chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Concussion, Headache, Memory impairment
Clinical narrative: CONCUSSION; NON SENSICAL; ONE WAS FOR STOMACH; TOTALED A CAR; LOSS OF MEMORY; GAPS IN MEMORY; HEADACHES SEVERE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included depression, anxiety, and cataracts, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. the patient was pro-vaccine and never had any reactions to any vaccines. the patient never had gaps or loss of memory or crash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headaches severe. On 14-MAR-2021, the subject experienced loss of memory. On 14-MAR-2021, the subject experienced gaps in memory. On 22-MAR-2021, the subject experienced totaled a car. On an unspecified date, the subject experienced concussion, non sensical, and one was for stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headaches severe, had not recovered from loss of memory, and gaps in memory, and the outcome of concussion, non sensical, one was for stomach and totaled a car was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident, Speech disorder
Clinical narrative: CONCUSSION; NON SENSICAL; ONE WAS FOR STOMACH; TOTALED A CAR; LOSS OF MEMORY; GAPS IN MEMORY; HEADACHES SEVERE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included depression, anxiety, and cataracts, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. the patient was pro-vaccine and never had any reactions to any vaccines. the patient never had gaps or loss of memory or crash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headaches severe. On 14-MAR-2021, the subject experienced loss of memory. On 14-MAR-2021, the subject experienced gaps in memory. On 22-MAR-2021, the subject experienced totaled a car. On an unspecified date, the subject experienced concussion, non sensical, and one was for stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headaches severe, had not recovered from loss of memory, and gaps in memory, and the outcome of concussion, non sensical, one was for stomach and totaled a car was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Dysarthria, Headache, Influenza
Clinical narrative: HEAVY ALL OVER; BODY ACHES ALL OVER; MUSCLE TIGHT; SLURRING WORDS; FEEL DIZZY; REAL BAD CASE OF THE FLU; POUNDING HEADACHE; SORE DELTOID FOR A FEW MINUTES/FELT IT IN HIS HANDS AND ARMS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the subject experienced sore deltoid for a few minutes/felt it in his hands and arms. On 01-AUG-2021, the subject experienced heavy all over. On 01-AUG-2021, the subject experienced body aches all over. On 01-AUG-2021, the subject experienced muscle tight. On 01-AUG-2021, the subject experienced slurring words. On 01-AUG-2021, the subject experienced feel dizzy. On 01-AUG-2021, the subject experienced real bad case of the flu. On 01-AUG-2021, the subject experienced pounding headache. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slurring words, feel dizzy, and real bad case of the flu, and sore deltoid for a few minutes on 31-JUL-2021, and had not recovered from heavy all over, pounding headache, body aches all over, and muscle tight. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pain
Clinical narrative: HEAVY ALL OVER; BODY ACHES ALL OVER; MUSCLE TIGHT; SLURRING WORDS; FEEL DIZZY; REAL BAD CASE OF THE FLU; POUNDING HEADACHE; SORE DELTOID FOR A FEW MINUTES/FELT IT IN HIS HANDS AND ARMS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the subject experienced sore deltoid for a few minutes/felt it in his hands and arms. On 01-AUG-2021, the subject experienced heavy all over. On 01-AUG-2021, the subject experienced body aches all over. On 01-AUG-2021, the subject experienced muscle tight. On 01-AUG-2021, the subject experienced slurring words. On 01-AUG-2021, the subject experienced feel dizzy. On 01-AUG-2021, the subject experienced real bad case of the flu. On 01-AUG-2021, the subject experienced pounding headache. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slurring words, feel dizzy, and real bad case of the flu, and sore deltoid for a few minutes on 31-JUL-2021, and had not recovered from heavy all over, pounding headache, body aches all over, and muscle tight. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Therapeutic response unexpected
Clinical narrative: DOES NOT SLEEP MUCH ONLY 4-6 HOURS INSTEAD OF 9 HOURS SLEEP AS USED TO; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included lyme disease, and concurrent conditions included headache.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for headache. On 23-JUN-2021, the subject experienced unexpected therapeutic benefit. On an unspecified date, the subject experienced does not sleep much only 4-6 hours instead of 9 hours sleep as used to. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unexpected therapeutic benefit and does not sleep much only 4-6 hours instead of 9 hours sleep as used to was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: STROKE; BLOOD CLOTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient did not have high blood pressure or cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date was unknown) dose was not reported, 1 total administered on mid MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2021, patient had a stoke then blood clots. Patient was on wheel chair and her entire left side was paralyzed. Patient had been staying with her mom because her house had ramps and handicap bars. A ramp had been built at patient's house so that patient could live at our home with her husband.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blood clots was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210802862-covid-19 vaccine ad26.cov2.s -Stroke, Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event (s.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Mobility decreased, Pancreatitis
Clinical narrative: UNABLE TO GET UP FROM  BED OFTEN; PANCREATITIS; This spontaneous report received from a patient concerned a 55-year-old, white and not Hispanic or Latino female. The patient's past medical history included endometriosis, and covid-19, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient stated that she had Covid-19 in Aug-2020 and continued to have antibodies for 11 months. On 05-Jul-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JAN55ZUC.1S2050210, and expiry: Unknown) dose was not reported, 1 total, administered on right arm for prophylactic vaccination.  No concomitant medications were reported.  On 27-Jul-2021, Tuesday, the patient was diagnosed with pancreatitis and was hospitalized on 28-Jul-2021. The patient stated she had not received any medication during her time in the hospital and only received fluids.  The patient mentioned she received heparin because she was not able to get up from bed often. The patient was discharged on 1-Aug-2021. The patient was hospitalized for 4 days. On an unspecified date in Jul-2021, Laboratory data included: Antibody test (NR: not provided) not specified and patient stated that she maintains natural immunity.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pancreatitis, and the outcome of unable to get up from bed often was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210802888-covid-19 vaccine ad26.cov2.s-Pancreatitis, unable to get up from bed often . 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).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram, Pancreatitis acute, Rheumatoid arthritis
Clinical narrative: UNABLE TO GET UP FROM  BED OFTEN; PANCREATITIS; This spontaneous report received from a patient concerned a 55-year-old, white and not Hispanic or Latino female. The patient's past medical history included endometriosis, and covid-19, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient stated that she had Covid-19 in Aug-2020 and continued to have antibodies for 11 months. On 05-Jul-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JAN55ZUC.1S2050210, and expiry: Unknown) dose was not reported, 1 total, administered on right arm for prophylactic vaccination.  No concomitant medications were reported.  On 27-Jul-2021, Tuesday, the patient was diagnosed with pancreatitis and was hospitalized on 28-Jul-2021. The patient stated she had not received any medication during her time in the hospital and only received fluids.  The patient mentioned she received heparin because she was not able to get up from bed often. The patient was discharged on 1-Aug-2021. The patient was hospitalized for 4 days. On an unspecified date in Jul-2021, Laboratory data included: Antibody test (NR: not provided) not specified and patient stated that she maintains natural immunity.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pancreatitis, and the outcome of unable to get up from bed often was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210802888-covid-19 vaccine ad26.cov2.s-Pancreatitis, unable to get up from bed often . 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).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: UNABLE TO GET UP FROM  BED OFTEN; PANCREATITIS; This spontaneous report received from a patient concerned a 55-year-old, white and not Hispanic or Latino female. The patient's past medical history included endometriosis, and covid-19, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient stated that she had Covid-19 in Aug-2020 and continued to have antibodies for 11 months. On 05-Jul-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JAN55ZUC.1S2050210, and expiry: Unknown) dose was not reported, 1 total, administered on right arm for prophylactic vaccination.  No concomitant medications were reported.  On 27-Jul-2021, Tuesday, the patient was diagnosed with pancreatitis and was hospitalized on 28-Jul-2021. The patient stated she had not received any medication during her time in the hospital and only received fluids.  The patient mentioned she received heparin because she was not able to get up from bed often. The patient was discharged on 1-Aug-2021. The patient was hospitalized for 4 days. On an unspecified date in Jul-2021, Laboratory data included: Antibody test (NR: not provided) not specified and patient stated that she maintains natural immunity.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pancreatitis, and the outcome of unable to get up from bed often was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210802888-covid-19 vaccine ad26.cov2.s-Pancreatitis, unable to get up from bed often . 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: Poor quality product administered
Clinical narrative: JANSSEN COVID-19 VACCINE ADMINISTERED POSSIBLE TEMPERATURE EXCURSION; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced janssen covid-19 vaccine administered possible temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine administered possible temperature excursion was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINES GIVEN OUTSIDE THE 6 HOUR TIME FRAME (PUNCTURED AT 13:00 ON 28-JUL-2021 AND ADMINISTERED NEXT DAY BETWEEN 10:00 TO 13:00); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced vaccines given outside the 6 hour time frame (punctured at 13:00 on 28-jul-2021 and administered next day between 10:00 to 13:00). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccines given outside the 6 hour time frame (punctured at 13:00 on 28-jul-2021 and administered next day between 10:00 to 13:00) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801 and 20210802909.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; INFECTED WITH  DELTA VARIANTS; This spontaneous report received from a company representative via a consumer at a social gathering (a hearsay case), concerned multiple patients (exact number unknown) of unspecified sex, age, race and ethnicity Height and weight of the patients were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry date; unknown) dose, start therapy date were not reported, 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 multiple patients who received the Janssen vaccine were infected with the delta variants (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and infected with delta variants was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187265.; Sender's Comments: V0: 20210803410- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT A BIT RUN DOWN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt a bit run down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt a bit run down was not reported. This report was non-serious. This case, from the same reporter is linked to 20210801192.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced partial dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: FELT LIKE HAD BEEN HIT BY A MACK TRUCK; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt like had been hit by a mack truck, fever, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like had been hit by a mack truck, fever, and bad headache. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: RECEIVED A DOSE OF VACCINE DRAWN FROM A VIAL THAT WAS HELD IN THE FRIDGE FOR NEARLY 24 HOURS; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE AREA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced incorrect product storage, and vaccine administered outside of recommended storage area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine administered outside of recommended storage area was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: RECEIVED A DOSE OF VACCINE DRAWN FROM A VIAL THAT WAS HELD IN THE FRIDGE FOR NEARLY 24 HOURS; PUNCTURED VIAL STORED IN FRIDGE FOR 24 HOURS; This spontaneous report received from a pharmacist concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours. On 29-JUL-2021, the subject experienced punctured vial stored in fridge for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours and punctured vial stored in fridge for 24 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210804917 and 20210805634.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine 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 an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Joint stiffness, Malaise
Clinical narrative: LOWER BACK PAIN; NECK PAIN; STIFF ELBOW/ARM WHERE HE GOT HIS SHOT IS STIFF; FEEL SLUGGISH; DID NOT FEEL WELL; JOINT PAIN/SORE ELBOW/ARM WHERE HE GOT HIS SHOT IS SORE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included alcohol user, non-smoker, and sinus allergies, 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the subject experienced lower back pain. On 01-AUG-2021, the subject experienced neck pain. On 01-AUG-2021, the subject experienced stiff elbow/arm where he got his shot is stiff. On 01-AUG-2021, the subject experienced feel sluggish. On 01-AUG-2021, the subject experienced did not feel well. On 01-AUG-2021, the subject experienced joint pain/sore elbow/arm where he got his shot is sore. On 01-AUG-2021, the subject experienced fever. On 01-AUG-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, lower back pain, neck pain, stiff elbow/arm where he got his shot is stiff, and joint pain/sore elbow/arm where he got his shot is sore, and the outcome of did not feel well and feel sluggish was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Sluggishness
Clinical narrative: LOWER BACK PAIN; NECK PAIN; STIFF ELBOW/ARM WHERE HE GOT HIS SHOT IS STIFF; FEEL SLUGGISH; DID NOT FEEL WELL; JOINT PAIN/SORE ELBOW/ARM WHERE HE GOT HIS SHOT IS SORE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included alcohol user, non-smoker, and sinus allergies, 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the subject experienced lower back pain. On 01-AUG-2021, the subject experienced neck pain. On 01-AUG-2021, the subject experienced stiff elbow/arm where he got his shot is stiff. On 01-AUG-2021, the subject experienced feel sluggish. On 01-AUG-2021, the subject experienced did not feel well. On 01-AUG-2021, the subject experienced joint pain/sore elbow/arm where he got his shot is sore. On 01-AUG-2021, the subject experienced fever. On 01-AUG-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, lower back pain, neck pain, stiff elbow/arm where he got his shot is stiff, and joint pain/sore elbow/arm where he got his shot is sore, and the outcome of did not feel well and feel sluggish was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: COULD STILL FEEL THE ARM WHERE INJECTION WENT INTO; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 20421A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced could still feel the arm where injection went into. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could still feel the arm where injection went into. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: EVERY SYMPTOM KNOWN TO MAN (EXCEPT FOR FULL BODY RASH); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy and had not been sick for least 15 plus years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 02-AUG-2021, the subject experienced every symptom known to man (except for full body rash). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of every symptom known to man (except for full body rash) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Pain in extremity, Paraesthesia
Clinical narrative: FELT SUPER HOT/ SWEATY; PAIN FROM ARM TO NECK; FELT LIKE LITTLE NEEDLES ALL OVER BODY; GOT A TINY BUMP THE SIZE OF A PEANUT  BETWEEN NECK AND SHOULDER; ARM SORE; HEADACHE; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUL-2021, the subject experienced felt super hot/ sweaty. On 25-JUL-2021, the subject experienced pain from arm to neck. On 25-JUL-2021, the subject experienced felt like little needles all over body. On 25-JUL-2021, the subject experienced got a tiny bump the size of a peanut between neck and shoulder. On 25-JUL-2021, the subject experienced arm sore. On 25-JUL-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain from arm to neck on 01-AUG-2021, and got a tiny bump the size of a peanut between neck and shoulder, and was recovering from arm sore, headache, felt super hot/ sweaty, and felt like little needles all over body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: FELT SUPER HOT/ SWEATY; PAIN FROM ARM TO NECK; FELT LIKE LITTLE NEEDLES ALL OVER BODY; GOT A TINY BUMP THE SIZE OF A PEANUT  BETWEEN NECK AND SHOULDER; ARM SORE; HEADACHE; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUL-2021, the subject experienced felt super hot/ sweaty. On 25-JUL-2021, the subject experienced pain from arm to neck. On 25-JUL-2021, the subject experienced felt like little needles all over body. On 25-JUL-2021, the subject experienced got a tiny bump the size of a peanut between neck and shoulder. On 25-JUL-2021, the subject experienced arm sore. On 25-JUL-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain from arm to neck on 01-AUG-2021, and got a tiny bump the size of a peanut between neck and shoulder, and was recovering from arm sore, headache, felt super hot/ sweaty, and felt like little needles all over body. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Dyspnoea, Headache
Clinical narrative: BIG PAUSE BETWEEN HEARTBEATS (HEAR RATE WITH A 3/4THS PAUSE BETWEEN AFIB (ATRIAL FIBRILLATION) AND DEFIB DE-FIBRILLATION)); SHORTNESS OF BREATH; HURTS TO BREATHE; PAIN IN THE AORTA; VOMITING; COLD WITH SHAKING; FEELING UNWELL; 10 SEVERE HEADACHE (8 OUT OF 10, WITH BEING WORST); NAUSEA; COUGHING; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient had no past medical history of cardiac problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 02-AUG-2021 17:11 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced coughing. On 02-AUG-2021, the subject experienced nausea. On 03-AUG-2021, the subject experienced big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation) ). On 03-AUG-2021, the subject experienced shortness of breath. On 03-AUG-2021, the subject experienced hurts to breathe. On 03-AUG-2021, the subject experienced pain in the aorta. On 03-AUG-2021, the subject experienced vomiting. On 03-AUG-2021, the subject experienced cold with shaking. On 03-AUG-2021, the subject experienced feeling unwell. On 03-AUG-2021, the subject experienced 10 severe headache (8 out of 10, with being worst). Laboratory data included: Heart rate (NR: not provided) 3/4ths pause between afib and defib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold with shaking, and had not recovered from coughing, big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation)), 10 severe headache (8 out of 10, with being worst), vomiting, pain in the aorta, shortness of breath, hurts to breathe, nausea, and feeling unwell. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Malaise, Nausea, Painful respiration
Clinical narrative: BIG PAUSE BETWEEN HEARTBEATS (HEAR RATE WITH A 3/4THS PAUSE BETWEEN AFIB (ATRIAL FIBRILLATION) AND DEFIB DE-FIBRILLATION)); SHORTNESS OF BREATH; HURTS TO BREATHE; PAIN IN THE AORTA; VOMITING; COLD WITH SHAKING; FEELING UNWELL; 10 SEVERE HEADACHE (8 OUT OF 10, WITH BEING WORST); NAUSEA; COUGHING; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient had no past medical history of cardiac problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 02-AUG-2021 17:11 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced coughing. On 02-AUG-2021, the subject experienced nausea. On 03-AUG-2021, the subject experienced big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation) ). On 03-AUG-2021, the subject experienced shortness of breath. On 03-AUG-2021, the subject experienced hurts to breathe. On 03-AUG-2021, the subject experienced pain in the aorta. On 03-AUG-2021, the subject experienced vomiting. On 03-AUG-2021, the subject experienced cold with shaking. On 03-AUG-2021, the subject experienced feeling unwell. On 03-AUG-2021, the subject experienced 10 severe headache (8 out of 10, with being worst). Laboratory data included: Heart rate (NR: not provided) 3/4ths pause between afib and defib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold with shaking, and had not recovered from coughing, big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation)), 10 severe headache (8 out of 10, with being worst), vomiting, pain in the aorta, shortness of breath, hurts to breathe, nausea, and feeling unwell. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BIG PAUSE BETWEEN HEARTBEATS (HEAR RATE WITH A 3/4THS PAUSE BETWEEN AFIB (ATRIAL FIBRILLATION) AND DEFIB DE-FIBRILLATION)); SHORTNESS OF BREATH; HURTS TO BREATHE; PAIN IN THE AORTA; VOMITING; COLD WITH SHAKING; FEELING UNWELL; 10 SEVERE HEADACHE (8 OUT OF 10, WITH BEING WORST); NAUSEA; COUGHING; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient had no past medical history of cardiac problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 02-AUG-2021 17:11 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced coughing. On 02-AUG-2021, the subject experienced nausea. On 03-AUG-2021, the subject experienced big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation) ). On 03-AUG-2021, the subject experienced shortness of breath. On 03-AUG-2021, the subject experienced hurts to breathe. On 03-AUG-2021, the subject experienced pain in the aorta. On 03-AUG-2021, the subject experienced vomiting. On 03-AUG-2021, the subject experienced cold with shaking. On 03-AUG-2021, the subject experienced feeling unwell. On 03-AUG-2021, the subject experienced 10 severe headache (8 out of 10, with being worst). Laboratory data included: Heart rate (NR: not provided) 3/4ths pause between afib and defib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold with shaking, and had not recovered from coughing, big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation)), 10 severe headache (8 out of 10, with being worst), vomiting, pain in the aorta, shortness of breath, hurts to breathe, nausea, and feeling unwell. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: PAINS ALL OVER THE BODY; VOMITING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pains all over the body, vomiting, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, vomiting, pains all over the body and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eczema, Pain in extremity, Pyrexia
Clinical narrative: ECZEMA OUTBREAK WORSE THAN USUAL THAT LASTED A COUPLE OF MONTHS INSTEAD OF A FEW DAYS; SORE ARM ABOUT TWO DAYS; FEVER THE NEXT DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included mild eczema outbreak. 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 an unspecified date, the subject experienced eczema outbreak worse than usual that lasted a couple of months instead of a few days, sore arm about two days, and fever the next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eczema outbreak worse than usual that lasted a couple of months instead of a few days, sore arm about two days, and fever the next day. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED VACCINE ON 28-JUL-2021 FROM VIAL PUNCTURED ON 27-JUL-2021; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced administered vaccine on 28-Jul-2021 from vial punctured on 27-Jul-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administered vaccine on 28-Jul-2021 from vial punctured on 27-Jul-2021. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Migraine, Nasal odour, Nausea, Vision blurred
Clinical narrative: BLURRY VISION; STRONG AWFUL SMELL; STOMACH ACHE; NAUSEA; MIGRAINE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced migraine. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced blurry vision. On 07-APR-2021, the subject experienced strong awful smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, and nausea on 06-APR-2021, and had not recovered from blurry vision, strong awful smell, and migraine. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED WHICH HAD PAST 87 HOURS STABILITY; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 02-AUG-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced vaccine administered which had past 87 hours stability. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered which had past 87 hours stability and incorrect product storage was not reported. This report was non-serious.