VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1743637
Sex: F
Age: 79
State: MA

Vax Date: 02/12/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 048A21A and 024M20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LORAZEPAM for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BURNING SENSATION (Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back) outcome was unknown. Concomitant product included unspecified BP medications. Patient received her 1st dose on 12Feb2021, 2nd dose on 09Mar2021 and 3rd dose on 01Sep2021 on her right arm intramuscularly in deltoid muscle. Immediately after receiving 3rd dose, she experienced burning in Torso. Her throat was also burning. Her upper arm was burning. She was kept at site. After she went to home, since that time, she has been having burning sensation in chest, torso, upper arm, lower back and throat.

Other Meds: SYNTHROID; LORAZEPAM

Current Illness:

ID: 1743638
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Erythema polymorphus; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA MULTIFORME (Erythema polymorphus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Erythema polymorphus) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema polymorphus) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was provided. Treatment information was not provided. Company Comment : This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of Erythema Multiforme. The event occurred on an unknown date and it is not clear if it was before or after the Moderna Covid-19 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of Erythema Multiforme. The event occurred on an unknown date and it is not clear if it was before or after the Moderna Covid-19 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1743639
Sex: F
Age:
State: NC

Vax Date: 09/16/2021
Onset Date: 09/17/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient had take IV Fluids as a treatment medication.

Other Meds:

Current Illness:

ID: 1743640
Sex: F
Age:
State: MD

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

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

Lab Data: Test Name: Anion gap; Result Unstructured Data: anion gap 27; Test Name: Blood bicarbonate; Result Unstructured Data: bicarbonate 14 meq/L; Test Name: Blood glucose; Result Unstructured Data: Blood glucose rose above 500 mg/dL; Test Name: Blood glucose; Result Unstructured Data: serum glucose 505 mg/dL; Test Name: Computed tomography; Result Unstructured Data: computed tomography of the lungs demonstrated non-specific discoid atelectasis of the lower lobes; Test Name: hemoglobin A1c; Result Unstructured Data: hemoglobin A1c 12.0%.; Test Name: Neutrophil; Result Unstructured Data: neutrophils 84%; Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative COVID-19; Test Name: Urine ketone body; Result Unstructured Data: large urine ketones; Test Name: White cell count; Result Unstructured Data: White cell count was elevated (16.56 K/mm3)

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Severe Diabetic Ketoacidosis; Leucocytosis; Tachypneic; Tachycardic; Severe Nausea; This literature-non-study case was reported in a literature article and describes the occurrence of DIABETIC KETOACIDOSIS (Severe Diabetic Ketoacidosis) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 1 diabetes mellitus and Obesity. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIABETIC KETOACIDOSIS (Severe Diabetic Ketoacidosis) (seriousness criteria hospitalization and medically significant), LEUKOCYTOSIS (Leucocytosis), TACHYPNOEA (Tachypneic), TACHYCARDIA (Tachycardic) and NAUSEA (Severe Nausea). The patient was treated with INSULIN for Diabetic ketoacidosis, at an unspecified dose and frequency. At the time of the report, DIABETIC KETOACIDOSIS (Severe Diabetic Ketoacidosis) and LEUKOCYTOSIS (Leucocytosis) had resolved and TACHYPNOEA (Tachypneic), TACHYCARDIA (Tachycardic) and NAUSEA (Severe Nausea) outcome was unknown. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anion gap: 27 anion gap 27. On an unknown date, Blood bicarbonate: 14 meq/l bicarbonate 14 meq/L. On an unknown date, Blood glucose: 500 mg/dl (High) Blood glucose rose above 500 mg/dL and 505 mg/dl (High) serum glucose 505 mg/dL. On an unknown date, Computerised tomogram: non-specific discoid atelectasis of the lower lobe computed tomography of the lungs demonstrated non-specific discoid atelectasis of the lower lobes. On an unknown date, Glycosylated haemoglobin: 12.0% (High) hemoglobin A1c 12.0%.. On an unknown date, Neutrophil count: 84% neutrophils 84%. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative COVID-19. On an unknown date, Urine ketone body: large urine ketones large urine ketones. On an unknown date, White blood cell count: 16.56 k/mm3 (High) White cell count was elevated (16.56 K/mm3). For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIABETIC KETOACIDOSIS (Severe Diabetic Ketoacidosis), LEUKOCYTOSIS (Leucocytosis), TACHYPNOEA (Tachypneic), TACHYCARDIA (Tachycardic) and NAUSEA (Severe Nausea) to be possibly related. This patient developed severe nausea 15 hours after vaccination, and blood glucose rose above 500 mg/dL. Despite multiple boluses of insulin via her insulin pump and changing the insulin pump delivery site, the patient remained severely hyperglycemic. The patient's home insulin total daily dose was 45 units/d. However, during the hospitalization, the patient was initially profoundly insulin resistant, requiring more than 220 units of intravenous regular insulin in the first 24 hours. On the third hospital day, insulin infusion requirements decreased to 1 unit/h, the diabetic ketoacidosis and leukocytosis resolved, and the patient was transitioned back to her subcutaneous insulin pump. Company Comment: This is a literature review case that concerns a 24 year old female with a history of Type 1 Diabetes and Obesity who experienced the unexpected event of Diabetic Ketoacidosis requiring hospitalization along with other non-serious events. The events occurred 15 hours after the second dose of Moderna COVID-19 vaccine. Rechallenge is not applicable as this was the second dose and no information is available for the first dose. The medical history of insulin dependent Type 1 Diabetes, uncontrolled as evidenced by a Hb A1c of 12%, and Obesity which can cause the events remain confounders. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received by safety on 22-Sep-2021 has Email with FTA received from team.; Sender's Comments: This is a literature review case that concerns a 24 year old female with a history of Type 1 Diabetes and Obesity who experienced the unexpected event of Diabetic Ketoacidosis requiring hospitalization along with other non-serious events. The events occurred 15 hours after the second dose of Moderna COVID-19 vaccine. Rechallenge is not applicable as this was the second dose and no information is available for the first dose. The medical history of insulin dependent Type 1 Diabetes, uncontrolled as evidenced by a Hb A1c of 12%, and Obesity which can cause the events remain confounders. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.

Other Meds:

Current Illness: Obesity; Type 1 diabetes mellitus

ID: 1743641
Sex: F
Age: 16
State: CO

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dose given past the 12 hour post puncture time; Patient aged 16 years took vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-327879 (Patient Link).

Other Meds:

Current Illness:

ID: 1743642
Sex: F
Age: 16
State: CA

Vax Date: 07/31/2021
Onset Date: 09/18/2021
Rec V Date: 09/29/2021
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: A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021; A 16 year old patient got her both doses; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 066D21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-325327 (Patient Link).

Other Meds:

Current Illness:

ID: 1743643
Sex: F
Age: 63
State: CO

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided. It was unable to clarify whether vial that underwent temperature excursions on 22Jul2021 and 10Aug2021 was administered to patient(s). Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Significant Follow up - Patient identifier added, patients date of birth added.

Other Meds:

Current Illness:

ID: 1743644
Sex: F
Age:
State: NJ

Vax Date: 07/21/2021
Onset Date: 07/22/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:96 degree; Comments: I had a temperature of 96 degree Which is low

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: low energy; low temperature on third day; I had very bad back pain the next day; then felt lethargic for four days after; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Right, on 21Jul2021 at 15:30 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included ongoing vertigo only (I have ongoing protentional vertigo and reduced occasionally) and known allergies: dairy products. Family history included gallbladder surgery (I had gallbladder surgery 1991), hernial surgery in 1997, and tonsils comrodin past 1972. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Right, on 22Jun2021 at 03:30 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that she felt fine with first shot but her second day of second shot on 22Jul2021 at 01:00 PM, felt intense back pain and bit low energy, then on 22Jul2021 at 12:30 PM, she felt lethargic for four days after and low temperature of 96 degree on third day on 24Jul2021 at 02:30 AM which was low and low energy at least five day. She was not told of when booster was and if protect against variants and shot needs to best improved if they people to got booster noone. beats to safest throughout the first shot is not one symptoms but others did. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included temperature with 96 degree (I had a temperature of 96 degree which was low) on an unspecified date. Outcome of the event I had very bad back pain the next day was recovering, then felt lethargic for four days after was recovered on an unspecified date, low temperature on third day was recovered on 26Jul2021, and low energy was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness: Vertigo (I have ongoing protentional vertigo and reduced occasionally)

ID: 1743645
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: dizzy; lightheaded; This is a spontaneous report from a contactable consumer. This 60-year-old female consumer reported for herself that. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included meningioma benign from 2017 to 2017 history of benign meningioma of the left side of her head and was diagnosed in 2017 , tension headache from an unknown date and unknown if ongoing she has had stress related headaches before and maybe this could be a stress related headache. The patient's concomitant medications were not reported. The patient experienced dizzy, and lightheaded on an unspecified date. Consumer reported that she had her second dose of the Pfizer Covid 19 vaccine on 26Jun2021. Approximately the first week of July she started to experience headaches. Her headaches occur off and on, 1-2 times a day, the duration is as long as 10 minutes or so before she takes medicine for the headache. She experiences a 3 o4 out of 10 pains during these headache episodes. She further explains that prior to receiving the first dose of the Pfizer Covid 19 vaccine she was not experiencing these headaches. She did further share that after her first dose of the Pfizer Covid 19 vaccine series she was dizzy and lightheaded but was unsure if she was dehydrated or what the cause was. Lastly, consumer has a history of benign meningioma of the left side of her head and was diagnosed in 2017. She is being evaluated by her HCP, she notes that she has had stress related headaches before and maybe this could be a stress related headache. Reporter asking in terms of the side effect (i.e., headache) after the second dose within hour or days. How long after having you had seen in any other reports. Has this reported before and after initial clinical trial for the general public. Would like consumer information e mailed. These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. Referenced the following from the EUA PI: Table 4: Study 2 - Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population. Headache reviewed data. The safety evaluation of participants is still ongoing. Participants were asked about local and systemic events and use of fever reducing medication after each vaccination. Participants continue to be monitored for non-requested adverse events, including serious adverse events up to 6 months after the last vaccine dose. Reporter asking Question Does Pfizer send a survey to all consumers after they have gotten the vaccine reporter had to go find this information online. It would be helpful if they did. The outcome of events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness: Benign meningioma (history of benign meningioma of the left side of her head and was diagnosed in 2017.)

ID: 1743646
Sex: F
Age:
State: FL

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: severe lower back pain; This is a spontaneous report from a contactable other HCP. This 34-year-old female other HCP (patient) reported for herself that: A 34-years-old non- pregnant female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Jul2021 13:15 (at a age of 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypertension, and back pain was ongoing. same pain 7 years ago after epidural for pregnancy. No covid prior vaccination, no covid tested post vaccination, no Known allergies and no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced severe lower back pain on 27Jul2021 13:15. No treatment received with AE. Outcome of event was recovered with lasting effects on unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1743647
Sex: F
Age:
State: CA

Vax Date: 05/30/2021
Onset Date: 05/31/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Second shot 05/30 I have had severe joint pains. Hands wrists ankles knees; This is a spontaneous report from a contactable other hcp (patient). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration on 27Apr2021 as, dose 1, single for covid-19 immunisation. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration on 30May2021 as dose 2, single for covid-19 immunisation. Medical history included overweight, depression, migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergy of morphine, melon and experienced hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31May2021, the patient experienced severe joint pains. hands wrists ankles knees. The patient did not receive any treatment for the events. The outcome of the event was not recovered. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1743648
Sex: M
Age:
State: CA

Vax Date: 05/29/2021
Onset Date: 07/03/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210712; Test Name: Nasal Swab/ SARS-CoV-2 RNA; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Lightheadedness started right after vaccine; severe palpitations; vertigo; This is a spontaneous report from a contactable consumer (patient himself). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 29May2021 14:15 (age at vaccination: 27 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. There were on known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) via an unspecified route of administration, administered in Arm Left on 08May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks nor had any other medications in two weeks. On 03Jul2021, the patient experienced lightheadedness started right after vaccine and continued for a few weeks, after 4 weeks severe palpitations rushed to urgent care and vertigo. The patient was prescribed medication for vertigo but later after going to a neural clinic, it was found to be effects of vaccine. On 12Jul2021, the patient underwent sars-cov-2 rna (nasal swab) was negative. The events resulted in physician's office and emergency room visit. The patient received Meclazine as treatment for the adverse events. The outcome of the events was not recovered. The device date was 02Aug2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743649
Sex: F
Age:
State: VA

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

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

Lab Data: Test Name: thyroid levels; Result Unstructured Data: Test Result:elevated thyroid levels

Allergies:

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

Symptoms: elevated thyroid levels/thyroid numbers are out of range; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (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 an unspecified date the patient experienced elevated thyroid levels/thyroid numbers are out of range. The patient underwent lab tests and procedures which included thyroid function test: elevated thyroid levels. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1743650
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: having slight discomfort at the site of injection; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having slight discom-fort at the site of injection and reported having no other side effects. Clinical 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: 1743651
Sex: F
Age:
State: LA

Vax Date: 08/13/2021
Onset Date: 08/14/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: Fever; Result Unstructured Data: Test Result:101.6; Test Date: 20210815; Test Name: Fever; Result Unstructured Data: Test Result:100.1

Allergies:

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

Symptoms: Injection site pain; tiredness; leg/thigh muscle pain; stumbling when walking; leg pain; fever spiked 101.6/ 15Aug2021 her highest temperature was 100.1; This is a spontaneous report from a contactable consumer (parent). A 12-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 13Aug2021 18:30 (age at vaccination 12-years -old) as dose 1, single for covid-19 immunization. Medical history included covid-19 Prior to vaccination and no known allergies. Concomitant medication include Children's Multivitamin Gummies was taken within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 11:00 am, patient experienced injection site pain, tiredness, leg/thigh muscle pain, stumbling when walking and leg pain, fever spiked 101.6. After treatment with Tylenol her symptoms improved. On 15Aug2021 her highest temperature was 100.1 and she has improved. AE resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature and result was 101.6 on 14Aug2021 and body temperature 100.1 on 15Aug2021. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was recovered. Follow-up attempts are completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1743652
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: pain in the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the first case out of 2 cases. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 13Aug2021 (Age at vaccination was 69 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included glaucoma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 23Jul2021 (Age at vaccination was 69 years) as dose 1, single for COVID-19 immunization. On 13Aug2021 the patient reported that, patient and his wife both got pains in their arms that they got them in, they went back to get the 2nd shot, now patient just got pain in the arm that he got it from. The treatment was not received. 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: 1743653
Sex: F
Age:
State: MO

Vax Date: 08/11/2021
Onset Date: 08/14/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (age at vaccination 21-years-old) as dose 2, single for covid-19 immunization. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in arm left on 01Jul201 (age at vaccination 21-years-old) as dose 1, single for covid-19 immunization. Medical history included anxiety, depression and patient previously took Prednisone and experienced allergies. Concomitant medications included citalopram, omeprazole (PRILOSEC), bupropion (BUPROPION) taken within two weeks. Patient did not any other vaccine in four weeks. On 14Aug2021, patient stated that she has begun losing taste and her ability to smell, everything smelled like a chemical now. She is also extremely nauseous all day but especially after eating anything, sore arm, raised skin at injection site and low-grade fever. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient received no treatment for the adverse events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.

Other Meds:

Current Illness:

ID: 1743654
Sex: F
Age:
State: WI

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

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

Lab Data: Test Date: 2021; Test Name: COVID test; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: endoscopy; Result Unstructured Data: Test Result:an endoscopy down her throat to expand her esophag; Comments: an endoscopy down her throat to expand her esophagus; Test Date: 2021; Test Name: ultrasound/MRI of her throat; Result Unstructured Data: Test Result:Everything was normal.; Comments: Everything was normal.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: This is a spontaneous report from a contactable consumer (patients Husband). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 08Jun2021 09:30 (at the age of 71 years old) as dose 1, single for COVID-19 immunisation. Medical history included stroke from May2021 to May2021 (She had the stroke 10 days before the vaccine). There were no concomitant medications. Patient did not received other vaccine within 4 weeks of COVID vaccine. The patient experienced sore throat on 08Jun2021, cough, she begins gagging so much she throws up, she stays in bed most of the day, her ribs hurt on 2021. Reported as, Immediately after receiving the vaccine she developed a sore throat and stayed for monitoring for 30 minutes instead of fifteen. Approximately 2-5 days after the vaccine she developed a cough and she begins gagging so much she throws up. She does not experience nausea prior to this. She was still experiencing this. The cough was intermittent and usually occurs in the morning after being in bed for the night. She wakes up and coughs, then walks over to the bathroom until she pukes. She was fine in May and now she stays in bed most of the day. She had an endoscopy and had her throat dilated but this has not helped. They thought it could have been from doubling her lisinopril dose after her stroke, but she has been off that medication for a month now. She did have numerous stuff changed in her life and her medications. They thought at first that was the problem. They juggled around her medications. She had numerous trips to medical facilities. They did an endoscopy down her throat to expand her esophagus. The doctor thought it would help, but it has been a week and nothing has changed. She was coughing all the time. She tried things to alleviate it with no success. She tried a couple of cough medicines. She tried cough suppressants, lozenges, some prescription for a pearl (thats what the doctor called it) that did not help at all. The cough drop soothes her throat some. She has tried inhalers like albuterol initially just to help open up the air ways. She has a nasal inhaler too. This past weekend she tried a different approach with that new inhaler, and seemed to give her some relief. She actually did not wake up coughing at 5 am which has been a regular thing for the last 8 weeks. She was in the hospital for 2 days after the stroke. The stroke was before the vaccine. She had no stroke symptoms for a week. Adverse event resulted in Emergency room, went to a walk in clinic a few weeks after that cough developed because she was so weak. Her Ribs hurt . They looked in her throat, and sent her to the Emergency room. They did a COVID test , an ultrasound/MRI of her throat, and checked her lungs. Everything was normal, and physician Office visit. The patient underwent lab tests and procedures which included covid-19: normal on 2021, endoscopy: an endoscopy down her throat to expand her esophagus on 2021, magnetic resonance imaging: everything was normal on 2021. Therapeutic measures were taken as a result of sore throat, cough, she begins gagging so much she throws up, she stays in bed most of the day. Outcome of the event sore throat, cough, she begins gagging so much she throws up were not resolved and unknown for she stays in bed most of the day and her ribs hurt. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1743655
Sex: F
Age:
State: CA

Vax Date: 07/23/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: an allergic reaction/ get one on her first dose with the Pfizer-BioNTech COVID-19 Vaccine; the injection site was really itchy and red like a mosquito bit it; the injection site was really itchy and red like a mosquito bit it; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an allergic reaction get one on her first dose with the pfizer-biontech covid-19 vaccine on 2021 with outcome of unknown, the injection site was really itchy and red like a mosquito bit it causing injection site pruritus and injection site erythema on 2021 with outcome of unknown. Follow-up (16Aug2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that: she is scheduled for the second dose of the Pfizer Covid-19 vaccine on 13Aug2021,.said that she was not able to get the second dose on 13Aug2021. She mentioned that she took the first dose on 23Jul2021. is asking if there is a grace period or timeframe for her to reschedule her second dose. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743656
Sex: F
Age:
State: IL

Vax Date: 08/07/2021
Onset Date: 08/09/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far...; 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far...; 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far...; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in Arm Left on 07Aug2021 at 15:30 (at the age of 35 years old) as single for covid-19 immunisation. Medical history included Hashimotos. The patient had known allergies to Amoxi-clavaunate. Concomitant medications included levothyroxine, liothyronine (NP THYROID), vitamins nos. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Aug2021 at 12:00 AM patient experienced 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far. The patient did not receive any treatments for the events. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

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

Current Illness:

ID: 1743657
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: feeling under the weather; pain that took her down for a day; felt like a cold with a stuffy nose; felt like a cold with a stuffy nose; felt run down for a day; This is a spontaneous report from a contactable consumer (patient's boyfriend) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on 09Feb2021 (45-year-old at vaccination) as Dose number unknown, Single for Covid-19 immunization. This report is related to study or program. The patient's medical history and concomitant medications were not reported. The reporter stated that, his girlfriend took the shot at the exact same time and same place. She did not experience any of those symptoms regarding heart palpitations. She had some issues with feeling under the weather and the pain took her down for a day. He believed this was a more normal reaction associated with the vaccine. The reporter stated that she received the vaccine at the same location at the same time, but he has no way to confirm at this time if it was the same lot number. He does not knew that. He knew that she took it in the same room together. Her experience was quite different. The reporter stated that the patient had significant but not profound reaction. It was like anything other people had when taking it, felt like a cold with stuffy nose. She felt run down for a day. Kind of frankly what he expected he would have had that as well. She considered the reaction she had as "normal". It was an expected reaction to the vaccine as described in the media. Any health care provider who gave it to them would consider her reaction completely normal. No other lasting effects or issues, what so ever. She had nothing with heart rhythm or sweating, or shortness of breath. The outcome of the events was recovered on an unknown date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743658
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: her immune system is jeopardized; When she has a cough she doesn't breathe right; When she has a cough she doesn't breathe right; as she was having a cold.; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored program. A female patient of an unspecified age received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. It was stated that she always gets the same cold around Christmas and in summer on an unknown date. She has this now and hasn't had it in a few years. stated it could be good for her immune system. States it was not any different than it always was. States it's no better or no worse; it was the same garbage. States it goes away when she takes Zithromycin, states she needs 500mg not the 250mg because the 250mg did not help. On an unknown date, the patient stated it was the same cough, something that she gets. Said of course when she has a cough she doesn't breathe right. The patient said she cannot take generic because that was not good. The patient wants to know how she can get the 3rd dose of covid-19 vaccine. She had both doses before. She said her immune system was jeopardized as she was having a cold on an unknown date. She took a cough medicine Zithromycin. Therapeutic measures were taken as a result of all events and treatment included Zithromycin. The outcome of the event was unknown. The follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1743659
Sex: M
Age:
State: TN

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

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

Lab Data: Test Date: 20210813; Test Name: Low grade fever; Result Unstructured Data: Test Result:100.1; Comments: never got past 100; Test Date: 20210813; Test Name: Low grade fever; Result Unstructured Data: Test Result:100.6; Comments: never got past 100

Allergies:

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

Symptoms: feeling tired; no energy; low grade fever that came on gradually (100.1, 100.6 and never got past 100); little soreness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on 06Aug2021 (at the age of 69-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little soreness on unspecified date in Aug2021, feeling tired, no energy, low grade fever that came on gradually (100.1, 100.6 and never got past 100) on 13Aug2021. The patient underwent lab tests and procedures which included body temperature: 100.1, 100.6 and never got past 100 on 13Aug2021. The events were not serious. Caller decided to get first Pfizer shot last Friday, 06Aug2021. Everything was fine, he just experienced a little soreness. However, he was feeling tired and has no energy at the time of this report. This started the day before this report, and he was not having any headaches. He wanted to know how long after the shot will the side effects show up and how long they last. Seven days after the first shot, started feeling all the effects, a low-grade fever that came on gradually (100.1, 100.6 and never got past 100), tired beyond belief and felt like he ran a marathon, and had no energy whatsoever on Friday, Saturday and Sunday (13Aug2021, 14Aug2021 and 15Aug2021). Friday and Saturday were tough days and Sunday it started to subside. He stated he called his afterhours doctor/nurse and they said if it gets worse come down. He stated it wasn't that bad, he let it ride out and the day before this report (yesterday; 16Aug2021) was fine. After providing the verbal response he stated he already got his answer because his symptoms came on after 7 days and subsided and everything was great. He was going to get his second dose on the 27th. Clinical outcome of events was recovered on an unspecified date in Aug2021. Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1743660
Sex: M
Age:
State: AL

Vax Date: 08/15/2021
Onset Date: 08/17/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Heart palpatations. I've never had this feeling ever.; This is a spontaneous report from a contactable Consumer. This 55-year-old male consumer (patient) reported that. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Aug2021 14:30 as (At the age of 55-years) dose 1, single for covid-19 immunisation. Medical history included Slight Asthma, Outdoor Allergies, Slight chronic obstructive pulmonary disease (COPD), Swelling of the legs and ankles from an unknown date and unknown if ongoing. Other medications in two weeks: Metformin, levothyroxine sodium (SYNTHROID), fexofenadine hydrochloride (ALLEGRA), Mens Multi-Vitamin taken for an unspecified indication, start and stop date were not reported.The patient previously Laundry detergent and experienced dermatitis contact Known allergies of Laundry detergent. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced heart palpatations. i've never had this feeling ever on 17Aug2021 04:00. Patient did not receive any treatment for event. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

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

Current Illness:

ID: 1743661
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: made her very sick; This is a spontaneous report from a contactable consumer(patient) or other non hcp report based on information received by Pfizer from Regulatory Agency (Docket No. 85D-0249). A 60-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that the 1st dose made her very sick. The event outcome was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743662
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Headache; can't walk/he needs a walker; tired; lazy; hiccups; This is a spontaneous report from a contactable consumer (Reporter's dad). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included diabetes mellitus reported as Diabetes; he has Diabetes, hypertension; High Blood Pressure and he had Brain Stroke (Medical History) 3 years ago, cerebrovascular accident (Brain Stroke) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other Prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced headache, can't walk/he need a walker, tired, lazy and hiccups. Reporter stated, I am reporting about my family member. He is my dad (patient) and he took (received) the (first dose) shot 10 day ago but I think he is having side effects from the shot and I don't know if that's normal. Reporter said, he (patient) had a headache, he can't walk, he can stand but he can't walk, so he needs a walker, hiccups and headache don't go away. He was tired, lazy. They didn't ask for any conditions and he either didn't say that he has Diabetes, High Blood Pressure and he had Brain Stroke (Medical History) 3 years ago. None of that was asked when he went to get the shot, so I am worried about him. Event start date was reported as, it was day after he took the shot like it was "10" (not clarified) days ago. Reporter stated anatomical site of vaccination as it was in his arm (Further not clarified). Reporter stated, I am not sure about that second shot. Reporter stated, "He only takes medications for Diabetes and High Blood Pressure, he only takes his "injection" (further not clarified) for his diabetes." Treatment received for the event reported as, no, he didn't take any medicine. Outcome of the headache was not recovered whereas, rest of the events were unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1743663
Sex: F
Age:
State: MD

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

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

Lab Data: Test Date: 20210813; Test Name: SARS-CoV-2 NAT, NP Swab, Symptomatic; Test Result: Negative ; Comments: SARS-CoV-2 NAT Nasal Swab

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Tinnitus in both ears is much worse; had a hard time hearing over it; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in arm left on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history included tinnitus, before I received the vaccine, I had slight tinnitus. Known allergies were reported as none. The patient's concomitant medications received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID), taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration in arm left on 31Jan2021 as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. Covid test type post vaccination included was nasal swab, Covid test name post vaccination was reported as SARS-CoV-2 NAT, NP Swab, Symptomatic. On an unspecified date in Mar2021, the patient experienced tinnitus in both ears was much worse since the second dose of the vaccine. Before the patient received the vaccine, had slight tinnitus but since the second dose it has gotten so loud, she had a hard time hearing over it. Stated that, she was concerned if she got a booster shot, she will not be able to hear over the tinnitus. Stated that, she hadn't experienced any loud noises that would have caused it to worsen. The reporter considered the seriousness criteria of the events as non-serious. Treatment was not received for the events. On 13Aug2021, the patient underwent lab tests and procedures which included SARS-CoV-2 NAT, Swab, Symptomatic (SARS-CoV-2 test), resulted as negative, SARS-CoV-2 NAT, Nasal Swab. The device date was on 17Aug2021. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743664
Sex: M
Age:
State: AZ

Vax Date: 08/12/2021
Onset Date: 08/14/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: COVID test; Result Unstructured Data: Test Result:COVID; Comments: If COVID prior vaccination: Yes

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: My heart feels like it is floating in fluid or slightly swollen; My heart feels like it is floating in fluid or slightly swollen; Energy levels are much lower than normal; 1st dose, 17May2021; 2nd dose, 12Aug2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm right on 12Aug2021 at 11:30 (at the age of 37-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included COVID-19 from an unknown date and unknown if ongoing. The patient was allergic to penicillin and Amoxicillin. The concomitant medications of the patient were not reported. The patient previously took first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm right on 17May2021 at 16:00 (at the age of 37-years-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 14Aug2021 at 10:00, the patient experienced my heart feels like it is floating in fluid or slightly swollen, energy levels are much lower than normal. The reporter reported this report as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on an unspecified date. It was unknown if the patient received the treatment. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743665
Sex: M
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: 20 minutes later started to feel very ill/feeling sick; stuffiness; Retching; very unusual; weakness; muscle pain; Headache; This is a spontaneous report received from contactable physician (patient father) via Pfizer sponsored program. A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Aug2021 as Dose 1, single for COVID-19 immunization. The patient was strong, good healthy and non-smoker. The patient medical history and concomitant medications were not reported. After 20 minutes of vaccination, the patient started to feel very ill/feeling sick, muscle pain, weakness, stuffiness in nose, headache, retching and very unusual on Aug2021. The patient does not have a fever and no adenopathy. The outcome of the events was unknown. No follow-up attempts were possible; information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1743666
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Unable to breathe through nose; Loss of voice; Throat hurt; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Father) reported for a 19-year-old female consumer patient (daughter) that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. Agent stated that the Caller reported that his daughter had side effects, this morning which include, unable to breathe through nose, lost her voice, and throat hurt. Agent also stated the Caller contacted an emergency advice line, and he was advised to call Pfizer, but if his daughter had breathing problems to go to the hospital. The outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1743667
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: chills; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiry Date: Not Provided) via an unspecified route of administration on an unspecified date as DOSE 2, 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, solution for injection, Batch/Lot number was not reported, expiry date: not provided) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, it was reported that the patient had the second shot and had chills and a fever and the next day, nothing. Outcome of event was recovered in 2021. The lot number for the vaccine, [BNT162B2], was not provided. Follow up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1743668
Sex: F
Age:
State: MN

Vax Date: 07/30/2021
Onset Date: 08/02/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: 100 degree temperature; Result Unstructured Data: Test Result:100; Comments: 3 days 100 degree temp; Test Date: 20210813; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown; Test Date: 20210816; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Left neck glands swelled after 3 days; Left leg lower swolled 5 days; Sick for 3 days; 100 degree temp; Numb hands; Legs pin pricks time to time; Weakness; Severe headaches; Sinus pain pressure; Sinus pain pressure; Insomnia; Facial pain; This is a spontaneous report received from a contactable consumer (patient). A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 30Jul2021 at 09:30 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included GI issues, ulcer, seasonal allergy, lactose intolerance and known allergies to amoxicillin, penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, it was unknown the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021 at 12:00, the patient experienced left neck glands swelled after 3 days, left leg lower swelled 5 days, sick for 3 days, 100 degree temp, numb hands and legs pin pricks time to time, weakness, severe headaches and sinus pain pressure, insomnia, facial pain. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for Head and sinus issues. 2 urgent care visits 1 ER. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743669
Sex: M
Age:
State: OK

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

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

Lab Data:

Allergies:

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

Symptoms: First Dose: sore arm/ Third dose/Booster: sore arm; Off label use; Extra dose administered; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 37-year-old) at dose 1, single and received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 18Aug2021 (at the age of 37-year-old) at dose 3, single, both the doses for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) for COVID-19 Immunization. On an unspecified date the patient experienced first dose: sore arm/ third dose/booster: sore arm. Reporter calling about the Covid 19 vaccine. He received the Covid 19 vaccine and he received the third dose/booster dose. He states he has not had any flu like symptoms with any of the three Covid 19 vaccines. Reporter concerned that since he did not have any flu like symptoms he's not having an immune response. Clarified he has NOT had any flu like symptoms with any of the three Covid 19 vaccines. He didn't have any side effects other than some soreness in his arm but nothing he didn't expect from an injection. He is asking if there is any research or antibody information regarding not having an immune response. He reports he does work in the medical field as a physician's assistant. When probing for the dates/NDC/Lot/Expiry of the three Covid 19 vaccines he has received, he reports he does not have his Covid 19 vaccine card with him. Dates of the first 2 Covid 19 vaccines unknown. Third Covid 19 vaccine received yesterday, 18Aug2021. NDC/Lot/Expiry for all three doses unknown. He reports he had a sore arm with the first and the third Covid 19 vaccines. Description of complaint: He states he has not had any flu like symptoms with any of the Covid 19 vaccines. He's concerned that since he did not have any flu like symptoms he's not having an immune response. When probing for the dates/NDC/Lot/Expiry of the three Covid 19 vaccines he has received, he reports he does not have his Covid 19 vaccine card with him. Dates of the first 2 Covid 19 vaccines unknown. Third Covid 19 vaccine received yesterday, 18Aug2021. NDC/Lot/Expiry for all three doses unknown. Outcome of the events was unknown. Relatedness of drug to reaction(s)/event(s). Reaction assessed First Dose: sore arm, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related, Relatedness of drug to reaction(s)/event(s), Reaction assessed Third dose/Booster: sore arm, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Verbatim event relatedness: Covid 19 vaccine: First Dose: sore arm-Related, Covid 19 vaccine: Third dose/Booster: sore arm-Related. The lot number for [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743670
Sex: M
Age:
State: UT

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Soft ball size lymph node in arm pit. Same side as injection/lymph node is still enlarged; Soft ball size lymph node in arm pit. Same side as injection. Very painful; vaccine received within 4 weeks PRIOR: Pfizer - Right arm/25Jul2021; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 25Jul2021 (at the age of 40-year-old) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm right on 08Aug2021 at 12:00 PM (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. Patient had no known allergies. The patient concomitant medication included omeprazole (received medication in two weeks) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 08Aug2021 at 12:00 PM, the patient experienced vaccine received within 4 weeks prior: Pfizer - right arm/25Jul2021. On 08Aug2021 at 16:00 (04:00 PM), the patient experienced soft ball size lymph node in arm pit, same side as injection/lymph node is still enlarged; soft ball size lymph node in arm pit, same side as injection, very painful. Adverse event: Soft ball size lymph node in arm pit. Same side as injection. Very painful for about a week starting the night I received the vaccine. I'm currently on day 13 and the lymph node is still enlarged, but only to the size of a golf ball. The patient did not receive treatment for the events. Outcome of the events lymph nodes enlarged, lymph node pain was not recovered and outcome of remaining event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743671
Sex: F
Age:
State: MD

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Experiencing sick, chemical smells bleach and all that; chemical smells bleach; This is a spontaneous report from a contactable consumer. This consumer reported for 25-year-old female patient (reporter's daughter) that: A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, in left arm on 13Aug2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date of Aug2021 the patient experienced sick, chemical smells bleach and all that. The reporter stated that the patient started experiencing sick a couple of days after reporters other daughter got the shot. Experiencing sick, chemical smells bleach and all that, patient told to reporter about that Thursday. Reporter thought it was something going on with patient sinuses. Reporter queried if that virus was introduced in patient body could get them sick. Reporter called the emergency room, and they could not tell reporter. Reporter queried if emergency room are sure, it cannot be shed. The response reporter had that Individuals who have received a COVID-19 vaccine cannot shed or release any of the vaccine components. In addition, none of the vaccines authorized for use contain a live virus so it was not possible to shed it. Reporter stated that for almost 2 years, they have been ok. When they go out, they wear masks, use hand sanitizers and sprays, and had never gotten sick. Reporter stated that she called the hospital the other day when her daughter got her shot and everyone else in the house got sick. Reporter was trying to figure out, even though they are not giving them the Corona virus, it was the same type of molecule or a fake virus. Reporter was clarified that her daughter, who took the COVID vaccine had not experienced anything. Reporters whole thing she read was that if it was COVID in the house, even if she got in the house, would they still experience the same type of symptoms. The outcome of the reported events was not recovered. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1743672
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: Sore arm at the injection site after her first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm at the injection site after her first dose. Verbatim and Event Description: Talked to (name) had both doses of the Pfizer Covid-19 vaccine in (withheld) (withheld), her 8 years old granddaughter attended a party and developed some symptoms like vomiting and she did a test on her that they found out that she's positive to Covid-19. Precautions how we should handle this to avoid the spread of the virus. (name) experienced Sore arm at the injection site after her first dose, can I visit my granddaughter if I am completely vaccinated. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743673
Sex: F
Age:
State: PA

Vax Date: 02/25/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had a rapid heartbeat and a skipped heartbeat for 2 months. I went to my primary care physician because I was scared...I have not ever had any heart related problems. In fact I am in good health. Th; I had a rapid heartbeat and a skipped heartbeat for 2 months. I went to my primary care physician because I was scared...I have not ever had any heart related problems. In fact I am in good health. Th; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old non-pregnant female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6206, Expiration Date: Unknown) via an unspecified route of administration in left arm on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (in excellent control A1c: 6.0) and allergic to mycins from an unspecified date and unknown if ongoing. Concomitant medications included metformin, start and stop date were not reported, bifidobacterium infantis (Align) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of (Pfizer COVID-19, Lot Number: EN6198, Expiration date: Unknown) via an unspecified route of administration in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. No other vaccine taken in four weeks. No COVID prior vaccination. COVID not tested post vaccination. On an unspecified date in Mar2021, the patient experienced rapid heartbeat and a skipped heartbeat for 2 months. Patient went to her primary care physician because she was scared. Patient have not ever had any heart related problems. Infact she was in good health. The skipped heartbeat went like this boom, boom boom. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for events. The outcome of event was recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.

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

Current Illness:

ID: 1743674
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: I had huge lump in my armpit pit swell up/It is just like a swollen ball probably a lymph node; Pain; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced huge lump in armpit pit swell up. It is just like a swollen ball probably a lymph node patient was assuming anyways it was really sore. Patient was wondering how long this thing is going to last. The clinical outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743675
Sex: M
Age:
State: GA

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

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

Lab Data:

Allergies:

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

Symptoms: Swollen glands; booster he received was out of super cooler but was stored overnight in refrigerator; Administered vaccine after a temperature excursion; He received a "booster dose" of the Pfizer BioNTech Covid-19 Vaccine last Monday; He received a "booster dose" of the Pfizer BioNTech Covid-19 Vaccine last Monday; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: FC3180) via an unspecified route of administration, administered in right arm on 23Aug2021 11:30 AM (age at vaccination was 66 years) as DOSE 3, SINGLE for COVID-19 immunization at pharmacy. The patient's medical history was not reported. There were no concomitant medications. The patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL0140, Expiry Date: 30Mar2021) via an unspecified route of administration, on 23Dec2020 11:00AM (age at vaccination was 65years) as DOSE 2, SINGLE for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL0140, Expiry Date: 30Mar2021) via an unspecified route of administration, on 13Jan2021 11:00AM (age at vaccination was 65years) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Aug2021, the patient got administered vaccine after a temperature excursion which was a booster dose of the Pfizer biotech covid-19 vaccine last Monday after receiving the dose 3 the patient experienced swollen glands on 26Aug2021, that evening noticed the swelling, he usually had a little swelling and possibly drainage after the allergy shot but it went away in a day, this was different. Reported that his glands were still swollen five days later. The patient had not seen a doctor or emergency room and had no treatment for the swollen glands. Follow-up (30Aug2021, 30Aug2021, 08Sep2021 and 22Sep2021): It was reported that the patient had received Pfizer booster shot. Someone told caller booster he received was out of super cooler but was stored overnight in refrigerator and it should not have been. Said he does not trust anyone and checking if the storage was ok and if ok to receive booster. The outcome of the event swollen glands was recovered with sequelae on an unspecified date in 2021 and other events was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (30Aug2021, 30Aug2021, 08Sep2021 and 22Sep2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: The patient had received Pfizer booster shot. Someone told caller booster he received was out of super cooler but was stored overnight in refrigerator and it shouldn't have been. Said he does not trust anyone and checking if the storage was ok and if ok to receive booster. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1743676
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: headache; a little bit of fever; tired; arm was sore; This is a spontaneous report from a contactable consumer (parent). A contactable consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; Lot number was not provided), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single and on an unspecified date of 2021 as dose 2, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced headache, a little bit of fever, tired and arm was sore. It was further reported that the patient got his COVID-19 vaccine about 3 months ago, he had both doses and had a headache, a little bit of fever, was tired so he slept and his arm was sore but overall he flew through both doses (meaning he was not worried about it all). The outcome of the events was unknown. The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127262 same reporter and drug, similar events but different patient

Other Meds:

Current Illness:

ID: 1743677
Sex: F
Age:
State: PA

Vax Date: 05/01/2021
Onset Date: 05/03/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Vertigo for 1 week; Right eye twitch for 1 month; Diffuse numbness/ tingling still present; Diffuse numbness/ tingling still present; This is a spontaneous report from a contactable Other HCP. This 58-year-old female Other HCP (patient) reported that. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Right on 01May2021 09:00 as (At the age of 58-years) dose 2, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, taken for an unspecified indication, start and stop date were not reported; estrogens conjugated (PREMARIN) taken for an unspecified indication, start and stop date were not reported and Multivitamin. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FP7534), dose 1 via an unspecified route of administration, administered in Arm Right on 05Apr2021 03:00 PM as (At the age of 58-years) dose 1, single for covid-19 immunisation. The patient experienced vertigo for 1-week, right eye twitch for 1-month, diffuse numbness/ tingling still present on 03May2021 05:00. Patient did not receive any treatment for events. The outcome of events was recovered with sequelae. Follow-up attempts are completed. No further information is expected.

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

Current Illness:

ID: 1743678
Sex: M
Age:
State: RI

Vax Date: 06/27/2021
Onset Date: 07/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; nausea; tired; diarrhea; rash on his head; He had a temperature; This is a spontaneous report from a contactable consumer (Mother). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN0196, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Deltoid Left on 27Jun2021 (at the age of 41-years-old) as a DOSE 1, SINGLE for covid-19 immunisation at Pharmacy/Drug Store. The patient medical history was none. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) or list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and event following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination) was none. Family medical history relevant to AEs was not provided. On 28Jul2021, the patient experienced headache, nausea, tired, diarrhea, rash on his head and he had a temperature. It was reported that, her son experienced some AE. He received first shot in Jun and had side effect only on 28Jul2021. She was asking if her son should get the second dose. He experienced headache, nausea, tired, diarrhea, rash on his head. She was questioning if that could be related to the vaccine as it has been far out after receiving the first dose and should the patient receive the second shot. Referred her to their HCP for a proper diagnosis and medical guidance and she was not happy with the response. She mentioned that they already went to an epidemiologist and a dermatologist saying that it may be cause by the vaccine, but no one really gave them an answer. No one had been helpful. She also said that the information provided was unhelpful as it did not answer her question. Reporter reported in regard to the Covid shot, the first shot. The Reporter stated she reported to VAERS for her son. She was told she could do that. Her son possibly could have had an adverse reaction. She was wondering if she has the Lot number from the vaccine certificate, if Pfizer can see if there have been any issues with that particular Lot number or vaccine? Reporter stated the possible reaction happened on 28Jul2021 and lasted for a few days. The actual first shot was administered on 27Jun2021. She spoke to a viral epidemiologist who said it could have been a reaction that many weeks out, but the doctors around where she lives were telling her that it would be too long to tie it to the vaccine. She clarified her patient had a headache; he was tired. He had nausea a few times during a 24-hour period. He had diarrhea. He had a temperature and a rash on his head. She stated by about 02Aug2021, he was better. He went to a dermatologist in regard to his rash because he still had the rash. At that point he was still feeling tired, he wasn't 100% but was feeling better. no symptoms are still ongoing at the time of reporting and, she stated patient seems good. Reporter said patient has not yet received his second dose. She was going to ask that question as well. If this was a possible reaction from the first shot, is he supposed to get the second shot? The dermatologist's response to her son was that they'll never know if it was a reaction or not? So how are they supposed to know what to do? Should he get the second shot? Reporter said she knows she can't be advised but she wanted to know what is she supposed to do? It's like they are shooting darts blind. It's upsetting because she felt like she was getting the run around. It's like she was in a rowboat with no paddle. Event did not require a visit to the emergency Room. Reporter stated her son was close to going, but he started feeling a little bit better, so he didn't go. Physician office visit was required as, she made an appointment with the dermatologist for her son regarding the rash. Relevant tests done were none. There was a Product Complaint. Reporter reported in regard to patient first dose of the Pfizer COVID shot. Her son possibly could have had an adverse reaction. The reporter stated the possible reaction happened on 28Jul2021 and lasted for a few days. The actual first shot was administered on 27Jun2021. She clarified her son had a headache he was tired. He had nausea for a few times during the 24-hour period. He had diarrhea. He had a temperature and a rash on his head. She was wondering if she has the Lot number from the vaccine certificate, if Pfizer can see if there have been any issues with that particular Lot number or vaccine. Lot was reported as EN0196, no further details were provided or obtained. Case was reported as non-serious. Outcome of the rash on his head was not resolved whereas, rest of the events were resolving. Follow-Up (09Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743679
Sex: F
Age:
State: UT

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

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

Lab Data: Test Date: 202108; Test Name: Nasal swab; Result Unstructured Data: Test Result:positive; Comments: positive by nasal swab; Test Date: 20210828; Test Name: Nasal swab; Result Unstructured Data: Test Result:negative; Comments: negative by nasal swab

Allergies:

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

Symptoms: severe body aches (myalgias); severe body aches (myalgias); joint pain throughout back/spine; joint pain throughout back/spine; joint pain throughout back/spine; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; This is a spontaneous report from a contactable physician (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FC3184), via intramuscular route o administration in left arm on 01Sep2021 (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included known allergy to PCN (Penicillin) and seasonal allergy, otherwise healthy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks were reported as none. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EU0168), via intramuscular route of administration in left arm on an unknown date in Aug2021 (at the age of 36-years-old) as historical vaccine dose 1, single for COVID-19 immunisation and experienced COVID test name post vaccination=Binax Now Antigen Card/Covid test result=Positive. On 01Sep2021, after the second dose, est 10 hrs later, severe body aches (myalgias), joint pain throughout back/spine, after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements). Yes, COVID tested prior vaccination and post vaccination. In Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted positive by nasal swab. On 28Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted negative by nasal swab. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743680
Sex: F
Age:
State: VA

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: My arms feel like bomb; It is some deformation; I have a ache in my arm where I got the vaccination; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2 Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (Batch/Lot Number: EW0153) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus. Patient did not receive any vaccine with in four weeks. The patient experienced my arms feel like bomb; some deformation, have a ache in my arm where got the vaccination on Apr2021 with outcome of unknown. Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743681
Sex: F
Age:
State: NC

Vax Date: 08/20/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Got the booster shot; Got the booster shot; Nausea; Abdominal discomfort; Fatigue; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0182, Expiry date: 31Aug2021) via an unspecified route of administration on 20Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history include hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to the vaccine, she was on no medication just an Epipen for allergies. She had no health problems no nothing. The patient previously took bnt162b2 (dose 1, Lot number: EL3248) on 21Jan2021 experienced Shingles and Raynaud's, the shingles went away, but the Raynaud's have not and dose 2 (Lot number: EL9266) on 11Feb2021 for COVID-19 immunization.On an unspecified date patient experienced nausea, abdominal discomfort, fatigue. It was reported that patient got the booster shot. The outcome of the event was unknown. Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743682
Sex: M
Age:
State: OH

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

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

Lab Data: Test Date: 202108; Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Lost all use of legs; legs were like Jell-O; Feet are swollen; Tired; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: PC3182), via an unspecified route of administration on 02Sep2021 (reported given in the morning, at the age of 52-years-old) at dose 2, single in the right arm for COVID-19 immunisation. Medical history included ongoing diabetes mellitus. No vaccine was administered at the same day Pfizer COVID-19 vaccine was given. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number reported as being either FA7435 or FA7485) received on 03Aug2021 (at the age of 52-years-old) at dose 1, single in the right arm for COVID-19 immunisation and experienced COVID-19 a week after the first dose vaccination and was admitted to a hospital for 4 days. The patient underwent COVID-19 test on Aug2021 with positive result. The patient had a doctor's appointment on 03Sep2021 and walked fine into that appointment. Then on 04Sep2021, 2 days after the vaccination, the patient lost all use of his leg. The patient stated that his legs were like Jell-O. The patient's feet are swollen 04Sep2021. Due to these, the patient went to the hospital. He was not admitted and came home the same day. The patient stated that these are getting better as time goes on. On Sep2021, the patient experienced tired and nauseous. The patient stated that these lasted for about 24 hours and then was gone. It was reported that the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" resulted in emergency room visit, and the events "lost all use of legs" and "legs were like Jello-O" also resulted in physician office visit. Outcome of the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" was recovering, and for events "tired" and "nauseous" was recovered on Sep2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Diabetic

ID: 1743683
Sex: M
Age:
State: WA

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

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

Lab Data: Test Date: 20210907; Test Name: blood sugars; Result Unstructured Data: Test Result:continually high

Allergies:

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

Symptoms: struggling to keep his blood sugar in check/blood sugars have been continually high; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number FC3184), via an unspecified route of administration, administered in arm left on 07Sep2021 08:30 as dose 1, single for covid-19 immunisation. Medical history included type 1 diabetes. Concomitant medication included insulin taken for type 1 diabetes, start and stop date were not reported. The patient did not receive other vaccines in four weeks. It was unknown if the patient had covid-19 prior to the vaccination. The patient informed that he was a type 1 diabetic and; he has been struggling to keep his blood sugar in check on 07Sep2021 since receiving the vaccine. His blood sugars have been continually high for no apparent reason since 07Sep2021, and his insulin dosage has increased immensely to compensate the high glucose levels (also reported as no treatment received). The patient had not recovered from the adverse event at the time of the report. The patient had not been tested for covid-19 post vaccination. Follow-up (17Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: INSULIN

Current Illness:

ID: 1743684
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID19 VACCINE), dose 1 at vaccination age of 55-year-old via an unspecified route of administration in the left arm (reported as upper, bicep of left arm) on 13Sep2021 at 09:20 (Lot Number: FA7485) as dose 1, single for covid-19 immunisation. Medical history included Graves' disease diagnosed in 2010 and had surgery in 2012. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect or other vaccines administered on same date of the Pfizer Suspect were none. The patient received the vaccine in a pharmacy. On 13Sep2021 at 10:20, the patient experienced tongue swelling started about an hour later. She feels like it has worsened since it feels like her tongue is wanting to go over her teeth. She added that she can feel it when she is talking. She inquired if this is a normal side effect of the vaccine. The patient was advised to consult with healthcare professional which the patient stated that she already called her doctor and is waiting on a call back. As for the treatment, it was mentioned that the patient declines any and she waiting to hear from her doctor. As of the time of this initial report, the adverse event did not result in emergency room visit or physician's office visit. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1743685
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Passing out; Could not feel arms and legs- Had numbness immediately along with weakness; Could not feel arms and legs- Had numbness immediately along with weakness; Distorted face; Dizziness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm on Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (age at vaccination was 59-year-old). Medical history included a lot of allergies. The patient's concomitant medications were not reported. Historical vaccine included flu shot for immunization and patient experienced allergies to the flu shot. The patient experienced a distorted face, passed out, dizziness and could not feel arms and legs on the day of vaccination. Clinical course was reported as distorted face- started immediately. She was passing out and they had to lay her down, put her feet up, and she told them she was going out. They laid her down and told them her face felt numb then it was noted her face was all distorted. This lasted four hours. Passing out-Occurred same day had the vaccine, immediately after the vaccine. This would have been really life threatening if she went out and hit her head, but she got down and was able to put feet up. Dizziness: this happened immediately after getting the vaccine. It lasted on and off for days. She had to miss a couple of days of work. Could not feel arms and legs- had numbness immediately along with weakness. This lasted 3-4 days. Passing out and could not feel arms and legs- Had numbness immediately along with weakness were reported as life-threatening by reporter. Distorted face and dizziness were reported as disability by reporter. Outcome of passing out was unknown. Outcome of distorted face was resolved in Jan2021. Outcome of other events was resolved in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events loss of consciousness, hypoaesthesia, muscular weakness, muscle twitching and dizziness cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1743686
Sex: M
Age:
State:

Vax Date: 07/26/2021
Onset Date: 08/07/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: nerve pain in my right hand; left arm started to twitch and spasm/twitches all over my body; left arm started to twitch and spasm; fatigue in my legs; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Fa7484, expiry date not reported), via an unspecified route of administration, administered in left arm on 26Jul2021 18:00 (at the age of 35 years old) as dose 1, single for covid-19 immunisation. There were no medical history and concomitant medications. The patient had no covid prior to vaccination. The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. On 07Aug2021 12:15, after vaccination, the patient experienced nerve pain in right hand (neuralgia), left arm started to twitch and spasm, left arm started to twitch and spasm, twitches all over body and fatigue in legs. This was further reported as 2 1/2 weeks after shot, left arm started to twitch and spasm. Over the next two days that grew to twitches all over the body. Patient was still twitching in left arm consistently. Predominately, twitch in belly, legs, and chest, but had twitch in random places in addition to that. Patient was still experiencing fatigue in legs. The events resulted to doctor or other healthcare professional office/clinic visit, and disability or permanent damage. The patient had tested for Covid post vaccination which included nasal swab negative on an unknown date in 2021. No treatments were received in response to the events reported. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am