chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: WHITE BLOOD CELL COUNT DECREASED; This spontaneous report received from a patient concerned a 73 year old white and Not Hispanic/Latino female. The patient's weight was not reported and height was 74 centimeters. The patient's past medical history included prediabetic and swelling, and concurrent conditions included penicillin allergy, nonalcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no 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: D11-458, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 30-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, patients white blood cell count had dropped from 3600 TO 2400. Also, patient wanted to know if this is cause by the vaccine, and if it is would it be temporary or permanent effect. She did not report any other side effects. On 22-May-2021, the patient is scheduled to have ultrasound and another blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of white blood cell count decreased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210458935-covid-19 vaccine ad26.cov2.s- white blood cell count decreased . 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).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED PRODUCT; 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: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-APR-2021, the subject experienced administered expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired product was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERS; WORSE 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shivers, and worse fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worse fever and shivers was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient underwent antibody test which was found to be negative even after seven weeks of post Covid vaccination. The patient did not specify the type of antibody test was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210459344-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Herpes zoster
Clinical narrative: SHINGLES; LEFT EYE SWOLLEN; SORENESS ON THE HEAD; This spontaneous report received from a patient concerned a 64 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: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-APR-2021, the subject experienced shingles. On 25-APR-2021, the subject experienced left eye swollen. On 25-APR-2021, the subject experienced soreness on the head. On 28-APR-2021, treatment medications included: valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles, and the outcome of soreness on the head and left eye swollen 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.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache
Clinical narrative: BONE PAIN; HEADACHE; This spontaneous report received from a consumer concerned a 39 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bone pain and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459724 and 20210459703.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: LOSS OF APPETITE; HEADACHE; NAUSEA; TIRED; COULDN'T SEE WELL; LEG MUSCLE CRAMPING; DECREASED BLOOD PRESSURE; FELT LIKE PASSING OUT; BAD FEELING; TROUBLE IN SPEAKING; LEG PAIN; CHILLS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled with weak /bad left leg, and migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A (maybe 201AZ1A), and batch number: 201A21A (MAYBE 201AZ1A) expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced couldn't see well. On 28-APR-2021, the subject experienced leg muscle cramping. On 28-APR-2021, the subject experienced decreased blood pressure. On 28-APR-2021, the subject experienced felt like passing out. On 28-APR-2021, the subject experienced bad feeling. On 28-APR-2021, the subject experienced trouble in speaking. On 28-APR-2021, the subject experienced leg pain. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced nausea. On 28-APR-2021, the subject experienced tired. On 29-APR-2021, the subject experienced loss of appetite. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, leg muscle cramping, felt like passing out, bad feeling, leg pain, chills, and nausea on 28-APR-2021, and the outcome of headache, loss of appetite, decreased blood pressure, trouble in speaking and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: LOSS OF APPETITE; HEADACHE; NAUSEA; TIRED; COULDN'T SEE WELL; LEG MUSCLE CRAMPING; DECREASED BLOOD PRESSURE; FELT LIKE PASSING OUT; BAD FEELING; TROUBLE IN SPEAKING; LEG PAIN; CHILLS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled with weak /bad left leg, and migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A (maybe 201AZ1A), and batch number: 201A21A (MAYBE 201AZ1A) expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced couldn't see well. On 28-APR-2021, the subject experienced leg muscle cramping. On 28-APR-2021, the subject experienced decreased blood pressure. On 28-APR-2021, the subject experienced felt like passing out. On 28-APR-2021, the subject experienced bad feeling. On 28-APR-2021, the subject experienced trouble in speaking. On 28-APR-2021, the subject experienced leg pain. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced nausea. On 28-APR-2021, the subject experienced tired. On 29-APR-2021, the subject experienced loss of appetite. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, leg muscle cramping, felt like passing out, bad feeling, leg pain, chills, and nausea on 28-APR-2021, and the outcome of headache, loss of appetite, decreased blood pressure, trouble in speaking and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Visual impairment
Clinical narrative: LOSS OF APPETITE; HEADACHE; NAUSEA; TIRED; COULDN'T SEE WELL; LEG MUSCLE CRAMPING; DECREASED BLOOD PRESSURE; FELT LIKE PASSING OUT; BAD FEELING; TROUBLE IN SPEAKING; LEG PAIN; CHILLS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled with weak /bad left leg, and migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A (maybe 201AZ1A), and batch number: 201A21A (MAYBE 201AZ1A) expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced couldn't see well. On 28-APR-2021, the subject experienced leg muscle cramping. On 28-APR-2021, the subject experienced decreased blood pressure. On 28-APR-2021, the subject experienced felt like passing out. On 28-APR-2021, the subject experienced bad feeling. On 28-APR-2021, the subject experienced trouble in speaking. On 28-APR-2021, the subject experienced leg pain. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced nausea. On 28-APR-2021, the subject experienced tired. On 29-APR-2021, the subject experienced loss of appetite. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, leg muscle cramping, felt like passing out, bad feeling, leg pain, chills, and nausea on 28-APR-2021, and the outcome of headache, loss of appetite, decreased blood pressure, trouble in speaking and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: SWEATS; SORENESS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 sweats. On APR-2021, the subject experienced soreness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweats, soreness and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; VACCINE RECEIVED THAT HAD BEEN PUNCTURED 2 WEEKS PRIOR TO ADMINISTRATION; This spontaneous report received from a health care professional concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies and unknown drug abuse or illicit drug usage. It was unknown that the patient smoke and consume alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and  expiry: 30-JUN-2021) .5 ml, administered on 15-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced vaccine received that had been punctured 2 weeks prior to administration. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine received that had been punctured 2 weeks prior to administration and incorrect storage of drug was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Product storage error
Clinical narrative: DIZZY; TIRED; PRODUCT STORED AT INAPPROPRIATE STORAGE CONDITION; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced dizzy. On 27-APR-2021, the subject experienced tired. On 27-APR-2021, the subject experienced product stored at inappropriate storage condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 27-APR-2021, and tired on 28-APR-2021, and the outcome of product stored at inappropriate storage condition was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Muscular weakness, Pyrexia, Tinnitus
Clinical narrative: WORSENED METALLIC TASTE IN MOUTH; WORSENED TINNITUS; MUSCLE WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of ear problems.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle weakness. On 10-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced worsened metallic taste in mouth. On 12-APR-2021, the subject experienced worsened tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle weakness, and fever on 11-APR-2021, and had not recovered from worsened tinnitus, and worsened metallic taste in mouth. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: SIDE EFFECTS INVOLVING SANGUINEOUS CLOTS; This spontaneous report received from a consumer (source: article published) concerned 6 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, expiry: unknown) dose, start therapy date were not reported, frequency 1 total  administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that the center for disease control and prevention (CDC) and arm of food and drug administration (FDA), the agency responsible for health surveillance, was about to discuss whether the pause in the use of covid-19 vaccine ad26.cov2.s is expected to continue after 6 people developed rare side effects involving sanguineous clots on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects involving sanguineous clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210460381-covid-19 vaccine ad26.cov2.s-side effects involving sanguineous clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: VACCINE LEFT AT ROOM TEMPERATURE MORE THAN 2 HOURS; POTENTIALLY EXPIRED DRUG ADMINISTERED; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine left at room temperature more than 2 hours, and potentially expired drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine left at room temperature more than 2 hours and potentially expired drug administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included eye surgeries.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included abiraterone acetate for drug used for unknown indication. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Night sweats
Clinical narrative: NIGHT SWEATS; CHEST HEAVINESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 33 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 14-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced night sweats, chest heaviness, and shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from night sweats, chest heaviness, and shortness of breath. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Colonoscopy, Diarrhoea, Malaise, Menstruation irregular
Clinical narrative: SEVERE ABDOMINAL PAIN; DIARRHEA; MENSTRUAL CYCLE IRREGULAR (10 DAYS EARLY); UNWELL FEELING; This spontaneous report received from a parent 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unwell feeling. On 12-APR-2021, the subject experienced severe abdominal pain. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced menstrual cycle irregular (10 days early). On 28-APR-2021, Laboratory data included: Colonoscopy (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe abdominal pain, diarrhea, menstrual cycle irregular (10 days early), and unwell feeling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Medication error, Product dispensing error, Product storage error
Clinical narrative: MEDICATION ERROR; INCORRECT STORAGE OF THE DRUG; EXPIRED VACCINE ADMINISTERED; THE UNPUNCTURED VIAL WAS LEFT OUT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.The patient's pre-existing medical conditions included unknown. 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.No concomitant medications were reported. On an unspecified date, the subject experienced medication error, incorrect storage of the drug, expired vaccine administered, and the unpunctured vial was left out at room temperature for more than 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error, incorrect storage of the drug, expired vaccine administered and the unpunctured vial was left out at room temperature for more than 2 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459605 and 20210459605.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; 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, Start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The company is unable to follow-up to request batch/ lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: CHILLS; SLIGHT FEVER; DULL ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced dull ache. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight fever, and had not recovered from dull ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS ON AND OFF FOR 6 HOURS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness, and chills on and off for 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and chills on and off for 6 hours was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; TIREDNESS; This spontaneous report received from a patient via a company representative concerned an adult 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: 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 fever, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: GENERALISED ACHING; NUMBNESS IN FINGERS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 28-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 an unspecified date, the subject experienced fever, chills, generalized aching, headache, and numbness in fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, generalized aching, headache and numbness in fingers was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Pyrexia
Clinical narrative: BONE ACHES; CHILLS; FEVER 101 F; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-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 an unspecified date, the subject experienced bone aches, chills, and fever 101 f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 101 f, bone aches and chills was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included no illicit drug usage or drug abuse.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Feeling abnormal, Headache, Nausea
Clinical narrative: FEELING MISERABLE; UNSPECIFIED ADVERSE EVENT; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative 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 feeling miserable, unspecified adverse event, nausea, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling miserable, unspecified adverse event, nausea, and severe headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHE; SORE ARM; FEVER; TIREDNESS; 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 2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced body ache. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, fever, body ache, and tiredness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: PUNCTURED VIAL HAD BEEN LEFT AT ROOM TEMPERATURE FOR GREATER THAN TWO HOURS; This spontaneous report received from a pharmacist concerned a 28 year old male. 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, intramuscular, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced punctured vial had been left at room temperature for greater than two hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured vial had been left at room temperature for greater than two hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZATION; This spontaneous report received from a consumer (cousin) 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) frequency 1 total, 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.  Consumer reported that ,on an unspecified date, the patient got the J&J vaccine and was hospitalized (date unspecified). 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: 20210500098-covid-19 vaccine ad26.cov2.s-Hospitalisation. 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).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED AT NIGHT; 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, 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 tired at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired at night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain, Nausea, Tremor
Clinical narrative: TREMOR; INJECTION SITE PAIN; FATIGUE/ TIRED; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 160 pounds, and height was 66 inches. The patient's concurrent conditions included thyroid, seasonal allergies, alcohol user, and non smoker, and other pre-existing medical conditions included patient had 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: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine/liothyronine for thyroid disorder, and aciclovir. On an unspecified date, the subject experienced tremor, injection site pain, fatigue/ tired, nausea, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue/ tired, nausea, and weakness, and the outcome of injection site pain and tremor was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: HEADACHE; FEVER; NAUSEOUS; DIZZY; PAIN IN ARM; This spontaneous report received from a patient via  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 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, dizzy, nauseous and pain in arm was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypoaesthesia, Peripheral coldness
Clinical narrative: NUMBNESS IN FEET; COLD FEET AND COLD FINGERNAILS ON LEFT HAND; PAIN IN  BONES OF FEET; This spontaneous report received from a patient concerned a 49 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, no significant medical history and medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced numbness in feet. On 30-APR-2021, the subject experienced cold feet and cold fingernails on left hand. On 30-APR-2021, the subject experienced pain in bones of feet. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in bones of feet on 01-MAY-2021, and had not recovered from numbness in feet, and cold feet and cold fingernails on left hand. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILL; 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: 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 chill, and tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, and tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; 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: Unknown) dose was not reported, administered on 09-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 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 10-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: DOSE ADMINISTERED FROM VIAL PUNCTURED FOR MORE THAN 6 HOURS; 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,) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced dose administered from vial punctured for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose administered from vial punctured for more than 6 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: PARTIAL BLACK TONGUE; 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced partial black tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial black tongue was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: PAINFUL NECK; SORE FROM HEAD TO TOE; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced burning during injection. On 09-APR-2021, the subject experienced sore from head to toe. On 24-APR-2021, the subject experienced painful neck. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore from head to toe on 10-APR-2021, and burning during injection on 08-APR-2021, and had not recovered from painful neck. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-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 an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Sensory disturbance
Clinical narrative: FEEL LIKE HIT BY A MACK TRUCK; FEELING CLAMMY; This spontaneous report received from a patient via a company representative 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 feel like hit by a mack truck, and feeling clammy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like hit by a mack truck and feeling clammy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Asthenia, Hypersomnia, Injection site pain, Injection site pruritus
Clinical narrative: SLEEP EXCESSIVE; INJECTION SITE ITCHING; BREAK OUTS; PUSTULE; FEELING UNWELL; LACK OF ENERGY; ITCHY; INJECTION SITE PAIN; LETHARGY; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included celiac disease, and concurrent conditions included gluten allergy, and rye allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-Apr-2021, the subject experienced lethargy, feeling unwell, lack of energy, sleep excessive, itchy, injection site pain, injection site itching, break outs, and pustule. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy, lack of energy, sleep excessive, injection site pain, injection site itching, feeling unwell, pustule, itchy and break outs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pruritus, Pustule
Clinical narrative: SLEEP EXCESSIVE; INJECTION SITE ITCHING; BREAK OUTS; PUSTULE; FEELING UNWELL; LACK OF ENERGY; ITCHY; INJECTION SITE PAIN; LETHARGY; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included celiac disease, and concurrent conditions included gluten allergy, and rye allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-Apr-2021, the subject experienced lethargy, feeling unwell, lack of energy, sleep excessive, itchy, injection site pain, injection site itching, break outs, and pustule. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy, lack of energy, sleep excessive, injection site pain, injection site itching, feeling unwell, pustule, itchy and break outs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES OVER NIGHT; CHILLS; LOW GRADE FEVER; 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 was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches over night, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches over night, chills, and low grade fever.  This report was non-serious.