VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1706549
Sex: F
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: BROKE OUT WITH A RASH SIMILAR TO PSORIASIS; This spontaneous report received from a consumer concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced broke out with a rash similar to psoriasis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out with a rash similar to psoriasis was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924422.

Other Meds:

Current Illness:

ID: 1706550
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706551
Sex: M
Age:
State:

Vax Date:
Onset Date: 09/13/2021
Rec V Date: 09/17/2021
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: Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: 103 F

Allergies:

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

Symptoms: THROWING UP; 103 FEVER; This spontaneous report received from a consumer 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-SEP-2021, the patient experienced throwing up. On 13-SEP-2021, the patient experienced 103 fever. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the throwing up and 103 fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706552
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 09/17/2021
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: KEEP SEEING WIERD THINGS; DISTURBED SLEEP; BAD HEADACHE; CHILLS; MILD FEVER; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. 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) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, after receiving the vaccine the patient experienced mild fever and chills after about 7 hours of feeling fine. Then it went away. On an unspecified date the patient had disturbed sleep with a bad headache. The patient thought that those were the right symptoms for body building an immunity. The patient also stated that he keep seeing weird things from mRNA. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild fever on APR-2021, and the outcome of disturbed sleep, bad headache and keep seeing weird things was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210926109.; Sender's Comments: V0: 20210925695-Covid-19 vaccine ad26.cov2.s-Keep seeing weird things . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1706553
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 09/17/2021
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: Laboratory test; Result Unstructured Data: Lymph node issues; Test Name: Mammogram; Result Unstructured Data: Found something (unspecified)

Allergies:

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

Symptoms: OTHER THINGS (UNSPECIFIED); PAIN IN LEFT BREAST; LYMPH NODE ISSUES; TWO LUMPS ON MY NECK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: homeless. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced two lumps on my neck. On an unspecified date, the patient experienced other things (unspecified), pain in left breast, and lymph node issues. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Lymph node issues, and Mammogram (NR: not provided) Found something (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two lumps on my neck, pain in left breast, and other things (unspecified), and the outcome of lymph node issues was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706554
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210908; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Name: Blood grouping; Result Unstructured Data: O +ve

Allergies:

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

Symptoms: TEETH PAIN; JAW CLENCHING; FEELING LAZY; FATIGUE; COUGH WORSENED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroid cancer, and thyroidectomy, and concurrent conditions included: environmental allergies, seasonal allergies, current respiratory infection (suspected rsv), seasonal mold allergy, shellfish allergy, cough, dust mites allergy, dog dander allergy, eggplant and wheat germ allergy and dust allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had allergy to Goldenrod. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced cough worsened. On 13-APR-2021, the patient experienced feeling lazy. On 13-APR-2021, the patient experienced fatigue. On 15-APR-2021, the patient experienced teeth pain. On 15-APR-2021, the patient experienced jaw clenching. On 08-SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood grouping (NR: not provided) O +ve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth pain, and jaw clenching on 17-APR-2021, and feeling lazy, and fatigue on 15-APR-2021, and had not recovered from cough worsened. This report was non-serious.

Other Meds:

Current Illness: Allergy to animal dander; Allergy to molds; Cough (Seasonal and environmental allergies causes cough); Dust allergy; Environmental allergy (Causes cough); Food allergy; House dust mite allergy; Respiratory infection; Seasonal allergy (Causes cough); Shellfish allergy

ID: 1706555
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
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: 202108; Test Name: COVID-19 antibody test; Result Unstructured Data: No antibodies

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. 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 and expiry date: Unknown) dose was not reported, 1 total administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. In AUG-2021, the patient had COVID-19 antibody test which showed no antibodies (confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193282.; Sender's Comments: V0: 20210925740-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1706556
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/17/2021
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: RECEIVED A DOSE OF THE JANSSEN COVID-19 VACCINE 6 HOURS AND 52 MINUTES AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced received a dose of the janssen covid-19 vaccine 6 hours and 52 minutes after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a dose of the janssen covid-19 vaccine 6 hours and 52 minutes after first puncture was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706557
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: SORE ARM; HEADACHE; A SMALL DOT AT INJECTION SITE; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 190 pounds, and height was 73 inches. The patient's concurrent conditions included: hay fever, and other pre-existing medical conditions included: The patient did not have past medical history and was not on medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: Unknown) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced a small dot at injection site. On 09-SEP-2021, the patient experienced sore arm. On 09-SEP-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache on 10-SEP-2021, and had not recovered from a small dot at injection site. This report was non-serious. This case, from the same reporter is linked to 20210926070.

Other Meds:

Current Illness: Hay fever

ID: 1706558
Sex: M
Age:
State: UT

Vax Date:
Onset Date: 09/09/2021
Rec V Date: 09/17/2021
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: RASH OVER ANKLES WRISTS AND BACK OF KNEES; FLU LIKE SYMPTOMS/BODY ACHES; MIGRAINE; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and eosinophilic esophagitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On 09-SEP-2021, the patient experienced flu like symptoms/body aches. On 09-SEP-2021, the patient experienced migraine. On 14-SEP-2021, the patient experienced rash over ankles wrists and back of knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms/body aches, and migraine on SEP-2021, and the outcome of rash over ankles wrists and back of knees was not reported. This report was non-serious.

Other Meds:

Current Illness: Eosinophilic esophagitis; Penicillin allergy

ID: 1706559
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 04/04/2021
Rec V Date: 09/17/2021
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: SLEEVE SURGERY; HIP PAIN; LEG PAIN THAT TRAVELS FROM KNEE TO THIGH TO HIP; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: open heart surgery, and concurrent conditions included: baker cyst, and hypertrophic cardiomyopathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included duloxetine hydrochloride. On 04-APR-2021, the patient experienced leg pain that travels from knee to thigh to hip. On MAY-2021, the patient experienced hip pain. On an unspecified date, the patient experienced sleeve surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain that travels from knee to thigh to hip, and hip pain, and the outcome of sleeve surgery was not reported. This report was non-serious.

Other Meds: CYMBALTA

Current Illness: Baker's cyst; Hypertrophic cardiomyopathy

ID: 1706560
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 09/08/2021
Rec V Date: 09/17/2021
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: 20210908; Test Name: Pain scale; Result Unstructured Data: scale 9/10; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: 102.4 degrees fahrenheit (F)

Allergies:

Symptom List: Rash, Urticaria

Symptoms: FEVER (102.4 DEGREES FAHRENHEIT (F)); TINGLING DOWN THE ARMS, HANDS AND FEET; SEVERE UPPER BACK PAIN (SCALE 9/10); ACHING; NUMBNESS DOWN THE ARMS, HANDS AND FEET; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient was not breastfeeding at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: 30-OCT-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for to prevent of blood clot. On 08-SEP-2021, the patient experienced severe upper back pain (scale 9/10). On 08-SEP-2021, the patient experienced aching. On 08-SEP-2021, the patient experienced numbness down the arms, hands and feet. On 08-SEP-2021, the patient experienced tingling down the arms, hands and feet. Laboratory data included: Pain scale (NR: not provided) scale 9/10. On 09-SEP-2021, the patient experienced fever (102.4 degrees fahrenheit (f) ). Laboratory data included: Body temperature (NR: not provided) 102.4 degrees fahrenheit (F). Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness down the arms, hands and feet, fever (102.4 degrees fahrenheit (f)), and tingling down the arms, hands and feet on 10-SEP-2021, and had not recovered from severe upper back pain (scale 9/10), and aching. This report was non-serious.

Other Meds: ASPIRINE

Current Illness: Penicillin allergy

ID: 1706561
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 09/13/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: KNEE PAIN; INJECTION SITE PAIN; GENERAL TIREDNESS; This spontaneous report received from a patient concerned a 28 year old male. 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: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 13-SEP-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced injection site pain. On 13-SEP-2021, the patient experienced general tiredness. On 14-SEP-2021, the patient experienced knee pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 14-SEP-2021, and had not recovered from knee pain, and general tiredness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706562
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/17/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: social alcohol drinker, non-smoker, and pollen allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness: Non-smoker; Pollen allergy; Social alcohol drinker (Occasional drinker)

ID: 1706563
Sex: M
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: PAIN IN LEFT LEG AND NOW THE PAIN WAS AFFECTING HIS RIGHT LEG; This spontaneous report received from a patient concerned an 89 year old male. 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: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain in left leg and now the pain was affecting his right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left leg and now the pain was affecting his right leg. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706564
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: A BIT OF SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925834.

Other Meds:

Current Illness:

ID: 1706565
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 09/17/2021
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: ATRIAL FIBRILLATION; ITCH; RASH ON BACK, LEGS, THIGHS, ARMS; This spontaneous report received from a patient concerned a 75 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: normal flu and cold. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805022 expiry: Unknown), dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included digoxin, furosemide, hydroxyzine, metoprolol succinate, and rivaroxaban. On an unspecified date in MAR-2021, after a week of receiving the vaccine, the patient got rash on back, legs, thighs, arms, and it was itching. The patient went to three physicians and three dermatologists, they could not do anything. The patient was prescribed EpiCeram skin barrier emulsion and triamcinolone acetonide cream. Another physician prescribed Xarelto. The patient's physician wanted to do skin biopsy because of rash to find out what is causing it. On an unspecified date, the patient experienced atrial fibrillation. The patient was going to visit back to cardiologist for checkup this coming Friday at the time of this report. The patient had never been on medication till this point. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash on back, legs, thighs, arms, and the outcome of atrial fibrillation and itch was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210925830-Covid-19 vaccine Atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: DIGOXIN; HYDROXYZINE; FUROSEMIDE; METOPROLOL SUCCINATE

Current Illness:

ID: 1706566
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: A BIT OF A SORE ARM; This spontaneous report received from a patient via a company representative concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of a sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit of a sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925820.

Other Meds:

Current Illness:

ID: 1706567
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210904; Test Name: Blood test; Result Unstructured Data: Kidney function normal, Severe blood loss(Anemia)

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: EASILY BRUISES; SWELLING OF HANDS AND FEET; BLURRY VISION; SHORT TERM MEMORY NOT WHAT IT WAS BEFORE; DIFFICULTY WALKING, HARD TIME LIFTING FEET; URINE COLOR CHANGED TO ORANGE-BROWN COLOR; LOWER BACK PAIN; RASH/ECZEMA; FEELS EQUILIBRIUM IS OFF; THRUSH/DIFFICULTY SWALLOWING PILLS/TONGUE BURNING SENSATION/DROOLING; BACTERIAL INFECTION ON CHEST; BLOOD LOSS; SEVERE ANEMIA; ACHINESS/BODY ACHE; DRY COUGH; DIFFICULTY BREATHING; MALAISE; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 71 year old Caucasian, Not Hispanic/Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to antibiotics, rheumatoid arthritis, fibromyalgia, osteoarthritis, autoimmune disorder and other pre-existing medical conditions included: The patient was allergic to everything. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 20-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included metronidazole for dental cleaning and other oral medications. First few days, after receiving vaccine, On JUL-2021 the patient experienced mild symptoms fever, malaise, achiness/body ache, headache, difficulty breathing and that it was very difficult to catch her breath, dry cough, fatigue. And patient reported, a rash appeared all over her body which she did see a dermatologist for and, on 03-AUG-2021, diagnosed with eczema. On an unspecified date the patient experienced bacterial infection on chest, thrush/difficulty swallowing pills/tongue burning sensation/drooling (stated that tongue burning sensation was due to thrush), easily bruises, swelling of hands and feet, blurry vision, short term memory not what it was before, difficulty walking due to had a hard time lifting feet, urine color changed to orange-brown color, lower back pain, feels equilibrium is off. On 04-SEP-2021, the patient experienced blood loss and severe anemia. And the rash was subsiding. On 04-SEP-2021 Laboratory data included: Blood test (NR: not provided) kidney function normal, but the patient was severely anemic (had blood loss). The patient stated that she had contacted her primary care physician regarding the events however her primary care doctor said he did not know what it could be. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash/eczema, had not recovered from fever, dry cough, and difficulty breathing, and the outcome of malaise, achiness/body ache, headache, fatigue, bacterial infection on chest, easily bruises, swelling of hands and feet, blurry vision, short term memory not what it was before, difficulty walking, hard time lifting feet, urine color changed to orange-brown color, lower back pain, feels equilibrium is off, thrush/difficulty swallowing pills/tongue burning sensation/drooling, severe anemia and blood loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210925867-covid-19 vaccine ad26.cov2.-Blood loss. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: FLAGYL [METRONIDAZOLE]

Current Illness: Allergy to antibiotic; Autoimmune disorder; Fibromyalgia; Osteoarthritis; Rheumatoid arthritis

ID: 1706568
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 09/13/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210914; Test Name: Body temperature; Result Unstructured Data: 99.8 F; Test Date: 20210914; Test Name: Body temperature; Result Unstructured Data: 99.32 F

Allergies:

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

Symptoms: NAUSEA; MUSCLE SORENESS (NECK, SHOULDERS AND BACK); FEVER; HEADACHE TURNED INTO A MIGRAINE; DIZZY; SENSITIVE SKIN; FEEL TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced headache turned into a migraine. On 13-SEP-2021, the patient experienced dizzy. On 13-SEP-2021, the patient experienced sensitive skin. On 13-SEP-2021, the patient experienced feel tired/fatigue. On 14-SEP-2021, the patient experienced nausea. On 14-SEP-2021, the patient experienced muscle soreness (neck, shoulders and back). On 14-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.32 F, 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feel tired/fatigue, dizzy, headache turned into a migraine, sensitive skin, nausea, muscle soreness (neck, shoulders and back), and fever. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1706569
Sex: M
Age:
State: GA

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

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

Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 102.6 F; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: 60 {beats}/min; Test Date: 20210908; Test Name: Blood pressure; Result Unstructured Data: 128/62 mmHg; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 101.4 F; Comments: an hour after taking motrin body temperature decreased; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: 84 {beats}/min; Comments: an hour after taking motrin heart rate decreased; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 98.9 F; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: 82 {beats}/min; Comments: Temperature was decreasing, but heart rate was not normal at about 60 beats per minute; Test Date: 20210908; Test Name: Pain scale; Result Unstructured Data: 5 out of 10; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 97.4 F; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: 69 {beats}/min; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: 118 {beats}/min; Test Date: 20210908; Test Name: Respiratory rate; Result Unstructured Data: 12 {beats}/min; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: 96.1 F; Test Date: 20210909; Test Name: Heart rate; Result Unstructured Data: 65 {beats}/min; Test Date: 20210909; Test Name: Pain scale; Result Unstructured Data: 4 out of 10; Test Date: 20210909; Test Name: Heart rate; Result Unstructured Data: 74 {beats}/min; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: 96.3 F

Allergies:

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

Symptoms: HEART FLUTTERING; HOT FLASH; PROFUSELY SWEATING; LETHARGIC; SPEAKING SLOWER THAN USUAL AND NOT IN COMPLETE SENTENCES; SHAKINESS; BODY ACHES; WEIRD, INDESCRIBABLE TASTE IN HIS MOUTH; HEAVY AND LABORED BREATHING; FLUSHED FACE; SLIGHTLY SWOLLEN TONGUE; INJECTION SITE ARM WAS WARM TO TOUCH; LEFT ARM PAIN; SEVERE CHILLS; SEVERE JOINT PAIN; EAR RINGING; HIGH FEVER; TINGLING SENSATION IN BOTH LEGS AND ARMS WHILE SITTING UPRIGHT; INJECTION SITE ARM WAS EXTREMELY TENDER; SEVERE HEADACHE; NUMBNESS IN BOTH LEG AND ARM ON SITTING; BECAME EXHAUSTED AGAIN; This spontaneous report received from a patient concerned a 32-year-old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: alcohol use, and non-smoker, conditions included: The patient had no known drug allergy and no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered on 08-SEP-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, in afternoon patient began to experience a severe headache, shortly after headache he had severe chills (felt like freezing in winter with no clothes on). Within 20 minutes of chills, he had a hot flash and began to profusely sweat. By 14:00 patient had a high fever at 102.6 Fahrenheit (F). Patient felt that his heart was fluttering. He went to the clinic, and he had a high heart rate with no beats per minute number. The healthcare professional at the base sent him home to rest. Patient wished to be seen by a healthcare professional due to these unforeseen side effects, because the fever should not have been that high. At approximately 15:30 to 16:00 was soaking in pool bath in Epsom salt. He was lethargic, speaking slower than usual and not in complete sentences. The nurse recommended him not go to urgent care and continue home therapy with over the counter Motrin for fever. At 16:30 he was lethargic, had heavy and labored breathing (respiration rate 12), face was flushed even though he washed with cool water. Patient vital signs were taken body temperature was still 102.6 Fahrenheit (F) although he was soaking in the pool bath for an hour. Heart rate was 118 beats per minute, blood pressure was 128/62 mmHg. This was all while patient was sitting and resting on the chair, with no exertion. Given 400mg of Motrin at 17:15. At 18:00, patient complained of ear's ringing for the past 2 hours, which may have started at 16:00. Only reported of ear ringing, because the ringing was unbearable. An hour after taking Motrin, body temperature was 101.4 Fahrenheit (F) and heart rate was 84 beats per minute. headache was still persistent, but felt like it was moving from one area to another. Patient stated that headache was painful by the frontal lobe area of his head. Complained of shakiness. He took a nap. At about 19:00, he woke up and ate a few snacks, then became exhausted again and fell asleep. Body temperature was 98.9 Fahrenheit (F) and heart rate 82 beats per minute. Temperature was decreasing, but heart rate was not normal at about 60 beats per minute. Patient complained that headache was still constant and now had left arm pain, body aches and severe joint pain in his entire body. He experienced a weird, indescribable taste in his mouth. His tongue was slightly swollen, but was not affecting his swallowing very much. Injection site on left arm was extremely tender and warm to touch. Nurse advised that him to seek treatment as soon as possible within 24 hours. Patient was not sure if he wanted to go to emergency room. At 22:00, patient woke up and ate a bit of homemade chicken and rice soup. He fell back to sleep after that. At 22:40, he was still complaining of headache and joint pain throughout body, and pain at injection site was a 5 out of 10. Sensation of tingling in both legs and arm started, while sitting upright. Tingling went away when he laid flat on his back and when he stood up, with mild improvement from the tingling sensation. Every time he sat, the sensation in both his legs and arms would go numb again. Body temperature was 97.4 Fahrenheit (F) and heart rate was 69 beats per minute. Patient went to bed for the night and at 2 AM. Vital signs were checked again. Body temperature dropped to 96.3 Fahrenheit (F) and heart rate was 74 beats per minute. Patient went back to sleep and woke up at 6:00 AM, body temperature was at 96.1 Fahrenheit (F) and heart rate was 65 beats per minute. Left arm pain decreased to a 4 out of 10. Patient went again to medical clinic at 9:30 AM on 10-SEP-2021. Patient looked fine that morning. The action taken with covid-19 vaccine was not applicable. The patient recovered from heart fluttering, hot flash, profusely sweating, lethargic, speaking slower than usual and not in complete sentences, shakiness, body aches, weird, indescribable taste in his mouth, heavy and labored breathing, flushed face, slightly swollen tongue, severe chills, severe joint pain, ear ringing, high fever, and tingling sensation in both legs and arms while sitting upright on 10-SEP-2021, recovered with sequelae from severe headache on 10-SEP-2021, was recovering from injection site arm was extremely tender, and left arm pain, and the outcome of injection site arm was warm to touch, numbness in both leg and arm on sitting and became exhausted again was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210925879-COVID-19 VACCINE-Heart fluttering. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Alcohol use (1 BEER IN EVERY 6 MONTH); Non-smoker

ID: 1706570
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Body temperature; Result Unstructured Data: Low grade fever

Allergies:

Symptom List: Unevaluable event

Symptoms: DIZZINESS; SWEATING BULLETS IN A COOL ROOM, LIKE HAD JUST CLIMBED OUT OF A POOL; BEEFY BODY ACHES; SORE ARM AS THE TECH POKED HUMERUS WITH THE NEEDLE; HEADACHES JUST SHY OF MIGRAINE-STRENGTH; LOW GRADE FEVER; VERY LOW GRADE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, headaches just shy of migraine-strength, low grade fever, and very low grade nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, low grade fever, and very low grade nausea, and the outcome of headaches just shy of migraine-strength was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1706571
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative from social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, it was reported as ''Hi Scientist! Explain why a friend of mine died a week after getting the J & J Vax with blood clots..'' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20210925910-COVID-19 VACCINE AD26.COV2.S-Blood Clots(Fatal). This event is considered un-assessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: BLOOD CLOT

Other Meds:

Current Illness:

ID: 1706572
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/13/2021
Rec V Date: 09/17/2021
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: REDNESS OF SKIN; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-AUG-2021, the patient experienced redness of skin. On 13-AUG-2021, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness of skin, and extreme tiredness on 15-AUG-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706573
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: MUSCLE ACHES SIX WEEKS AFTER GETTING VACCINE; This spontaneous report received from a parent concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced muscle aches six weeks after getting vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle aches six weeks after getting vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706574
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: LITTLE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and heart attack, and concurrent conditions included: open heart surgery, non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little headache was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Open heart surgery (Patient stated his heart surgery has nothing to do with the vaccine.)

ID: 1706575
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: POSSIBLE COVID-19 REINFECTION; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced possible covid-19 reinfection, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and possible covid-19 reinfection was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1706576
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: THREE DEATHS; This spontaneous report received from a consumer via a company representative via social media concerned 3 multiple patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified dates, the 3 multiple patients experienced deaths. As per the reporter, "Well, investigations happened and so far, three deaths in total have been confirmed, connected to the J and J vaccine. On an unspecified dates, the 3 multiple patients died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210925983-CDOVID-19 VACCINE AD26.COV2.S-Three deaths. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1706577
Sex: F
Age:
State: UT

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

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

Lab Data: Test Name: Pain scale; Result Unstructured Data: 7/10

Allergies:

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

Symptoms: LEFT ANKLE SWELLING (LEFT ANKLE APPEAR PUFFY SUCH THAT CAN NOT SEE THE BONES AND LOOKS THIRD BIGGER THAN THE RIGHT ANKLE); LEFT ANKLE PAIN ( FEELS LIKE A CONSTANT THROB, 7/10 PAIN LEVEL, PAIN FELT SHARP WHEN STANDS OR GOES DOWN THE STAIRS); TOP OF THE LEFT FOOT LOOKED DISCOLORED LIKE A LIGHT BRUISE/PURPLE; WANTED TO SLEEP; LEFT FOOT FELT STRAINED IN THE TOP ARCH; REALLY TIRED; SLIGHTLY NAUSEATED; TENDOR TO TOUCH; TENDER RIGHT ARM/LEFT FOOT PAIN/LEFT FOOT FELT TENDER AND MOVED TO THE ENTIRE LEFT ANKLE; RIGHT ARM THROBBED FOR 5 MINUTES AT THE INJECTION SITE; FEELS LIKE A BRUISE THAT'S 2 WEEKS OLD; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 180 pounds, and height was 66 inches. The patient's past medical history included: covid-19 infection, and concurrent conditions included: mold allergy, and heavy metals allergy, and other pre-existing medical conditions included: The patient had not taking daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced right arm throbbed for 5 minutes at the injection site. On 08-SEP-2021, the patient experienced feels like a bruise that's 2 weeks old. On 08-SEP-2021, the patient experienced tender right arm/left foot pain/left foot felt tender and moved to the entire left ankle. On 08-SEP-2021, the patient experienced tendor to touch. On 09-SEP-2021, the patient experienced wanted to sleep. On 09-SEP-2021, the patient experienced left foot felt strained in the top arch. On 09-SEP-2021, the patient experienced really tired. On 09-SEP-2021, the patient experienced slightly nauseated. On 10-SEP-2021, the patient experienced top of the left foot looked discolored like a light bruise/purple. On 14-SEP-2021, the patient experienced left ankle swelling (left ankle appear puffy such that can not see the bones and looks third bigger than the right ankle). On 14-SEP-2021, the patient experienced left ankle pain ( feels like a constant throb, 7/10 pain level, pain felt sharp when stands or goes down the stairs). Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 7/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right arm throbbed for 5 minutes at the injection site on 08-SEP-2021, left foot felt strained in the top arch, and really tired, and slightly nauseated on 10-SEP-2021, was recovering from top of the left foot looked discolored like a light bruise/purple, had not recovered from tender right arm/left foot pain/left foot felt tender and moved to the entire left ankle, left ankle swelling (left ankle appear puffy such that can not see the bones and looks third bigger than the right ankle), left ankle pain ( feels like a constant throb, 7/10 pain level, pain felt sharp when stands or goes down the stairs), feels like a bruise that's 2 weeks old, and tendor to touch, and the outcome of wanted to sleep was not reported. This report was non-serious.

Other Meds:

Current Illness: Allergy to metals; Allergy to molds

ID: 1706578
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: INJECTION SITE LUMP VERY SORE; INJECTION SITE LUMP (HARD LUMP ABOUT THE SIZE OF A QUARTER); INJECTION SITE HARD; SWOLLEN VEINS (BLUE JAGGED LINE EXTENDING FROM THE INJECTION SITE ACROSS HER CHEST TO THE OTHER ARM, LOCATED ON HER FRONT, BELOW THE COLLARBONE ON THE LEFT SIDE); INJECTION SITE WARM TO TOUCH/WARM AT BUMP; FEELS LIKE THERE SOMETHING UNDER HER SKIN THAT SHE RUBBING; MILD HEADACHE (DESCRIBED IT AT THE FRONT OF HER FOREHEAD, AND DESCRIBES FEELING A BIT WARM); INJECTION SITE SWOLLEN; INJECTION SITE RED; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included: tore her other arm, and concurrent conditions included: thin skin, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient have no history of drug abuse or illicit drug usage. The patient had no medical history. The patient past drug history included vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816207, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced injection site lump (hard lump about the size of a quarter). On SEP-2021, the patient experienced injection site hard. On SEP-2021, the patient experienced swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side). On SEP-2021, the patient experienced injection site warm to touch/warm at bump. On SEP-2021, the patient experienced feels like there something under her skin that she rubbing. On SEP-2021, the patient experienced mild headache (described it at the front of her forehead, and describes feeling a bit warm). On SEP-2021, the patient experienced injection site swollen. On SEP-2021, the patient experienced injection site red. Treatment medications included: paracetamol, and trolamine salicylate. On 14-SEP-2021, the patient experienced injection site lump very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site lump very sore, mild headache (described it at the front of her forehead, and describes feeling a bit warm), swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side), and injection site lump (hard lump about the size of a quarter), and the outcome of injection site swollen, injection site red, injection site warm to touch/warm at bump, feels like there something under her skin that she rubbing and injection site hard was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925766.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Skin thinness

ID: 1706579
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 09/17/2021
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: WENT TO THE EMERGENCY ROOM THEY SAID IT WAS HEART; RIGHT ARM WAS 100 PERCENT NUMB FROM THE ELBOW TO FINGER TIPS AND NO FEELING IN PINKY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced went to the emergency room they said it was heart. On APR-2021, the patient experienced right arm was 100 percent numb from the elbow to finger tips and no feeling in pinky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm was 100 percent numb from the elbow to finger tips and no feeling in pinky, and the outcome of went to the emergency room they said it was heart was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706580
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 09/17/2021
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: 20210824; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: human immunodeficiency virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Human immunodeficiency virus syndrome

ID: 1706581
Sex: U
Age:
State: MO

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/17/2021
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: ADMINISTRATION OF EXPIRED VACCINE WHOSE VIAL WAS PUNCTURED AT 8:30 AM STORED IN THE REFRIGERATOR AND THEN ADMINISTERED APPROXIMATELY AT 3:20 PM (7 HOURS AFTER PUNCTURE, 50 MINUTES PAST EXPIRATION); This spontaneous report received from a health care professional concerned multiple patients. 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: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced administration of expired vaccine whose vial was punctured at 8:30 am stored in the refrigerator and then administered approximately at 3:20 pm (7 hours after puncture, 50 minutes past expiration). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine whose vial was punctured at 8:30 am stored in the refrigerator and then administered approximately at 3:20 pm (7 hours after puncture, 50 minutes past expiration) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706583
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 09/17/2021
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 Name: Magnetic resonance imaging head; Result Unstructured Data: Normal; Test Name: Magnetic resonance imaging neck; Result Unstructured Data: Normal

Allergies:

Symptom List: Tremor

Symptoms: SEVERE DEBILITATING VERTIGO; PERIPHERAL PARESTHESIA IN LOWER LEG AND HANDS; FLU SYMPTOMS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043821A, batch number: 0438219, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced flu symptoms. On 17-APR-2021, the patient experienced peripheral paresthesia in lower leg and hands. On 17-APR-2021, the patient experienced severe debilitating vertigo. Laboratory data (dates unspecified) included: Magnetic resonance imaging head (NR: not provided) Normal, and Magnetic resonance imaging neck (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from flu symptoms, had not recovered from peripheral paresthesia in lower leg and hands, and the outcome of severe debilitating vertigo was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706584
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: STROKE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. 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, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stroke within12 hours of the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210926436- COVID-19 VACCINE AD26.COV2.S-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1706585
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 09/17/2021
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: Test Name: Lab test; Result Unstructured Data: not a blood clot

Allergies:

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

Symptoms: SEVERE SWELLING; AFFECTING DAILY LIFE; LYMPH NODE SWOLLEN LEFT SIDE OF BODY; CAN NOT BEND LEGS; REACTION FROM VACCINE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient don't have blood clots. The patient had ruling out orthopedic issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 22-FEB-2022) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced reaction from vaccine. On 25-AUG-2021, the patient experienced can not bend legs. On SEP-2021, the patient experienced lymph node swollen left side of body. On an unspecified date, the patient experienced severe swelling, and affecting daily life. Laboratory data (dates unspecified) included: Lab test (NR: not provided) not a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reaction from vaccine, can not bend legs, severe swelling, lymph node swollen left side of body, and affecting daily life. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706586
Sex: M
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: DOES NOT SEEM LIKE HIMSELF; VOMITING; This spontaneous report received from a consumer 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced does not seem like himself. On SEP-2021, the patient experienced vomiting. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting, and does not seem like himself. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706587
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
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: Condition aggravated; Pain; Cramps; Stools watery; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported. On 07-SEP-2021, the patient experienced condition aggravated. On 07-SEP-2021, the patient experienced pain. On 07-SEP-2021, the patient experienced cramps. On 07-SEP-2021, the patient experienced stools watery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the condition aggravated, pain, stools watery and cramps was not reported. This report was non-serious.

Other Meds:

Current Illness: Crohn's disease; Ulcerative colitis

ID: 1706588
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: COLD SWEATS; PAIN ALL OVER THE BODY; COULD FEEL EACH ONE OF BONES BECAUSE THEY WERE HURTING SO BAD; FEVER THAT WOULD NOT GO DOWN; EXTREME HEADACHE (SWOLLEN BRAIN); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced cold sweats, pain all over the body, could feel each one of bones because they were hurting so bad, fever that would not go down, and extreme headache (swollen brain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold sweats, pain all over the body, could feel each one of bones because they were hurting so bad, fever that would not go down and extreme headache (swollen brain) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706589
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: SEVERE SHIVERING FOR 3 DAYS; This spontaneous report received from a consumer concerned a 25 year old male. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe shivering for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe shivering for 3 days. This report was non-serious. This case, from the same reporter is linked to 20210926966.

Other Meds:

Current Illness:

ID: 1706590
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: VERY ANGRY; NOT FEELING WELL; This spontaneous report received from a patient concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very angry, and not feeling well. The outcome of the not feeling well and very angry was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706591
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: SHIVERING FOR 3 DAYS; This spontaneous report received from a consumer concerned a 25 year old male. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shivering for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering for 3 days. This report was non-serious. This case, from the same reporter is linked to 20210926785.

Other Meds:

Current Illness:

ID: 1706592
Sex: U
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: LEG PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925773.

Other Meds:

Current Illness:

ID: 1706593
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 09/13/2021
Rec V Date: 09/17/2021
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: SEQUENTIAL USE OF JANSSEN COVID-19 VACCINE AFTER USE OF PFIZER COVID-19 VACCINES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: stroke, dementia, high blood pressure, and high cholesterol, and other pre-existing medical conditions included: The patient had no known medication allergies. 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, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162. On 13-SEP-2021, the patient experienced sequential use of janssen covid-19 vaccine after use of pfizer covid-19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use of janssen covid-19 vaccine after use of pfizer covid-19 vaccines was not reported. This report was non-serious.

Other Meds: PFIZER VACCINE

Current Illness: Blood pressure high; Dementia; High cholesterol; Stroke

ID: 1706594
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: TINGLING IN HIS LEGS; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tingling in his legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in his legs was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920710.

Other Meds:

Current Illness:

ID: 1706595
Sex: M
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: BLOOD CLOTS; This spontaneous report received from a consumer via social media concerned multiple male patients of unspecified age, 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 and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, as per the reporter "Blood clots reported in the media for male patients who received the Janssen covid-19 vaccine.". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210928799, 20210929648 and 20210929077.; Sender's Comments: V0: 20210928678-covid-19 vaccine ad26.cov2.s -Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1706596
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/15/2021
Rec V Date: 09/17/2021
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: STIFF NECK; HEADACHES; NUMBNESS IN ARM; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient had no current medical conditions, and was taking no medications besides allergy medications. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced stiff neck. On 15-SEP-2021, the patient experienced headaches. On 15-SEP-2021, the patient experienced numbness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, numbness in arm, and stiff neck. This report was non-serious.

Other Meds:

Current Illness: Penicillin allergy (taking allergy medications)

ID: 1706597
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/17/2021
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: SWOLLEN FACE; RAPID HEARTBEAT; DIFFICULTY WALKING; EYES ARE BLURRY; RIGHT EYE TWITCHING/LIPS SHAKE WHEN SMILE; FEELS LIKE AN ANXIETY ATTACK IN COMING; WEAK MUSCLES; SORE MUSCLES; NAUSEA; HEADACHE; FACE FEEL TIGHT; DIZZY; SHORT OF BREATH; TEETH FEEL FUNNY; JAW FEEL TIGHT; FACE IS DOING WEIRD MOVEMENT; This spontaneous report received from a patient concerned a 57 year old female. 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced dizzy. On 14-SEP-2021, the patient experienced short of breath. On 14-SEP-2021, the patient experienced face is doing weird movement. On 14-SEP-2021, the patient experienced teeth feel funny. On 14-SEP-2021, the patient experienced jaw feel tight. On 14-SEP-2021, the patient experienced face feel tight. On 14-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced swollen face. On 15-SEP-2021, the patient experienced rapid heartbeat. On 15-SEP-2021, the patient experienced difficulty walking. On 15-SEP-2021, the patient experienced eyes are blurry. On 15-SEP-2021, the patient experienced right eye twitching/lips shake when smile. On 15-SEP-2021, the patient experienced feels like an anxiety attack in coming. On 15-SEP-2021, the patient experienced weak muscles. On 15-SEP-2021, the patient experienced sore muscles. On 15-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and short of breath, and the outcome of swollen face, rapid heartbeat, nausea, sore muscles, difficulty walking, face is doing weird movement, eyes are blurry, right eye twitching/lips shake when smile, teeth feel funny, jaw feel tight, headache, feels like an anxiety attack in coming, weak muscles and face feel tight was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706598
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/17/2021
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: FELT LIKE ATTACKING IMMUNE SYSTEM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 14-SEP-2021 18:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-SEP-2021, the patient experienced felt like attacking immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like attacking immune system. This report was non-serious.

Other Meds:

Current Illness:

ID: 1706599
Sex: U
Age:
State: OR

Vax Date:
Onset Date: 03/20/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: JANSSEN COVID-19 VACCINE AS SECOND DOSE AFTER RECEIVING MODERNA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 20-MAR-2021, the patient experienced janssen covid-19 vaccine as second dose after receiving moderna. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine as second dose after receiving moderna was not reported. This report was non-serious.

Other Meds: MRNA 1273

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am