chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Asthma, Bone pain
Clinical narrative: PAIN; REDNESS; BONE ACHES; STOMACH PAIN; ASTHMA (BREATHING DIFFICULTY); VERTIGO; LEFT FOOT INFLAMMATION (AS BIG AS A SOCCER BALL); KEPT ON SLEEPING; SEVERE DEEP PAIN IN THE LEFT FOOT; CHILLS/ SHIVERS; JOINT ACHES; HEADACHE; NAUSEA; MUSCLE PAIN; DIARRHEA; GENERAL WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 53 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced severe deep pain in the left foot. On 14-MAR-2021, the patient experienced pain. On 14-MAR-2021, the patient experienced redness. On 14-MAR-2021, the patient experienced bone aches. On 14-MAR-2021, the patient experienced stomach pain. On 14-MAR-2021, the patient experienced asthma (breathing difficulty). On 14-MAR-2021, the patient experienced vertigo. On 14-MAR-2021, the patient experienced left foot inflammation (as big as a soccer ball). On 14-MAR-2021, the patient experienced kept on sleeping. On 14-MAR-2021, the patient experienced chills/ shivers. On 14-MAR-2021, the patient experienced joint aches. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced nausea. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced diarrhea. On 14-MAR-2021, the patient experienced general weakness. On 14-MAR-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot inflammation (as big as a soccer ball) on 15-MAR-2021, and the outcome of pain, redness, fever, nausea, bone aches, headache, joint aches, muscle pain, chills/ shivers, stomach pain, diarrhea, asthma (breathing difficulty), vertigo, general weakness, severe deep pain in the left foot and kept on sleeping was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Headache, Hypersomnia
Clinical narrative: PAIN; REDNESS; BONE ACHES; STOMACH PAIN; ASTHMA (BREATHING DIFFICULTY); VERTIGO; LEFT FOOT INFLAMMATION (AS BIG AS A SOCCER BALL); KEPT ON SLEEPING; SEVERE DEEP PAIN IN THE LEFT FOOT; CHILLS/ SHIVERS; JOINT ACHES; HEADACHE; NAUSEA; MUSCLE PAIN; DIARRHEA; GENERAL WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 53 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced severe deep pain in the left foot. On 14-MAR-2021, the patient experienced pain. On 14-MAR-2021, the patient experienced redness. On 14-MAR-2021, the patient experienced bone aches. On 14-MAR-2021, the patient experienced stomach pain. On 14-MAR-2021, the patient experienced asthma (breathing difficulty). On 14-MAR-2021, the patient experienced vertigo. On 14-MAR-2021, the patient experienced left foot inflammation (as big as a soccer ball). On 14-MAR-2021, the patient experienced kept on sleeping. On 14-MAR-2021, the patient experienced chills/ shivers. On 14-MAR-2021, the patient experienced joint aches. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced nausea. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced diarrhea. On 14-MAR-2021, the patient experienced general weakness. On 14-MAR-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot inflammation (as big as a soccer ball) on 15-MAR-2021, and the outcome of pain, redness, fever, nausea, bone aches, headache, joint aches, muscle pain, chills/ shivers, stomach pain, diarrhea, asthma (breathing difficulty), vertigo, general weakness, severe deep pain in the left foot and kept on sleeping was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: PAIN; REDNESS; BONE ACHES; STOMACH PAIN; ASTHMA (BREATHING DIFFICULTY); VERTIGO; LEFT FOOT INFLAMMATION (AS BIG AS A SOCCER BALL); KEPT ON SLEEPING; SEVERE DEEP PAIN IN THE LEFT FOOT; CHILLS/ SHIVERS; JOINT ACHES; HEADACHE; NAUSEA; MUSCLE PAIN; DIARRHEA; GENERAL WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 53 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced severe deep pain in the left foot. On 14-MAR-2021, the patient experienced pain. On 14-MAR-2021, the patient experienced redness. On 14-MAR-2021, the patient experienced bone aches. On 14-MAR-2021, the patient experienced stomach pain. On 14-MAR-2021, the patient experienced asthma (breathing difficulty). On 14-MAR-2021, the patient experienced vertigo. On 14-MAR-2021, the patient experienced left foot inflammation (as big as a soccer ball). On 14-MAR-2021, the patient experienced kept on sleeping. On 14-MAR-2021, the patient experienced chills/ shivers. On 14-MAR-2021, the patient experienced joint aches. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced nausea. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced diarrhea. On 14-MAR-2021, the patient experienced general weakness. On 14-MAR-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot inflammation (as big as a soccer ball) on 15-MAR-2021, and the outcome of pain, redness, fever, nausea, bone aches, headache, joint aches, muscle pain, chills/ shivers, stomach pain, diarrhea, asthma (breathing difficulty), vertigo, general weakness, severe deep pain in the left foot and kept on sleeping was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: PAIN; REDNESS; BONE ACHES; STOMACH PAIN; ASTHMA (BREATHING DIFFICULTY); VERTIGO; LEFT FOOT INFLAMMATION (AS BIG AS A SOCCER BALL); KEPT ON SLEEPING; SEVERE DEEP PAIN IN THE LEFT FOOT; CHILLS/ SHIVERS; JOINT ACHES; HEADACHE; NAUSEA; MUSCLE PAIN; DIARRHEA; GENERAL WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 53 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced severe deep pain in the left foot. On 14-MAR-2021, the patient experienced pain. On 14-MAR-2021, the patient experienced redness. On 14-MAR-2021, the patient experienced bone aches. On 14-MAR-2021, the patient experienced stomach pain. On 14-MAR-2021, the patient experienced asthma (breathing difficulty). On 14-MAR-2021, the patient experienced vertigo. On 14-MAR-2021, the patient experienced left foot inflammation (as big as a soccer ball). On 14-MAR-2021, the patient experienced kept on sleeping. On 14-MAR-2021, the patient experienced chills/ shivers. On 14-MAR-2021, the patient experienced joint aches. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced nausea. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced diarrhea. On 14-MAR-2021, the patient experienced general weakness. On 14-MAR-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot inflammation (as big as a soccer ball) on 15-MAR-2021, and the outcome of pain, redness, fever, nausea, bone aches, headache, joint aches, muscle pain, chills/ shivers, stomach pain, diarrhea, asthma (breathing difficulty), vertigo, general weakness, severe deep pain in the left foot and kept on sleeping was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Injection site pain
Clinical narrative: CHANGE IN VOICE; PAIN AT INJECTION SITE; 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. 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 was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced pain at injection site. On an unspecified date, the patient experienced change in voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, and the outcome of change in voice was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Dizziness, Hypoaesthesia, Insomnia
Clinical narrative: SEVERE NEEDLE/JABS ALL OVER BODY/NOT ON FACE; PRESSURE IN CHEST LIKE CALCULUS BOOKS  SITTING ON CHEST; NECK PAIN; LIGHT-HEADEDNESS; DIFFICULTY SLEEPING; STOMACH IS QUEASY; OVERALL MALAISE; SEVERE MUSCLE PAINS/COMING FROM INSIDE OF MUSCLES; NUMBNESS IN RIGHT FOOT/TWO LEFT TOES; This spontaneous report received from a patient concerned a 56 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: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced severe needle/jabs all over body/not on face. On 21-SEP-2021, the patient experienced pressure in chest like calculus books sitting on chest. On 21-SEP-2021, the patient experienced neck pain. On 21-SEP-2021, the patient experienced light-headedness. On 21-SEP-2021, the patient experienced difficulty sleeping. On 21-SEP-2021, the patient experienced overall malaise. On 21-SEP-2021, the patient experienced stomach is queasy. On 21-SEP-2021, the patient experienced severe muscle pains/coming from inside of muscles. On 21-SEP-2021, the patient experienced numbness in right foot/two left toes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in chest like calculus books sitting on chest on 23-SEP-2021, had not recovered from severe muscle pains/coming from inside of muscles, severe needle/jabs all over body/not on face, numbness in right foot/two left toes, overall malaise, neck pain, stomach is queasy, and light-headedness, and the outcome of difficulty sleeping was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Neck pain, Pain
Clinical narrative: SEVERE NEEDLE/JABS ALL OVER BODY/NOT ON FACE; PRESSURE IN CHEST LIKE CALCULUS BOOKS  SITTING ON CHEST; NECK PAIN; LIGHT-HEADEDNESS; DIFFICULTY SLEEPING; STOMACH IS QUEASY; OVERALL MALAISE; SEVERE MUSCLE PAINS/COMING FROM INSIDE OF MUSCLES; NUMBNESS IN RIGHT FOOT/TWO LEFT TOES; This spontaneous report received from a patient concerned a 56 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: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced severe needle/jabs all over body/not on face. On 21-SEP-2021, the patient experienced pressure in chest like calculus books sitting on chest. On 21-SEP-2021, the patient experienced neck pain. On 21-SEP-2021, the patient experienced light-headedness. On 21-SEP-2021, the patient experienced difficulty sleeping. On 21-SEP-2021, the patient experienced overall malaise. On 21-SEP-2021, the patient experienced stomach is queasy. On 21-SEP-2021, the patient experienced severe muscle pains/coming from inside of muscles. On 21-SEP-2021, the patient experienced numbness in right foot/two left toes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in chest like calculus books sitting on chest on 23-SEP-2021, had not recovered from severe muscle pains/coming from inside of muscles, severe needle/jabs all over body/not on face, numbness in right foot/two left toes, overall malaise, neck pain, stomach is queasy, and light-headedness, and the outcome of difficulty sleeping was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Migraine, Nausea, Pain
Clinical narrative: BODY ACHES; MIGRAINES; LOW GRADE FEVER; NAUSEA; FATIGUE; 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 pre-existing medical conditions included: The patient has other health problems. 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 patient experienced body aches, migraines, low grade fever, nausea, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, migraines, low grade fever, nausea, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; MIGRAINES; LOW GRADE FEVER; NAUSEA; FATIGUE; 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 pre-existing medical conditions included: The patient has other health problems. 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 patient experienced body aches, migraines, low grade fever, nausea, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, migraines, low grade fever, nausea, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED DOSE OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a pharmacist 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced received an expired dose of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired dose of the janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; 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 (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 25 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 (suspension for injection, route of admin not reported, batch number: 206A21, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946519.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: FEELS LIKE SHE HAD THE FLU; FELT LIKE WAS DYING; STOMACH STARTED HURTING; FELT SICK; DIARRHEA 2 TIMES; NAUSEOUS; HEADACHE/INTERMITTENT HEADACHE; ARM HURT REALLY BAD/HARD TO LIFT; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's concurrent conditions included: diabetes mellitus, supraventricular tachycardia, no alcohol use, non-smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient had allergy to a preservative that used to be in contact lenses. The patient experienced drug allergy when treated with alprazolam, and ibuprofen. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced arm hurt really bad/hard to lift. On 21-SEP-2021, the patient experienced feels like she had the flu. On 21-SEP-2021, the patient experienced felt like was dying. On 21-SEP-2021, the patient experienced stomach started hurting. On 21-SEP-2021, the patient experienced felt sick. On 21-SEP-2021, the patient experienced diarrhea 2 times. On 21-SEP-2021, the patient experienced nauseous. On 21-SEP-2021, the patient experienced headache/intermittent headache. Laboratory data included: Body temperature (NR: not provided) 97 F, and Pain scale (NR: not provided) 10. On 22-SEP-2021, Laboratory data included: Pain scale (NR: not provided) 6. On 23-SEP-2021, Laboratory data included: Pain scale (NR: not provided) 4. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseous, and headache/intermittent headache, was recovering from felt like was dying, had not recovered from feels like she had the flu, and the outcome of arm hurt really bad/hard to lift, felt sick, diarrhea 2 times and stomach started hurting was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nausea, Pain assessment, Pain in extremity
Clinical narrative: FEELS LIKE SHE HAD THE FLU; FELT LIKE WAS DYING; STOMACH STARTED HURTING; FELT SICK; DIARRHEA 2 TIMES; NAUSEOUS; HEADACHE/INTERMITTENT HEADACHE; ARM HURT REALLY BAD/HARD TO LIFT; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's concurrent conditions included: diabetes mellitus, supraventricular tachycardia, no alcohol use, non-smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient had allergy to a preservative that used to be in contact lenses. The patient experienced drug allergy when treated with alprazolam, and ibuprofen. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced arm hurt really bad/hard to lift. On 21-SEP-2021, the patient experienced feels like she had the flu. On 21-SEP-2021, the patient experienced felt like was dying. On 21-SEP-2021, the patient experienced stomach started hurting. On 21-SEP-2021, the patient experienced felt sick. On 21-SEP-2021, the patient experienced diarrhea 2 times. On 21-SEP-2021, the patient experienced nauseous. On 21-SEP-2021, the patient experienced headache/intermittent headache. Laboratory data included: Body temperature (NR: not provided) 97 F, and Pain scale (NR: not provided) 10. On 22-SEP-2021, Laboratory data included: Pain scale (NR: not provided) 6. On 23-SEP-2021, Laboratory data included: Pain scale (NR: not provided) 4. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseous, and headache/intermittent headache, was recovering from felt like was dying, had not recovered from feels like she had the flu, and the outcome of arm hurt really bad/hard to lift, felt sick, diarrhea 2 times and stomach started hurting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Injection site lymphadenopathy
Clinical narrative: ACHES; BECAME EXTREMELY SICK; CHILLS; 15 DAYS AFTER RECEIVING THE VACCINE, STARTED TO DEVELOP A RASH ON THE INJECTION ARM; RASH AROUND CHEST AREA; HEADACHES; SICK TO STOMACH; SWOLLEN LYMPH NODE IN ARMPIT OF INJECTED ARM; FEELING VERY TIRED; This spontaneous report received from a patient 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 (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced aches, became extremely sick, chills, 15 days after receiving the vaccine, started to develop a rash on the injection arm, rash around chest area, headaches, sick to stomach, swollen lymph node in armpit of injected arm, and feeling very tired. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, aches, headaches, sick to stomach, swollen lymph node in armpit of injected arm, feeling very tired, 15 days after receiving the vaccine, started to develop a rash on the injection arm, became extremely sick and rash around chest area was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Nausea, Pain, Rash
Clinical narrative: ACHES; BECAME EXTREMELY SICK; CHILLS; 15 DAYS AFTER RECEIVING THE VACCINE, STARTED TO DEVELOP A RASH ON THE INJECTION ARM; RASH AROUND CHEST AREA; HEADACHES; SICK TO STOMACH; SWOLLEN LYMPH NODE IN ARMPIT OF INJECTED ARM; FEELING VERY TIRED; This spontaneous report received from a patient 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 (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced aches, became extremely sick, chills, 15 days after receiving the vaccine, started to develop a rash on the injection arm, rash around chest area, headaches, sick to stomach, swollen lymph node in armpit of injected arm, and feeling very tired. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, aches, headaches, sick to stomach, swollen lymph node in armpit of injected arm, feeling very tired, 15 days after receiving the vaccine, started to develop a rash on the injection arm, became extremely sick and rash around chest area was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: USE OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 44 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 (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced use of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of use of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210947464.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: JANSSEN COVID-19 VACCINE WAS ADMINISTERED AFTER THE VIAL WAS PUNCTURED AND LEFT IN THE FRIDGE AT 4C FOR OVER 6 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a consumer concerned a 29 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 (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced janssen covid-19 vaccine was administered after the vial was punctured and left in the fridge at 4c for over 6 hours. On 22-SEP-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine  was not applicable. The outcome of the janssen covid-19 vaccine was administered after the vial was punctured and left in the fridge at 4c for over 6 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210947074.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: FELT FLUISH; FELT CRUMMY; 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. 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 patient experienced felt fluish, and felt crummy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt fluish, and felt crummy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: 5 DOSES OF EXPIRED VACCINE ADMINISTERED TO PATIENTS; OFF-LABEL USE; This spontaneous report received from a health care professional concerned 5 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patients experienced medication error: 5 doses of expired vaccine administered to subjects. On 23-SEP-2021, the patients experienced off-label use. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error: 5 doses of expired vaccine administered to patients and off-label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE VIAL WAS PUNCTURED AND LEFT IN THE FRIDGE FOR OVER 6 HOURS PRIOR TO ADMINISTRATION; POTENTIAL ADMINISTRATION ERROR (EXPIRED JANSSEN COVID-19 VACCINE ADMINISTERED); This spontaneous report received from a consumer concerned an 18 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 (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced vaccine vial was punctured and left in the fridge for over 6 hours prior to administration. On 22-SEP-2021, the patient experienced potential administration error (expired janssen covid-19 vaccine administered). The action taken with covid-19 vaccine was not applicable. The outcome of the potential administration error (expired janssen covid-19 vaccine administered) and vaccine vial was punctured and left in the fridge for over 6 hours prior to administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946821.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Viral infection
Clinical narrative: SEVERE VESTIBULAR VERTIGO; VIRAL ATTACK ON THE VESTIBULAR NERVE; This spontaneous report received from a patient via a company representative 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: 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 MAY-2021, the patient experienced severe vestibular vertigo. On MAY-2021, the patient experienced viral attack on the vestibular nerve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vestibular vertigo, and the outcome of viral attack on the vestibular nerve was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946701.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a patient concerned an 81 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED This spontaneous report received from a health care professional concerned a 54 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 (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946811.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a health care professional concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; 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 (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chest pain. Laboratory data (dates unspecified) included: EKG (NR: not provided) Not Reported, and MRI (NR: not provided) Not Reported. The action taken with covid-19 vaccine was not applicable. The outcome of chest pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This solicited report received from a patient via JS2021-30756: COVID 19 Consumer. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and died was not related.  This report was serious (Death). This case, from the same reporter is linked to 20210941085 and 20210941906.; Sender's Comments: V0: 20210947994-COVID-19 VACCINE AD26.COV2.S -Died. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: BODY ACHES; CHILLS; BEING SICK; FEVER; TIREDNESS; HEADACHES; 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. 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 patient experienced body aches, chills, being sick, fever, tiredness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from being sick, and the outcome of fever, chills, tiredness, body aches and headaches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210948000.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; CHILLS; BEING SICK; FEVER; TIREDNESS; HEADACHES; 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. 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 patient experienced body aches, chills, being sick, fever, tiredness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from being sick, and the outcome of fever, chills, tiredness, body aches and headaches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210948000.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding, Nausea
Clinical narrative: SEVERE BLEEDING; CRAMPING FOR SIX DAYS; RECEIVED PERIOD 10 DAYS EARLY; SPOTTING ON THE FIRST DAY; BODY ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced severe bleeding. On SEP-2021, the patient experienced cramping for six days. On SEP-2021, the patient experienced received period 10 days early. On SEP-2021, the patient experienced spotting on the first day. On SEP-2021, the patient experienced body aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, nausea, and fatigue on SEP-2021, and had not recovered from severe bleeding, cramping for six days, received period 10 days early, and spotting on the first day. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Polymenorrhoea
Clinical narrative: SEVERE BLEEDING; CRAMPING FOR SIX DAYS; RECEIVED PERIOD 10 DAYS EARLY; SPOTTING ON THE FIRST DAY; BODY ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced severe bleeding. On SEP-2021, the patient experienced cramping for six days. On SEP-2021, the patient experienced received period 10 days early. On SEP-2021, the patient experienced spotting on the first day. On SEP-2021, the patient experienced body aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, nausea, and fatigue on SEP-2021, and had not recovered from severe bleeding, cramping for six days, received period 10 days early, and spotting on the first day. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; 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 (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 37 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious.