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: 1790911
Sex: F
Age:
State: NY

Vax Date: 09/25/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Rash on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Sep2021 at around 09:00, as the first single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced breaking out in rash on her arm. The patient stated that from time to time, without thinking about it, she pulled weeds when they grew up and she did that a couple of days before, but she washed her arms. She was not sure if she came into contact with poison ivy or if this was one of the side effects. Event outcome was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790912
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: COVID-19; COVID-19; This is a solicited report based on information received by Pfizer (Control No: 21K-163-4090627-00). A contactable consumer (patient) reported that a 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly in May2021 (Batch/Lot number was not reported) at age of 36 years old as a single dose, 2nd dose intramuscularly in Jun2021 (Batch/Lot number was not reported) at age of 36 years old as a single dose for covid-19 immunisation. HUMIRA, subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 in Sep2021 with outcome resolving. The action taken in response to the event for HUMIRA was unknown. Solicited report by a consumer of a 36 years old female with an event of non-serious COVID-19 with HUMIRA. There was no reported medical history. In Sep2021, the patient experienced COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On May2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Jun2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The reporter's causality for the event of COVID-19 with HUMIRA was no reasonable possibility. Causality as per reporter for the event COVID-19 with BNT162B2 was possible. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. The efficacy of a drug varies from patient to patient and can be affected by different factors, however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.

Other Meds: HUMIRA

Current Illness:

ID: 1790913
Sex: F
Age:
State: CA

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: looks like acne but she said it's painful on her forehead./Broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead; The forehead was little bit, some of it is inflamed and she said it looks like white head all over her forehead actually on her cheeks and even on her chin like more dominant on her forehead; broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead; This is a spontaneous report from a contactable physician. A 15-year-old female patient received bnt162b2, intramuscular, administered in Arm Left on 27Sep2021 17:45 (Batch/Lot Number: 301458A) as DOSE 1, SINGLE at age of 15-year-old for covid-19 immunization. Patient History was No. No Other medical Conditions and Drugs taken, she doesn't have any medical problems or allergies. The patient's concomitant medications were no. Patient is a 15 year old female (15 Years 11 months, almost 16) who received the first dose of the vaccine on Monday (27Sep2021). One day later on Tuesday (28Sep2021) she got a rash like acne and painful all over her face. It looks like white heads and is more on her forehead. She has had no changes in detergents, lotions or anything. On Tuesday (28Sep2021) the patient broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead. The reporter said the patient has had no change in detergent or lotions or anything like that and she wanted to know if there any other reports of rashes like that has been reported and she said she is not sure how to treat it. It looks like acne but she said it's painful on her forehead. The forehead was little bit, some of it is inflamed and she said it looks like white head all over her forehead actually on her cheeks and even on her chin like more dominant on her forehead. Yesterday (28Sep2021) and today (29Sep2021) things are a little bit worse. She got a couple more on the chin that she didn't have before. Patient feels it's a little worse from yesterday. She got a couple of new ones. She got the COVID shot on the 27th and then she said on the 28th she got this rash on her face. It was also reported that the patient got the painful looks like almost like white head acne lesion all on her face and this develop yesterday (28Sep2021), painful all over her face, did not notice anything anybody else reporting something like that, white head. Scheduled Date and Time of second shot was on 18Oct2021 at 17:45 PM. No Prior vaccination(4 weeks). Causality was no, the reporter hasn't seen anything like this. No Lab tests, haven't done any lab tests. Treatment for adverse events included Benadryl, she took it one time. The outcome of the events was not recovered.; Sender's Comments: Based on known disease pathophysiology, the events of rash, acne and dermatitis are assessed as not related to BNT162B2 and more likely due to underlying hormonal imbalances.

Other Meds:

Current Illness:

ID: 1790914
Sex: M
Age:
State: CO

Vax Date: 09/11/2021
Onset Date: 09/21/2021
Rec V Date: 10/16/2021
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: Severe shingles; Severe shingles rash about 10 days out from vaccine; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6204; Expiration date: not provided) via an intramuscular route of administration on 11Sep2021 (age at vaccination 77-year-old) as dose 2, single for Covid-19 immunization at hospital. The patients medical history included antisynthetase syndrome and hypertension. The patients known allergies was statins. The patients concomitant medication included mycophenolate mofetil (CELLCEPT [MYCOPHENOLATE MOFETIL]); hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIZIDE); metoprolol; metformin; isosorbide mononitrate (IMDUR); aspirin [acetylsalicylic acid] and allopurinol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9269; Expiration date: not provided) via an unspecified route of administration on an unspecified date (age at vaccination 77-year-old) as dose 1, single for Covid-19 immunization. The patient had not received any other vaccine within 4 weeks. The patient was not diagnosed with Covid-19 prior to vaccination. The patient was not tested for Covid since the vaccination. On 21Sep2021, 10 days after vaccination the patient experienced severe shingles rash. An adverse events resulted into physicians office visit. Therapeutic measures were taken for the events was valtrex, prednisone and gabapentin. The reporter assessed the events as non-serious. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: CELLCEPT [MYCOPHENOLATE MOFETIL]; TRIAMTERENE AND HYDROCHLOROTHIZIDE; METOPROLOL; METFORMIN; IMDUR; ASPIRIN [ACETYLSALICYLIC ACID]; ALLOPURINOL

Current Illness:

ID: 1790915
Sex: F
Age:
State: UT

Vax Date: 09/11/2021
Onset Date: 09/11/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swollen lymph nodes; extreme fatigue/tire easily; difficult to get out of bed in the morning unable to work a full day or do the things that I would like to do; body aches; normal fever the evening after shot was received; This is a spontaneous report from a contactable consumer (patient). A non- pregnant 40-year-old female patient (age at vaccination: 40-year-old) received bnt162b2 (BNT162B2, lot FE3592), via an unspecified route of administration in left arm, on 11Sep2021 15:30 as dose 2, single for Covid-19 immunisation. Medical history included autoimmune thyroiditis, seasonal allergy and allergic to pesticides and cleaning products. She had her dose 1 of bnt162b2 (lot Fd8448) via unknown route in the left arm on 20Aug2021 (age of 40-year-old) for Covid-19 immunisation. There were no concomitant medications. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. On 11Sep2021, she experienced a normal fever the evening after shot was received and a fever the full day after that. She had swollen lymph nodes extreme fatigue/ tire easily, finding it difficult to get out of bed in the morning and was unable to work a full day or do the things that she would like to do and body aches on 13Sep2021. No treatment for the events. She went for a clinic visit to a doctor or other healthcare professional. The outcome of loss of personal independence was recovering; for pyrexia was recovered on unspecified date in Sep2021; for other events was not recovered.

Other Meds:

Current Illness:

ID: 1790916
Sex: F
Age:
State: MS

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: right breast implant completely ruptured; sharp pain in chest; pain that caused insomnia; pain that caused insomnia; chest tightness; discomfort; shortness of breath; Other vaccine same date vaccine date: 10Aug2021; Other vaccine same date vaccine date: 10Aug2021; This is a spontaneous report from a contactable other hcp (patient). A 36-years-old female patient (not pregnant) received bnt162b2 (Brand: Pfizer) intramuscularly administered in Arm Left on 10Aug2021 (vaccination age was 36 years old) (Batch/Lot Number: Fc3180) as DOSE 1, SINGLE for covid-19 immunisation. Other unspecified Pfizer vaccine administered via an unspecified route of administration in Arm Left on 10Aug2021 (Batch/Lot Number: Fc3181) as DOSE 2, SINGLE for immunization. Facility type vaccine was in Pharmacy or Drug Store. Medical history included generalized dystonia and covid-19 (prior vaccination), no known allergies. There is no other vaccine in four weeks. Concomitant medication(s) included amantadine; carbidopa monohydrate, levodopa (SINEMET); amfetamine (ADZENYS ER); vitamin d nos (VITAMIN D); ascorbic acid (VITAMIN C); zinc; all taken for an unspecified indication, start and stop date were not reported. The patient experienced right sharp pain in chest that started the night of the second vaccination that lasted for 48 hours, pain that caused insomnia, followed by 2 weeks of chest tightness, discomfort and shortness of breath. 2 1/2 weeks later right breast implant completely ruptured. Patient will now have to have breast revision surgery. Adverse events start date was reported as on 31Aug2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of right sharp pain in chest, pain that caused insomnia, chest tightness, discomfort and shortness of breath, right breast implant completely ruptured was not recovered with unknown treatment received. No covid tested post vaccination.; Sender's Comments: Based on the information in the case report, a possible causal association between the event device breakage and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: AMANTADINE; SINEMET; ADZENYS ER; VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; ZINC

Current Illness:

ID: 1790917
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 06/16/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: my hands were kind of swollen and numb; my hands were kind of swollen and numb; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief; Numbness is focused on my hands; don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip; don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 as dose 2, Single for covid-19 immunisation. Medical history included none. Concomitant medication included Ibuprofen ADVIL LIQUI GELS taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine first vaccine bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration, administered in Arm Left on 25Apr2021 04:15 as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. On 16Jun2021, the patient experienced my hands were kind of swollen and numb, swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief, swelling and pain and numbness moved to elbows knees ankles and now hips are giving me some grief, numbness is focused on my hands, don't sleep much because i cant' stop the buzzing in my hands and I can't do my job because I cannot grip. Further explained that about almost a month after she got the second shot and hands were kind of swollen and numb. As time progressed swelling and pain and numbness moved to elbows knees ankles and now hips are giving her some grief. Numbness was focused on her hands, and she couldn't make a fist, don't sleep much because she couldn't stop the buzzing her hands, and she could not do job because she cannot grip. The patient did not receive any treatment for the events. The outcome of all events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: ADVIL LIQUI GELS

Current Illness:

ID: 1790918
Sex: F
Age:
State: FL

Vax Date: 09/11/2021
Onset Date: 09/13/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Severe migraines accompanied by mild seizure; Severe migraines accompanied by mild seizure; No appetite after dosage; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCIN), first dose, via an unspecified route of administration, administered in arm left on 11Sep2021 10:00 at the age of 24 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine which the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe migraines accompanied by mild seizure, no appetite after dosage, all on 13Sep2021. It is unknown if treatment received. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1790919
Sex: U
Age:
State: AZ

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: PTSD; This is a spontaneous report from a contactable consumer (patient). A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly, administered in Arm Left on 18May2021 (Lot Number: EW0161, expiration date unknown) at age of 36 years old as a single dose for covid-19 immunisation. Medical history included ongoing celiac disease (onset date: Childhood Patient Details: Maintains a gluten free lifestyle as much as possible). Concomitant medication included sertraline taken for antidepressant from an unspecified start date and ongoing. The patient experienced PTSD (post-traumatic stress disorder) on 18May2021 with outcome of recovering. Therapeutic measures were taken as a result of event. The event was reported as being medically significant. Follow-up attempts are completed. No further information is expected.

Other Meds: SERTRALINE

Current Illness: Celiac disease (Onset Date: Childhood Patient Details: Maintains a gluten free lifestyle as much as possible.)

ID: 1790920
Sex: F
Age:
State: CT

Vax Date: 09/24/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: COVID-19; Result Unstructured Data: Test Result:Positive; Comments: Prior to vaccination

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Swollen pain full arm, extremely red, hot, kept spreading down the arm; Swollen pain full arm, extremely red, hot, kept spreading down the arm; Swollen pain full arm, extremely red, hot, kept spreading down the arm; There seemed to be almost a whited head in the center and it looked like it's bruising; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2587), via an unspecified route of administration, administered in right arm on 24Sep2021 (at the age of 56 years old) as dose 1, single for COVID-19 immunization. Medical history included being diagnosed with COVID-19 from an unknown date prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) on 13Sep2021, taken as a single dose in left arm, for immunization. In Sep2021, the patient experienced a swollen pain full arm, extremely red, hot, kept spreading down the arm, and at the time of the report, there seemed to be almost a whited head in the center, and it looked like it's bruising. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unknown date prior to vaccination. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1790921
Sex: F
Age:
State: KY

Vax Date: 09/26/2021
Onset Date: 09/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210927; Test Name: Temperature; Result Unstructured Data: Test Result:102.8; Test Date: 20210928; Test Name: Temperature; Result Unstructured Data: Test Result:99; Comments: Temperature down to 99 on Tues. morn. Normal later in day; Test Date: 20210928; Test Name: Temperature; Result Unstructured Data: Test Result:Normal; Comments: Temperature down to 99 on Tues. morn. Normal later in day; Test Date: 20210929; Test Name: Temperature; Result Unstructured Data: Test Result:99; Comments: Back to 99 Wed. night.

Allergies:

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

Symptoms: severe hives on trunk of body; general malaise; temperature of 102.8 next day; Very sore arm; mild headache; cold/unable to get warm in middle of first night (Sun.); This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnancy female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Sep2021 14:30 (Lot Number: EW0176, at age of 71 years old) as single dose for COVID-19 immunisation. Medical history included hypo-thyroid, osteopenia, mild MGUS. Concomitant medications included levothyroxine; raloxifene; calcium; colecalciferol (D3); krill oil. The patient previously took codeine and amoxicillin and experienced drug allergy. The patient experienced very sore arm and a mild headache a few hours after (at 04:30 PM on 26Sep2021) and throughout, cold/unable to get warm in middle of first night (Sun. on 26Sep2021), general malaise and temperature of 102.8 next day (Mon. on 27Sep2021), severe hives on trunk of body (discovered on 2nd day (Tues on 28Sep2021), but did not undress on Monday (on 27Sep2021) so don't know if were there on Mon (on 27Sep2021). Temperature down to 99 on Tues. morn (on 28Sep2021). Normal later in day (on 28Sep2021). Back to 99 Wed. night (on 29Sep2021). Hives remain but less solid. Self-treating temperature with tylenol beginning Mon. (on 27Sep2021) and starting benadryl Wed. night (on 29Sep2021). The outcome of events hives and fever was recovering, the outcome of rest events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE; RALOXIFENE; CALCIUM; D3; KRILL OIL.

Current Illness:

ID: 1790922
Sex: M
Age:
State: MI

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 10/16/2021
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: Chest X-ray; Result Unstructured Data: Test Result:everything was normal; Comments: he was monitored, had a chest x ray, an echo, everything was normal.; Test Name: Echo; Result Unstructured Data: Test Result:everything was normal; Comments: he was monitored, had a chest x ray, an echo, everything was normal.; Test Name: Echo; Result Unstructured Data: Test Result:normal; Comments: he converted spontaneously the same day and went home. States he then followed up with the doctor 3 days later, echo results normal.; Test Name: EKG; Result Unstructured Data: Test Result:he was in Afib; Comments: they came out and hooked him to EKG, saw he was in Afib; Test Name: MRI; Result Unstructured Data: Test Result:all of it is normal; Comments: 41mL, slightly dilated, unchanged for 6 years, has an MRI and imaging every year, all of it is normal, has a normal aortic valve, no leakage, maybe mild regurgitation, nothing of importance or concern.; Test Name: MRI; Result Unstructured Data: Test Result:all of it is normal; Comments: 41mL, slightly dilated, unchanged for 6 years, has an MRI and imaging every year, all of it is normal, has a normal aortic valve, no leakage, maybe mild regurgitation, nothing of importance or concern.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: weird fluttering in the chest; took pulse it was racing and skipping; AFib; he got his booster shot of the Pfizer Covid 19 vaccine; he got his booster shot of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 18Aug2021 (Batch/Lot Number: FC3183) as DOSE 3 (BOOSTER), 0.3ML SINGLE for covid-19 immunisation. Medical history included ongoing dialating aortic root, anxiety and depression, premature ventricular contractions (PVCs) from an unspecified date and unknown if ongoing. Additional Information for Other Conditions: 41mL, slightly dilated, unchanged for 6 years, has an MRI and imaging every year, all of it was normal, has a normal aortic valve, no leakage, maybe mild regurgitation, nothing of importance or concern. The patient received the first dose (Lot number: EL1283, 0.3mL) on 12Jan2021 and second dose (Lot number: EL9265, 0.3mL) on 01Feb2021. Concomitant medications included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for depression and anxiety from an unspecified start date and ongoing (on for 6 years); diazepam (VALIUM) taken for depression and anxiety from an unspecified start date and ongoing (been taking for about 6 years). The patient experienced Afib on 04Sep2021 and recovered on 04Sep2021. Caller states that he had an interesting occurrence, states he got his booster shot of the Pfizer Covid 19 vaccine, states he had both original vaccines in Jan and Feb2021, states 18 days after the booster he had his first ever incidence of Afib, states he self converted and required no intervention. States he was doing some research, noticed in a few studies printed in the (name withheld), there was some information about myocarditis in younger folks, states he is 65 and read that older folks were showing some 20 days out they were seeing some cases of pericarditis, states that pericarditis can also have an arrhythmia as a symptom, states he thought it was important for him to report his experience. Caller states he was in the emergency room for just half the day, states they did not have to have any conversion, states he does not have risk factors for Afib, states he has had calcium scores and seen cardiology for 10 years. Caller states that it was fine on its own, all tests were normal, states it was transient. Caller states to treat the event, the doctor did put him on a low dose beta blocker, states it slowed heart rate down, taking 12.5mg, is also on Eliquis as a precaution for stroke risk. Caller states he will follow up again in a couple of weeks and talk about being taken off of the blood thinner, states he does not want to be on a blood thinner his whole life. Got Booster on 18Aug2021, states he was one of the early people to get the first two doses of the vaccines due to his relationship with the hospital as a donor. States he received the first dose on 12Jan2021 and second dose 01Feb2021 and third dose on 18Aug2021. States on 04Sep2021 he woke up that morning, laying in bed around 7AM and had weird fluttering in the chest, took pulse it was racing and skipping, caller states he was used to having periodic PVCs which everyone has, states they had been diagnosed benign before, prior to vaccine, states this was different on the morning of 04Sep2021, states his heart was racing/fluttering, did a couple of things like the Valsalva Maneuver to try and change it, states that did not work, he then called 911 they came out and hooked him to EKG, saw he was in Afib, took him into the hospital ER, he was monitored, had a chest x ray, an echo, everything was normal, states he converted spontaneously the same day and went home. States he then followed up with the doctor 3 days later, echo results normal. The outcome of Afib was recovered on 04Sep2021, of other events was unknown.

Other Meds: PAXIL [PAROXETINE HYDROCHLORIDE]; VALIUM

Current Illness: Anxiety ((Verbatim): anxiety and depression); Aortic dilatation (Verbatim: dialating aortic root); Depression ((Verbatim): anxiety and depression)

ID: 1790923
Sex: M
Age:
State: NM

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine; patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) at the age of 77-year-old as single dose; dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) in 2021 at the age of 77-year-old, as single dose for covid-19 immunisation. Patient history reported as no. There were no concomitant medications. The patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine and was currently hospitalized. He's in the hospital and he's been sick for 26 days and it's real bad. He got diagnosed 28 days before, so sometime in Aug2021, he had worsened since being in the hospital. The patient got the vaccine 3 months before he got COVID. Event reported as serious as hospitalization from 01Sep2021. The outcome of the event was not recovered (reported as worsened). The reporter's concern was why did the patient get Covid, why did it hit him so strong after having the vaccine, the vaccine was to prevent, so why did it hit him so hard. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790924
Sex: F
Age:
State: WA

Vax Date: 03/10/2021
Onset Date: 07/10/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 202107; Test Name: blood tests twice a day; Result Unstructured Data: Test Result:Normal; Test Date: 202107; Test Name: tested for a blood clot; Result Unstructured Data: Test Result:she didn't have one; Comments: was told she didn't have one; Test Date: 20210710; Test Name: COVID-19 test; Test Result: Positive

Allergies:

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

Symptoms: COVID-19; COVID-19; can''t walk; can''t move; can't lift her arms; headaches; memory loss, like a brain fog, foggy memory; memory loss, like a brain fog, foggy memory; can''t smell; can''t taste; blue feet; She can't drive her car; had a problem with her hands; blood problems; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored Program. A 72-year-old female patient received first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 13Feb2021 (Batch/Lot Number: EN6204) at age of 71-year-old at 0.3 ml single dose, second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number not clarify, unknown FC3194 or FC3184) at age of 71-year-old at 0.3 ml single dose, for covid-19 immunisation. Medical history included allergies to the sulfa family, she did have allergies to the sulfa family, she can't take any of that or she goes into shock, that's it. She mentioned she was anemic, but she was okay now. She stated she had problems, but hadn't had any recently- she had been watching it. The patient stated a couple years back, she and her husband had the pneumonia shots and they got the flu vaccine every year on time, and never had any problems. The patient received vaccines at the same facility. She clarifies it was a clinic they went to on the top floor (3rd floor). No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She stated she started no new medications, nothing. She clarifies no new medications was given to her until they were in the hospital. Patient had COVID-19 test on 08Jul2021. They got her positive results on 10Jul2021 which was when they went to the hospital. Reported seriousness for COVID-19 was hospitalization, patient was in hospital for COVID-19 from 11Jul2021 to 19Jul2021. Prior to that, her and her husband thought they had a cold. She clarifies further on 10Jul2021, her and her husband went to the emergency room. They spent 24 hours in the ER. She and her husband were given a room on 11Jul2021. She spent approximately 8 days in the hospital, so it would have been approximately 19Jul2021 when she was discharged. She can't walk. She can't drive her car. She can't lift her arms go get the stuff to wash her clothes. She had to hire one person to get things down to wash the clothes with and to clean. She stated she was a mess. She was vaccinated. The patient mentioned she couldn't do two things at once anymore. She can't walk anymore. She got COVID really bad. She can't believe she got sick. The patient stated she had a foggy memory, too. She stated she was a long hauler. She can't walk. She can't move. She has headaches, memory loss like a brain fog. She can't smell and she can't taste still. She had blue feet but did not have a blood clot. She was tested for a blood clot and was told she didn't have one, but that there were 25 patients with the same symptoms, like younger people with the same problems. She was told she was to be seen again in 3 months. She had to deal with this on top of the stress from losing her husband. The only thing that was given to her and her husband was the medication that is supposed to get them out of the hospital, it starts with a d but she forgot the name of it. She states even though she has had all of these problems, she still got her booster. She doesn't want to give up. She did believe in science. She confirmed she already got her booster shot. She was able to retrieve Lot number for her booster shot and mentions it's hard to read due to the person's handwriting. She initially stated it may be FC3194 or FC3144. She then states maybe the last two digits or 94 or 84. She mentioned she had a problem with her hands and she was trying to see if she can open something else. She clarifies she believed the Lot number was FC3194 or FC3184. She confirms she received this COVID-19 booster shot on 25Sep2021. The only other number she sees on the card is #, but she doesn't know what that is. The patient confirmed she had physicals which were okay. She had blood problems in the hospital. She clarified in the hospital, they did blood tests twice a day and everything was normal when she got out. She clarified she was given an injection/ shot in the thigh so she wouldn't get a blood clot because COVID gives you blood clots. She clarified she thought she was anemic, but she was told she wasn't. She states she was a long hauler, and she was just exhausted, and was going through all of this stuff. The outcome of events was unknown. Product Quality Complaint Group provided the Investigation results: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Product Description (CR): compound bnt162b2 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1, Lot-# (CR): EN6204. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 vaccine lot EN6204 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790925
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: developed blindness due to worsening of diabetic retinopathy in his right eye/developed partial blindness in his other eye too; worsening of diabetic retinopathy in his right eye; worsening of diabetic retinopathy in his right eye; Eczema; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE NUMBER, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. A man reported that 13 hours after receiving PREVNAR-13 he developed blindness due to worsening of diabetic retinopathy in his right eye. After treatment by his eye doctor, (Name and address withheld) 70% of his vision returned. He developed partial blindness in his other eye too but not as bad as the right eye. He continues to have eczema as well. The outcome of blindness was recovering, outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1790926
Sex: U
Age:
State: TN

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood clot that was several years ago, following a surgical procedure. The patient's concomitant medications were not reported. The patient had a blood clot in the right leg in Sep2021 with outcome of unknown. The clinical course was reported as: A little over a month ago, the patient got the first dose of the Covid-10 Pfizer vaccine. A week ago, the patient had a blood clot in the right leg. The patient has only had a blood clot one other time in the life, and that was several years ago, following a surgical procedure. The patient went to the ER when realized it was a clot and was currently waiting on a follow up appointment with the regular doctor. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790927
Sex: F
Age:
State: NC

Vax Date: 09/08/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 202109; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: she took her blood pressure at home and it was sky high; Test Date: 202109; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Saw a spot on her lung; Test Date: 202109; Test Name: Heart rate; Result Unstructured Data: Test Result:135; Test Date: 20210924; Test Name: Covid test; Test Result: Negative ; Test Date: 20210924; Test Name: COVID-19 PCR test; Test Result: Negative

Allergies:

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

Symptoms: Shortness of breath; Heart racing; Elevated blood pressure; Wheezing; Spot on her lungs; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 08Sep2021 in the morning (Batch/Lot Number: FF2588) as DOSE 2, SINGLE for covid-19 immunisation at the age of 45-year-old. Medical history included ongoing blood pressure high (diagnosed years ago, has had since 2004 or 2005), ongoing arthritis (Diagnosed in 2018 or 2019), ongoing diabetes (Borderline in 2018, but started taking medication this year in 2021), urine analysis abnormal, nerve pain in joints, bone disorder, swelling, mild pain, Non-smoker. Family Medical History Relevant were Grandmother had asthma; had an oxygen tank in her house. Mother and father were both on dialysis. Concomitant medication(s) included metformin taken for Diabetes; losartan taken for Blood pressure high; hydrochlorothiazide taken for Blood pressure high, urine analysis abnormal (makes her pee); vitamin d [vitamin d nos] taken for Bone support; folic acid; methotrexate taken for arthritis; gabapentin taken for arthritis (she takes this medication at bedtime because it generally makes her sleepy), nerve pain in joints; furosemide taken for swelling; celecoxib (CELEBREX) taken for pain (doctor wanted her to take this instead of 800mg Ibuprofen for pain so it doesn't mess up her stomach), all were from an unspecified start date and ongoing. The patent received 1st dose (Lot: EW0175) on 18Aug2021 in left arm muscle in the afternoon. After the first dose, she had a little soreness in her shoulder and felt like her chest was a little different but it went away. She felt tired, and it made her sleepy and tired, but she didn't have what she's had with this 2nd dose. This 2nd dose didn't even make her arm sore. The patient experienced shortness of breath and wheezing on 24Sep2021 01:00 with outcome of not recovered, heart racing and elevated blood pressure on 24Sep2021 01:00 with outcome of recovered on 25Sep2021, spot on her lungs in Sep2021 with outcome of unknown. The patient was hospitalized for shortness of breath, heart racing, elevated blood pressure from 24Sep2021 to 26Sep2021. Therapeutic measures were taken as a result of shortness of breath, heart racing. The events Shortness of breath, heart beating too fast, and blood pressure was sky high resulted in Emergency Room visit. The clinical course was reported as: she got the 1st dose of the vaccine, then this month she got the 2nd dose on 08Sep2021. On 24Sep2021, that morning she drove herself to the ER because she couldn't hardly breathe and her heart was beating too fast. She took her blood pressure at home and it was sky high. she has never had shortness of breathe like that, and it was worse when she was laying down. At first she thought she had covid, but she didn't have any problems when eating. When she got to the ER, they put her in a wheelchair, and took her to the back right away and gave her oxygen. They did a covid test, and the doctor asked her how long she's had asthma. She doesn't have asthma and she doesn't smoke. They did two Covid tests, one they just swabbed the inside of her nose and the other one they went all the way up inside her nose; both Covid tests were negative. They kept her overnight for about 3 days total, and kept her on oxygen and was giving her breathing treatments. They also did a couple of chest x-rays. The doctor told her the day before she went home that they saw a spot on her lungs. The doctor said that it wasn't cancer, but that they were going to bring her back soon to do another x-ray to see if there are any changes. When she was discharged, they gave her albuterol treatments and pumps to do for her breathing, and she is supposed to see her doctor on Monday. She gets short of breath whenever she gets up to do something, and has to do a breathing treatment every 4-6 hours. Her lungs feel different than they did before. Before she was able to feel like she could breathe, but now she feels like her lungs are closing on her; she is wheezing and stuff, which she never had before. These all started Friday morning, 24Sep2021, at 1am. She is still doing Albuterol breathing treatments for shortness of breath. At the hospital they said her heart rate was 135 and they gave her medication to bring it down. She was on a heart monitor the whole time she was in the hospital. Follow-up attempts are completed. No further information is expected.

Other Meds: METFORMIN; LOSARTAN; HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; FOLIC ACID; METHOTREXATE; GABAPENTIN; FUROSEMIDE; CELEBREX

Current Illness: Arthritis (Diagnosed in 2018 or 2019); Blood pressure high (Diagnosed years ago, has had since 2004 or 2005.); Diabetes (Borderline in 2018, but started taking medication this year in 2021.)

ID: 1790928
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 08/27/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:unknwon results; Comments: If COVID tested post vaccination: Yes

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Deep Vein Thrombosis discovered at the end of August.; Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 (Batch/Lot Number: EW1070) as DOSE 2, SINGLE for covid-19 immunisation at the age of 43-year-old. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]); clarithromycin (CLARITIN), Birth control, allergy to Ibuprofen. The patient previously took bnt162b2 dose 1 (Batch/Lot Number: ER8734) in Left arm on 01Apr2021 for covid-19 immunisation at the age of 43-year-old. The patient experienced Pulmonary Embolism and Deep Vein Thrombosis on 27Aug2021 with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 4 days. No COVID prior vaccination and COVID tested post vaccination with unknown results. Therapeutic measures taken for deep vein thrombosis and pulmonary embolism included Blood thinners. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN D [COLECALCIFEROL]; CLARITIN

Current Illness:

ID: 1790929
Sex: F
Age:
State:

Vax Date: 05/28/2021
Onset Date: 07/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: blood clots when she wipes, they're shaped and formed/menstrual bleeding with the cramping and clots/shouldn't even have a menstrual cycle and its getting worse; heavy menstrual like bleeding; nausea; severe cramping/menstrual bleeding...with the cramping; back pain; headache; very uncomfortable; a lot of pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 28May2021 (Batch/Lot Number: EW0191) (at the age of 32-year-old) as dose 1, single and via an unspecified route of administration on 18Jun2021 (Batch/Lot Number: EW0191) (at the age of 32-year-old) as dose 2, single for COVID-19 immunisation. Medical history included hoshimottos diagnosed at age 12 or 13 and hypertension. Concomitant medication included calcium levomefolate, drospirenone, ethinylestradiol betadex clathrate (BEYAZ) taken for birth control. The patient had been on birth control for a few years now and with her doctors okay she skipped her placebo week. The patient got the first vaccine 28May2021 and the second one on 18Jun2021. The patient had noticed that where she wasn't having break through bleeding and issues before, she was having a lot break through bleeding and blood clots when she wiped, they're shaped and formed in Jul2021. The patient stated she should not be bleeding at all and when she noticed the issues she switched her birth control with a different hormone combo that may have been more effective. The patient was having heavy menstrual like bleeding, severe cramping, and nausea so bad that she was considering going to the emergency room in Jul2021. The patient's doctor said it could take a few months to adjust to the new birth control but she had noticed these problems with the other birth control. The patient shouldn't even have a menstrual cycle and its getting worse. The patient didn't have problems before the shot and this was the only thing she can assume. The patient wasn't the only one reporting menstrual bleeding after the vaccine. She stated the menstrual bleeding was nonstop for a couple of months. It had amped up in the last couple of months with the cramping and clots in Jul2021. It felt like the patient wasn't taking birth control. The patient was originally on BEYAZ when she got the vaccine and experienced breakthrough bleeding. The patient was then switched to Apri and experienced worsened bleeding. The patient was then swapped to Seasonique and had been on it a month now. The patient had had cramping, blood clots, heavier bleeding, back pain, nausea and a headache. The patient's doctor wanted her to stay on this and didn't think the blood clots were alarming. The patient stated she was very uncomfortable and in a lot of pain daily in 2021. The outcome of the events "blood clots when she wipes, they're shaped and formed/menstrual bleeding with the cramping and clots/shouldn't even have a menstrual cycle and its getting worse", "heavy menstrual like bleeding" and "severe cramping/menstrual bleeding...with the cramping" was not recovered, of the other events was unknown.

Other Meds: BEYAZ

Current Illness:

ID: 1790930
Sex: M
Age:
State: TX

Vax Date: 09/18/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 202109; Test Name: Blood test; Result Unstructured Data: Test Result:its a common issue and will go away with time; Test Date: 20210922; Test Name: chest x-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 202109; Test Name: chest x-ray with the dye; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210922; Test Name: abdominal CT scan; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210924; Test Name: CT of the abdomen with dye; Result Unstructured Data: Test Result:Unknown results; Test Date: 202109; Test Name: They took blood and did another scan with dye; Result Unstructured Data: Test Result:its a common issue and will go away with time; Comments: At 02:45; Test Date: 20210923; Test Name: scan of his stomach with dye; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210924; Test Name: scan of his stomach with dye; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: he has a bad kidney; By Tuesday the caller could barely walk; the pain went to this kidney; damage to the spleen; spleen had blood clots; the pain went from the pancreatitis area and kidney area to his chest and left arm.; he loses his balance; vertigo; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FF8839, Expiration date: Not reported), via an unspecified route of administration in left arm, on 18Sep2021 at 11:45 (at the age of 54-years-old) as dose 2, single for COVID-19 immunization. The patient's vaccine was not administered in a military facility. Medical history included type 1 diabetes mellitus and took insulin for it, had pancreatitis and was hospitalized for 4 days in 2017. No family history was reported. There were no concomitant medications/other products reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3184, Expiration date: Not reported), via an unspecified route of administration in left arm, on 25Aug2021 as dose 1, single for COVID-19 immunization. The patient previously took insulin for type-1 diabetes mellitus. There was no history of any previous immunization with the Pfizer vaccine considered as suspect and there were no additional vaccines administered on the same date of the Pfizer suspect. No prior vaccinations within 4 weeks prior to COVID vaccine. No adverse events following the prior vaccinations. On 19Sep2021, the family had their breakfast at 11:15 which was usually followed by the family. The patient had his food, and experienced the pain at pancreatitis area which he had 4 years ago. The patient had bad pains in his stomach on 19Sep2021. On 20Sep2021, the patient woke up with the pain that went to his kidney and also had a bad kidney. On 21Sep2021, the patient could barely walk. On 22Sep2021, the patient went to the hospital because of the pain which went from the pancreatitis area and kidney area to his chest and left arm which happened in Sep2021. It was reported that the patient's spleen had blood clots in Sep2021 and insisted that he was in a fight or car accident, but the patient was not in any of them. On 22Sep2021, the patient had a chest x-ray and abdominal computerized tomogram (CT) scan with unknown results. The patient was hospitalized and then had to go back to the emergency room on the next day. The patient went to the emergency room (ER) on 22Sep2021 at 10:30 and was admitted by 17:00. The patient had a second scan of his stomach with dye on 23Sep2021 with unknown results. The patient was discharged from the hospital on 23Sep2021 at 14:30. After the discharge, the patient went back to the hospital because of pain, but the hospital didn't have a hematologist or gastrologist for the weekend, so he was sent to another hospital. The other hospital blew it off and said it will go away. The patient regarding his pain because he could barely stand. The patient didn't want to be hospitalized for the pain because he is uninsured, so they gave him some tramadol and something that keeps him from getting nauseous as treatment for the events. The nurse at the hospital wanted the patient to go to another hospital because they have the scans and everything in their system, but the patient was sent to another hospital because he needs a hematologist and a gastrologist for his condition. The patient was at the other emergency room from 21:00 to 03:00 on the next day. They took blood in Sep2021 and did another scan with dye and at 02:45, they said it's a common issue and will go away with the time. When the patient got up in Sep2021, he loses his balance and his spouse thought it's vertigo, but he thinks it's because of his spleen. On 24Sep2021, the patient had another stomach scan with the dye at the emergency room (ER) then the patient got to another ER, they did another CT abdomen with the dye. They did another scan since the patient wasn't given a compatible disc (CD) with the images of the scans. They did a second chest x-ray with the dye, but they said they can only do half of the dye because he just had the test done. They reported to do another test on the patient's stomach and said there was damage to the spleen. The doctor said it was common for a damaged spleen/damage to the spleen observed in Sep2021 and asked the patient whether he could wait until 25Sep2021 to be seen. They wanted the patient to promise that he would go to the other hospital. All the reported events were resulted in emergency room but reported as only for pain in chest and left arm. It was reported that there was no physician's office visit. The investigator's assessment was reported. The outcome of bad pains in his stomach was not recovered while the outcome of other events was unknown at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790931
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: new diagnosis of a-fib received within 1 month of vaccine; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date in Jul2021 (at the age of 85-year-old) at single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history included Blood pressure high (HBP). The patient had no known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced new diagnosis of a-fib received within 1 month of vaccine in Aug2021. The event was considered serious due to Hospitalization, Disability or permanent damage. The patient was hospitalized for the event for 5 days. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included Eliquis and amiodarone. The patient had not been tested for COVID post vaccination. The event outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790932
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Have myocarditis from Pfizer vaccine; This is a spontaneous report from a contactable consumer. A patient (friend's children of reporter) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOW, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced have myocarditis from pfizer vaccine on an unspecified date with outcome of unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790933
Sex: F
Age:
State:

Vax Date: 09/19/2021
Onset Date: 09/19/2021
Rec V Date: 10/16/2021
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: 20210919; Test Name: Body Temperature; Result Unstructured Data: Test Result:101-102 for 24 hours

Allergies:

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

Symptoms: Fever of 101-102 for 24 hours; shakes for 8 hours; Throwing up twice; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in left arm on 19Sep2021 (at the age of 23-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. The patient had no known allergies. Concomitant medications were none. The patient did not received any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 29Aug2021 at 13:00 as single dose for COVID-19 immunization. The patient experienced fever of 101-102 for 24 hours, shakes for 8 hours, throwing up twice and headache on 19Sep2021 21:00. No treatment was received as a result of the events. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered in Sep2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790934
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210928; Test Name: covid test; Test Result: Positive ; Comments: Nasal Swab, PCR

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: just got a positive PCR result for COVID-19; just got a positive PCR result for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received bnt162b2 (at the age of 47-year-old), dose 2 on 23Mar2021 13:00 (Lot number was not reported) as single dose, dose 1 on 02Mar2021 13:00 (Lot number was not reported) as single dose; both via an unspecified route of administration, administered in Arm Left for covid-19 immunisation. There were no medical history and concomitant medications. It's that patient just got a positive PCR result for COVID-19, test taken on 28Sep2021, result 29Sep2021. No treatment received. The patient underwent lab tests and procedures which included covid test: positive (Nasal Swab, PCR) on 28Sep2021. The outcome of the events was recovering. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790935
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Blood pressure; Result Unstructured Data: Test Result:200; Comments: Blood pressure just goes through the roof, up over 200

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Blood pressure just goes through the roof, up over 200; had a really terrible reaction to a booster shot; had a really terrible reaction to a booster shot; This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), first dose on unknown date for COVID-19 immunization and second dose on unknown date (8 months ago) for COVID-19 immunization and experienced blood pressure just goes through the roof, up over 200. It was reported that the patient had a really terrible reaction to a booster shot on an unspecified date, the Pfizer booster and reported that she had the same reaction from the second shot, eight months ago and her blood pressure just goes through the roof, up over 200. It was wondered if anybody else reported that and asked for recommendation on how to neutralize it. Stated that the patient was having a 'crisis' during the report and she might have to be taken back to the emergency. The patient underwent lab tests and procedures which included blood pressure measurement: 200 on unspecified date, blood pressure just goes through the roof, up over 200. The outcome of the event blood pressure just goes through the roof, up over 200 was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790936
Sex: F
Age:
State: IN

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
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: 202104; Test Name: ANA titer; Test Result: Positive; Comments: ANA titer was drawn and it came back positive, a speckled pattern; Test Date: 202104; Test Name: she had bloodwork; Result Unstructured Data: Test Result: Unknown result.

Allergies:

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

Symptoms: something like a connective tissue disease or lupus.; something like a connective tissue disease; ANA titer was drawn and it came back positive; rash; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 02Mar2021, as dose 2, single, for COVID-19 immunisation. Medical history included high levels of Epstein Barr in her body. She has not seen a rheumatologist yet. The patient's concomitant medications were not reported. Patient had no prior vaccinations within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021, as dose 1, single, for COVID-19 immunisation and experienced hematoma, itchy rash and got swelled up and got huge and had a bruise. The patient experienced rash after second dose (Mar2021). But it was not bad since she took Benadryl and Advil before the second dose. After the second dose in her right arm, the rash did show up sooner, within 24 to 48 hours after the shot. The rash after the second dose did not last as long and took about 5 to 7 days to recover. On an unspecified date in Apr2021, the patient went for her yearly checkup and had bloodwork and her ANA titer came out positive, a speckled pattern, which means something like a connective tissue disease or lupus (immunocompromised). The reporter stated she might have had this before the vaccine since she had high levels of Epstein Barr in her body previously. She has not seen a rheumatologist yet. It was reported that, she heard that people who are immunocompromised might not have protection against COVID19. She went to the doctor and asked if she can get the third dose booster. The outcome for rash was recovered while for other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294311 same reporter/drug, different patient/event

Other Meds:

Current Illness:

ID: 1790937
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: she got her first dose of covid vaccine but got covid a month ago; she got her first dose of covid vaccine but got covid a month ago; This is a spontaneous report from a contactable other health care professional and non-contactable other health care professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports no side effects to xeljanz. The patient experienced she got her first dose of covid vaccine but got covid a month ago on an unspecified date (medically significant) and was waiting 90 days until she can get second covid dose of vaccine. She reports missing a few doses. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event s drug ineffective and covid19 cannot be totally excluded.

Other Meds:

Current Illness:

ID: 1790938
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood Pressure; Result Unstructured Data: Test Result:up over 200; Comments: Blood pressure just goes through the roof up over 200

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: had the same reaction from the second shot/Blood pressure just goes through the roof, up over 200; received dose 3 (booster); received dose 3 (booster); This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in 2021 (lot number and expiry date: unknown) as dose 3 (booster), single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date, and second dose on unspecified date in 2021 (8 months ago), for Covid-19 immunisation. The reporter stated that the patient had a terrible reaction to the Pfizer booster. She had the same reaction from the second shot, eight months ago (not clarified further). On unspecified date in 2021, patient's blood pressure just goes through the roof, up over 200 so, they were wondering how to neutralize it. Patient experienced 'crisis' at the time of the report and reporter stated that she might be taken back to the emergency. Outcome of the event was unknown. The lot number for BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790939
Sex: F
Age:
State: IN

Vax Date: 08/16/2021
Onset Date: 09/08/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MISCARRIAGE; This is a spontaneous report received from a contactable consumer (patient). This is a maternal report. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Aug2021 10:00 (Batch/Lot number was not reported) at the age of 37-years-old as SINGLE DOSE for covid-19 immunisation. Vaccine was administered at Public Health Clinic/Military Administration facility. The patient's medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient experienced miscarriage on 08Sep2021. Event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Dilatation and Curettage (D&C). The mother reported she pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 16Apr2022. The last menstrual period (LMP) was on 10Jul2021. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790940
Sex: F
Age:
State: MI

Vax Date: 08/19/2021
Onset Date: 08/20/2021
Rec V Date: 10/16/2021
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: Nausea

Symptoms: All over body itching but no rash or swelling; Extreme fatigue; Change in menstrual cycle; This is a spontaneous report from a contactable other hcp reported for herself that. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 19Aug2021 (Batch/Lot Number: EW0183, expiry date: unknown) as dose 2, single for COVID-19 immunization (age at vaccination:41-Year-old). Medical history included anxiety, obesity, and allergy to Penicillin. Concomitant medication included sertraline hydrochloride (ZOLOFT) 150 mg daily taken for an unspecified indication, start and stop date were not reported (medications within 2 weeks prior to the vaccination). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 15Jul2021(Batch/Lot Number: EW0183, expiry date: unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with covid-19 before vaccination, and not tested post vaccination. On 20Aug2021 the patient experienced all over body itching but no rash or swelling, extreme fatigue, and change in menstrual cycle. The patient had not received treatment for the events. The outcome of the events was recovering.

Other Meds: ZOLOFT

Current Illness:

ID: 1790941
Sex: F
Age:
State:

Vax Date: 09/28/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
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: Hypothermia; Myalgia; Joint pain; Tachycardia; Headache; This is a spontaneous report from a non-contactable other HCP (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: FF8839, expiration date unknown) intramuscularly in the arm left on 28Sep2021 at 12:30 PM at age of 58-year-old as unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included hypothyroid, osteoporosis, known allergies to penicillin. Patient previously received influenza vaccine (reported as Flu) on 13Sep2021 within 4 weeks at age of 58-year-old for influenza immunization. Concomitant medications were not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient had hypothermia, myalgia, joint pain, tachycardia, headache; all on 29Sep2021 at 12:00 AM with outcome of recovering. Patient received naproxen as treatment for the events. The events didn't result in emergency room visit or physician office visit. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event hypothermia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1790942
Sex: F
Age:
State: MI

Vax Date: 09/03/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: 202109; Test Name: Blood work; Result Unstructured Data: Test Result:none of my test results were indicating any cardio; Comments: none of my test results were indicating any cardiovascular or circulatory issue; Test Date: 20210904; Test Name: Fever; Result Unstructured Data: Test Result:99.6

Allergies:

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

Symptoms: had a fever of 99.6; had pretty debilitating Chest pain for 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 03Sep2021 (at the age of 34 years old) (Batch/Lot Number: FE3592) as dose 1, single for covid-19 immunisation. Medical history included Grave's disease from an unknown date and unknown if ongoing. Patient has ongoing blood work, she takes blood work every 3 weeks to monitor that. Concomitant medication included thiamazole (METHIMAZOLE) taken for Grave's disease, start and stop date were not reported. Patient has no prior vaccinations. The patient experienced had a fever of 99.6 for 24 hours on 04Sep2021, had pretty debilitating chest pain for 2 weeks in Sep2021. Patient had her first dose on 03Sep and had a Fever of 99.6 for 24 hour after. As soon as the fever broke, she had pretty debilitating chest pain for 2 weeks after that and then it stopped so she wanted to call and seek any advice. The patient underwent lab tests and procedures which included blood work: none of patient's test results were indicating any cardiovascular or circulatory issue in Sep2021, pyrexia: 99.6 on 04Sep2021. Therapeutic measures were taken as a result of had a fever of 99.6 and had pretty debilitating chest pain for 2 weeks. Patient took aspirin and then she went to the emergency room (further not clarified) and the emergency room physician advised her to stop taking Aspirin because none of her blood work, none of her test results were indicating any cardiovascular or circulatory issue so he said stop taking the Aspirin and start taking Ibuprofen and so that was her treatment, so to take so she took the aspirin and then she quit the Aspirin and start taking Ibuprofen. The outcome of fever was recovering while chest pain recovered in Sep2021. Follow-up attempts are completed. No further information is expected.

Other Meds: METHIMAZOLE

Current Illness:

ID: 1790943
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID-19 Test; Result Unstructured Data: Test Result: Positive: Got COVID.

Allergies:

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

Symptoms: After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; Has been in severe flare up; Has a hard time walking; Stiffness in her ankle; This is a spontaneous report received from a contactable nurse and contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162b2 (covid-19 vaccine), first dose, via an unspecified route of administration on an unspecified date as single dose, second dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included BIOTIN, CITRACAL + D3, VITAMIN D2, PLAQUENIL, HYDROXZINE, AMLODIPINE BESYLATE, GABAPENTIN, CELEBREX, and MULTIVITAMIN. In 2021, after getting her first 2 covid vaccines she got covid back in Apr2021 or May2021 and she has been in a severe flare ever since then, has a hard time walking. Ready for a rit (uncertain what this means) was starting to get better still has stiffness in her ankle has a hard time walking. Improved but not resolved. The patient underwent lab tests and procedures which included COVID-19 Test positive, got covid in 2021. The outcome of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and Covid 19 and suspect drug BNT162B2 cannot be excluded.

Other Meds: BIOTIN; CITRACAL + D3; VITAMIN D2; LOSARTAN POTASSIUM; PLAQUENIL; HYDROXYZINE HCL; AMLODIPINE BESYLATE; GABAPENTIN; CELEBREX

Current Illness:

ID: 1790944
Sex: F
Age:
State: PA

Vax Date: 04/07/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
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: 20210930; Test Name: COVID test; Test Result: Positive; Comments: test type unknown.

Allergies:

Symptom List: Tremor

Symptoms: Tested positive for COVID around 10AM EDT on 30Sep2021 via at home COVID test.; Tested positive for COVID around 10AM EDT on 30Sep2021 via at home COVID test.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscularly on 07Apr2021 (Batch/Lot number was not reported) (age at vaccination: 23 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162b2 (Batch/Lot number was not reported) on 17Mar2021 for COVID-19 immunization. No other vaccine received in four weeks. The patient was tested positive for COVID around 10 am EDT on 30Sep2021 via at home COVID test (test type unknown). No treatment was received for the event. The patient was recovering from the event. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790945
Sex: F
Age:
State: FL

Vax Date: 04/21/2021
Onset Date:
Rec V Date: 10/16/2021
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: experiencing more MS relapses and hospitalized for an MS relapse; foggy brain; been forgetful; foggy brain and been forgetful, she feels it has worsened since she had the COVID vaccine; Right leg affected; walking was affected; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 21Apr2021 (at the age of 29-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included ongoing MS (multiple sclerosis) ongoing foggy brain and ongoing forgetfulness (since before Kesimpta). Concomitant medication included ofatumumab (KESIMPTA). The patient had been experiencing more MS relapses after COVID vaccine and hospitalized for an MS relapse for observation at one hospital from 08Jun2021 to 10Jun2021 and left that hospital as there was not an MS specialist overseeing her, and went to another hospital where she was hospitalized and treated for an MS relapse from 10Jun2021 to 13Jun2021. The patient right leg was affected, and her walking was affected. She received 3 days of IV steroids. The patient had foggy brain and been forgetful since before Kesimpta and the patient feels it had worsened since she had the COVID vaccine. The outcome of right leg was affected, and walking was affected was unknown while the outcome for other events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: KESIMPTA

Current Illness: Foggy feeling in head; Forgetfulness; MS

ID: 1790946
Sex: F
Age:
State: MI

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Brain swelling sensation/ like it was swelling again; Severe pressure in my head; Extreme fatigue for 4 days; Sore arm; It felt like I had just had the surgery again.This sensation tapered off over a month/ brain swelling sensation; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 09:15 (Lot Number: EL9261) (at the age of 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included brain surgery, brain bleed and brain blood clotting throughout patient's brain in 2018, small stroke, sulfa allergy, gluten allergy and rice allergy. Concomitant medications within 2 weeks of vaccination included apixaban (ELIQUIS), baclofen and daily vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Vicodin and Celebrex, and experienced allergy with both drugs. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient stated that she was an early vaxer in January due to medical status. This first dose of the vaccine resulted in severe pressure in her head, like it was swelling again, it felt like she had just had the surgery again. This sensation tapered off over a month. She had extreme fatigue for 4 days and sore arm but those weren't a big deal. The onset of all the events was reported as 26Jan2021 21:15. The events did not cause hospitalization. The patient did not receive treatment for the events. It was the brain swelling sensation that resulted in her not getting the 2nd vaccine. The outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected. Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ELIQUIS; BACLOFEN

Current Illness:

ID: 1790947
Sex: U
Age:
State: NM

Vax Date: 09/24/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: Neuropathy pain in right leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 24Sep2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced neuropathy pain in right leg in Sep2021. The patient felt like (withheld), the patient had neuropathy pain in right leg; the patient's doctor thought it was a pseudo relapse that was coming from the patient's 2nd Pfizer COVID 19 Vaccination which was 4 days ago, the patient's doctor does not want to do anything because it might do something with the vaccination; he said for the patient to just wait. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790948
Sex: M
Age:
State: FL

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 10/16/2021
Hospital: Y

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: 20210923; Test Name: COVID-19 test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Numbness and tingling throughout body; Numbness and tingling throughout body; dizziness in standing; cold feet and body sporadically; cold feet and body sporadically; administration date=03Sep2021, dose number=2, administration date=18May2021,dose number=1; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in the left arm on 03Sep2021 at 16:30 (Batch/Lot Number: PC3181) (age at vaccination: 14 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Concomitant medication(s) included cefotaxime sodium (OMNICEF) taken for an unspecified indication, start and stop date were not reported. The patient had previously received the first dose of BNT162b2 on 18May2021 (Batch/lot number : EW0178) for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numbness and tingling throughout body, dizziness in standing, and cold feet and body sporadically. Onset date was 09Sep2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were serious as caused hospitalization. The patient was hospitalized for 2 days. No treatment was received for the adverse events. SARS-COV-2 test (Nasal Swab) was negative on 23Sep2021. The adverse events were not resolved.

Other Meds: OMNICEF [CEFOTAXIME SODIUM]

Current Illness:

ID: 1790949
Sex: F
Age:
State: KY

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210929; Test Name: Heart rate; Result Unstructured Data: Test Result:96; Test Date: 20210929; Test Name: oxygen level; Result Unstructured Data: Test Result:92; Comments: low

Allergies:

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

Symptoms: Fever; chills; nausea-vomiting; nausea-vomiting; aches/pain; low oxygen level. 92; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration in the left arm, on 29Sep2021 13:00 (lot number: FF8839), at age 71 years old, as dose number unknown, single, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Relevant medical history included Graves' disease, high BP, and thyroid disease from unknown dates, not reported if ongoing or not. Concomitant medications included levothyroxine sodium, aloe barbadensis and vitamin b nos all taken for unknown indications, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines in four weeks. The patient previously took erythromycin and had an allergy. On 29Sep2021 19:00, the patient experienced fever, chills, nausea, vomiting, aches/pain, and low oxygen level at 92. On the same day, the patient's heart rate was 96. The events resulted to physician's office visit. Treatment for the events included unspecified nausea medications (as reported). The outcome of the events was not resolved.

Other Meds: LEVOTHYROXINE SODIUM; ALOE BARBADENSIS; VITAMIN B NOS

Current Illness:

ID: 1790950
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: Test Date: 202102; Test Name: BP; Result Unstructured Data: Test Result:190/80; Test Date: 202102; Test Name: BP; Result Unstructured Data: Test Result:190/80; Test Date: 202102; Test Name: BP; Result Unstructured Data: Test Result:180/90; Comments: BP shoot up to 180 over 90; Test Date: 202102; Test Name: BP; Result Unstructured Data: Test Result:down to 140; Comments: My blood pressure now went down to 140 over I don't exactly; Test Date: 202102; Test Name: cardiology workup; Result Unstructured Data: Test Result:No problem; Comments: Had a cardiology workup and no problems found; Test Date: 202102; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Comments: she had an EKG it was normal; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:140; Comments: my heart rate is 140, 150, 140; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:150; Comments: my heart rate is 140, 150, 140; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:140; Comments: my heart rate is 140, 150, 140; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:140; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:160; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:140; Comments: they checked it and it was 140; Test Date: 202102; Test Name: HR; Result Unstructured Data: Test Result:160

Allergies:

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

Symptoms: heart racing/palpitation/; BP:180/90/ my BP shoot up to 180 over 90; My heart rate raised up to 140/ Heart rate is really so high; tinnitus in left ear; felt dizzy; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Feb2021 (at the age of 56 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient experienced heart racing/palpitation, BP:180/90/ bp shoot up to 180 over 90, heart rate raised up to 140/ heart rate is really so high, tinnitus in left ear in Feb2021, felt dizzy in 2021. Patient had 1st dose of Pfizer covid vaccine in February in a hospital setting; shortly afterward felt her heart racing/palpitations at the vaccine facility. Staff checked her vitals; . HR 140; BP:180/90 and 10 mins later HR: 160 BP:190/80. She was sent to Emergency Room and slowly her vitals were normal. By the time she had an EKG it was normal. Had a cardiology workup and no problems found. She takes no medication and has no known medical hx. Reports 2 weeks after receiving vaccine, she felt dizzy and felt heart racing; it went on for a few minutes and then resolved. States after 2 weeks it completely resolved (unclear if caller experienced this intermittently for 2 weeks). Also reports tinnitus in left ear since receiving covid vaccine in Feb2021; she has no prior hx of tinnitus. States it is still bothering her. She was seen by ENT but they didn't find anything wrong. States she did not get her 2nd dose due to adverse effects from the first dose. States she works in a hospital. States she asked for medical exemption for 2nd dose but was denied. She was told her reactions weren't considered adverse reactions. Asking if her reactions were considered adverse and if we have any information that would help her case (regarding adverse reactions). Asking if it is advisable to take 2nd dose given her reactions to the first dose. Patient had her vaccine in February and the reaction she had is, 5 minute into after the injection her heart rate raised up to 140 and my BP shoot up to 180 over 90, so she felt her heart rate just, she was sitting there and she started feeling her heart rate just raising, she feels the palpitation and she asked her nurse and she said kindly check her vitals because she could hear her heart beat raising. So they checked it and it was 140 and they said just drink water just relax, they were thinking probably she has a lot of thinking but then they said just relax, they gave her some water, they were talking to her and then she said okay she was just talking to them and then they send and she said she think her heart rate is still going faster then what it is, so they check it again like an estimate on the timing right. So it is about 10 minutes, they checked it again her heart rate now is 160 and her blood pressure 190 over 80. Now at the time now they said well they have to call the rapid response for her because the heart rate is really so high. She could feel really her heart rate is like raising and the palpitation and she could even feel it on the back of the chair her heart. So they just called the RP, the rapid response in the hospital and she got it in the hospital. They have the program in the hospital where they had the vaccinations at the time and then they sent her to the emergency room. Now within that time frame the emergency room, within the time frame now of course they were still , her heart rate is 140, 150, 140. So they were waiting because there was EKG by that place where by the injection site, even if they call RP they take her to the emergency room. She thinks it was '30' minutes or so that she was finally in the emergency room, but by that time her heart rate now was about 120 or 110 something like that, she did not remember exactly. Her blood pressure now went down to 140 over she did not exactly remember she has that in 140 over 80 or 150 over 80 something like that. So they did an EKG and of course did the heart rate. They actually this is her injection was about 10:30 in the morning and then 10:45 in the morning, she was in the emergency room and then they were in the emergency room, by the time she 'finish' in the emergency room it was about 01:30 in the afternoon. For that time frame she was all there. So she was asking for second, she didn't get the second dose because of the effect and she said like she was asking for medical exemption for second dose because of the reaction that she had. So she was now calling for advice because this is the COVID vaccine that she has and they are telling them they might deny her medical exception. So patient wanted to know if anybody who had also had that experience. She did not know if everybody is calling because right now like she said she had her vaccination in February and only now that she was calling because she did not know that there is a 'site' that she was supposed to call for Pfizer adverse reaction. The outcome of tinnitus was not recovered, while the rest of the events recovered on an unknown date. Information on the batch/lot number has been requested.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events blood pressure increased, palpitations, heart rate increased, tinnitus, dizziness and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1790951
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: PCR+ COVID-19; Test Result: Positive

Allergies:

Symptom List: Pain in extremity

Symptoms: developed PCR + COVID; developed PCR + COVID; EOM paralysis; intraocular myositis; This is a spontaneous report from a contactable physician via a company representative. A healthy young adult male patient (reporter's son) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in summer of 2021 (unspecified date, Batch/lot number and expiration date unknown) at dose 1 and dose 2, single for COVID-19 immunization. Medical history included COVID-19 in spring of 2020 (not ongoing). The patient's concomitant medications were not reported. The patient developed intraocular myositis with extraocular movement (EOM) paralysis, treated with 40 days of prednisone with resolution, then developed PCR+ COVID-19 again "this week", 16 weeks after second shot. The outcome of events intraocular myositis with extraocular movement (EOM) paralysis was resolved on an unspecified date in 2021, for other events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported event Covid-19, Drug ineffective, Ophthalmoplegia, Orbital myositis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1790952
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 03/09/2021
Rec V Date: 10/16/2021
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: possible cellulitis right axillary skin and right breast skin; possible cellulitis right axillary skin and right breast skin; injection site on right deltoid with painful swelling lymph nodes; injection site on right deltoid with painful swelling lymph nodes; erythema/erythema over right axilla/progressive erythema over breast; This is a spontaneous report from a contactable other health care professional (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), intramuscularly in the deltoid right on 13Jan2021 at 07:00 (at the age of 62-year-old), dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included levocetirizine dihydrochloride (XYZAL); mometasone furoate (FLONASE); pregabalin (LYRICA); baclofen; ibuprofen; diazepam (VALIUM). The patient previously took Sulfa and had allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) intramuscularly in the right deltoid on 23Dec2020 at 13:00 (at the age of 62-year-old), dose 1, single for COVID-19 immunisation. On 09Mar2021, the patient had erythema. On 09May2021, the patient started Keflex for possible cellulitis right axillary skin and right breast skin. The patient had erythema over right axilla, the injection site on right deltoid with painful swelling lymph nodes and progressive erythema over breast. The patient seen at physician on 09May2021. The patient received Keflex for the events. The patient was not hospitalized for the events. The events did not result in multiorgan involvement but had dermatological/mucosal involvement. The patient did not receive any recent vaccines for any other conditions prior to the event and did not receive any other vaccines around the time of COVID-19 vaccine. The outcome of the events was unknown.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101206514 Same reporter/patient/ product, different dose/events.

Other Meds: XYZAL; FLONASE [MOMETASONE FUROATE]; LYRICA; BACLOFEN; IBUPROFEN; VALIUM

Current Illness:

ID: 1790953
Sex: M
Age:
State: MO

Vax Date: 07/30/2021
Onset Date: 07/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccine location=Left leg; Joint pain; increased pain at sites of old injuries; Increase in allergy symptoms.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 via an unspecified route of administration on 30Jul2021 10:00 (at 69-year-old) (Batch/Lot number was not reported) as unknown dose, single in leg left (inappropriate site) for COVID-19 immunisation. Medical history included asthma, high fever, ongoing old injuries pain, and known allergy: morphine. No COVID prior vaccination. Concomitant medications included rosuvastatin; and losartan. The patient experienced joint pain, increased pain at sites of old injuries, increase in allergy symptoms in Jul2021 at 10:00 AM. Emergency room visit and treatment received. The seriousness criteria of this case was reported as disability. No COVID tested post vaccination. The outcome of the events except vaccine administered at inappropriate site was not resolved. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds: ROSUVASTATIN; LOSARTAN

Current Illness: Pain (old injuries pain)

ID: 1790954
Sex: M
Age:
State: FL

Vax Date: 04/13/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: 20210928; Test Name: COVID-19 virus test; Test Result: Positive

Allergies:

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

Symptoms: Tested positive for Covid 19 virus; Tested positive for Covid 19 virus; This is a spontaneous report from a contactable consumer (patient), via medical information team. A 57-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 23Mar2021 (at 56-year-old) (Lot Number: FP7534 or EP7534) as dose 1, single, and on 13Apr2021 (at 56-year-old) (Lot Number: EN8729) as dose 2, single; both in arm left for COVID-19 immunisation. The physician denied any other medical history or immunosuppression. There were no concomitant medications. The patient didn't have any medical conditions in terms of making him compromised for the COVID 19 virus and he had no medical history or problems with being immune compromised. He tested positive for the COVID 19 virus on 28Sep2021 at a large testing site. He stated he works in an office and has zero exposure to the public, and he did go out to buy coffee and a few things here and there. He stated he did not have any positive contact with any persons infected by COVID-19 and also had very little exposure to the public except for occasional shopping trips. The outcome of the events was unknown. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds:

Current Illness:

ID: 1790955
Sex: F
Age:
State:

Vax Date: 09/05/2021
Onset Date: 09/15/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210915; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Vomiting

Symptoms: Appendicitis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3183, Expiration date: Not reported), via an unspecified route of administration in left arm on 05Sep2021 at 15:30 as dose 1, single for COVID-19 immunization in a pharmacy or drug store. The patient's medical history was not reported. Concomitant medications/other medications received within 2 weeks of vaccination included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN). No past drug history was reported. The patient was not pregnant at the time of report and didn't 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 experienced appendicitis on 15Sep2021 at 13:00. The patient was hospitalized for this events in Sep2021 for 3 days and there was no prolongation of hospital. This event resulted in emergency room/department or urgent care and received the treatment with surgery. Since the vaccination, the patient had been tested for COVID-19 with nasal swab and the result was negative on 15Sep2021. The outcome of the event was recovering at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds: MULTIVITAMIN FOR WOMEN

Current Illness:

ID: 1790956
Sex: M
Age:
State: NC

Vax Date: 08/17/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:elevated; Test Date: 2021; Test Name: testing; Result Unstructured Data: Test Result:unknown result

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: neuropathy of the feet and hands; headaches; chest pain; elevated heart rate; exhaustion/ am extremely fatigued following minor tasks; severe inflammation; belching; excessive sweating; cant' sleep through the night; am out of breath frequently; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 16:00 (Lot Number: EW0175) as single dose, at the age of 34-year-old, for COVID-19 immunisation. Medical history reported as none. There was concomitant therapy but unspecified. No other vaccine in four weeks. And there were other medications in two weeks. The patient had not contracted COVID prior vaccination and no COVID tested post vaccination. No known allergies. The patient experienced neuropathy of the feet and hands, headaches, chest pain, elevated heart rate, exhaustion/ am extremely fatigued following minor tasks, severe inflammation, belching, excessive sweating, cant' sleep through the night, am out of breath frequently, all in 2021 with outcome of not recovered. Occasionally had elevated heart rate, and still deal with the belching and sweating, all in 2021. The patient underwent lab tests and procedures which included heart rate: elevated in 2021; testing: unknown result in 2021. Treatment received for the events that included various medications and testing. Events resulted in physician office visit.

Other Meds:

Current Illness:

ID: 1790957
Sex: M
Age:
State: KS

Vax Date: 03/07/2021
Onset Date: 03/10/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: pulmonary embolism; has issues with breathing; pain in his left upper chest; This is a spontaneous report from a contactable consumer (patient self). An 88-year-old male patient received second dose of bnt162b2 via an unspecified route of administration, administered in left deltoid on 07Mar2021 (Batch/Lot Number: EN6206) at age of 88-year-old as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient previous received first dose of bnt162b2 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EN5318) at age of 88-year-old as single dose for covid-19 immunisation. There were no concomitant medications. The patient experienced pain in left upper chest on 10Mar2021. On 20Mar2021, 13 days post vaccine, patient had issues with breathing, patient was admitted to the hospital with pulmonary embolism on the same day. Seriousness criteria of events were reported as caused/ prolonged hospitalization. Patient was on an oxygen generator at night and during day if needed. Stated that he had pain in his left upper chest and thought that he was having a heart attack but was told it was pulmonary embolism and was hospitalized. Stated that the breathing has become a chronic situation. Stated that he was given blood thinners. Was taking Eliquis to prevent future blood clots. The patient was discharged on 22Sep2021. The outcome of event pain in left upper chest was recovered with sequel on unknown date in 2021, of other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790958
Sex: F
Age:
State:

Vax Date: 09/20/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: Severe bruising; This is a spontaneous report from a Pfizer sponsored program regulatory authority. A non-contactable female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Sep2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date on Sep2021 the patient experienced severe bruising. She had the 1st dose of the vaccine on 20Sep2021 and within a week she developed severe bruising, after vaccination ever since then she has had severe bruising - She called her pharmacist and told her that it is a rare side effect of the vaccine. She went to her primary care who said it was not a side effect of the Pfizer COVID19 vaccine. Her primary care physician told her that it is not vaccine related - She wants to know if severe bruising is side effect of the vaccine. The reporter asked if it could be side effect. She just wanted to see if it is a possibility that it is a side effect. The reporter stated that it doesn't matter what lot number she got. The pharmacist seems to be in agreement or has first-hand knowledge of reports of this with people. It has been rare. 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: 1790959
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: Psoriasis/SEVERE Psoriasis covering her entire body from her Toes to the Scalp; This is a spontaneous report from a contactable consumer (patient's daughter/caregiver). An 88-year-old female patient received bnt162b2 (BNT162B2, Lot number was not reported), dose 2 via an unspecified route of administration in Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 in Feb2021 as single dose for COVID-19 immunization. In Apr2021 the patient was diagnosed with Psoriasis (which she had never had prior) this subsequently went to severe psoriasis covering her entire body from her toes to the scalp. The outcome of the event was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790960
Sex: M
Age:
State:

Vax Date: 06/23/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: heart monitor; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Carditis; Palpitation; Sudden Heart Beat; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4093548-000). A contactable consumer (patient) reported a 50-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 23Jun2021 at the age of 50 years old, as single dose, second dose, intramuscularly on 21Jul2021 as single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe chronic plaque psoriasis. Medical history included moderate to severe chronic plaque psoriasis. The patient's concomitant medications were not reported. On an unknown date, the patient experienced slowed not as thick but persisting plaques with HUMIRA (adalimumab). The patient experienced carditis in 2021, palpitation in 2021, sudden heart beat in 2021. In 2021, the patient experienced noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat. The patient underwent lab tests and procedures which included heart monitor: unknown results in Aug2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovered in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat onset in 2021 with humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat onset in 2021 with BNT162b2 was possible. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported event of carditis, palpitation, heart rate increased is assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am