VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1276563
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: NUMBNESS IN LEG; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced numbness in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in leg was not reported. This report was non-serious. This case, from the same reporter is linked.

Other Meds:

Current Illness:

ID: 1276564
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: LOW GRADE FEVER; MUSCLE ACHE; This spontaneous report received from a patient 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, 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 subject experienced low grade fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and muscle ache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276565
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FATIGUE; This spontaneous report received from a patient via a company representative 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, 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 subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious. This case, from the same reporter is linked to 20210453743.

Other Meds:

Current Illness:

ID: 1276566
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: BLOOD CLOT; SEVERE HEADACHE/ FEEL LIKE A CAP ON HER HEAD; This spontaneous report received from a consumer concerned a female of unspecified age. 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, 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 blood clot, and severe headache/ felt like a cap on her head. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache/ feel like a cap on her head and blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: AER 20210455412-Covid-19 vaccine ad26.cov2.s-BLOOD CLOT. 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: 1276567
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXTREME BODY ACHE; CRAY LEG CRAMP; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced extreme body ache, cray leg cramp, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extreme body ache, cray leg cramp and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276568
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FEVER; HEADACHE; NO ENERGY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced no energy. On 27-APR-2021, the subject experienced fever. On 27-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and no energy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276569
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: STOMACH ISSUES; HEADACHES; NAUSEA; This spontaneous report received from a consumer concerned a 55 year old male. 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, expiry: 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 subject experienced stomach issues, headaches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, stomach issues, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276570
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: MID-STROKE; BLOOD CLOTS IN BRAIN; POST STROKE DEPRESSION; CANE USER; This spontaneous report received from a consumer (sister) concerned a 69 year old female. The patient's weight, height, and medical history were not reported. Patient was a completely healthy woman and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency once total, dose, start therapy date was 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 suffered a mid-stroke. Stroke showed that she suffered from blood clots in her brain. All of this happened after receiving Janssen vaccine. Patient had to walk with a cane (coded as cane user) and had been prescribed medication. Patient had to deal with other issues including depression (coded as post stroke depression) because of her new life long issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mid-stroke, blood clots in brain, cane user and post stroke depression was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210455571-Covid-19 vaccine.ad26.cov2.S-MId-stroke,Blood clots in Brain,Post stroke depression. 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: 1276571
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: THROMBOSIS (RED PATCHES ON HANDS, ARMS, LEGS AND FEET); SEVERE MIGRAINES; SEVERE VACCINATION REACTION; This spontaneous report received from a patient via a company representative concerned a 3 decade old male. 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 and expiry date: Unknown) dose, 1 total administered, start therapy date was 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. The patient had a severe vaccination reaction, experienced red patches on hands, arms, legs and feet. The patient had visited the hospital and was diagnosed with thrombosis by the physician. Patient was monitored and later discharged. The patient had reattended hospital for severe migraines, also had contacted centers for disease control and prevention regarding vaccination reaction. The patient was unknown for company representative and had only this information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis (red patches on hands, arms, legs and feet), severe migraines and severe vaccination reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210455657- COVID-19 VACCINE Ad26.COV2. S -Thrombosis, severe migraines , severe vaccination reaction. This event(s) is considered unassessable. The event(s) 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(s).

Other Meds:

Current Illness:

ID: 1276572
Sex: F
Age:
State: NH

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: ITCHY LEGS; LEG SHAKING; SWELLING OF LEGS/FEET; TOENAILS TURNING BLUE; TIRED; This spontaneous report received from a patient concerned a 27 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced swelling of legs/feet. On 09-APR-2021, the subject experienced toenails turning blue. On 28-APR-2021, the subject experienced leg shaking. On an unspecified date, the subject experienced itchy legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, had not recovered from swelling of legs/feet, and the outcome of toenails turning blue, leg shaking and itchy legs was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276573
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HEADACHE; FELT TIRED; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. 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 was not reported, administered on 27-APR-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 subject experienced headache. On APR-2021, the subject experienced felt tired. On APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, felt tired and nausea was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276574
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: NEUROLOGICAL SHAKING; LOSS OF APPETITE; WEAKNESS; This spontaneous report received from a consumer concerned a 49 year old male. 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: 1808941 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced neurological shaking. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological shaking, loss of appetite, and weakness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276575
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, 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 subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276576
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276577
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; 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 attention deficit disorder, back pain, cigarette smoker, and cough, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.

Other Meds:

Current Illness: Attention deficit disorder; Back pain; Cigarette smoker (Patient smoked all her life but cough was not like it is since taking vaccine); Cough (Patient smoked all her life but cough was not like it is since taking vaccine)

ID: 1276578
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: WEIRD FEELING; NO STRENGTH IN HAND; GROGGY HEAD; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced weird feeling. On APR-2021, the subject experienced no strength in hand. On APR-2021, the subject experienced groggy head. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 28-APR-2021, and the outcome of weird feeling, no strength in hand and groggy head was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died: 04/27/2021

ID: 1276579
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 04/26/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DEATH; NON-RESPONSIVE; NOT FEELING WELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included on blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,1 total, 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. The consumer had called and stated that their father had passed away and had received JANSSEN covid 19 vaccine 10 to 12 days before. On 26-Apr-2021 the patient was non responsive, lethargic, seemed out of it and was not feeling well. The patient was on blood thinners. On 27-Apr-2021 the consumer's father had passed away, the consumer was still waiting for the cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 27-APR-2021, and the outcome of non-responsive, not feeling well was not reported. This report was serious (Death, Medically significant).; Sender's Comments: 20210456243-covid-19 vaccine ad26.cov2.s -Death, Non responsive. 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: CAUSE OF DEATH UNKNOWN

Other Meds:

Current Illness:

ID: 1276580
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/20/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: SORE LUMP TO LEFT CALF AREA; BRUISE ON CALF; BIG BROWN SPOT ON LEFT CALF; LEG SPASM WITH MUSCLE TIGHTNESS AND PAIN TO LEFT SIDE HIP TO KNEE AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bad wiring heart condition, neuropathy, arthritis through out the body, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, sacubitril valsartan sodium hydrate for heart condition, and montelukast sodium for seasonal allergies. On 20-APR-2021, the subject experienced leg spasm with muscle tightness and pain to left side hip to knee area. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. On 26-APR-2021, the subject experienced big brown spot on left calf. On 27-APR-2021, the subject experienced sore lump to left calf area. On 27-APR-2021, the subject experienced bruise on calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg spasm with muscle tightness and pain to left side hip to knee area, and bruise on calf on 28-APR-2021, and big brown spot on left calf on 27-APR-2021, and had not recovered from sore lump to left calf area. This report was non-serious.

Other Meds: IBUPROFEN; ENTRESTO; SINGULAIR

Current Illness: Arrhythmia; Arthritis; Neuropathy; Seasonal allergy

ID: 1276581
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/16/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: WHITE BLOOD CELL COUNT INCREASE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stage iii myelofibrosis, and penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced white blood cell count increase. Laboratory data included: WBC (NR: not provided) 109.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of white blood cell count increase was not reported. This report was non-serious.

Other Meds:

Current Illness: Myelofibrosis; Penicillin allergy

Date Died:

ID: 1276582
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DEATH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown cause of death. 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 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient received the Janssen COVID-19 vaccine and then died 15 days later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). .; Sender's Comments: V0-20210456256- COVID-19 VACCINE AD26.COV2.s.adverse effect . This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1276583
Sex: M
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HIVES ALL OVER THE BODY; This spontaneous report received from a physician concerned a male of unspecified age. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced hives all over the body. Laboratory data (dates unspecified) included: CBC (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) Normal, and WBC (NR: not provided) 10.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over the body. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276584
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: FELT LIKE ARM IS KILLING; INJECTION SITE HURTING; This spontaneous report received from a patient 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 was not reported, administered on 24-MAR-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 an unspecified date, the subject experienced felt like arm is killing, and injection site hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site hurting and felt like arm is killing was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276585
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VOMITING; SWEATING; BODY CHILLS; FEVER; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, 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 subject experienced vomiting, sweating, body chills, fever, headache, fatigue, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body chills, sweating, headache, fatigue, nausea and vomiting was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276586
Sex: M
Age:
State: GA

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: LEFT LEG PAIN; HEADACHES; This spontaneous report received from a parent concerned a 25 year old male. 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) no findings. On 11-APR-2021, the subject experienced left leg pain. On 11-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headaches, and left leg pain. This report was non-serious. This case, from the same reporter is linked to 20210456965.

Other Meds:

Current Illness:

ID: 1276587
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: DIZZINESS WHEN SUPINE; KNEE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery - complete knee replacement, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: CAT scan (NR: not provided) unknown. On 12-APR-2021, the subject experienced knee pain. On 19-APR-2021, the subject experienced dizziness when supine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain on 28-APR-2021, and had not recovered from dizziness when supine. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Penicillin allergy

ID: 1276588
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 57 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's past medical history included previous back injury, and concurrent conditions included alcohol intake 2-3 beers a day, and smoking 1-2 cigarettes per month, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and vaccination site not reported, batch number: 1808607 or 1808609, expiry: UNKNOWN) administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, patient experienced pain and tingling sensation on his back but he still went to work. On 16-APR-2021, he did not go to work, tingling sensation started going on his hands. On 17-APR-2021, patient went to the emergency clinic, and was told the symptoms might be cause by herniated disc. On 19-APR- 2021, he went to fill out worker's compensation and was seen by his worker's comp doctor. X-ray was taken and showed some abnormality in the neck area. On 20-APR-2021, symptoms worsened and patient was paralyzed from the shoulder down. On 21-APR-2021, patient went to the hospital and was admitted. Magnetic resonance imaging (MRI) found nothing on patient's neck and showed old back injury, but per patient's doctor it should not cause the paralysis. Unspecified additional tests were done, and Guillain-Barre Syndrome was diagnosed. On 25-APR-2021, hospital physician ruled out other causes and confirmed that Guillain-Barre Syndrome (GBS) was caused by Janssen COVID vaccine. At the time of report, the patient was intubated at the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Life Threatening).; Sender's Comments: V0: 20210456333-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome . 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; Cigarette smoker

ID: 1276589
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 04/23/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: NOSE BLEED; LOSS OF APPETITE; DIARRHEA; LOW GRADE FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and samter's triad disease, and other pre-existing medical conditions included patient have allergies . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, cetirizine hydrochloride, estradiol, fluticasone propionate, guaifenesin, hydroxyzine, ibuprofen, lansoprazole, levothyroxine sodium, montelukast sodium, omalizumab, and pseudoephedrine. From 20-MAR-2021 the subject experienced a low grade fever, extreme fatigue, diarrhea, headache, and nose bleed till 29-MAR-2021. On 23-APR-2021, the subject again experienced nose bleed, loss of appetite, diarrhea and low grade fever ,her fever reduced to a low grade on 27-APR-2021. On 23-APR-2021, the subject experienced headache, extreme fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) over 100 degree, and COVID-19 (NR: not provided) Negative (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, diarrhea, headache, extreme fatigue, nose bleed, and loss of appetite. This report was non-serious.

Other Meds: ESTRADIOL; SYNTHROID; ADVIL [IBUPROFEN]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR; PREVACID; BABY ASPIRIN; PSEUDOEPHEDRINE; GUAIFENESIN; XOLAIR; FLOVENT; HYDROXYZINE

Current Illness: Aspirin-exacerbated respiratory disease; Asthma

ID: 1276590
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
Hospital: Y

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: CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a 45 year old male. 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: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1276591
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/27/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MUSCLE WEAKNESS; SEVERE HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 120 pounds, and height was 165 centimeters. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. the patient was not pregnant at the time of report.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced muscle weakness. On 27-APR-2021, the subject experienced severe headache. On 27-APR-2021, the subject experienced extreme fatigue. Laboratory data included: Pain scale (NR: not provided) 7/10 severe headache with a pain level. On 28-APR-2021, Laboratory data included: Pain scale (NR: not provided) 1/10 severe headache with a pain level drops. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, extreme fatigue, and muscle weakness. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1276592
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: COLD; SHAKING; This spontaneous report received from a patient 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, 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 subject experienced cold, and shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold, and shaking. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276593
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: INFLAMMATION AT INJECTION SITE; MUSCLE ACHE; REDNESS AT INJECTION SITE; HEADACHE; LEG PAIN; KNEE PAIN; MUSCLE KNOT; This spontaneous report received from a patient concerned a 35 year old female. 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced muscle knot. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced knee pain. On 10-APR-2021, the subject experienced inflammation at injection site. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced redness at injection site. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation at injection site, muscle ache, redness at injection site, and headache, and had not recovered from knee pain, muscle knot, and leg pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276594
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HARDLY ABLE TO WALK; LEGS HURT- NUMBNESS TO BOTH LEGS; 'FEELING VERY TIRED' WORSE WITH WALKING; SORE THROAT; HEADACHE -ALL THE TIME; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced headache -all the time. On 09-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced hardly able to walk. On 12-APR-2021, the subject experienced legs hurt- numbness to both legs. On 12-APR-2021, the subject experienced 'feeling very tired' worse with walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, and had not recovered from headache -all the time, legs hurt- numbness to both legs, hardly able to walk, and 'feeling very tired' worse with walking. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276595
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BODY ACHES; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, nausea, and headache on 14-APR-2021. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (one glass of wine per month); Non-smoker

ID: 1276596
Sex: F
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: BODY ACHE; CHILLS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a 23 year old female. 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: not reported) 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 subject experienced body ache, chills, and low fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low fever and body ache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276597
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: BODY PAIN; FEELING TIRED; This spontaneous report received from a patient 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, 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. Concomitant medications included dienogest/estradiol valerate for contraceptive method. On an unspecified date, the subject experienced body pain, and feeling tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling tired and body pain was not reported. This report was non-serious.

Other Meds: QLAIRA

Current Illness:

ID: 1276598
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BRUISING ALL OVER BODY; VAGINAL BLEEDING; PAIN; PAIN IN ARM; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 07-APR-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 subject experienced bruising all over body. On APR-2021, the subject experienced vaginal bleeding. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising all over body, vaginal bleeding, muscle ache, pain and pain in arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276599
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CHEST PAIN; ANXIETY; MUSCLE PAIN; FATIGUE/TIREDNESS; This spontaneous report received from a patient 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: 1808482, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chest pain, anxiety, muscle pain, and fatigue/tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, fatigue/tiredness, muscle pain and anxiety was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276600
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcoholic (The 4 glasses of wine per week (weekends only). and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced swelling of tongue when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 11-MAR-2021 18:44 in left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021 she had performed antibody test at Doctor's office that was negative. she Had second antibody test on April 15th which was negative as well, which was considered a 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).; Sender's Comments: V0: 20210456470-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Alcoholic (The 4 glasses of wine per week (weekends only).); Non-smoker

ID: 1276601
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FELT HAD NOT SLEPT MUCH; INJECTION SITE TENDER TO TOUCH; 1 INCH LUMP AT INJECTION SITE; PAIN AT INJECTION SITE; TIREDNESS/FATIGUE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and bladder issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paroxetine for hypertension. On 06-APR-2021, the subject experienced 1 inch lump at injection site. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced tiredness/fatigue. On an unspecified date, the subject experienced felt had not slept much, and injection site tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and tiredness/fatigue, had not recovered from 1 inch lump at injection site, and injection site tender to touch, and the outcome of felt had not slept much was not reported. This report was non-serious.

Other Meds: PAROXETINE

Current Illness: Bladder disorder; Hypertension

ID: 1276602
Sex: F
Age: 46
State: MA

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: LIP SWELLING; HIVES; SEAFOOD ALLERGY; BODY HOT; SORE LYMPH NODES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, treatment medications included: oxycodone/paracetamol. On 07-MAR-2021 17:00, the subject experienced sore lymph nodes. On 10-MAR-2021, the subject experienced body hot. On APR-2021, treatment medications included: epinephrine. On 13-APR-2021, the subject experienced seafood allergy. On 13-APR-2021, the subject experienced hives. On 20-APR-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore lymph nodes on 09-MAR-2021, had not recovered from seafood allergy, and body hot, and the outcome of hives and lip swelling was not reported. This report was non-serious.

Other Meds:

Current Illness: Shellfish allergy (After taking lobster and scallop causes hives and swelling on lips. she had never before this.)

ID: 1276603
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 03/18/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.

Other Meds: AMOXICILLIN; STEROIDS

Current Illness: Alcohol use (once every 3-5 months); Cigarette smoker; Drug allergy

ID: 1276604
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: NEGATIVE ANTIBODIES; This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, administered on 24-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 24-MAR-2021, the subject experienced negative antibodies. On 28-APR-2021, Laboratory data included: IgG (NR: not provided) Negative, and IgM (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative antibodies was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276605
Sex: M
Age:
State: ID

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A PUNCTURE VACCINE VIAL WAS ADMINISTER AFTER 18HRS; This spontaneous report received from a pharmacist concerned a 73 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced a puncture vaccine vial was administer after 18hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a puncture vaccine vial was administer after 18hrs was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276606
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DIARRHEA; RASH (3 INCHES RED SPOT AND BLUE SPOT ON LEG AND ARM); NAUSEA; HEADACHE(ELECTRIC SHOCK LIKE FEELING); HOT FLASHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced rash (3 inches red spot and blue spot on leg and arm). On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headache (electric shock like feeling). On 15-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 22-APR-2021, and had not recovered from rash (3 inches red spot and blue spot on leg and arm), nausea, headache(electric shock like feeling), and hot flashes. This report was non-serious.

Other Meds:

Current Illness: Hypertension; Smoker

ID: 1276607
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: FATIGUE; HEADACHE; This spontaneous report received from a patient 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, 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 subject experienced fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276608
Sex: M
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: COUGH; FEELS BAD; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on 01-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 subject experienced cough, and feels bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough and feels bad was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276609
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: BURNING SENSATION IN THE GROIN AREA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included groin discomfort, and covid 19 infection. The patient was previously treated with steroids for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, and antibiotics 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 12-APR-2021, the subject experienced burning sensation in the groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation in the groin area. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276610
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: LONG HEAVY PERIOD WITH CLOTS; LOWER BACK PAIN; SLEEPINESS; WEAK; HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included seasonal allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced long heavy period with clots. On 12-APR-2021, the subject experienced lower back pain. On 12-APR-2021, the subject experienced sleepiness. On 12-APR-2021, the subject experienced weak. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long heavy period with clots, headache, lower back pain, weak, and sleepiness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276611
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPIRED PRODUCT ADMINISTERED; OFF LABEL USE; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a 62 year old female. 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, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced expired product administered. On 28-APR-2021, the subject experienced off label use. On 28-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired product administered, off label use and medication error was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1276612
Sex: F
Age:
State: KY

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FEVER; BURNING IN EYES; COUGH; HEADACHE; CHILLS; INJECTION SITE PAIN; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included seasonal allergies, and non-alcoholic, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. Cigarette smoking: half-a-pack a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1808980) dose was not reported, administered on 07-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced nausea. On 24-APR-2021, the subject experienced headache. On 25-APR-2021, the subject experienced cough. On 26-APR-2021, the subject experienced fever. On 26-APR-2021, the subject experienced burning in eyes. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.0 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, injection site pain, tiredness, and nausea on 08-APR-2021, had not recovered from fever, headache, and cough, and the outcome of burning in eyes was not reported. This report was non-serious.

Other Meds:

Current Illness: Cigarette smoker

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm