; Test Result: Positive

Allergies:

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

Symptoms: Had stuffy nose,; sore throat minor aches.; sore throat minor aches; Rapid Test 24Aug21 positive.; Rapid Test 24Aug21 positive.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021 the patient did rapid test 24Aug21 result was positive and on an unspecified date the patient had stuffy nose, sore throat and minor aches. It was reported that event took place after use of products. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 24Aug2021. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661262
Sex: M
Age:
State:

Vax Date: 02/03/2021
Onset Date: 08/21/2021
Rec V Date: 09/01/2021
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: 20210823; Test Name: COVID; Test Result: Positive; Comments: Nasal Swab.

Allergies:

Symptom List: Tremor

Symptoms: This is a spontaneous report from a non contactable Nurse. A 27-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL3248) via intramuscular route of administration on 03Feb2021 at 8:15 (age at the time of vaccination was 27-year-old) in right arm, as single dose for COVID-19 immunization. Medical his-tory and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was EL3248) via intramuscular route in right arm on an unspecified date at 07:45 as a single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was tested for COVID post vaccination. It was unknown if the patient had other vaccines in 4 weeks. On 21Aug2021, the patient experienced 8/23- live in daughter tested positive for COVID yesterday. The patient underwent lab test and procedure of SARS-CoV-2 test positive on 23Aug2021. Outcome of events was recovering. No follow-up attempts are needed. No further information is expected. As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the product and on the conduct of the study is evaluated as part of 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, as appropriate.

Other Meds:

Current Illness:

Date Died: 08/25/2021

ID: 1661263
Sex: F
Age:
State: TX

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Died; Her sister in law received a booster dose the day before yesterday; Her sister in law received a booster dose the day before yesterday; This is a spontaneous report from a contactable consumer (patient's caregiver) via medical information team. A 70-year-old female patient received third dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Aug2021 (Batch/Lot number and expiry date was not reported, age at vaccination: 70-year-old) as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, the patient received first and second dose of BNT162B2 (Batch/Lot number and expiry date was not reported) on an unknown date as dose 1, single and dose 2, single for covid-19 immunization. On 24Aug2021, the patient received a booster dose and went home first. No one lives with her and she lives alone. The reporter's brother went to see her, and she was almost at her death. He called 911 and they took her to the hospital, and she died on 25Aug2021. An autopsy was not performed. The reporter wanted to know why did this happen to her and what caused her death and what happened to her. She was just trying to help the public after this happened. Doctors should be informed and the public needs to be informed on when to take the shot and when not to take the shot. She doesn't have all that information on when the patient received the first and second dose and just know that patient took it at the doctor's office, she went home, and she died after getting the vaccine. The caller asked if adverse reaction/experience may be related to the product or not and response was provided that Pfizer cannot assess causality and doctor/healthcare provider is in the best position to assess and advise as your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. And also informed that Pfizer was unable to make recommendations or diagnoses on a case-by-case basis for individual patients. It was the healthcare professional's discretion with their use of clinical judgment to determine the safety of their patients. The caller was offered to provide CICP information and offered to provide Pfizer legal teams address and fax number. The reported that it was her sister in law so she doesn't have all the information, she doesn't have the doctors name or what was going on with her. She doesn't know a lot of information to give at this time. She said there was type of website to get some compensation. Do they reimbursement right after or when? She talked to someone in VAERS. She really doesn't know what to report, or why or what happened. She doesn't know if it was a blood clot or what. The doctor just gave her the shot. Maybe the patient needed the booster because her immune system was not up to par. She would like to know more information from the doctor. The caller asked who is capable of getting the booster shot? Is it just people that are immunocompromised or is it specific ages like people above 65 years old? The caller asked if people taking certain medications that don't allow the vaccine to work properly would be included in this group or not. The caller stated the way they have it on TV and everywhere she was thinking that everyone is able to get a booster. She stated the understanding is that certain ages over 65 can get it. (documenting as potential Pfizer complaint because she was commenting on how the guidance is not clear). The caller asked how long it will take to get the email from, agent (she just spoke with her prior to getting transferred. She stated everything is important in regard to timing, this needs to be handled quickly. She was not sure if Pfizer would want an autopsy, but they cannot afford it. She had spoken with (withheld) about wanting compensation and (withheld) was going to send an email because she asked for this in writing and not verbally. She stated she could take this information verbally now. The caller stated she has another family member that takes medication that is on the list of meds that keeps the covid vaccine from working and wanted to know if they could get a booster dose. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: unknown

Other Meds:

Current Illness:

Date Died:

ID: 1661264
Sex: M
Age:
State: AZ

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

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: Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Date: 20210406; Test Name: Covid test; Test Result: Positive

Allergies:

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

Symptoms: Uncontrollable sugar levels; stroke; heart attack; My father passed away.; Covid test date was on 06Apr2021 with result positive; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 08:00 (at age of 72-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure. No known allergies. No other vaccine in four weeks. Other medications in two weeks included diabetes injections and high blood pressure meds. The patient experienced uncontrollable sugar levels, stroke, and heart attack, all on 06Apr2021. The patient was hospitalization for 7 days. Treatment received was reported as unknown. The patient passed away on an unknown date. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No covid prior vaccination. Covid was tested post vaccination, covid test type post vaccination was unknown. Covid test date was on 06Apr2021 with result positive. The event outcome for uncontrollable sugar levels, stroke was not recovered. The outcome for "Covid test date was on 06Apr2021 with result positive" was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: My father passed away

Other Meds:

Current Illness:

ID: 1661265
Sex: F
Age:
State:

Vax Date: 08/07/2021
Onset Date: 08/14/2021
Rec V Date: 09/01/2021
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: first signs and symptoms for COVID; body aches; sick; This is a spontaneous report from a contactable consumer (parent). This consumer reported that an 18-year-old female patient (consumer's daughter) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Aug2021 (age 18-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter (parent) called for her 18-year-old daughter with asthma who received her first dose of the Pfizer COVID Vaccine on 07Aug2021 and showed her first signs and symptoms for COVID on 14Aug2021. She mentioned that she had body aches and other symptoms that made her sick on 14Aug2021 but did not require hospitalization. She mentioned that she seems to be okay and was herself with no symptoms as of now. She mentioned that they have also completed isolation. Her daughter was due for her second dose on 28Aug2021. She was asking when the best time for someone was who had COVID to get the vaccine's second dose because their doctor and the daughter's physician told them different things. The Physician told them to wait 60 days in which she mentioned differed from what she knew was the 42-day maximum interval. She also mentioned that some guidelines told them to wait 90 days given that people who received an infection are more protected. She wanted to know the guidance from Pfizer. Caller disconnected before survey was offered. The outcome of the events was reported as 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: 1661266
Sex: F
Age:
State: CT

Vax Date: 05/15/2021
Onset Date: 05/25/2021
Rec V Date: 09/01/2021
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: 20210817; Test Name: Nasal swab; Test Result: Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: About 2 weeks after vaccine vertigo started; First week of June experienced burning sensation in arms and legs; Then crawling sensation on arms and legs; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 32-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ew0185) via an unspecified route of administration, administered in arm left on 15May2021 10:00 (at the age of 32-year-old) at dose 1, single for covid-19 immunisation. Medical history was not reported. Patient had no Known allergies. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient has not tested for covid post vaccination. Concomitant medication included magnesium (MAGNESIUM); paracetamol (TYLENOL); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) (Other medications in two weeks), all taken for an unspecified indication, start and stop date were not reported. On 25May2021 10:00, the patient experienced about 2 weeks after vaccine vertigo started, first week of june experienced burning sensation in arms and legs, then crawling sensation on arms and legs. Clinical course of events includes; about 2 weeks after vaccine vertigo started then went away after about 2 weeks. First week of June experienced burning sensation in arms and legs. Then crawling sensation on arms and legs u tik this date. The patient underwent lab tests and procedures which included Nasal swab, PCR (sars-cov-2 test): negative on 17Aug2021. Patient received treatment with Meclizzine, prednisone, ibuprofen, flexral, gabap for the adverse events. Outcome of the events was not recovered, at the time of reporting. No FU attempts possible. No further information expected.

Other Meds: MAGNESIUM; TYLENOL; VITAMIN D [VITAMIN D NOS]

Current Illness:

Date Died:

ID: 1661267
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: recently died from covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter had a good friend who was fully vaccinated and didn't know which vaccine he got, who recently died from covid. The reporter knew nothing was 100%. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: recently died from covid

Other Meds:

Current Illness:

Date Died:

ID: 1661268
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: aneurysm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender may received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Caller claimed that some guy she knows got an aneurysm and died but she was not sure if that person took the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: aneurysm

Other Meds:

Current Illness:

Date Died:

ID: 1661269
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: passed away; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was stated that patient passed away one week after receiving the 1st Pfizer covid vaccine injection. He was young and healthy. The patient died on an unspecified date due to unknown cause of death. It was unknown if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away

Other Meds:

Current Illness:

Date Died:

ID: 1661270
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: died at 36 years old.; This is a spontaneous report from a non-contactable consumer. A 36-years-old male patient received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient died at 36 years old. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died at 36 years old

Other Meds:

Current Illness:

ID: 1661271
Sex: F
Age:
State: NC

Vax Date: 03/25/2021
Onset Date: 03/27/2021
Rec V Date: 09/01/2021
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: 202006; Test Name: CT Lungs; Result Unstructured Data: Test Result:Unknown; Comments: Stated that on Jun 2020 had CT of lungs had bilateral midlobe pulmonary nodules

Allergies:

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

Symptoms: blistering of fingers and swelling and palms of hands burning flare up; blistering of fingers bilaterally; palms of hands were burning; swelling of the fingers bilaterally; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer (patient) reported for herself that a 46-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP69SS, Expiry date, number: unknown), via intramuscular, administered in left arm on 25Mar2021 (age at vaccination was 46 years) as dose 1, single for COVID-19 immunisation. The patient taking Pfizer BioNTech Covid 19 vaccine due to obesity and knew she had allergies where immune system compromised; not catch Covid. The patient medical history includes allergies and asthma; both ongoing. The patient stated that she does not think vaccine caused asthma because she had allergies and they did tests prior to the vaccine, PTSD (Post-traumatic stress disorder) from an unspecified date in 2010 and ongoing. No Concomitants reported and she takes other medications for other conditions. No further details provided. On 27Mar2021, the patient experienced blistering of fingers bilaterally, palms of hands were burning and swelling of the fingers bilaterally. Additional context reported as, a consumer who has a history of asthma that received the Pfizer BioNTech Covid 19 vaccine in April. The patient had a reaction with each injection. Stated that with the first injection that she caught Covid fingers which is blistering of fingers with swelling and the palms of her hands were burning. Stated that whenever her immune system kicks in that the blistering of fingers and swelling and palms of hands burning flare up. The patient went to the emergency room and reported it to VAERS. The patient reported that since she had reaction to first two doses will the booster vaccine benefit her. Wanted to know once over delta variant and well enough for booster should she attempt since she had two adverse reactions to two doses. Stated that on Jun2020 had CT of lungs had bilateral midlobe pulmonary nodules. The patient has them bilaterally upper and lower lobes and still to her middle lobes prior to the vaccine. Treatment was none for the symptoms of the hands.Outcome of the events were resolving.

Other Meds:

Current Illness: Allergy (Verbatim: allergies); Asthma (Verbatim: Asthma); Post-traumatic stress disorder (Verbatim: PTSD)

Date Died:

ID: 1661272
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: stroke; This is a spontaneous report from a contactable consumer (patient's brother). 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 medical history and concomitant medications were not reported. The reporter said that his brother passed away after receiving the vaccine and had a stroke on an unspecified date, and there was nothing wrong with him prior to that. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reporter would like to know what exactly is in the shot and what the chemicals are that are in the shot. He has been recently notified that the FDA has approved the booster and wants to know what is in that one too. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Reported Cause(s) of Death: stroke

Other Meds:

Current Illness:

Date Died: 08/24/2021

ID: 1661273
Sex: F
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: She took her second dose and she died five days after; This is a spontaneous report from a contactable consumer. This female patient of unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient took her second dose and she died five days after on 24Aug2021. No prior health issues (further not clarified). The reporting consumer had coffee with patient that morning and she died hour and a half later. In moment reporting consumer find her on ground because of the vaccine. The reporting consumer asked how you guys can give a vaccine that kills people. Like it killed patient two days back (further not clarified) when she took it. Covid was not even that serious. The reporting consumer was going to file a huge lawsuit against you guys, a huge law site. But patient didn't have to die if you guys didn't fear among her and taking your stupid vaccine. She only died because she took up the vaccine. You know that right! because she took Pfizer. There's more than 11 thousand deaths (not clarified) because of that shit. The very system was wrong, they are probably knowing that people are dying because of your stupid vaccine. There's no way that could be approved if it is killing over 11 thousand people. The outcome of the event was fatal. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: She took her second dose and she died five days after

Other Meds:

Current Illness:

Date Died:

ID: 1661274
Sex: M
Age:
State: VA

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

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

Lab Data: Test Name: alanine transferase; Result Unstructured Data: Test Result:7995 IU/l; Comments: u/l; Test Name: anti-nucleocapsid IgG; Test Result: Negative ; Test Name: aspartate transferase; Result Unstructured Data: Test Result:9003 IU/l; Comments: u/l; Test Name: creatine kinase myocardial band level; Result Unstructured Data: Test Result:252 ng/ml; Comments: normal value less than 5; Test Name: fibrinogen; Test Result: 100 mg/dl; Comments: dropped to 100 mg/dL; Test Name: Lactic acid; Result Unstructured Data: Test Result:6 mmol/L; Test Name: Lactic acid; Result Unstructured Data: Test Result:28 mmol/L; Comments: increased (NV - Less than 2); Test Name: blood pressure; Result Unstructured Data: Test Result:77/54 mmHg; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:showed no coronary obstructions; Test Name: CRP; Test Result: 13.1 mg/dl; Comments: highly elevated on admission; Test Name: Transthoracic echocardiogram; Test Result: 20 %; Comments: showed severe left ventricular systolic dysfunction (LVEF 20%) and a small circumferential pericardial effusion without tamponade; Test Name: electrocardiogram; Result Unstructured Data: Test Result:diffuse ST segment elevation; Comments: found to have diffuse ST segment elevation; Test Name: D-dimer; Result Unstructured Data: Test Result:4.21 ug/ml; Test Name: D-dimer; Result Unstructured Data: Test Result:greater than 20 ug/ml; Comments: increased critically high greater than 5.0; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.7; Comments: decreased; Test Name: heart rate; Result Unstructured Data: Test Result:133; Comments: per min; Test Name: Interleukin-6; Result Unstructured Data: Test Result:333 pg/mL; Comments: (NV less than 13); Test Name: INR; Result Unstructured Data: Test Result:2.0; Test Name: INR; Result Unstructured Data: Test Result:10.0; Comments: increased; Test Name: other respiratory virus; Test Result: Negative ; Comments: other common respiratory viruses more frequently associated with myocarditis was negative; Test Name: thrombocytes; Result Unstructured Data: Test Result:223 x10 9/l; Test Name: thrombocytes; Result Unstructured Data: Test Result:21 x10 9/l; Comments: developed progressively; Test Name: Polymerase chain reaction; Test Result: Negative ; Comments: for SARS-CoV2; Test Name: SARS-CoV2 NC igG; Test Result: Negative ; Test Name: SARS-CoV2 spike igG; Result Unstructured Data: Test Result:62.8; Comments: a.u./ml; Test Name: SARS-CoV2 spike protein IgG antibody; Test Result: Positive ; Comments: (62.8 arbitrary units/ml [NV less than 15.0]); Test Name: Ferritin; Result Unstructured Data: Test Result:23000 ng/ml; Comments: highly elevated on admission

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: fulminant myocarditis; recurrent cardiac arrest; refractory shock; This is a literature report from the International Journal of Cardiology, 2021, DOI:10.1016/j.ijcard.2021.08.018 entitled Fulminant myocarditis and systemic hyperinflammation temporally associated with BNT162b2 mRNA COVID-19 vaccination in two patients. This author reported similar events for two patients. This is first of two reports. A 27-year-old male with trisomy 21 complicated by speech impairment without history of cardiovascular disease presented in cardiogenic shock 2 days after his second vaccine dose. He had received the first dose without adverse effects. Approximately 36 h after the second dose, he developed nausea and vomiting. He presented to another hospital in shock (blood pressure 77/54 mmHg and heart rate 133/min) and found to have diffuse ST segment elevation in electrocardiogram (Fig. 1). Cardiac catheterization showed no coronary obstructions. Initially, creatine kinase myocardial band level (CK-MB) was 252 ng/mL (normal value [NV] < 5). Transthoracic echocardiogram showed severe left ventricular systolic dysfunction (LVEF 20%) and a small circumferential pericardial effusion without tamponade. A diagnosis of presumed fulminant pericarditis was made and methylprednisolone 1000 mg and human immunoglobulin (IVIG) 60 g were given. The course was complicated by hemodynamically unstable ventricular tachycardia refractory to electrical cardioversion followed by pulseless electrical activity. He was resuscitated with veno-arterial extracorporeal mechanical oxygenation (VA-ECMO). After return of circulation, he was supported by multiple vasopressors, mechanical ventilation, and renal replacement therapy (RRT). Despite these interventions, multiorgan failure and refractory shock persisted. Lactic acid increased from 6 to 28 mmol/L (NV less than 2), D-dimer increased from 4.21 to greater than 20 ug/mL (critically high >5.0), INR increased from 2.0 to 10.0, and fibrinogen dropped to 100 mg/dL. C-reactive protein (CRP) and ferritin were highly elevated on admission at 13.1 mg/dL (NV less than 0.5) and 23,000 ng/mL, respectively, leading to a decision to administer anakinra (Kineret). Interleukin-6 level eventually came back highly elevated at 333 pg/mL (NV less than 13). thrombocytopenia developed progressively from 223x10 9 /L to 21x10 9 /L, while hemoglobin decreased from 11.5 to 8.7 g/dL. The patient demonstrated acute liver injury (ALI) with alanine transferase (ALT) and aspartate transferase (AST) at 7995 and 9003 u/L. Polymerase chain reaction (PCR) for SARS-CoV2 and other common respiratory viruses more frequently associated with myocarditis was negative. SARS-CoV2 spike protein IgG antibody was positive (62.8 arbitrary units/ml [NV less than 15), and anti-nucleocapsid IgG was negative, consistent with immunization status. Approximately 21 h after admission, patient died due to recurrent cardiac arrest and refractory shock. Family declined request for autopsy. In summary, both cases presented features of fulminant myocarditis with a temporal association with the BNT162b2 mRNA Covid-19 vaccination, in absence of other apparent causes and with unique features of systemic hyperinflammation associated with refractory shock. These cases identify the need for awareness of a potential, albeit extremely rare, link of BNT162b2 mRNA Covid-19 vaccination associated with fulminant myocarditis as part of a severe systemic hyperinflammatory syndrome, requiring mechanical cardiac support and, most importantly, immunosuppressive therapy. The degree of the inflammatory biomarkers and multiorgan dysfunction seen in the two cases described, as in some patients with Covid-19, is indeed out of proportion to with hemodynamic failure and shock and it is not rapidly resolved by cardiac mechanical support, reflecting a significant degree of vasoplegia. The optimal immunosuppressive treatment for systemic hyperinflammation associated with fulminant myocarditis is unknown. They chose a combination of high dose methylprednisolone, IVIG and anakinra (Table 1) as a strategy used across a variety of immunologic and rheumatologic diseases characterized with inappropriate macrophage activation. Table 1 Key biomarkers at admission and immunomodulating therapy: Patient #1: Presentation included Symptoms: Nausea and vomiting. Vaccine type was BNT162b2 mRNA Covid-19. Timing was 2 days after second dose. Hemodynamics included Hypotension and tachycardia. ECG: ST segment elevation. Echocardiogram: LVEF 20%. Biomarkers included: CRP: 13.1 mg/dl; Interleukin-6 : 333 pg/ml; Ferritin : 23,000 ng/ml; INR : 2.0; D-dimer : 4.21 ug/ml; Lactic acid : 6 mmol/l; CK-MB : 252 ng/ml; SARS-CoV2 spike IgG : 62.8 a.u./ml; SARS-CoV2 NC IgG : negative. Immunosuppressive Therapy included: Methylprednisolone : 1000 mg; Immunoglobulins : 60 mg; Anakinra : 100 mg (2 doses). Outcome was Deceased 21 h after admission. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of events myocarditis, cardiac arrest, and shock. This case will be reassessed upon receipt of additional information.,Linked Report(s) :PFIZER INC-202101116531 Same article/ drug/event and different patient; Reported Cause(s) of Death: recurrent cardiac arrest; refractory shock; fulminant myocarditis

Other Meds:

Current Illness: Speech impairment NOS; Trisomy 21 (complicated by speech impairment)

ID: 1661275
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: Test Name: ALT; Result Unstructured Data: Test Result:14477 IU/l; Comments: ALI was noted u/l; Test Name: IgG anti-nucleocapsid; Test Result: Negative ; Test Name: AST; Result Unstructured Data: Test Result:6086 IU/l; Comments: u/l ALI was noted; Test Name: endomyocardial biopsy; Result Unstructured Data: Test Result:showed cardiomyocytes with minute foci of cytoplas; Comments: performed on day 13 of hospital admission, showed cardiomyocytes with minute foci of cytoplasmic vacuolization and rare interstitial lymphocytic infiltrate, which is consistent with healing myocarditis, but did not meet conventional diagnostic criteria for acute myocarditis; Test Name: CK-MB; Result Unstructured Data: Test Result:42 ng/ml; Test Name: CK-MB; Result Unstructured Data: Test Result:42.4 ng/ml; Comments: elevated; Test Name: Lactic acid; Result Unstructured Data: Test Result:13 mmol/L; Comments: on admission normalized within 24 h of ECMO onset; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:Showed no obstructive coronary artery disease; Comments: showed no obstructive coronary artery disease; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result:showed preservation of cardiac output and normal f; Comments: showed preservation of cardiac output and normal filling pressures, on day 13 of hospital admission; Test Name: CRP; Test Result: 5.6 mg/dl; Comments: elevated; Test Name: LVEF; Test Result: 15 %; Test Name: LVEF; Test Result: 50 %; Comments: documented by transthoracic echocardiography; Test Name: ECG; Result Unstructured Data: Test Result:Non-specific changes; Test Name: D-dimer; Result Unstructured Data: Test Result:greater than 20 ug/ml; Test Name: Interleukin-6; Result Unstructured Data: Test Result:17.2 pg/mL; Comments: [12 h after therapy]; Test Name: Interleukin-6; Result Unstructured Data: Test Result:17 pg/mL; Comments: mildly elevated; Test Name: interleukin-2 soluble receptor alpha; Result Unstructured Data: Test Result:1067 IU/ml; Comments: u/ml (NV <710); Test Name: INR; Result Unstructured Data: Test Result:4.5; Test Name: INR; Result Unstructured Data: Test Result:1.7; Comments: improved; Test Name: cardiac magnetic resonance; Result Unstructured Data: Test Result:showed LVEF of 35%, diffuse elevation of native T1; Comments: performed 45 days after the initial presentation, showed LVEF of 35%, diffuse elevation of native T1 values, small pericardial effusion with enhancement of the pericardium anterior and anterolaterally and small patchy areas of enhancement following delayed imaging after gadolinium in the mid-wall of the anterior wall, consistent with myopericarditis; Test Name: thrombocytes; Result Unstructured Data: Test Result:106 x10 9/l; Comments: Thrombocytopenia was noted persisted for several days; Test Name: PCR; Test Result: Negative ; Comments: PCR for SARS-CoV2 and other common respiratory viruses was negative; Test Name: SARS-CoV2 NC IgG; Test Result: Negative ; Test Name: SARS-CoV2 spike IgG; Result Unstructured Data: Test Result:64; C

Allergies:

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

Symptoms: fulminant myocarditis; This is a literature report associated with BNT162b2 mRNA COVID-19 vaccination in two patients. This author reported similar event for two patients. This is second of two reports. A 34-year-old female without prior medical history presented 9 days after her first vaccine dose. On day 4 after vaccine, she developed fevers, cough, chest pain, nausea, and vomiting. She presented to another institution with hypotension and sinus tachycardia, an echocardiogram showed severely reduced LVEF of 15%. Cardiac catheterization showed no obstructive coronary artery disease. She was transferred for initiation of VA-ECMO. On admission, she was in severe shock requiring multiple vasopressors. CRP, ferritin and CK-MB were elevated at 5.6 mg/dL, >30,000 ng/mL, and 42.4 ng/mL, respectively. VA-ECMO and RRT were initiated. Treatment was initiated with methylprednisolone 1000 mg daily and continued for 3 days followed by a slow taper over, with IVIG 30 mg daily for 4 days, and anakinra 100 mg daily. Lactic acid 13 mmol/ L on admission normalized within 24 h of ECMO onset, INR improved from 4.5 to 1.7. Interleukin-6 level was mildly elevated at 17 pg/mL and interleukin-2 soluble receptor alpha was 1067 U/mL (NV less than 710). Thrombocytopenia was noted at 106x10 9 /L which persisted for several days. ALI was noted with ALT and AST at 14,477 and 6086 u/L which steadily improved thereafter. PCR for SARS-CoV2 and other common respiratory viruses was negative. SARS-CoV2 spike protein IgG antibody was positive (64 arbitrary units/ml), and IgG anti-nucleocapsid was negative, consistent with immunization due to vaccine without prior infection. Vasopressors were weaned off, LVEF was documented at 50% by transthoracic echocardiography, VA-ECMO was discontinued. She was treated with prednisone 1 mg/kg and anakinra with prednisone tapered first (by reducing 0.1 mg every week) and tapering anakinra planned after prednisone is discontinued. An endomyocardial biopsy performed on day 13 of hospital admission, after recovery of cardiac function and near resolution of the systemic hyperinflammation, showed cardiomyocytes with minute foci of cytoplasmic vacuolization and rare interstitial lymphocytic infiltrate, which is consistent with healing myocarditis, but did not meet conventional diagnostic criteria for acute myocarditis. A cardiac catheterization at the same time showed preservation of cardiac output and normal filling pressures. A cardiac magnetic resonance, performed 45 days after the initial presentation, showed LVEF of 35%, diffuse elevation of native T1 values, small pericardial effusion with enhancement of the pericardium anterior and anterolaterally and small patchy areas of enhancement following delayed imaging after gadolinium in the mid-wall of the anterior wall, consistent with myopericarditis. Genetic testing for 121 genes showed no variants associated with genetic disorders. Guideline-directed heart failure treatment was also initiated. She was discharged from the hospital after 73 days. In summary, both cases presented features of fulminant myocarditis with a temporal association with the BNT162b2 mRNA Covid-19 vaccination, in absence of other apparent causes, and with unique features of systemic hyperinflammation associated with refractory shock. These cases identify the need for awareness of a potential, albeit extremely rare, link of BNT162b2 mRNA Covid-19 vaccination associated with fulminant myocarditis as part of a severe systemic hyperinflammatory syndrome, requiring mechanical cardiac support and, most importantly, immunosuppressive therapy. The degree of the inflammatory biomarkers and multiorgan dysfunction seen in the two cases described, as in some patients with Covid-19, is indeed out of proportion to with hemodynamic failure and shock and it is not rapidly resolved by cardiac mechanical support, reflecting a significant degree of vasoplegia. The optimal immunosuppressive treatment for systemic hyperinflammation associated with fulminant myocarditis is unknown. They chose a combination of high dose methylprednisolone, IVIG and anakinra (Table 1) as a strategy used across a variety of immunologic and rheumatologic diseases characterized with inappropriate macrophage activation. Table 1 Key biomarkers at admission and immunomodulating therapy: Patient #2: Presentation included: Symptoms: Fever, cough, chest pain, nausea and vomiting. Vaccine type was BNT162b2 mRNA Covid-19. Timing was 9 days after 1st dose. Hemodynamics included Hypotension and tachycardia. ECG : Non-specific changes. Echocardiogram: LVEF 15%. Biomarkers included: CRP : 5.6 mg/dl; Interleukin: 17.2 pg/ml [12 h after therapy]; Ferritin : greater than 30,000 ng/ml; INR : 4.5; D-dimer : greater than 20 ug/ml; Lactic acid : 13 mmol/l; CK-MB : 42 ng/ml; SARS-CoV2 spike IgG : 64 a.u./ml; SARS-CoV2 NC IgG : negative. Immunosuppressive therapy included: Methylprednisolone : 1000 mg daily for 3 days, followed by a slow prednisone taper over several weeks; Immunoglobulins : 30 mg daily for 4 days; Anakinra : 100 mg daily. Outcome was Recovering, minimal symptoms, LVEF 35%, delayed enhancement after gadolinium at cardiac magnetic resonance; discharged from the hospital after 73 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event myocarditis is considered possibly related to suspect BNT162b2 mRNA COVID-19 vaccination, based on temporal association and in absence of other apparent causes, and with unique features of systemic hyperinflammation associated with refractory shock. 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-202101116136 Same article/ drug/event and different patient

Other Meds:

Current Illness:

ID: 1661276
Sex: F
Age:
State: WA

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 09/01/2021
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: This is a spontaneous report from a program from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 12:00 (Batch/Lot Number: EW0181) (at the age of 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included complex regional pain syndrome from 1985 to an unknown date (Nerve reflection dystrophy bilateral hands and arms), milk allergy from an unknown date and unknown if ongoing, weight increased from an unknown date and unknown if ongoing, allergy reactions for decades and knows to what to do, mold allergy for decades, urticaria from an unknown date and unknown if ongoing (Initially she had to delay getting the vaccine because she was having hives). There were no concomitant medications. The patient previously took varicella zoster vaccine for immunization on 2021 (Ten weeks prior she had shingles vaccine). Patient stated that she experienced the same allergic reaction within 3 to 4 hours after both doses of the vaccine, initially sinus pressure, head ache that eventually involved entire head, neck, and shoulders, nausea, and congestion that resulted in a really thick heavy mucus when able to clear my sinuses. Within 4 hours of getting the first dose patient had a headache across her sinuses and over her head around the back. This lasted for 2.5 - 3 days. She had neck and shoulder pain and nausea. Described all of this as a heavy ache. Usually all of her reactions are about that long. That tells her there is a lot of mold in the vaccine (as reported). Patient took pain and other medications. Patient added with both doses she had sinus pressure and thick mucus formation. She hasn't had this in a long time. She had an onset of sinus pain. She has had a recurring headache since then. Her neighbor flooded the bathroom floor. Patient feels that there was mold between the flooring. She thinks she was currently being exposed to mold. She developed a bad headache in her forehead that went to the back and sides. This lasted for 2.5 days. She still has a headache but cannot rule out if it is related or not. She also had nausea after the second dose. Patient stated the symptoms took 4 days to resolve after the first dose and 3 to 3.5 days to resolve after the second dose. Patient stated this reaction mimics a classic reaction to mold. Patient stated she has had a mold allergy for decades. Patient stated, It has been years since I have been this sick with an allergic reaction. Patient suspects there may either be a mold component to the vaccine or that the vaccine was stored improperly resulting in microbial growth in the vial. Initially patient had to delay getting the vaccine because she was having hives. She received the second dose on 06Aug2021. It was given in her right arm. Lot: EW0181. The outcome of events was recovered.

Other Meds:

Current Illness:

Date Died:

ID: 1661277
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: she died; This is a spontaneous report from a contactable consumer (patient was reporter's girlfriend). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she died (death, medically significant) on an unspecified date immediately, 49-year-old from Pfizer. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: she died

Other Meds:

Current Illness:

ID: 1661278
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: Tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-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 immunisation. The patient medical history and concomitant medications were not reported. COVID prior vaccination and COVID tested post vaccination was Unknown. The patient experienced tired on an unspecified date. 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:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am