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: 1635955
Sex: F
Age: 81
State: IL

Vax Date: 03/19/2021
Onset Date: 05/01/2021
Rec V Date: 08/26/2021
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: Memory Impaired; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory Impaired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 642L20A and 029A21A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. Concomitant products included SIMVASTATIN for Cholesterol, METOPROLOL for product use for unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram. In May 2021, the patient experienced MEMORY IMPAIRMENT (Memory Impaired). At the time of the report, MEMORY IMPAIRMENT (Memory Impaired) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MEMORY IMPAIRMENT (Memory Impaired) to be not related. Treatment information was not provided.

Other Meds: METOPROLOL; SIMVASTATIN; HUMIRA

Current Illness:

ID: 1635956
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Extreme pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Extreme pain). At the time of the report, PAIN (Extreme pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. patient's lab test data not reported. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1635957
Sex: F
Age: 72
State: CA

Vax Date: 02/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/26/2021
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: Thinking affected and could not think clear after Second Shot; Stronger Reaction after Second Shot; Severe Pain all over body after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Thinking affected and could not think clear after Second Shot), VACCINATION COMPLICATION (Stronger Reaction after Second Shot) and PAIN (Severe Pain all over body after Second Shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced THINKING ABNORMAL (Thinking affected and could not think clear after Second Shot), VACCINATION COMPLICATION (Stronger Reaction after Second Shot) and PAIN (Severe Pain all over body after Second Shot). On 13-Mar-2021, THINKING ABNORMAL (Thinking affected and could not think clear after Second Shot), VACCINATION COMPLICATION (Stronger Reaction after Second Shot) and PAIN (Severe Pain all over body after Second Shot) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Patient was told not to take Anti-Inflammatory. But patient took Celebrex after 24hours after the second shot. Treatment medication was not reported. Patient stated she never consulted with MD regarding her side effects after vaccination. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-223015 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: CELEBREX

Current Illness:

ID: 1635958
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: I had it today (side effects)/ Had it few hours ago (side effects); This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)). At the time of the report, ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)) outcome was unknown. Treatment information was not provided by reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635959
Sex: M
Age: 69
State: TX

Vax Date: 04/23/2021
Onset Date: 05/20/2021
Rec V Date: 08/26/2021
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: 20210520; Test Name: Blood glucose; Result Unstructured Data: Patient states that blood sugar level increased after getting the second dose of Moderna vaccine

Allergies:

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

Symptoms: sugar level went up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (sugar level went up) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 0017B12A) for COVID-19 vaccination. No Medical History was provided by the reporter. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced BLOOD GLUCOSE INCREASED (sugar level went up). At the time of the report, BLOOD GLUCOSE INCREASED (sugar level went up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood glucose: 9.9 (High) Patient states that blood sugar level increased after getting the second dose of Moderna vaccine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: METFORMIN

Current Illness: Diabetes

ID: 1635960
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 18-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. On an unknown date, patient had fever of 101.8 F after 2nd dose of Moderna as reported. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1635961
Sex: F
Age: 59
State: OH

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 08/26/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No medical history was provided by the reporter. . Concomitant products included 12 VITAMINS for an unknown indication. On 09-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-027951 (Patient Link).

Other Meds: 12 VITAMINS

Current Illness:

ID: 1635962
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Pregnant; Didnt make it to your second appointment (fir second shot); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)) in an elderly female patient (gravida 1) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635963
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (more than 35 days from 1st vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (more than 35 days from 1st vaccination). At the time of the report, inappropriate schedule of product administration (more than 35 days from 1st vaccination) resolved. No concomitant medications, laboratory details or treatment information provided. The patient was actually scheduled for 2nd dose on Jun 1, 2021. Action taken with mRNA-1273 in response to the events: not applicable.

Other Meds:

Current Illness:

ID: 1635964
Sex: F
Age: 65
State: IL

Vax Date: 01/08/2021
Onset Date: 02/06/2021
Rec V Date: 08/26/2021
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: slight fever; nausea; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired). At the time of the report, PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired) had resolved. no treatment and concomitant medication reported. This case was linked to MOD-2021-004903, MOD-2021-004903 (Patient Link).

Other Meds:

Current Illness:

ID: 1635965
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Diarrhea every time I eat anything; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea every time I eat anything) in a patient of an unknown age and gender 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 DIARRHOEA (Diarrhea every time I eat anything). At the time of the report, DIARRHOEA (Diarrhea every time I eat anything) 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. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1635966
Sex: F
Age: 60
State: MN

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: covid arm; hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle) and VACCINATION COMPLICATION (covid arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle). On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm). On 01-Mar-2021, URTICARIA (hives on left side of face, neck and arms/patient had a hive that was massive that was purple and red in a big circle) had resolved. At the time of the report, VACCINATION COMPLICATION (covid arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication: The doctor prescribed Benadryl and hydrocortisone cream.

Other Meds: AMLODIPINE; SIMVASTATIN

Current Illness:

ID: 1635967
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 202101; Test Name: SARS-CoV-2 test positive; Test Result: Positive ; Result Unstructured Data: Patient had COVID-19

Allergies:

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

Symptoms: Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was provided by the reporter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test positive: positive (Positive) Patient had COVID-19. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1635968
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 08/26/2021
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: Neck meets the back of the head on both sides; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides) 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 15-Jun-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck meets the back of the head on both sides) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-222262 (Patient Link).

Other Meds:

Current Illness:

ID: 1635969
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diarrhea every time I eat anything; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea every time I eat anything) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea every time I eat anything). At the time of the report, DIARRHOEA (Diarrhea every time I eat anything) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by reporter. This case was linked to MOD-2021-223096 (Parent-Child Link). See case MOD-2021-223096 for details regarding the child case. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635970
Sex: U
Age:
State:

Vax Date: 06/14/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: i have chills now and have a light jacket on; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (i have chills now and have a light jacket on) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced CHILLS (i have chills now and have a light jacket on). At the time of the report, CHILLS (i have chills now and have a light jacket on) outcome was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter

Other Meds:

Current Illness:

ID: 1635971
Sex: F
Age: 60
State: MN

Vax Date: 02/05/2021
Onset Date: 03/29/2021
Rec V Date: 08/26/2021
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: metallic taste in mouth; steel made fork and nail cutter stick to her body (chest and right arm); abdominal pain; pain in my joints; Decrease in appetite/loss of appetite; intesnse freezing cold chils for 2 days/third day moderate chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decrease in appetite/loss of appetite), DYSGEUSIA (metallic taste in mouth), STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)), ABDOMINAL PAIN (abdominal pain) and CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DECREASED APPETITE (Decrease in appetite/loss of appetite). 29-Mar-2021, the patient experienced CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills). On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth), STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints). On 31-Mar-2021, CHILLS (intesnse freezing cold chils for 2 days/third day moderate chills) had resolved. At the time of the report, DECREASED APPETITE (Decrease in appetite/loss of appetite), DYSGEUSIA (metallic taste in mouth) and STICKY SKIN (steel made fork and nail cutter stick to her body (chest and right arm)) outcome was unknown and ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints) had not resolved. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up Information Received on 16-JUN-2021 contains No NewInformation. On 29-Jun-2021: Added new Events such as Joint pain and Abdominal pain.

Other Meds: AMLODIPINE; SIMVASTATIN

Current Illness:

ID: 1635972
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Two patients have not received the second dose of the vaccine after 42 days of the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1636100
Sex: F
Age: 19
State: PA

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 08/26/2021
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: Sensitivity to light; Inappropriate route of vaccination; Body aches; Headache; Chills; Fever; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 19-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. The patient's past medical history included Streptococcal infection (Tonsils and adenoids removed due to chronic strep throat.) in 2007, Tonsillectomy in 2007 and Tonsillectomy & Adenoidectomy in 2007. On 28-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 28-May-2021, the patient experienced PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). On 28-May-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PHOTOPHOBIA (Sensitivity to light), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1636101
Sex: F
Age: 47
State: NY

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Name: Elevated Transaminase Level; Result Unstructured Data: Elevated Transaminase Level

Allergies:

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

Symptoms: low platelets; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low platelets) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. Elevated Transaminase Level, Fatty Liver, Lumbar Adrenal Mass, Kidney Stone, Essential Hypertension, Hyperlipidemia, Vitamin D Deficiency, Gastroesophageal Reflux disease with out esophagitis, Rosacea, Migraines, Asthma, PTSD, Panic attacks, Anxiety, Low grade Bells palsy (from recent face surgery), pre diabetes. Gallbladder Surgery 10/2016 Uterine Ablation 1/2013 Parotid Gland 3/15/21 Allergies: Doxycycline, Nitrofurantoin, Lisinopril, Sulfa antibiotics, Sumatriptan. The patient's past medical history included Gallbladder operation NOS in October 2016 and Uterine ablation in January 2013. Concurrent medical conditions included Fatty liver, Adrenal mass (Lumbar Adrenal Mass), Kidney stone (Kidney Stone), Essential hypertension, Hyperlipidemia, Vitamin D deficiency, Gastroesophageal reflux disease (with out esophagitis), Rosacea, Migraine, Asthma, Post-traumatic stress disorder, Panic attacks, Bell's palsy (Low grade Bells palsy from recent facial surgery), Parotid gland enlargement of (Parotid Gland) since 15-Mar-2021, Allergic reaction to antibiotics (Doxycycline), Allergic reaction to antibiotics (Nitrofurantoin), Allergic reaction to antibiotics (Lisinopril), Allergic reaction to antibiotics (Sulfa) and Allergic reaction to drug (Sumatriptan). On 23-Apr-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 an unknown date, the patient experienced PLATELET COUNT DECREASED (low platelets). At the time of the report, PLATELET COUNT DECREASED (low platelets) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Transaminases: other (High) Elevated Transaminase Level. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness: Adrenal mass (Lumbar Adrenal Mass); Allergic reaction to antibiotics (Sulfa); Allergic reaction to antibiotics (Nitrofurantoin); Allergic reaction to antibiotics (Lisinopril); Allergic reaction to antibiotics (Doxycycline); Allergic reaction to drug (Sumatriptan); Asthma; Bell's palsy (Low grade Bells palsy from recent facial surgery); Essential hypertension; Fatty liver; Gastroesophageal reflux disease (with out esophagitis); Hyperlipidemia; Kidney stone (Kidney Stone); Migraine; Parotid gland enlargement of (Parotid Gland); Rosacea; Vitamin D deficiency

ID: 1636102
Sex: M
Age: 24
State: TX

Vax Date: 08/14/2021
Onset Date:
Rec V Date: 08/26/2021
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: Bad rash all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bad rash all over my body) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced RASH (Bad rash all over my body). At the time of the report, RASH (Bad rash all over my body) had not resolved. No concomitant medications were reported. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. There's no evidence of seriousness from a clinical or regulatory standpoint.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. There's no evidence of seriousness from a clinical or regulatory standpoint.

Other Meds:

Current Illness:

ID: 1636111
Sex: F
Age: 32
State: SC

Vax Date: 04/02/2021
Onset Date: 04/07/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: None

Allergies: Sulfa, penicillin

Symptom List: Unevaluable event

Symptoms: On April 7 and and 9, day 11 and 13 of my menstrual cycle I experienced spotting. That cycle ended up being only 26 days with me beginning to bleed on April 23rd, and during my menses I had a headache for 3 days in a row and greater moodiness. My next cycle was 36 days, then 30, the 26, and currently waiting for my period and on day 34. So it is unclear whether my cycle has re regulated.

Other Meds: None

Current Illness: None

ID: 1636112
Sex: M
Age: 73
State: PA

Vax Date: 05/04/2021
Onset Date: 08/12/2021
Rec V Date: 08/26/2021
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: ? X-ray chest 2 views ? COVID-19 PCR ? Comprehensive metabolic panel ? B-type natriuretic peptide ? COVID-19 (SARS CoV-2,RNA Molecular Amplification)

Allergies: No Known Allergies

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

Symptoms: Shortness of breath Leg swelling Hypertension Diarrhea Cough

Other Meds: acetaminophen (TYLENOL EXTRA STRENGTH) 500 mg tablet aspirin 81 mg tablet atenoloL (TENORMIN) 50 mg tablet atorvastatin (LIPITOR) 40 mg tablet chlorthalidone (HYGROTON) 25 mg tablet citalopram (CeleXA) 20 mg tablet diazePAM (VALIUM) 5

Current Illness:

ID: 1636113
Sex: M
Age: 62
State: PA

Vax Date: 05/04/2021
Onset Date: 08/21/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: COVID-19 (SARS CoV-2,RNA Molecular Amplification) COVID-19 PCR

Allergies: Not on File

Symptom List: Injection site pain, Pain

Symptoms: Tested positive for COVID-19

Other Meds: None

Current Illness:

ID: 1636114
Sex: F
Age: 70
State:

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Went to the GP on Tuesday (24/8/2021), and he prescribed some meds for Gastro

Allergies: aspirin, penicillin

Symptom List: Injection site pain, Menorrhagia

Symptoms: 12 - 18 hours after getting the second dose of the vaccine, my mother started feeling dizzy, nauseous, severe headache and full body pains. Then it moved to chest pains, reflux and heartburn, spasms in her neck and pain in her joints. Shortness of breath, hand shakes (trembling), then stomach cramps started as well with some diarrhea. it is now day 6 of these side effects, and only starting to subside now.

Other Meds: Vitamins, High BP medication, High cholesterol medication

Current Illness: none

ID: 1636115
Sex: M
Age: 55
State: PA

Vax Date: 05/04/2021
Onset Date: 08/16/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: COVID-19 PCR

Allergies: Not on file

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

Symptoms: Cough Congestion Runny nose Sore throat

Other Meds: None

Current Illness:

ID: 1636116
Sex: F
Age: 40
State: PA

Vax Date: 05/08/2021
Onset Date: 08/13/2021
Rec V Date: 08/26/2021
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: COVID-19 PCR

Allergies: Contrast [Iodinated Contrast Media]Hives / Urticaria ClarithromycinDizziness / Lightheaded, Nausea and Vomiting Oxycodone-acetaminophenNausea Only

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Headaches Sore throat

Other Meds: albuterol HFA (PROAIR HFA) 90 mcg/actuation inhaler fexofenadine (ALLEGRA) 180 mg tablet HEATHER 0.35 mg tablet multivitamin-minerals (THERAGRAN M) 9 mg iron-400 mcg tablet SPRINTEC, 28, 0.25-35 mg-mcg per tablet

Current Illness:

ID: 1636117
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: My husband got the shot and still got a terrible case of shingles. /Suspected Vaccination Failure; My husband got the shot and still got a terrible case of shingles.; They are horrible to deal with and very painful.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband got the shot and still got a terrible case of shingles. They were horrible to deal with and very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1636118
Sex: M
Age: 52
State: SD

Vax Date: 01/24/2021
Onset Date: 02/04/2021
Rec V Date: 08/26/2021
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: Ultrasounds for blood clots in my left leg.

Allergies: NoneNone

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

Symptoms: Within one week of both Moderna Covid vaccination shots I began to develop left leg pain and swelling. I was checked by my doctor on both events. Both times I was sent to the hospital to have my leg ultrasound. Following the first shot there was no finding of blood clots. I was able to treat my leg swelling with compression socks and rest. Following my second dose of the Moderna Covid vaccine a blood clot was discovered. My doctor has been treating it with Eliquis. Both events of leg swelling happened within a 10 day period of the vaccine. No prior history of like swelling or blood clots prior to the vaccine shots.

Other Meds: None

Current Illness: None

ID: 1636119
Sex: F
Age: 31
State: WA

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies: Lavender, shrimp, seasonal

Symptom List: Nausea

Symptoms: Beginning immediately after the injection I began feeling a tingly or itchy sensation in the forearm of the arm I received the vaccine. The sensation has come and went sende receiving the vaccine. There is not any kind of physical action that triggers the sensation. 6 days after the vaccine I have started feeling discomfort in my left armpit - the sensation almost feels like a sore Or tender muscle Sensation and is more tender to touch. I have also had a slightly heavy Or tight feeling in my chest since receiving the vaccine. I plan to both call Walgreens pharmacy where I received the vaccine as well as visit a health care provider should the symptoms persist past a week of receiving the vaccine.

Other Meds: Women?s multi-vitamin, omega, Vitex, ashwaganda, vitamin d3, magnesium,

Current Illness:

ID: 1636120
Sex: F
Age: 37
State: PA

Vax Date: 05/03/2021
Onset Date: 08/19/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: COVID-19 PCR

Allergies: No Known Allergies

Symptom List: Injection site pain

Symptoms: Headache started thursday ? Chills ? Cough ? Nasal Congestion ? Generalized Body Aches

Other Meds: diclofenac sodium (VOLTAREN GEL) 1 % gel ferrous sulfate 325 mg (65 mg iron) tablet mometasone (ELOCON) 0.1 % ointment

Current Illness:

ID: 1636121
Sex: M
Age: 62
State: PA

Vax Date: 04/30/2021
Onset Date: 08/17/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: COVID-19 PCR

Allergies: LisinoprilCoughing

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

Symptoms: Sore throat cough chills

Other Meds: amLODIPine (NORVASC) 10 mg tablet aspirin 81 mg chewable tablet benzonatate (TESSALON) 100 mg capsule buPROPion XL (WELLBUTRIN XL) 300 mg 24 hr tablet fexofenadine (ALLEGRA) 180 mg tablet fluticasone propionate (FLONASE) 50 mcg/actuati

Current Illness:

ID: 1636122
Sex: F
Age: 40
State: RI

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: 8/25 - blood work (CBC, BMP, LFTs, ammonia, Vit B12, Vit D, TSH, UA, ) All blood work currently resulted has been WNL.

Allergies: SULFA seasonal allergies

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

Symptoms: Approximately 15 hours after injection, felt very mild dizziness and sore arm. Arm soreness went away within 24 hours, but dizziness progressively worsened. By Day 3 dizziness was accompanied by cognitive impairment/ brain fog, profuse sweating with temp of 99.0 - 99.5 deg F and tachycardia to 120s upon standing with no change in blood pressure and resting HR in the 60s. As a Registered Nurse, I was unable to care for patients in this condition. Contacted PCP. Symptoms intensified on Days 4-5. Blood work done, pending results. Follow up care to be provided by PCP. Will not be receiving second vaccine.

Other Meds: Zyrtec 10mg Vitamn D 1000 IU Vitamin C 500mg Zinc 15mg

Current Illness:

ID: 1636123
Sex: F
Age: 37
State: PA

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 08/26/2021
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: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium

Other Meds:

Current Illness:

ID: 1636124
Sex: F
Age: 73
State: PA

Vax Date: 05/04/2021
Onset Date: 08/16/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: POCT COVID-19 PCR

Allergies: Iv Dye [Gadolinium-containing Contrast Media]Swelling Dye ParoxetineDiarrhea

Symptom List: Erythema, Pruritus

Symptoms: fever, fatigue, nasal congestion, sore throat, headache and cough

Other Meds: cholecalciferol, vitamin D3, 2,000 unit capsule co-enzyme Q-10 50 mg capsule fluticasone (FLONASE) 50 mcg/actuation nasal spray metFORMIN (GLUCOPHAGE) 500 mg tablet montelukast (SINGULAIR) 10 mg tablet omega-3 fatty acids-fish oil (FIS

Current Illness:

ID: 1636125
Sex: M
Age: 17
State: MS

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 08/26/2021
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: Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

Other Meds:

Current Illness:

ID: 1636126
Sex: U
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: stomach discomfort / upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of stomach discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 16th August 2021, the patient received Shingles vaccine. In August 2021, 4 days after receiving Shingles vaccine, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was not recovered/not resolved. It was unknown if the reporter considered the stomach discomfort to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the vaccine for shingles on Monday and four days after getting shingles vaccine, the patient had stomach upset. The patient enquired what he/she could do about this.

Other Meds:

Current Illness:

ID: 1636127
Sex: M
Age: 33
State: TX

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 08/26/2021
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: Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe

Other Meds:

Current Illness:

ID: 1636128
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Shingrix has not been as effective / suspected vaccination failure; Shingrix has not been as effective; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingles vaccine (received on unknown date). On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The Shingrix has not been as effective as the previous shingles vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedulelaboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. Note: The case has been conservatively kept valid as no further information can be obtained.

Other Meds:

Current Illness:

ID: 1636129
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: The shingles shot gave me the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and gave him/her the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1636130
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Didnt feel good.; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got second shot a few days ago and did not feel good. The patient was better on day of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1636131
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: got the shot and still got shingles / Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patients family member. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1636132
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had two shots,got the shingles anyway / Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had two shots of vaccine and got the shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1636133
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccine and then got the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1636134
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected Vaccination Failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient had shingles one year after receiving shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting

Other Meds:

Current Illness:

ID: 1636135
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: got shingles after she got the shot/ Suspected Vaccination Failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got shingles after she got the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1636136
Sex: F
Age: 23
State: TX

Vax Date: 07/24/2021
Onset Date:
Rec V Date: 08/26/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: received 2 vaccines on July 24, 2021 / found out 2 weeks ago that she is 6 weeks pregnant; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis. On 24th July 2021, the patient received HPV vaccine and Tetanus vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received HPV vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving HPV vaccine and Tetanus vaccine, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional case details were reported as follows: The case was reported by the patient. The patient received 2 vaccines on 24th July 2021. She could not remember the names of the vaccines but stated one was for HPV and the other for tetanus. She found out 2 weeks before the date of reporting that she was 6 weeks pregnant.

Other Meds:

Current Illness:

ID: 1636137
Sex: F
Age: 66
State: OH

Vax Date: 11/01/2019
Onset Date: 12/01/2019
Rec V Date: 08/26/2021
Hospital: Y

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: was hospitalized for Guillain Barre Syndrome; numbness in her feet; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2019, 6 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced numbness in feet. On an unknown date, the outcome of the guillain barre syndrome and numbness in feet were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome and numbness in feet to be related to Shingrix. Additional details wee reported as follows: The case was reported by the patient's spouse. The patient received dose of Shingrix at the end of November 2019 and 6 days later, she was hospitalized for Guillain Barre syndrome. The patient was hospitalized and was in rehabilitation for 7 months and that had not resolved. The patient had ongoing numbness in her feet. The lot number and expiration date were unknown at the time of reporting. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1636138
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Result Unstructured Data: positive

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: unknown) dose was not reported, 1 total administered on 12-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021 the patient had suspected clinical vaccination failure and suspected covid-19 infection. The patient underwent laboratory test included: COVID-19 virus test with result positive The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000190583.; Sender's Comments: V0: 20210846305 -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1636139
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/26/2021
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: 202104; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 66 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced symptoms such as loss of taste and lethargy. On an unspecified date in APR-2021, the patient underwent COVID-19 virus test which showed positive result (suspected clinical vaccination failure and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190700. This case, from the same reporter is linked to 20210846926.; Sender's Comments: V0: 20210846583-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am