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: 1329040
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1329048
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: you still can get Shingles after having the shot because I did!; you still can get Shingles after having the shot because I did!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1329049
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: I've had the vaccine, too. But I have had the shingles since; I've had the vaccine, too. But I have had the shingles since. A very mild case; Pain; Numbness / Still having numbness; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and numbness. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles and numbness were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain and numbness to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received shingles vaccine and experienced shingles, pain, numbness and a mild case with no blisters. The reporter mentioned that, patient still had numbness. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1329051
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/09/2020
Rec V Date: 05/19/2021
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: Shingles / into eye; Double dose vaccine / he got it / One year later he got shingles so bad / covered from hairline, accross eyebrow, eyelid and into the eye; Scabs have healed; Still has nerve damage with daily attacks; Still has nerve damage with daily attacks; Double dose vaccine / he got it / One year later he got shingles so bad / suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had twice, pretty bad each time). Previously administered products included Shingles vaccine (one dose vaccine received on an unknown date) and Acyclovir (took for years because the one dose vaccine would not work for him and was told he did not need acyclovir and to stop taking it). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 9th May 2020, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and neurological symptom. On 9th May 2021, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, scab and nerve damage. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and scab were recovered/resolved and the outcome of the nerve damage and neurological symptom were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, scab, nerve damage and neurological symptom to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. In 2019, the patient received the both doses of Shingles vaccine (double dose vaccine). One year later (the day before Mother's Day 2020), the patient got shingles so bad he was covered from hairline, across eyebrow, eyelid and into eye. The reporter stated that even though the scabs had healed the patient still had nerve damage with daily attacks and was lucky that his eye has healed with no significant damage. The reporter mentioned that during treatment they had learned that there were lots of people like this patient. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104433, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104433:Same reporter. Master case: "lots of people"

Other Meds:

Current Illness:

ID: 1329052
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: I've had both shots. I had shingles a few years ago, but a mild case! / suspected vaccination failure; had shingles a few years ago, but a mild case!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated he/she had both Shingles shots and had shingles a few years ago but was mild case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1329053
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: suspected vaccination failure; Shingles / into eye; Double dose vaccine / got it / One year later got shingles / lots of people like him; So bad / lots of people like him; Scabs have healed / lots of people like him; Still has nerve damage with daily attacks / lots of people like him; This case was reported by a consumer and described the occurrence of suspected vaccination failure in an unknown number of adult patients who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, feeling bad, scab and nerve damage. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage were unknown. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was selected as adult as per vaccine indication. It was reported that lots of patients got shingles so bad he and covered from hairline, across eyebrow, eyelid and into eye. The patient also experienced scabs and nerve damage. This case was considered as suspected vaccination failure as detail regarding time to onset and laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104425, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104425:Same reporter. Husband's case. US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case.

Other Meds:

Current Illness:

ID: 1329071
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/19/2021
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: ANAPHYLAXIS; HOT AND BRUISED SHOULDER; FLUSHING; BODY ACHES; LOSS OF FEELING IN FACE; LOSS OF APPETITE; VOMITING; CAN NOT SLEEP; CAN NOT DRINK WATER; STOMACH FEELS LIKE SODA; SWOLLEN ARM AND SHOULDER; COULD NOT MOVE FINGER; VERY HOT LEFT ARM; LEFT ARM SENSITIVE TO TOUCH; HOT SHOULDER; LOWER BACK PAIN; DEHYDRATED; SORE ARM; RASH; HIVES AND BUMPS AROUND THE INJECTION SITE; WEAKNESS; INJECTION SITE PAIN; HEADACHE; VERY TENDER ARM AND SHOULDER; TERRIBLE NAUSEA; FEVER; LOSS OF TASTE; LOSS OF SMELL; BRUISE ON LEFT WRIST; PALMS TURNED BLUE FROM CLAPPING; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, crohn's disease, heart murmur, chronic vertigo, panic attack disorder, depression, drug allergy, fish allergy, and perimenopause, anxiety and other pre-existing medical conditions included patient had no drug abuse or illicit drug, patient is allergic to all the narcotics, passes large clots of blood during menstruation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, administered on 06-MAY-2021 13:15 for prophylactic vaccination. Concomitant medication included meclozine for vertigo. After receiving vaccination the first thing she felt like there was hot lava going down her left arm ( where she got injected) and she could not move her finger then that went away after 10-15 minutes later. they told her that symptom was normal and everyone experience the same kind of symptom. She completely lost her appetite, the smell of food made her sick ever since she got the shot. Patient stated her left arm was very hot, sensitive to the touch, bumpy around the injection site and sore. all these symptoms were the same day of her shot (on 6-MAY-2021). since the injection she had the headache and it wont go away and she still has the headache today. her relative was telling her that her shoulder was hot. she had body aches ( lower back pain and everywhere, the pain was moving though her body). the second day everything got worse; her arm where she received the injection her whole shoulder was black it looks like if someone threw brick at her, she had hives and bumps around the injection site. she cannot sleep, she cannot eat and she cannot drink water. she was tired and she was not feeling good. she had anaphylaxis 30 hours, dizziness, loss of feeling in her face, her heart was racing. she took two tablets of antihistamine to manage the anaphylaxis reaction. 30 hours after the vaccination she has dizziness, wheezing, she had flushing , rapid pulse, she was throwing up for hours then she had to take the antihistamine. On an unspecified date patient had weakness. Patient said that her fever gets worse every day. On the day of vaccination (on 6-MAY-2021) her temperature was 99.4, and has checked it 5 to 6 times with the same reading. on 7-MAY-2021 it was 99.6 and on 8-MAY-2021 it was 100.3. she said it felt like both sides of her throat were touching. Patient had barely been able to eat since 6-MAY-2021, but has been able to drink small amounts of water. Patient stated her saliva makes her nauseated. On 10-MAY-2021 she clapped her hands and they turned blue and also developed an egg shaped bump/hematoma on her left wrist after bumping it. She went to urgent care where she was instructed to use ice pack for bump, which gave her no relief. There, she was stuck with a needle 4 times to get blood work because she was dehydrated. Patient stated that her whole body felt like a walking pin cushion and skin was hypersensitive. Urgent care checked platelets and hemoglobin which came back normal. Patient stated her menstrual cycle started on 10-MAY-2021 was different than usual with super heavy, red flow, no clots, and soaked pad in an hour, it was slowed down since but flow was heavy. Urgent care advised this may be normal due to change of hormone during perimenopause. As of today, patient could not smell or taste anything. Patient was taking antihistamines 2 a day. Temperature was normal. Patient stated nausea and vomiting were better but would definitely come back if she stopped taking meclizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move finger, had not recovered from sore arm, headache, loss of appetite, vomiting, injection site pain, stomach feels like soda, terrible nausea, swollen arm and shoulder, feels like both sides of throat are touching, weakness, bruise on left wrist, loss of taste, and loss of smell, and the outcome of sore body, hot and bruised shoulder, rash, anaphylaxis, flushing, body aches, not feeling good, dizziness, loss of feeling in face, wheezing, rapid pulse, hives and bumps around the injection site, can not sleep, can not drink water, fever, very tender arm and shoulder, very hot left arm, left arm sensitive to touch, hot shoulder, lower back pain, palms turned blue from clapping and dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516682-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds: MECLIZINE [MECLOZINE]

Current Illness: Abstains from alcohol; Anxiety; Crohn's disease; Depression; Drug allergy; Fish allergy; Heart murmur; Menorrhagia; Panic attack; Perimenopause; Smoker; Vertigo

ID: 1329072
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/28/2021
Rec V Date: 05/19/2021
Hospital: Y

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: STROKE; SORE ARM; 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 hypertension, and diabetes type 2.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 04-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On unspecified date, the patient had sore arm. On 28-MAR-2021, the patient's right peripheral vision was gone and went to emergency room and diagnosed with stroke. The patient got hospitalized. At hospital, alteplase was administered as the treatment medication for stroke. Patient was discharged on 02-APR-2021. The magnetic resonance imaging (MRI) has shown small spot (stroke confirmed) while Computerized axial tomography scan (CAT) scan did not show the stroke. The patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 02-APR-2021 and the outcome of sore arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;20210518127-covid-19 vaccine ad26.cov2.s-Stroke. 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: MEDICAL HISTORY, UNDERLYING DISEASE.

Other Meds:

Current Illness: Hypertension; Type II diabetes mellitus

ID: 1329073
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/19/2021
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: STROKE; SHORT WINDED; This spontaneous report received from a patient concerned a 78 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg around 10 year ago, and concurrent conditions included high blood pressure, social drinker, hole in heart from birth, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. 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 left arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel bisulfate, colecalciferol, escitalopram, finasteride, gabapentin, hydroxychloroquine sulfate, levothyroxine, lisinopril, thioctic acid, ticagrelor and verapamil hydrochloride were drug used for unknown indication. On 12-APR-2021, the patient experienced headaches, which lasted 1 week. On 18-APR-2021, the patient had CT scan (computerized tomography) result was not reported. Patient was sent home for tension headache. On same day, patient had also experienced no energy. On 19-APR-2021, the patient was Hospitalized for MRI (Magnetic resonance imaging) which showed patient had stroke within 5 days and also had plaque around the brain. Patient was started on Plavix and aspirin. On 21-APR-2021, the patient discharged from hospital. On same date, the patient went to cardiologist to have monitor placed where patient had another stroke and patient was readmitted to the hospital. patient was taken off Plavix and started on Lisinopril and placed on heart monitor. On 23-APR-2021, the patient was discharged from hospital. Patient was hospitalized for 5 days. On APR-2021 patient had experienced down hill, short winded and voice was gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and had not recovered from short winded. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210518146-COVID-19 VACCINE AD26.COV2.S-Stroke. 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: MEDICAL HISTORY

Other Meds: ASPRIN; LISINOPRIL; CLOPIDOGREL BISULFATE; VERAPAMIL HCL; BRILINTA; ATORVASTATIN; GABAPENTIN; LEVOTHYROXINE; HYDROXYCHLOROQUINE SULFATE; FINASTERIDE; ESCITALOPRAM; VITAMIN D3; ALPHA LIPOIC ACID

Current Illness: Blood pressure high; Cardiac disorder; Non-smoker; Social alcohol drinker (On special occasions.)

ID: 1329074
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 05/19/2021
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: MPV IS HIGH; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Mean platelet volume (NR: not provided) Normal. On 08-APR-2021, the subject experienced mpv is high. Laboratory data included: Mean platelet volume (NR: not provided) High. The action taken with covid-19 vaccine was not applicable. The outcome of mpv is high was not reported. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness:

ID: 1329075
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: HEART PAIN; LEG PAIN; 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 (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 subject experienced heart pain, and leg pain. The action taken with covid-19 vaccine was not applicable. The outcome of the heart pain and leg pain 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:

ID: 1329076
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 05/19/2021
Hospital: Y

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: MULTIPLE BLOOD CLOTS ON BOTH SIDES OF THE LUNGS/NAUSEA(THREW UP BLOOD TWICE)/BLACK STOOL (WAS LIKE DIARRHEA)/FEVER/OXYGEN WAS ON 80S/; WEIRD TASTE (AWFUL); BONE PAIN/BONE PAIN AS BONES FELT LIKE A GLASS/PAINFUL (ANYTHING THAT TOUCHED WAS HURTING); SORE ARM; POSITIVE COVID TEST (RAPID TEST)/CAME POSITIVE BOTH TIMES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old White and Non Hispanic or Latino 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: Unknown, expiry: unknown) dose was not reported,1 total dose administered on 10-APR-2021 on left arm as prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 10-APR-2021, 5 hours after the vaccination, the patient started experiencing headache. On an unknown date the patient experienced sore arm for about a week. On an unknown date the patient experienced bone pain as felt like a glass, painful and anything that touched was hurting. On an unknown date the patient experienced weird taste that was awful. On 16-APR-2021 the patient tested positive for covid-19 (rapid test) (coded as: suspected covid-19). On 17-APR-2021 the patient was again tested positive for covid-19 (rapid test) on both time tested as positive. On 17-APR-2021 the patient experienced 2 episodes nausea (threw up blood twice) before visiting hospital and at the hospital. On an unknown date the patient experienced black stool (was like diarrhea). On 18-APR-2021 the patient had body temperature 100.8 to 100.9 and went to hospital again there diagnosed with multiple blood clots on both sides of the lungs. On an unspecified date the patient was taken with tums and pedialyte for an unknown indication. The patient was treated with tylenol (for an unknown indication), nausea medicine, steroids, blood thinner and oxygen (for oxygen level in 80s). On 21-APR-2021 the patient was discharged from hospital. The patient was hospitalized for 4 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. On 26-APR-2021 the patient was recovered from headache. On an unknown date the patient was recovered from sore arm and not recovered from multiple blood clots on both sides of the lungs/nausea(threw up blood twice)/black stool (was like diarrhea)/fever/oxygen was on 80s/, and the outcome of positive covid test (rapid test)/came positive both times, weird taste (awful) and bone pain/bone pain as bones felt like a glass/painful (anything that touched was hurting) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000179162 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210521944.; Sender's Comments: V0: 20210520244-Covid-19 vaccine ad26.cov2.s-multiple blood clots on both sides of the lungs. 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: 1329077
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: ROCKHARD TUMORS IN BREAST; CONGESTION; CANNOT STAND UP; DIZZINESS; SHAKING; SWELLING OF FEET; CANNOT EAT MUCH; SICK; CANNOT WALK; VOMITING; FALL; LEGS HURT; NO STRENGTH; TROUBLE HOLDING THINGS; HEADACHE; TIRED; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient stated that she had breast cancer before and undergone chemo radiation last year. she stated that her left breast is missing. She was on chemo radiation per three week. The patient stated that she had been through two rotator cuff surgeries with joints replacement and metal screws in 2011 and her concurrent conditions included non alcoholic, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-MAR-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 congestion, she was unable to stand and shaking up, she felt dizziness and fall. The patient also experienced swelling of her feet, she was not eating much and feeling sick, with difficulty in walking and was vomiting. She was not doing good as she noticed large rock-hard tumors had popped up in her breast after covid shot, her legs were crumbled, she had no strength and experienced trouble in holding things even had headache, felt tired and nauseous. The patient stated that she don't drive she don't use caffeine, her limb was crippled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot stand up, dizziness, shaking, swelling of feet, legs hurt, headache, congestion, tired, cannot eat much, sick, nausea, no strength, trouble holding things, cannot walk, vomiting, rock-hard tumors in breast and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521006- Covid-19 vaccine ad26.cov2.s-Rock hard tumors in breast. 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: MEDICAL HISTORY

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

Date Died:

ID: 1329078
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: REACTION TO COVID VACCINE; This spontaneous report received from a patient concerned a 45 year old female of unspecified race and ethnicity. The patient's weight was 88.2 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and 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. The patient received epoprostenol sodium (form of admin unknown, intravenous, batch number: MM248M0101 expiry: 30-JUN-2022) 1.5 mg, frequency, and therapy dates were not reported for drug used for unknown indication. Concomitant medications included macitentan and warfarin for drug used for unknown indication. On an unspecified date, the patient experienced reaction to covid vaccine, and was hospitalized on 07-MAY-2021. On an unspecified date, the patient died from reaction to covid vaccine. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of epoprostenol sodium was not changed. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210521894-COVID-19 VACCINE AD26.COV2.S-REACTION TO COVID VACCINE. This event(s) is considered not related. 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).; Reported Cause(s) of Death: REACTION TO COVID VACCINE

Other Meds: OPSUMIT; WARFARIN

Current Illness: Primary pulmonary hypertension

ID: 1329079
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 04/27/2021
Rec V Date: 05/19/2021
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: BACK PAIN; PAIN IN LEFT SIDE OF CHEST; ARMS PAIN; BODY PAIN/EXCRUCIATING PAIN; FELT SO SICK; CHILLS; NAUSEA; TIREDNESS/EXHAUSTED; BURNING SENSATION ON RIGHT ARM; COLD AS INSIDE AN IGLOO; DIZZINESS; ABDOMINAL PAIN; PAIN IN THE BONES OF THE CHEST; BURNING SENSATION ON RIGHT ARM THAT EXTENDED TO ABDOMEN; SWEATING; HEAVINESS IN RIGHT ARM; TIGHTNESS ON THE RIGHT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 158 pounds, and height was 159 centimeters. The patient's concurrent conditions included hereditary condition called g6pd, type 2 diabetes, osteoporosis, allergy to sulfa based meds, allergy to soy, non smoker, non alcohol user, and tetracycline allergy, and other pre-existing medical conditions included there was no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported. On 2021, the subject experienced tightness on the right arm. On 2021, the subject experienced sweating. On 2021, the subject experienced heaviness in right arm. On 27-APR-2021, the subject experienced abdominal pain. On 27-APR-2021, the subject experienced pain in the bones of the chest. On 27-APR-2021, the subject experienced burning sensation on right arm that extended to abdomen. On 27-APR-2021, the subject experienced dizziness. On 27-APR-2021, the subject experienced cold as inside an igloo. On 27-APR-2021, the subject experienced felt so sick. On 27-APR-2021, the subject experienced chills. On 27-APR-2021, the subject experienced nausea. On 27-APR-2021, the subject experienced tiredness/exhausted. On 27-APR-2021, the subject experienced burning sensation on right arm. On 10-MAY-2021, the subject experienced body pain/excruciating pain. On 11-MAY-2021, the subject experienced back pain. On 11-MAY-2021, the subject experienced pain in left side of chest. On 11-MAY-2021, the subject experienced arms pain. Laboratory data included: Chest X-ray (NR: not provided) Negative for heart attack, and ECG (NR: not provided) Negative for heart attack. Treatment medications (dates unspecified) included: ketorolac tromethamine, paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from abdominal pain, chills, pain in the bones of the chest, dizziness, tiredness/exhausted, nausea, body pain/excruciating pain, and cold as inside an igloo, and the outcome of burning sensation on right arm that extended to abdomen, felt so sick, pain in left side of chest, arms pain, heaviness in right arm, burning sensation on right arm, sweating, back pain and tightness on the right arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

Other Meds:

Current Illness: Abstains from alcohol; Glucose-6-phosphate dehydrogenase deficiency; Non-smoker; Osteoporosis; Soy allergy; Sulfonamide allergy; Type II diabetes mellitus

ID: 1329080
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: ON A VENTILATOR; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, start therapy date were not reported 1 in 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, following vaccination, the patient was put on a ventilator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a ventilator was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210523218-covid-19 vaccine ad26.cov2.s -On a ventilator . 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: 1329081
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/29/2021
Rec V Date: 05/19/2021
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: LEGS WERE RUBBERY; TIRED FEELING FROM BOTTOM TO MY NECK/ARMS AND CHEST TIRED; HAD SHORTNESS OF BREATH; VERY LIGHT-HEADED/VERY DIZZY; FEEL BEAT UP; NO ENERGY; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, chronic bronchitis, macular degeneration, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 20UA21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included rivaroxaban for atrial fibrillation, atorvastatin, calcium carbonate/colecalciferol, diltiazem, dofetilide, ergocalciferol, and spironolactone. On 2021, the subject experienced feel beat up. On 2021, the subject experienced no energy. On 29-APR-2021, the subject experienced very light-headed/very dizzy. On 30-APR-2021, the subject experienced legs were rubbery. On 30-APR-2021, the subject experienced tired feeling from bottom to my neck/arms and chest tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from very light-headed/very dizzy on 2021, and tired feeling from bottom to my neck/arms and chest tired on 05-MAY-2021, was recovering from feel beat up, and the outcome of legs were rubbery, no energy and had shortness of breath 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: XARELTO; TIKOSYN; DILTIAZEM; SPIRONOLACTONE; ATORVASTATIN; CALTRATE D3; VITAMIN D [ERGOCALCIFEROL]

Current Illness: Abstains from alcohol; Atrial fibrillation; Chronic bronchitis; Macular degeneration; Non-smoker

ID: 1329082
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/19/2021
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: FLUTTERING FEELING AROUND HEART; HOT FLASHES; This spontaneous report received from a patient concerned a 60 year old Not Hispanic or Latino African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, menopause and other pre-existing medical conditions included the patient had drug allergies. past unremarkable history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced hot flashes and On 07-APR-2021 experienced cardiac flutter and fast beating of heart. She stated hot flashes symptoms come and go and sometimes had this feeling after eating peppermint candy, unknown if she had peppermint candy before receiving the Janssen COVID-19 vaccine. Her medical doctor was not yet notified and she had not treated her symptoms with any over the counter medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes and cardiac flutter. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210523500-Covid-19 vaccine ad26.cov2.s -Fluttering feeling around heart. 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: Menopause (Patient was going through menopause when she received vaccine.); Penicillin allergy (Patient experienced severe penicillin allergy when she was child.)

ID: 1329083
Sex: U
Age:
State: OR

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/19/2021
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: CONSTIPATION; STOMACH CRAMPS; ABDOMINAL PAIN; TROUBLE DEFECATING; 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 concurrent conditions included Hashimoto's disease. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced trouble defecating. On 28-APR-2021, the subject experienced constipation. On 28-APR-2021, the subject experienced stomach cramps. On 28-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from stomach cramps, abdominal pain, and constipation, and the outcome of trouble defecating was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Hashimoto's disease

ID: 1329084
Sex: M
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 50 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: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Reporter stated that on 22-Apr-2021, patient took an antibody test (semi-quantitative spike protein test) post vaccination which came negative. On 10-May-2021, patient repeated antibody test which was also negative. On 22-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On 10-MAY-2021, Laboratory data included: Antibody test (NR: not provided) Negative. 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: 20210524105-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:

ID: 1329085
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 05/19/2021
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: NEURALGIA; NEURITIS; VOMITING; DIZZINESS; 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 (suspension for injection, route of admin not reported, batch number: XD955 and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced headache. On 11-MAY-2021, the subject experienced neuralgia. On 11-MAY-2021, the subject experienced neuritis. On 11-MAY-2021, the subject experienced vomiting. On 11-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine was not applicable. The outcome of the headache, vomiting, dizziness, neuralgia and neuritis 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:

ID: 1329086
Sex: U
Age:
State: LA

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 05/19/2021
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: Unevaluable event

Symptoms: BILATERAL PULMONARY EMBOLISM; EXTENSIVE CLOTTING TO RIGHT LEFT AND ABDOMEN; DEEP VEIN THROMBOSIS; 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 four spine surgeries, and concurrent conditions included tendinosis, high blood pressure, type 2 diabetes, and platelet rich plasma therapy, and other pre-existing medical conditions included patient had no genetic conditions which would explain the clotting. patient had no prior history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, frequency 1 total, administered on 21-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021 and 1-APR-2021 patient underwent a series of Platelet Rich Plasma (PRP) Injections for left elbow for tendinosis. On 02-APR-2021, the patient experienced deep vein thrombosis and extensive clotting to right left and abdomen, and was hospitalized. Laboratory data included: Diagnostic ultrasound (NR: not provided) DVT and clot blood confirmed. Treatment medications included: heparin non-company. The patient was discharged on 03-APR-2021 with instructions to take Eliquis. On 07-APR-2021, the patient experienced bilateral pulmonary embolism and the patient was readmitted to the hospital. Laboratory data included: computed tomography (CT) scan (NR: not provided) Bilateral pulmonary embolism. Discharged on 09-APR-2021. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) not provided. On 26-APR-2021, the patient was readmitted and thrombectomy was performed. The patient was discharged on 27-APR-2021. On 30-APR-2021, the patient experienced rethrombosis. Laboratory data included: Diagnostic ultrasound (NR: not provided) Rethrombosis confirmed. Treatment medications included: bivalirudin, where doctor placed a catheter and administered an Angiomax IV for 72 hours. On 03-MAY-2021, thrombolysis and thrombectomy surgery was performed. Patient was discharged on an unspcified date with additional treatment medications (dates unspecified) included: clopidogrel bisulfate, acetylsalicylic acid, and levofloxacin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extensive clotting to right left and abdomen, deep vein thrombosis, and bilateral pulmonary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210525688-COVID-19 VACCINE AD26.COV2.S-extensive clotting to right left and abdomen, deep vein thrombosis, bilateral pulmonary embolism. 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: MEDICAL HISTORY, UNDERLYING DISEASE

Other Meds:

Current Illness: Blood pressure high (Well controlled); Platelet rich plasma therapy (PRP therapy at left elbow for tendonosis); Tendinosis (Platelet rich plasma therapy); Type II diabetes mellitus

ID: 1329087
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: GIVEN EXPIRED DOSE OF VACCINATION; This spontaneous report received from a pharmacist concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced given expired dose of vaccination. The action taken with covid-19 vaccine was not applicable. The outcome of the given expired dose of vaccination was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329088
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 05/19/2021
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: BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE RIBCAGE NEAR THE HEART/LEFT CALF SORENESS; PUMPING SENSATION IN RIGHT SIDE OF HEAD; TIREDNESS; RIGHT ARM SORENESS; COUGHING; LIGHT HEADEDNESS SENSATION; HEMORRHOIDS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient had no relevant medical history and was not on regular medication. 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, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he received the vaccine on 01-APR-2021. Approximately 2 days after he coughed and felt lightheaded and noticed some lights around his eyes. Approximately 7 days after patient noticed a list of symptoms including a pumping sensation in the right side of his head, left calf soreness, soreness in the ribcage near the heart, a tingling sensation in the fingertips and toes (but not at the center), sense of tiredness, shortness of breath, blood in stool that he referred to repeatedly as clots, right arm soreness (although the injection was given in the left arm). Patient called his doctor twice and was told to go to the hospital. Patient went to the hospital on 04-MAY-2021. Arrived at 12 PM and discharged at 11 PM approximately. Conducted a chest x-ray, took a blood sample twice, and put some stuff on patient's chest. Patient was discharged on 04-MAY-2021 and given a prescription for Motrin 800 mg taken three times per day as needed, and for cyclobenzaprine 10 mg taken twice a day as needed for spasms. Patient decided not to take these medications as he was unsure if they were pain medications and felt apprehensive. He main concerns seemed to be the pumping sensation in the right side of his head and the blood in his stool which he repeatedly referred to as a clot. His family doctor is aware of the situation and says he thinks its hemorrhoids. He refers to the clot as darker red in colour and also mentions that there is regular red blood in stool alongside the darker clot. Patient notices this about 3 times per week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, and light headedness sensation on 03-APR-2021, was recovering from right arm soreness, and had not recovered from pumping sensation in right side of head, soreness in the ribcage near the heart/left calf soreness, tingling in the fingertips and the toes, tiredness, shortness of breathe, blood in the stool, and hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210526242-covid-19 vaccine ad26.cov2.s -blood in stool . 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: 1329089
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: PATIENT FELL AT HOME AFTER VACCINATION; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 70.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, every 1 day, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: ZE019B0101) dose, start therapy date were not reported, for prophylactic vaccination. Concomitant medications included riociguat. On an unspecified date, the subject experienced subject fell at home after vaccination. The action taken with covid-19 vaccine was not applicable; and dose of macitentan was not changed. The outcome of patient fell at home after vaccination was not reported. This report was non-serious.

Other Meds: ADEMPAS

Current Illness: Primary pulmonary hypertension

ID: 1329090
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/19/2021
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: BELLS PALSY; INDEX AND MIDDLE FINGER NOT FUNCTIONING / BENDING PROPERLY; This spontaneous report received from a consumer 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 21-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 06-MAY-2021, the patient experienced index and middle finger not functioning and not bending properly. On 07-MAY-2021, the patient experienced loss of facial muscle activity, loss of mouth muscle activity (Bells palsy) and was unable to suck on a straw. No medications were taken at that time. Patient consulted a health care provider who refereed a neurologist. The neurologists after seeing also referred the patient to the emergency department to get a computed tomography scan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy, and index and middle finger not functioning / bending properly. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210527130- Covid-19 vaccine ad26.cov2.s-Bell's palsy. 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: 1329091
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: CHILLS; WIPED OUT FOR TWO DAYS; WOKE UP WITH MUSCLE ACHE FROM ALL SHIVERING; 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 (suspension for injection, route of admin not reported, batch number: Unk) 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 chills, wiped out for two days, and woke up with muscle ache from all shivering. The action taken with covid-19 vaccine was not applicable. The outcome of the wiped out for two days, chills and woke up with muscle ache from all shivering was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329093
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 05/19/2021
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: HIGH BLOOD PRESSURE; HEART PALPITATION; SEVERE DIARRHEA; HEADACHE/THROBBING IN THE TEMPLES; TIRED; INJECTION SITE PAIN; VOMITING/THROWING UP; SICK; FELL ASLEEP; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included adverse reaction to beta blockers, and concurrent conditions included blood pressure, and hypersensitive to drugs, and other pre-existing medical conditions included the patient had adverse reaction to beta blockers. The patient had 15 medicinal allergies and reaction to drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 03-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: nebivolol hydrochloride (form of admin, route of admin, and batch number were not reported) 5 mg, frequency was not reported, from 2021, and 2.5 mg, frequency, and therapy dates were not reported for high blood pressure; and losartan (form of admin, route of admin, and batch number were not reported) 25 mg, 2 times every 1 day, from 2021 for high blood pressure. No concomitant medications were reported. On 03-APR-2021 (on the day of injection), the patient had injection site pain on the day of injection. On 05-APR-2021, the patient starred to getting tired. On 07-APR-2021 or 08-APR-2021, the patient woke up with heart palpitation, throbbing in the temples and diarrhea. Were on vacation, left and came home, still did not feel good, went to urgent care on 11-APR-2021 and blood pressure was 190/100 mmHg. The patient have had blood pressure before, but had been controlled for years until this. Went to cardiologist twice, gave her another medication (carvedilol) which did not bring it down. Carvedilol increased her blood pressure. She was taking 3.175 in morning and 3.175 at night. The patient was tried another medication Bystolic 5 mg that did not bring it down. Cardiologist said they could not do anything else for patient. Referred to a nephrologist that she was not seen yet. No tests from the nephrologist yet. Kidneys were working fine. Meanwhile went to her primary care 3 times, tried on 2 other medications but blood pressure didn't come down. primary care physician lowered the Bystolic to 2.5 mg because she was getting sick from it. Started Losartan 25 mg morning and 25 mg at night, started getting headache. Last night she started getting headaches and throwing up which she said were side effects of the losartan. She went to emergency room on 09-MAY-2021 blood pressure was 215/105 mmHg and kidney was fine, heart was fine, all tests were good (coded as unspecified lab test) and emergency room physician gave her clonidine 0.1 and blood pressure went really low to 129 mmHg over something and she got really sick. They gave her a prescription of clonidine. Family physician told her to take 1/2 of the clonidine if her blood pressure was over 190. On 15-MAY-2021, the patient went to emergency room again because the heart rate was higher (95 ) usually was 60 and blood pressure was 210 over 99 mmHg. She took 1/4 of clonidine and it did drop it down to 160/79 mmHg. She took 1/4 of Xanax and fell asleep. She woke up with severe diarrhea and threw up. Medications included 1/4 Losartan last night. 20 mg Enalapril (original medication) and Hydrochlorothiazide 25 mg and xanax and blood pressure didn't come down. She was taking a 3 course medication therapy all along. For 5 weeks she had been housebound, tryied different medications, throwing up, diarrhea, and xanax tried to bring it down blood pressure right now 188/ 86 mmHg. The patient had been taking the blood pressure medicine and diuretic and a quarter of the Xanax . Her usual BP was 130/140 over 70 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nebivolol hydrochloride, and losartan was not reported. The patient was recovering from high blood pressure, and the outcome of injection site pain, headache/throbbing in the temples, heart palpitation, severe diarrhea, vomiting/throwing up, tired, sick and fell asleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210529638--High blood pressure. 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: MEDICAL HISTORY

Other Meds:

Current Illness: Blood pressure; Drug hypersensitivity

ID: 1329094
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: MIGRAINE; BAD COLD UNCONTROLLABLE CHILLS; FEVER OF 101.7; 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 pre-existing medical conditions included the patient never had a positive covid-19 test but the whole family was sick in JAN-2020 and had all the symptoms of covid-19.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced migraine. On 13-MAY-2021, the subject experienced bad cold uncontrollable chills. On 13-MAY-2021, the subject experienced fever of 101.7. On 13-MAY-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from migraine, and fever of 101.7 on 15-MAY-2021, and the outcome of bad cold uncontrollable chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.

Other Meds:

Current Illness:

ID: 1329095
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 05/07/2021
Rec V Date: 05/19/2021
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: BODY ACHE; MIGRAINE HEADACHE; FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced body ache. On 07-MAY-2021, the subject experienced migraine headache. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced extreme fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAY-2021, had not recovered from fever, extreme fatigue, and body ache, and the outcome of migraine headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329096
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/19/2021
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: LEFT SIDE LIPS NUMBNESS; LEFT SIDE OF NECK AREA HURTS; THROAT SWELLING; SWOLLEN LEFT SIDE OF THE NECK; HARD TIME TO SWALLOW; COLD; TIRED; HEADACHES; DIDN'T SLEEP VERY WELL; SWALLOWING HURTS A LOT; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swallowing hurts a lot. On 12-MAY-2021, the subject experienced didn't sleep very well. On 12-MAY-2021, the subject experienced tired. On 12-MAY-2021, the subject experienced headaches. On 13-MAY-2021, the subject experienced cold. On 14-MAY-2021, the subject experienced throat swelling. On 14-MAY-2021, the subject experienced hard time to swallow. On 14-MAY-2021, the subject experienced left side of neck area hurts. On 14-MAY-2021, the subject experienced swollen left side of the neck. On 15-MAY-2021, the subject experienced left side lips numbness. The action taken with covid-19 vaccine was not applicable. The patient recovered from didn't sleep very well, and cold on MAY-2021, tired on 12-MAY-2021, and headaches on 13-MAY-2021, and had not recovered from throat swelling, hard time to swallow, left side lips numbness, left side of neck area hurts, swallowing hurts a lot, and swollen left side of the neck. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329097
Sex: F
Age:
State: DE

Vax Date:
Onset Date: 05/05/2021
Rec V Date: 05/19/2021
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: SWELLING OF LEFT ARM; LEFT SIDE CHEST BROKEN VEIN; LYMPH GLAND CLOSEST TO VACCINE SWELLED UP; SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, dermatomyositis, antisynthetase syndrome, interstitial lung disease, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any known drug history. the patient did not have any history of 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: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced soreness. On 12-MAY-2021, the subject experienced lymph gland closest to vaccine swelled up. On 13-MAY-2021, the subject experienced left side chest broken vein. On 16-MAY-2021, the subject experienced swelling of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, lymph gland closest to vaccine swelled up, left side chest broken vein, and swelling of left arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious

Other Meds:

Current Illness: Abstains from alcohol; Antisynthetase syndrome; Autoimmune disorder; Dermatomyositis; Interstitial lung disease; Non-smoker

ID: 1329098
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: SORE THROAT; PINK EYE; HEADACHE; RIGHT EYE PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non alcohol consumer, 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: Unk) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced right eye pain. On 14-MAY-2021, the subject experienced sore throat. On 14-MAY-2021, the subject experienced pink eye. On 14-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right eye pain, sore throat, and headache, and the outcome of pink eye was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Smoker (1 pack/day)

ID: 1329099
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: HEART PROBLEMS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced heart problems. The action taken with covid-19 vaccine was not applicable. The outcome of heart problems was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329100
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/19/2021
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: VEIN WAS TURNING PURPLE APPEARING BLACK AND DARK (BLACK GROWTH ON THE WRIST); RAISED SMALL BUMPS ON LEFT WRIST; 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 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: 042B21A, expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced raised small bumps on left wrist. On 10-MAY-2021, the subject experienced vein was turning purple appearing black and dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein was turning purple appearing black and dark, and the outcome of raised small bumps on left wrist was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329101
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 20 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: 201a21a, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530455.

Other Meds:

Current Illness:

ID: 1329102
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: PAIN IN NECK; JOINT PAIN/ MIDDLE FINGER JOINT PAIN; PAIN IN BOTH CHINS,SHOULDER, FOREARMS AND HANDS; PAIN IN BOTH ANKLES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in neck. On 2021, the subject experienced joint pain/ middle finger joint pain. On 2021, the subject experienced pain in both chins, shoulder, forearms and hands. On 2021, the subject experienced pain in both ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain/ middle finger joint pain, pain in neck, pain in both ankles, pain in both chins, shoulder, forearms and hands, and headache. This report was non-serious.

Other Meds:

Current Illness: Pain

ID: 1329103
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 05/14/2021
Rec V Date: 05/19/2021
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: FEELS WORSE; FEELING AWFUL; FEELING SICK; CHILLS; NAUSEA; HEADACHE; BODY ACHES; DID NOT SLEEP WELL; 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 14-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body aches. On 14-MAY-2021, the subject experienced did not sleep well. On 14-MAY-2021, the subject experienced feeling sick. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced feels worse. On 15-MAY-2021, the subject experienced feeling awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, body aches, headache, nausea, chills, did not sleep well, and feels worse, and the outcome of feeling awful was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329104
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: PACKAGE INSERT IS BLANK ON BOTH SIDES; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced package insert is blank on both sides. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from package insert is blank on both sides. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329105
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 05/14/2021
Rec V Date: 05/19/2021
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: BODY ACHE; ARMPIT PAIN; ARMPIT SWELLING; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 150 pounds, and height was 168 centimeters. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, drug abuse/illicit drug use. the patient was not pregnant at the time of reporting. no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body ache. On 14-MAY-2021, the subject experienced armpit pain. On 14-MAY-2021, the subject experienced armpit swelling. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8 degree F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, nausea, headache, and fever on 14-MAY-2021, and was recovering from armpit pain, and armpit swelling. This report was non-serious.

Other Meds:

Current Illness: Alcoholic (4 times a week (Social drinker)); Non-smoker

ID: 1329106
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/19/2021
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: PAIN ALL OVER BODY, FROM ANKLES UP TO HEAD (WORST BACK, CHEST NOT GOOD); SLEEPLESSNESS; FEELING LIKE DYING, NOT MAKING IT; SHORTNESS OF BREATH; NOT EATEN ANYTHING IN DAYS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's past medical history included horrible accident, right femur replaced, both ankles replaced, both knees replaced, and fuse lower back, and concurrent conditions included artificial hip, blurry vision, ptds (post traumatic demoralization syndrome), and panic attacks. 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 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced pain all over body, from ankles up to head (worst back, chest not good). On MAY-2021, the subject experienced sleeplessness. On MAY-2021, the subject experienced feeling like dying, not making it. On MAY-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced not eaten anything in days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over body, from ankles up to head (worst back, chest not good), and the outcome of sleeplessness, feeling like dying, not making it, shortness of breath and not eaten anything in days was not reported. This report was non-serious.

Other Meds:

Current Illness: Blurry vision; Hip replacement; Panic attacks; Post-traumatic stress disorder

ID: 1329107
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/19/2021
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: MIGRAINE; DIFFICULTY SPEAKING (STUTTER WITH A SLIGHT SLUR); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use the patient did not have any no known allergies. the patient was not pregnant at the time of reporting. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced difficulty speaking (stutter with a slight slur). On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) Clear, EKG (NR: not provided) Negative, and Toxicologic test (NR: not provided) Negative. On an unspecified date, the subject experienced migraine. Treatment medications (dates unspecified) included: escitalopram oxalate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty speaking (stutter with a slight slur), and the outcome of migraine was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1329108
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/19/2021
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: HEADACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and smoker, and other pre-existing medical conditions included patient had no known drug allergies and no known 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: 09-JUN-2021) dose was not reported, administered on 14-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Smoker (less than a pack per day)

ID: 1329109
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/14/2021
Rec V Date: 05/19/2021
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: PHARMACIST UNSURE HOW MUCH OF A DOSE PATIENT RECEIVED DUE TO "SYRINGE EXPLODED"; SYRINGE EXPLODED; UNDERDOSE; This spontaneous report received from a pharmacist concerned a 42 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: 207A21A, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced pharmacist unsure how much of a dose subject received due to "syringe exploded". On 14-MAY-2021, the subject experienced syringe exploded. On 14-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pharmacist unsure how much of a dose patient received due to "syringe exploded", syringe exploded and underdose was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329110
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/19/2021
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: VEINS ARE APPEARING EVERYWHERE ON BODY MOSTLY ON THIGHS/SHOULDERS/GROIN; 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced veins are appearing everywhere on body mostly on thighs/shoulders/groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of veins are appearing everywhere on body mostly on thighs/shoulders/groin was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329111
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 05/14/2021
Rec V Date: 05/19/2021
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: DOSE GIVEN BEYOND 2 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a health care professional 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 14:40 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced dose given beyond 2 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given beyond 2 hours at room temperature was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329112
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210531096.

Other Meds:

Current Illness:

ID: 1329113
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 04/27/2021
Rec V Date: 05/19/2021
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: TRANSIENT HEART PALPITATIONS; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled hypertension, and smoking. The patient received covid-19 vaccine (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 27-APR-2021, the subject experienced transient heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from transient heart palpitations on 30-APR-2021. This report was non-serious.

Other Meds:

Current Illness: Hypertension; Smoker

ID: 1329114
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/19/2021
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: POTENTIAL ADMINISTRATION OF AN EXPIRED JANSSEN COVID VACCINE; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown if patient was pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced potential administration of an expired janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration of an expired janssen covid vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1329115
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/19/2021
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: SEIZURE; SEVERE MUSCLE ACHES; 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. 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 seizure and transported to hospital. CT scan performed -no problems. Patient experienced sever muscle ache. Laboratory data (dates unspecified) included: CT scan (NR: not provided) No Problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure and severe muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210530480- covid-19 vaccine ad26.cov2.s-Seizure. This event is considered un assessable. 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.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm