chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scan brain, Seizure, Vision blurred
Clinical narrative: MULTIPLE (7 OR 8) SEIZURES; PROBLEMS/ISSUE SWALLOWING; NERVE ISSUE; DIZZY; TROUBLE SEEING/VISION PROBLEMS; TINGLING KNEE/TINGLING LEG; NUMBNESS IN RIGHT LEG; SWOLLEN KNEE; SWOLLEN LEG; This spontaneous report received from a patient concerned a 62 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, and marijuana drug abuse (every once in a while). The patient stated that he had no medical history and was very healthy. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total administered in left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, few weeks after the vaccination, the patient had numbing in the right leg above his knee that has gone into his foot. The numbness was only in the right leg, in the surface of his leg in the nerves or veins and it swelled and got worse because he's a tennis player. On 23-SEP-2021, the patient experienced multiple (7 or 8) seizures on the tennis court while playing and taken to the emergency room (ER) and was admitted to the hospital. The patient said that, doctors could not pinpoint what was going on but there were suspicions, and they were sure that the numbing in his leg was caused by the vaccine. While admitted he received Magnetic resonance imaging (MRI) scan (NR: not provided) result not reported and they put something on his head to record activity for 24 hours and determine if there were any more seizures to came. On an unspecified date, the patient had experienced dizzy, tingling knee/tingling leg, trouble seeing (vision problems) and problem/issues swallowing where if he drinks something very cold, he would gag. He reported that numbness in his leg was nothing that he had experienced before. He was prescribed with Levetiracetam 1000 milligram (mg) twice daily upon discharge. The patient was hospitalized for 4 days and discharged on 26-SEP-2021. The patient had made appointment with his primary care physician for next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from problems/issue swallowing, and had not recovered from numbness in right leg, nerve issue, dizzy, swollen knee, swollen leg, tingling knee/tingling leg, trouble seeing/vision problems, and multiple (7 or 8) seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210955573-COVID-19 VACCINE AD26.COV2.S- Multiple (7 or 8) seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: STILLBIRTH; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned multiple female (three mothers) patients with unspecified ethnic origin and race. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date was unknown) dose was not reported, therapy start date were not reported, 1 total dose administered 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. unspecified date, the patients experienced stillbirth, and vaccine exposure during pregnancy. Reporter stated that, the patients (three mothers) had stillbirths due to the vaccine (the pregnancy resulted in a stillbirth). The date of the patient's last menstrual period and expected delivery date were not reported.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stillbirth and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210955784-COVID-19 VACCINE AD26.COV2.S- Still birth. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210955784-COVID-19 VACCINE AD26.COV2.S- Vaccine exposure during pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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. 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, expiry: 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 patient got sick with Covid (suspected clinical vaccination failure, and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210955985-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Feeling abnormal, Food intolerance
Clinical narrative: LITTLE DIZZY; LOW GRADE FEVER; IRRITABLE; SLEPT ALL AFTERNOON; HARD TIME EATING; STOMACH MESSED UP; LACK OF APPETITE CONSUMING FOOD DID HELP A BIT; STOMACH QUEASY; THREW UP TWICE REALLY BAD; SORE ARM FOR COUPLE OF DAYS; VERY LETHARGIC; DOES NOT FEEL HIMSELF; CAN NOT GO TO WORK; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 140 pounds, and height was 69 inches. The patient's past medical history included: anxiety, and concurrent conditions included: pmhx discoid lupus (dle), pre diabetic, early kidney stage, early stage copd, marijuana usage, alcohol user, and cigarettes smoker, and other pre-existing medical conditions included: The patient had experienced sulfamethoxazole screwed up really bad and made lupus get bad on his arms. The patient was previously treated with diazepam for anxiety; and experienced drug allergy when treated with sulfamethoxazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced very lethargic. On SEP-2021, the patient experienced does not feel himself. On SEP-2021, the patient experienced can not go to work. On SEP-2021, the patient experienced sore arm for couple of days. On 26-SEP-2021, the patient experienced slept all afternoon. On 26-SEP-2021, the patient experienced hard time eating. On 26-SEP-2021, the patient experienced stomach messed up. On 26-SEP-2021, the patient experienced lack of appetite consuming food did help a bit. On 26-SEP-2021, the patient experienced stomach queasy. On 26-SEP-2021, the patient experienced threw up twice really bad. On 27-SEP-2021, the patient experienced irritable. On 28-SEP-2021, the patient experienced little dizzy. On 28-SEP-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for couple of days on SEP-2021, had not recovered from very lethargic, irritable, little dizzy, hard time eating, stomach queasy, lack of appetite consuming food did help a bit, and stomach messed up, and the outcome of threw up twice really bad, slept all afternoon, does not feel himself, can not go to work and low grade fever was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Irritability, Lethargy, Nausea, Pain in extremity
Clinical narrative: LITTLE DIZZY; LOW GRADE FEVER; IRRITABLE; SLEPT ALL AFTERNOON; HARD TIME EATING; STOMACH MESSED UP; LACK OF APPETITE CONSUMING FOOD DID HELP A BIT; STOMACH QUEASY; THREW UP TWICE REALLY BAD; SORE ARM FOR COUPLE OF DAYS; VERY LETHARGIC; DOES NOT FEEL HIMSELF; CAN NOT GO TO WORK; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 140 pounds, and height was 69 inches. The patient's past medical history included: anxiety, and concurrent conditions included: pmhx discoid lupus (dle), pre diabetic, early kidney stage, early stage copd, marijuana usage, alcohol user, and cigarettes smoker, and other pre-existing medical conditions included: The patient had experienced sulfamethoxazole screwed up really bad and made lupus get bad on his arms. The patient was previously treated with diazepam for anxiety; and experienced drug allergy when treated with sulfamethoxazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced very lethargic. On SEP-2021, the patient experienced does not feel himself. On SEP-2021, the patient experienced can not go to work. On SEP-2021, the patient experienced sore arm for couple of days. On 26-SEP-2021, the patient experienced slept all afternoon. On 26-SEP-2021, the patient experienced hard time eating. On 26-SEP-2021, the patient experienced stomach messed up. On 26-SEP-2021, the patient experienced lack of appetite consuming food did help a bit. On 26-SEP-2021, the patient experienced stomach queasy. On 26-SEP-2021, the patient experienced threw up twice really bad. On 27-SEP-2021, the patient experienced irritable. On 28-SEP-2021, the patient experienced little dizzy. On 28-SEP-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for couple of days on SEP-2021, had not recovered from very lethargic, irritable, little dizzy, hard time eating, stomach queasy, lack of appetite consuming food did help a bit, and stomach messed up, and the outcome of threw up twice really bad, slept all afternoon, does not feel himself, can not go to work and low grade fever was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: LITTLE DIZZY; LOW GRADE FEVER; IRRITABLE; SLEPT ALL AFTERNOON; HARD TIME EATING; STOMACH MESSED UP; LACK OF APPETITE CONSUMING FOOD DID HELP A BIT; STOMACH QUEASY; THREW UP TWICE REALLY BAD; SORE ARM FOR COUPLE OF DAYS; VERY LETHARGIC; DOES NOT FEEL HIMSELF; CAN NOT GO TO WORK; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 140 pounds, and height was 69 inches. The patient's past medical history included: anxiety, and concurrent conditions included: pmhx discoid lupus (dle), pre diabetic, early kidney stage, early stage copd, marijuana usage, alcohol user, and cigarettes smoker, and other pre-existing medical conditions included: The patient had experienced sulfamethoxazole screwed up really bad and made lupus get bad on his arms. The patient was previously treated with diazepam for anxiety; and experienced drug allergy when treated with sulfamethoxazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced very lethargic. On SEP-2021, the patient experienced does not feel himself. On SEP-2021, the patient experienced can not go to work. On SEP-2021, the patient experienced sore arm for couple of days. On 26-SEP-2021, the patient experienced slept all afternoon. On 26-SEP-2021, the patient experienced hard time eating. On 26-SEP-2021, the patient experienced stomach messed up. On 26-SEP-2021, the patient experienced lack of appetite consuming food did help a bit. On 26-SEP-2021, the patient experienced stomach queasy. On 26-SEP-2021, the patient experienced threw up twice really bad. On 27-SEP-2021, the patient experienced irritable. On 28-SEP-2021, the patient experienced little dizzy. On 28-SEP-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for couple of days on SEP-2021, had not recovered from very lethargic, irritable, little dizzy, hard time eating, stomach queasy, lack of appetite consuming food did help a bit, and stomach messed up, and the outcome of threw up twice really bad, slept all afternoon, does not feel himself, can not go to work and low grade fever was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Pyrexia
Clinical narrative: LITTLE FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition, chronic obstructive pulmonary disease (copd), congestive heart failure (chf), and human immunodeficiency virus (hiv). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced little fever. Laboratory data (dates unspecified) included: HIV test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 25-MAR-2021. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: VIGOROUSLY SHOOK THE VACCINE VIAL BEFORE ADMINISTERING; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 132 pounds, and height was 68 inches. 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: 204B21A expiry: 11-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced vigorously shook the vaccine vial before administering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vigorously shook the vaccine vial before administering was not reported. This report was associated with product quality complaint 90000195049 This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED LOT VACCINE ADMINISTERED; 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: 043A21A, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced expired lot vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired lot vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients. 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, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Scrotal swelling, Ultrasound scan
Clinical narrative: STILL FEELS ABNORMAL AND DIFFERENT; SWELLING OF THE RIGHT SIDE OF TESTICULAR AREA; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 205 pounds, and height was 69 inches. The patient's concurrent conditions included: seasonal allergy, alcohol user, non smoker, back problems, blood pressure, and cholesterol, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced slight headache. On 11-APR-2021, the patient experienced swelling of the right side of testicular area. On an unspecified date, the patient experienced still feels abnormal and different. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the right side of testicular area on MAY-2021, and slight headache on 11-APR-2021, and the outcome of still feels abnormal and different was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED A DOSE OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's weight was 85 kilograms, and height was 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-SEP-2021, the patient experienced administered a dose of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered a dose of expired vaccine was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Skin irritation
Clinical narrative: IRRITABLE SENSATION IN BACK OF NECK; COLD FEELING IN CHEST AND BACK OF NECK; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced irritable sensation in back of neck. On 29-SEP-2021, the patient experienced cold feeling in chest and back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold feeling in chest and back of neck, and irritable sensation in back of neck. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID; This spontaneous report received from a patient who reported via a company representative via social media which concerned a patient of unspecified age, sex, race and ethnic origin. 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, expiry: unknown) dose was not reported, frequency one total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021 (first part of September), the patient experienced breakthrough covid with Flu/cold like symptoms that lasted 3 to 4 weeks (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid on SEP-2021 and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195171.; Sender's Comments: V0: 20210957362-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal disorder, Muscular weakness, Neuralgia, Pneumonia
Clinical narrative: PNEUMONIA; INTESTINAL ISSUES; BRAIN FOG; NERVE PAIN; MUSCLE WEAKNESS; This spontaneous report received from a consumer via a company representative via social media concerned a female of an unspecified age, race and ethnic origin. 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, and expiry: unknown) dose, frequency time was 1 total, 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 had brain fog, muscle weakness, and breathing problems. She also developed pneumonia, intestinal issues, and nerve pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain fog, muscle weakness, pneumonia, intestinal issues, and nerve pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210957410-COVID-19 VACCINE AD26.COV2.S - Pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO 11 PATIENTS; 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered to 11 subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 11 patients was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSES WERE ADMINISTERED AFTER EXPIRATION DATE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: 21-SEP-2021) 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 patients experienced doses were administered after expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of doses were administered after expiration date was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Intensive care
Clinical narrative: PUT IN ICU; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. 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, Expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, after vaccination the patient was kept in intensive care unit (ICU) for an unspecified adverse event. The hospitalization date was unknown. It was also reported that the patient cried that she had to get the vaccine because she did not want to get the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of put in ICU was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210958237-COVID-19 VACCINE AD26.COV2.S Put in ICU. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958321, 20210958993, 20210958502, 20210958716, 20210958892 and 20210958366.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Vomiting
Clinical narrative: VOMITING/THROWING UP/CAN'T HOLD ANYTHING DOWN; CAN'T GET OUT OF BED; This spontaneous report received from a consumer concerned a 39 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: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced can't get out of bed. On 27-SEP-2021, the patient experienced vomiting /throwing up/can't hold anything down. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting/throwing up/can't hold anything down, and can't get out of bed. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 29 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958249, 20210958405, 20210958993, 20210958405, 20210958366, 20210958502 and 20210958716.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Chills, Headache, Oral herpes, Pain
Clinical narrative: RECURRENT COLD SORES (AROUND, TOP AND BOTTOM OF LIPS AND SIDE OF TONGUE); SPLITTING OF THE LIPS; BITING OF THE TONGUE; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 165 pounds, and height was 64 inches. The patient's concurrent conditions included: neuropathic pain, social alcohol drinker, and non smoker, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for neuropathic pain, cyanocobalamin for neuropathic pain, ergocalciferol for neuropathic pain, and pregabalin for neuropathic pain. On 31-AUG-2021, the patient experienced recurrent cold sores (around, top and bottom of lips and side of tongue). On 31-AUG-2021, the patient experienced splitting of the lips. On 31-AUG-2021, the patient experienced biting of the tongue. On 31-AUG-2021, the patient experienced body aches. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 07-SEP-2021, and had not recovered from recurrent cold sores (around, top and bottom of lips and side of tongue), splitting of the lips, and biting of the tongue. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tongue biting
Clinical narrative: RECURRENT COLD SORES (AROUND, TOP AND BOTTOM OF LIPS AND SIDE OF TONGUE); SPLITTING OF THE LIPS; BITING OF THE TONGUE; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 165 pounds, and height was 64 inches. The patient's concurrent conditions included: neuropathic pain, social alcohol drinker, and non smoker, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for neuropathic pain, cyanocobalamin for neuropathic pain, ergocalciferol for neuropathic pain, and pregabalin for neuropathic pain. On 31-AUG-2021, the patient experienced recurrent cold sores (around, top and bottom of lips and side of tongue). On 31-AUG-2021, the patient experienced splitting of the lips. On 31-AUG-2021, the patient experienced biting of the tongue. On 31-AUG-2021, the patient experienced body aches. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 07-SEP-2021, and had not recovered from recurrent cold sores (around, top and bottom of lips and side of tongue), splitting of the lips, and biting of the tongue. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21/SEP/2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958806 and 20210958405.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; 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 ,expiry: unknown) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423 and 20210958321. This case, from the Others is linked to 20210958425.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958425.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician 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: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 09:37 for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Feeling abnormal
Clinical narrative: FELT A LITTLE BIT IF SOMETHING; RECEIVED AN EXPIRED VACCINE; FATIGUE; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: high blood pressure, arthritis, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient experienced felt a little bit if something. On 22-SEP-2021, the patient experienced received an expired vaccine. On 22-SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received an expired vaccine, fatigue and felt a little bit if something was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: WARM ON THE SECOND DAY AFTER THE SHOT; MILD ACHE; SWEATING ON THE SECOND DAY AFTER THE SHOT; SORE ARM THE FIRST DAY AFTER THE SHOT; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, abstains from alcohol, sore arm and other pre-existing medical conditions included: Patient was healthy. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the patient experienced warm on the second day after the shot. On APR-2021, the patient experienced mild ache. On APR-2021, the patient experienced sweating on the second day after the shot. On APR-2021, the patient experienced sore arm the first day after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm the first day after the shot, warm on the second day after the shot, mild ache and sweating on the second day after the shot was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 32 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958348, 20210958321, 20210958423, 20210958993 and 20210958806.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF VACCINE 40-110 HOURS POST EXPIRY; This spontaneous report received from a physician 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, the patient experienced administration of vaccine 40-110 hours post expiry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administration of vaccine 40-110 hours post expiry. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 54 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958249, 20210958321, 20210958892, 20210958366, 20210958993, 20210958405, 20210958502 and 20210933076. This case, from the Others is linked to 20210959351 and 20210958518.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 48 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958371, 20210958806, 20210958566, 20210959351, 20210958518, 20210959620, 20210959581, 20210958977, 20210958348, 20210958321, 20210958525 and 20210959909. This case, from the Others is linked to 20210958366.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Palpitations
Clinical narrative: RACING HEART FEELING FOR 4 TO 5 TIMES; RASH AT SITE OF INJECTION LIKE RED DOTS ALONG ALL THE ARM; This spontaneous report received from a consumer concerned a 53 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) dose was not reported, administered on AUG-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. No concomitant medications were reported. On an unspecified date, the patient experienced racing heart feeling for 4 to 5 times, and rash at site of injection like red dots along all the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the racing heart feeling for 4 to 5 times and rash at site of injection like red dots along all the arm was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a 63 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: 205A21A expiry: unknown) dose was not reported, frequency time 1 total was administered on 13-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, (2 weeks after the vaccination) the patient had blood clots, about 6 on upper arm near the injection site and they travelled down the arm. The patient stated that, on the day of report one clot was appeared on the finger. The patient had not been gone to the doctor because it still appeared to be superficial and one of them felt like little lump that patient could feel it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210958476-COVID-19 VACCINE AD26.COV2.S-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).