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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






Manufacturers

Total Manufacturer

Incidents per State

State Total
37,124
AK1,214
AL2,802
AR1,810
AS34
AZ8,484
CA34,669
CO6,660
CT4,530
DC911
DE914
FL18,912
FM3
GA7,386
GU52
HI1,237
IA2,787
ID1,492
IL11,097
IN17,183
KS2,701
KY3,518
LA2,670
MA8,310
MD7,140
ME1,860
MH6
MI10,177
MN6,876
MO5,232
MP12
MS1,409
MT1,430
NC8,771
ND780
NE1,703
NH1,891
NJ9,040
NM2,238
NV2,132
NY18,644
OH10,904
OK2,834
OR4,643
PA12,634
PR1,247
QM1
RI1,262
SC3,249
SD747
TN4,796
TX18,288
UT2,519
VA8,468
VI28
VT1,105
WA7,950
WI6,398
WV1,372
WY496
XB4
XL1
XV2

ID: 1298761
Sex: F
Age:
State: CO

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Amnesia; Cardiac disorder; Thrombosis; Transient ischaemic attack; This case was received via another Manufacturer (Reference number: vsafe) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Glaucoma and Hypothyroidism. Concurrent medical conditions included Stroke. Concomitant products included LEVOTHYROXINE, BRIMONIDINE, LATANOPROST and TIMOLOL for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), CARDIAC DISORDER (Cardiac disorder) (seriousness criterion hospitalization), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criteria hospitalization and medically significant). At the time of the report, AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Catheterisation cardiac: inconclusive. On 14-Jan-2021, Echocardiogram: inconclusive. On 14-Jan-2021, Magnetic resonance imaging: inconclusive. On 14-Jan-2021, Ultrasound scan: inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The next day, the patient had short term memory loss, patient went to the hospital, and they said patient had some type of heart episode. The patient was taken by ambulance to the hospital and was told had a blood clot in brain and had suffered a mini stroke. The patient was hospitalized for 4 nights. The patient was given blood thinner and got improved. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded. However patient had an underlying risk in the past history of stroke.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded. However patient had an underlying risk in the past history of stroke.

Other Meds: LEVOTHYROXINE; BRIMONIDINE; LATANOPROST; TIMOLOL

Current Illness:

ID: 1298762
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Had a bad case that lasted about six months( had the shot) / Have taken the new shot/Suspected vaccination failure; Had a bad case that lasted about six months; 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 was unknown and the outcome of the shingles was recovered/resolved. 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 case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient received the shot and had a bad case that lasted about six months. The reporter stated that vaccine did not prevent shingles. The patient had taken new shot and hoping to never get it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation and time to onset of shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1298763
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: got shingles twice even after I got the vaccine/suspected vaccination failure; got shingles twice even after I got the vaccine; 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 case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shingles twice even after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1298764
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Suspected Vaccination failure; shinghles on left side and back; 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, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient got Shingles shot first and following year patient had gotten the shingles on left side and back. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, exact time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1298765
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: I had the flu shot and got the flu / Suspected vaccination failure; flu; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included whooping cough vaccine with an associated reaction of pertussis (received on an unknown date). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had the flu shot and got the flu so he/she did not have it any more. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming Influenza were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.

Other Meds:

Current Illness:

ID: 1298776
Sex: F
Age: 62
State: SC

Vax Date: 03/23/2021
Onset Date: 04/06/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Bruising on sides of legs and stomach.; Blisters on chest and arms / travelling down her legs; Reactions of hives on her chest / spread to her back, butt, and arms / spread to her face; This case was reported by a consumer and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included celecoxib (Celebrex) for product used for unknown indication. On 23rd March 2021, the patient received the 1st dose of Shingrix (intramuscular) and Celebrex at an unknown dose and frequency. On 6th April 2021, 14 days after receiving Shingrix, the patient experienced hives (serious criteria clinically significant/intervention required). On 10th April 2021, the patient experienced blister (serious criteria clinically significant/intervention required). On 13th April 2021, the patient experienced bruising of leg (serious criteria clinically significant/intervention required). The patient was treated with cortisone (non-proprietary) (Cortisone Shot), prednisone and dermatologicals nos (Anti-Itch Cream (Medication Unknown)). The action taken with Celebrex was unknown. On an unknown date, the outcome of the hives, blister and bruising of leg were not recovered/not resolved. It was unknown if the reporter considered the hives, blister and bruising of leg to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix vaccine and experienced reactions of hives on her chest. On 10th April 2021, the patient had hives spread to her back, butt, arms, blisters on chest and arms, started traveling down her legs. Consumer went to an urgent care in (contact information unknown) and received a Cortisone shot and also visited local Urgent care. On 13th April 2021, the consumer returned to PCP with little improvement of adverse reactions, and now with bruising on sides of the legs and stomach. PCP administered second Cortisone shot and as of today, has continues with little improvement of adverse reactions.

Other Meds:

Current Illness:

ID: 1298782
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: experienced a shingles outbreak/ Suspected vaccination failure/ Lack of drug effect; shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE PFIZER for prophylaxis. The patient's past medical history included shingles (several shingles outbreaks). Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER). On an unknown date, the patient received Shingrix and the 2nd dose of COVID-19 VACCINE PFIZER. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. Additional details were provided as follows: The case was reported by the daughter of the patient The age at vaccination was not reported. The patient's daughter reported the patient had several shingles outbreaks prior to receiving the Shingrix vaccine. The patient has had previous shingles outbreaks in the setting of stress. The patient received Shingrix approximately one and a half years ago from the time of reporting. The patient received the COVID-19 vaccine (dates were not available). One week following the patient's second COVID-19 vaccine, the patient experienced a shingles outbreak. The reporter did not want to share any additional information. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The reporter did not consent to follow up.

Other Meds: COVID-19 VACCINE PFIZER

Current Illness:

ID: 1298802
Sex: U
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LOW IRON; MUSCLE ACHES; This solicited 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 crohns disease, and other pre-existing medical conditions included unknown. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 time every 4 weeks, from 22-MAR-2021 for crohns disease. Product constituent parts included . The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced low iron. On MAR-2021, the patient experienced muscle aches. Treatment medications (dates unspecified) included: iron. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of the muscle aches and low iron was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and low iron, and muscle aches as possible; and between ustekinumab, and low iron, and muscle aches as possible. This report was non-serious.

Other Meds:

Current Illness: Crohn's disease (Crohn's since 1963. Started Stelara in 9/2019. On q 4 week dosing.)

ID: 1298803
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BRUISE IN LEFT GROIN; BUMP IN LEFT GROIN; MIGRAINE; HAMSTRING AND QUADRICEP PAIN; MAJOR ARM PAIN; INTERMITTENT HEADACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included norethisterone. On APR-2021, treatment medications included: acetylsalicylic acid, ibuprofen, and paracetamol. On 09-APR-2021, the subject experienced intermittent headaches. On 09-APR-2021, the subject experienced sore arm at injection site. On 14-APR-2021, the subject experienced major arm pain. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced hamstring and quadricep pain. On 24-APR-2021, the subject experienced bruise in left groin. On 24-APR-2021, the subject experienced bump in left groin. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 20-APR-2021, major arm pain on 17-APR-2021, and sore arm at injection site on 16-APR-2021, was recovering from hamstring and quadricep pain, bruise in left groin, and bump in left groin, and had not recovered from intermittent headaches. This report was non-serious. This case, from the same reporter is linked to 20210458898.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds: MINI-PILL

Current Illness: Allergy multiple; Migraine

ID: 1298804
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: HOSPITALIZATION; This spontaneous report received from a patient via a company representative concerned five adult female patients. 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, 1 total, start therapy date were not reported on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Non-company co-suspect medications included unspecified birth control pills (pills, oral) dose, start therapy date were not reported for contraception. No concomitant medications were reported. On an unspecified date, the patients were hospitalized for heart transplant to be performed. As per their physician, this could be due to Janssen Covid-19 vaccine and unspecified birth control pills. Number of hospitalization days were not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210458940 -COVID-19 VACCINE AD26.COV2.S- Hospitalization. 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: 1298805
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LIGHT HEADED; This spontaneous report received from a patient via a company representative concerned a 96 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed on MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298806
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TRANSIENT ISCHAEMIC ATTACK; BLINDNESS UNILATERAL; VISION BLURRED; COMPUTERISED TOMOGRAM HEAD; ECHOCARDIOGRAM; MAGNETIC RESONANCE IMAGING HEAD; ULTRASOUND DOPPLER; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1231357) concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure, and atrial fibrillation, and concurrent conditions included diabetes, and other pre-existing medical conditions included patient has no allergy or illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, magnesium, and mecobalamin. On 06-APR-2021, the patient woke up with lost of vision in left eye for 4 to 5 hours. Patient went to her ophthalmologist; the sight came back but very blurry. Retina specialist had seen patient on 13-APR-2021 and diagnosed transient ischaemic attack of left eye. The patient was guided to go to ER on 13-APR-2021. On 06-APR-2021, the patient experienced blindness unilateral, vision blurred. The patient was admitted in the hospital on 13-APR-2021 and was hospitalized for 3 days. Laboratory data included: Computerized tomogram head (NR: not provided) UNKNOWN, Echocardiogram (NR: not provided) UNKNOWN, Magnetic resonance imaging head (NR: not provided) UNKNOWN, and Ultrasound Doppler (NR: not provided) UNKNOWN. Laboratory data (dates unspecified) included: Eye exam (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210500771 - Covid-19 vaccine ad26.cov2.s- blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. 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: VITAMIN D [ERGOCALCIFEROL]; B12 ACTIVE; MAGNESIUM

Current Illness: Diabetes

ID: 1298807
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/30/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; 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 height, and weight were not reported. The patient's concurrent conditions included high-blood pressure, non smoker, no alcohol use, pain, and allergy-sneezing, and other pre-existing medical conditions included no 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, administered on 01-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergies-sneezing, ascorbic acid/thiamine hydrochloride for drug used for unknown indication, amlodipine for high blood pressure, and ibuprofen for pain. The patient had no adverse events after the vaccine. On 30-APR-2021, the patient underwent a swab test for COVID-19 which was positive. At the time of the report, patient was not feeling well with runny nose, light cough, light body aches and no appetite. She further reported that she felt warm and cold occasionally. Laboratory data included: Coronavirus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and confirmed clinical vaccination failure. This report was serious (Other Medically Important Condition).; Sender's Comments: 2021501889-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: AMLODIPINE; MOTRIN [IBUPROFEN]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN B AND C COMPLEX

Current Illness: Abstains from alcohol; Blood pressure high; Multiple allergies; Non-smoker; Pain

ID: 1298808
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; This spontaneous report received from a patient concerned a 28 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit 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: 1298809
Sex: M
Age:
State: MD

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient concerned a 54 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: 1808609 and expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. The patient received the Janssen covid vaccine on 31-MAR-2021 then travelled on 17-APR-2021. On 18-APR-2021, the patient went to get tested, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-MAY-2021, patient was tested again using a Polymerase chain reaction (PCR) test and it was found out that the patient was positive (confirmed covid-19 positive and confirmed clinical vaccination failure). It was reported that the patient was asymptomatic and did not exhibited any signs of a Covid 19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 positive was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178236.; Sender's Comments: V0:20210502752- COVID-19 VACCINE AD26.COV2.S-CONFIRMED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1298810
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: GO INTO A FIB MUCH MORE THAN I DID; THOUGHT WAS GONNA DIE FOR 10 DAYS; This spontaneous report received from a patient via social media concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject was gonna die for 10 days. It had been a Montblanc doing better except she went into atrial fibrillation much more than she did. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thought was gonna die for 10 days and go into a fib much more than I did was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503103-covid-19 vaccine ad26.cov2.s -Go into a fib much more than i did. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Atrial fibrillation; Autoimmune disorder

ID: 1298811
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 04/29/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEIZURE; RED PETECHIAE ON ABDOMEN; FEVER OF 103; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke from patent foramen ovale (PFO), and concurrent conditions included lupus, epilepsy, menopause, and patent foramen ovale. 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 29-APR-2021 at 17:00PM, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-APR-2021, within an hour after vaccination, the patient experienced seizure and about five hours later the patient experienced red petechiae on abdomen and fever of 103 F. The patient consulted doctor and started taking 10 mg of prednisone. The patient's seizures were still spiking; they were trying to control the seizures with Lorazepam. The patient was expecting that prednisone will help. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seizure, and the outcome of red petechiae on abdomen and fever of 103 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503252-COVID-19 VACCINE AD26.COV2.S-SEIZURE. 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: UNDERLYING DISEASE

Other Meds:

Current Illness: Epilepsy; Foramen ovale patent; Lupus erythematosus; Menopause

ID: 1298812
Sex: F
Age:
State: ME

Vax Date:
Onset Date: 03/17/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CARDIAC ARREST; HYPOTHERMIA; HER BG WAS LOW; DIARRHEA; NAUSEA; FELT SOMETHING WAS GOING THROUGH HER BODY; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bypass, and concurrent conditions included type 1 diabetes mellitus (T1DM), and heart disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021 after receiving the vaccine, the patient felt something was going through her body for 45 minutes. She experienced nausea and a slight headache. On 18-MAR-2021, she felt fine. On 29-MAR-2021, she woke up middle on the night and felt he blood glucose (BG) was low (T1DM). Later she woke up again and experienced nausea and drank juice. She developed diarrhea and sever chest pain. The ambulance arrived, her body temperature was 93.7 degrees F, her BG was 54 mg/dL. She developed cardiac arrest and admitted to the hospital for 3 day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest, hypothermia, diarrhea, nausea, and felt something was going through her body, and slight headache on 18-MAR-2021, and the outcome of her BG was low was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210503747-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST, HYPOTHERMIA, HER BG WAS LOW. 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 20210503747-COVID-19 VACCINE AD26.COV2.S-DIARRHEA. 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). 20210503747-COVID-19 VACCINE AD26.COV2.S-NAUSEA. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Heart disease, unspecified; Type 1 diabetes mellitus

ID: 1298813
Sex: F
Age:
State: OK

Vax Date:
Onset Date: 04/30/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: POTENTIALLY EXPIRED DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 50 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 30-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced expired dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298814
Sex: F
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ELECTRIC SHOCK SENSATIONS; STOMACH PAIN; HEADACHE, NAUSEA, MUSCLE SORENESS; LACK OF ENERGY AND TIREDNESS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was non alcoholic, non smoker and had no known drug allergies. the patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced lack of energy and tiredness. On 02-MAY-2021, the subject experienced electric shock sensations, stomach pain, headache, nausea, muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain on 02-MAY-2021, and headache, nausea, muscle soreness, and had not recovered from electric shock sensations, and lack of energy and tiredness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298815
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SLEEP FOR FEW HOURS; FEELING HIGH; CHILLS FOR FEW HOURS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced sleep for few hours. On APR-2021, the subject experienced feeling high. On APR-2021, the subject experienced chills for few hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep for few hours, feeling high, and chills for few hours. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298816
Sex: M
Age:
State: AZ

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VOMITTING/CANNOT KEEP ANYTHING DOWN, IT KEEPS COMING BACK UP; CHILLS; MALAISE; FEVER 102; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced vomiting /cannot keep anything down, it keeps coming back up. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced malaise. On 03-MAY-2021, the subject experienced fever 102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 102, malaise, vomiting/cannot keep anything down, it keeps coming back up, and chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298817
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 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: Unknown) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s ?nausea. This event is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1298818
Sex: F
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: HYPOTHYROIDISM; POSSIBLE VACCINE TRIGGERED ANTIBODY OVER REACTION; DEBILITATING HEADACHE; FELT LIKE THROWING UP; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had debilitating headache, felt like throwing up a week after receiving covid-19 vaccine ad26.cov2.s. Got bloodwork done and she had hypothyroidism. Endocrinologist thought that vaccine may have triggered an antibody overreaction. She would still do it again 1000 times over. Get it checked out. On an unspecified date, laboratory data included: Blood test (NR: not provided) hypothyroidism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the debilitating headache, hypothyroidism, possible vaccine triggered antibody over reaction and felt like throwing up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504098-covid-19 vaccine ad26.cov2.s-Hypothyroidism. 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: 1298819
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD IN EYE; DO NOT HAVE TOTAL VISION IN LEFT EYE; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed along with the additional information received on 06-MAY-2021. 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, 1 total, administered on 05-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On 22-MAR-2021, the patient experienced blood in eye. On an unspecified date, the patient experienced losing vision in left eye and reports she has not yet got back complete vision in the eye. It was reported that, the patient would love to get compensated for all the physician visits, blood test, prescriptions, and time out of work. He also said that he knew when he signed for the vaccination that they are not responsible. He also mentioned that he would never get another shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from don't have total vision in left eye, and the outcome of blood in eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210504249 -COVID-19 VACCINE AD26.COV2.S- Do not have total vision in left eye, Blood in eye. 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: 1298820
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: MINOR HALLUCINATIONS; BLURRED VISION; HIGH FEVER; FEELS LIKE A BAD HANGOVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 30-APR-2021 at mid afternoon 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 01-MAY-2021 around 12:00 AM, the patient woke up with a high fever of 105, blurred vision and minor hallucinations. Laboratory data included: Body temperature (NR: not provided) 105 F. Per patient it sounds bad but it was just from the high fever. On the day of report, the patient had slight fever along with which the feeling of a bad hangover. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, had not recovered from feels like a bad hangover, and the outcome of blurred vision and minor hallucinations was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504263-COVID-19 VACCINE AD26.COV2.S -Minor Hallucinations. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1298821
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CHRONIC BRONCHITIS; DIZZINESS; DIARRHEA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included bacteria (took antibiotic) and concurrent conditions included bronchitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included azithromycin, and fexofenadine hydrochloride/pseudoephedrine hydrochloride. On 06-APR-2021, the patient experienced coughing, chills, hard to breathe. On 06-APR-2021, the patient experienced vomiting and had more coughing. Patient started coughing blood and called the insurance company for an urgent care. On 01-MAY-2021, patient diagnosed with chronic bronchitis and started on Zpak and prescribed Allegra D. The patient recovered from vomiting, had not recovered from dizziness, diarrhea, and headache, and the outcome of chronic bronchitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210505177-covid-19 vaccine ad26.cov2.s-chronic bronchitis. 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: Bronchitis

ID: 1298822
Sex: U
Age:
State: MI

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIDN'T RECEIVE THE FULL DOSE; This spontaneous report received from a pharmacist 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced didn't receive the full dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of didn't receive the full dose was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298823
Sex: F
Age:
State: MD

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ACHES; FLU-LIKE SYMPTOMS; HARD TO WALK; This spontaneous report received from a consumer concerned a 63 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced aches. On 03-MAY-2021, the subject experienced flu-like symptoms. On 03-MAY-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, flu-like symptoms, and hard to walk. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298824
Sex: F
Age:
State: CT

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: MUSCLE TWITCHING ON THE RIGHT LEG; TWITCHING IN THE BRAIN; CHILLS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, high cholesterol, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced muscle twitching on the right leg. On 02-MAY-2021, the subject experienced twitching in the brain. On 02-MAY-2021, the subject experienced chills. On 02-MAY-2021, the subject experienced muscle aches. On 02-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from twitching in the brain, and fever on MAY-2021, was recovering from muscle twitching on the right leg, and the outcome of muscle aches and chills was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; High cholesterol; Migraine; Non-smoker

ID: 1298825
Sex: M
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIDN'T SLEEP WELL; SHIVERING A LOT; ARM SORE; EXHAUSTED; LOW FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced didn't sleep well, shivering a lot, arm sore, exhausted, and low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from didn't sleep well, shivering a lot, exhausted, and low fever, and the outcome of arm sore was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298826
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SHORTNESS OF BREATH; SWOLLEN MOUTH; BUMPS IN DIFFERENT PARTS OF THE BODY; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced swollen mouth. On 2021, the subject experienced bumps in different parts of the body. On 2021, the subject experienced constant headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the constant headache, nausea, shortness of breath, swollen mouth and bumps in different parts of the body was not reported. This report was non-serious. This case is a duplicate of 20210505746.

Other Meds:

Current Illness:

ID: 1298827
Sex: M
Age:
State: AL

Vax Date:
Onset Date: 04/25/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: STROKE; This spontaneous report received from a patient via a company representative concerned a 52 or 53 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, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-APR-2021, the patient experienced stroke and another stroke was on 28-APR-2021. Patient was hospitalized on unspecified date and discharge date was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210505957-Covid-19 Vaccine.Ad 26.Cov2.S-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1298828
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a social media via company representative concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on more medication due to event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse event. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure, as the case is assessed non serious.

Other Meds:

Current Illness:

ID: 1298829
Sex: F
Age:
State: OR

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.

Other Meds: NEXPLANON

Current Illness: Birth control

ID: 1298830
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: PAINFUL ARM; WEAKNESS OF ARM; FELT LIKE HIT BY TRUCK; 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: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced felt like hit by truck. On an unspecified date, the subject experienced painful arm, and weakness of arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit by truck, and the outcome of painful arm and weakness of arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298831
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FLU LIKE SYMPTOMS (CHILLS AND FELT TIRED EXHAUSTED); SORE ARM AFTER VACCINATION; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 130 pounds, and height was 61.5 inches. The patient's past medical history included foot surgery, and pain in injection site, and concurrent conditions included rheumatoid arthritis, auto-immune hives as a reaction to heat, alcohol user, no tobacco use, bone spurs got worse, hypothyroidism, dry eyes, chronic urticaria, calcium depletion, joint pain, morton's neuroma, limping, numbness, and weak ankle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: UNNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline hydrochloride for autoimmune disorder, omalizumab for chronic urticaria, ciclosporin for dry eyes, levothyroxine sodium for hypothyroidism, liothyronine for hypothyroidism, conjugated linoleic acid/linum usitatissimum seed oil/ubidecarenone for supplement, and calcium/colecalciferol for supplement, calcium depletion, and joint pain. On MAR-2021, the subject experienced flu like symptoms (chills and felt tired exhausted). On MAR-2021, the subject experienced sore arm after vaccination. Laboratory data (dates unspecified) included: X-ray (NR: not provided) No significant findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm after vaccination on MAR-2021, and the outcome of flu like symptoms (chills and felt tired exhausted) was not reported. This report was non-serious.

Other Meds: SYNTHROID; LIOTHYRONINE; RESTASIS; AMITRIPTYLLINE; XOLAIR; CALCIUM WITH VITAMIN D3 [CALCIUM;COLECALCIFEROL]; COQ10 [CONJUGATED LINOLEIC ACID;LINUM USITATISSIMUM SEED OIL;UBIDECARENONE]

Current Illness: Alcohol use (ONE-TWO GLASSES OF RED WINE ONCE A WEEK); Autoimmune disorder (reaction to heat); Bone spur; Calcium depletion; Chronic urticaria; Dry eyes; Hypothyroidism; Joint pain; Limping; Morton's neuroma; Non-smoker; Numbness; Rheumatoid arthritis

Date Died:

ID: 1298832
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DEATH; This spontaneous report received from 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 and expiry date: Unknown) dose, 1 total administered, 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 died after getting Janssen vaccine. The patient died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210507041-covid-19 vaccine ad26.cov2.s-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1298833
Sex: F
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: HEART ATTACK; SEVERE PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included was that the patient had lot of medical problems but the caller was unable to elaborate (unspecified medical problems). 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 to left arm on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, right after the vaccination the patient experienced severe headache. The patient also had a heart attack couple of days after vaccination. It was reported that the patient made it through the heart attack. On follow up with the parent, it was reported that the patient did not had a heart attack diagnosed by a doctor and was not hospitalized or seen in an emergency room (ER). It was also reported that the patient did not like to go to hospital and just stayed in bed. The patient experienced severe pain, started in her head as a real deep pain. The reporter was not sure about the symptoms of the reported event heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart attack on an unspecified date in 2021, and the outcome of severe headache and severe pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210507105-COVID-19 VACCINE AD26.COV2.S -Heart attack,severe pain,severe headache.. 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: 1298834
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SWOLLEN ARM; RED ARM; TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 swollen arm, red arm, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, tired, and red arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298835
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ACHES; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298836
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298837
Sex: F
Age:
State: PA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIZZINESS; FEEL LIKE LEGS WERE GOING TO COLLAPSE; This spontaneous report received from a consumer concerned a 62 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 drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUNE-2021) dose was not reported, administered on 04-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced dizziness. On 05-MAY-2021, the subject experienced feel like legs were going to collapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like legs were going to collapse, and dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298838
Sex: F
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD ABOUT THE SIZE OF A PENNY FROM NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced blood about the size of a penny from nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood about the size of a penny from nose was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298839
Sex: F
Age:
State: KS

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: INCORRECT PRODUCT STORAGE; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 4 decade 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced incorrect product storage. On 05-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509988.

Other Meds:

Current Illness:

ID: 1298840
Sex: M
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).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 07-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.

Other Meds:

Current Illness: Sciatica; Seasonal allergy; Seasonal asthma

ID: 1298841
Sex: M
Age:
State: WA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LEFT AND RIGHT LEG PAIN; FEVER MAXIMUM OF 100 DEGREE F; HEADACHE; SORE BODY; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no health conditions, the patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown exp 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 14:00 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAY-2021, the subject experienced sore body. On 04-MAY-2021, the subject experienced fever maximum of 100 degree f. On 04-MAY-2021, the subject experienced headache. On 05-MAY-2021, the subject experienced left and right leg pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever maximum of 100 degree f, sore body, and headache, and had not recovered from left and right leg pain. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1298842
Sex: M
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: PAIN IN HAMSTRINGS; PAIN IN BUTT; 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, 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 pain in hamstrings, and pain in butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in hamstrings and pain in butt was not reported. This report was non-serious. This case, from the same reporter is linked to 20210510142.

Other Meds:

Current Illness:

ID: 1298843
Sex: F
Age:
State: NC

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: NOT CLEAR VISION; SENSATION IN RIGHT SIDE OF THROAT; SENSATION ON TOP OF HEAD; DIZZY SPELLS; SORENESS UP SPINE; SORENESS IN JOINTS (HIPS, PELVIC, AND LEGS DOWN TO KNEES); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included half thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 43AZIA expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness up spine. On APR-2021, the subject experienced soreness in joints (hips, pelvic, and legs down to knees). Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensation in right side of throat. On 10-APR-2021, the subject experienced sensation on top of head. On 10-APR-2021, the subject experienced dizzy spells. On MAY-2021, the subject experienced not clear vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation in right side of throat, sensation on top of head, and dizzy spells on APR-2021, and the outcome of soreness in joints (hips, pelvic, and legs down to knees), soreness up spine and not clear vision was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1298844
Sex: U
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: PARTIAL DOSE ADMINISTERED; 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: Unk) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 344,955

Page last modified: 03 October 2021 5:28pm