chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was vaccinated with with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received an additional company suspect of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 total, administered on 03-DEC-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 in DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient had a blood clot and was taken to the emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211227747- Covid-19 vaccine ad26.cov2.s-blood clot. 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: Fatigue, Headache
Clinical narrative: TIRED; REALLY BAD HEADACHES; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (Unspecified manufacturer)(suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s.  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, 1 total, administered on 10-DEC-2021 for prophylactic vaccination (Dose number in series 2). 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 11-DEC-2021, the patient experienced tired and really bad headaches. It was reported that, the patient got booster two days ago and yesterday was tired and had really bad headaches but after a good nap and some food felt really good. And on day of reporting felt amazing. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired and really bad headaches on DEC-2021. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Illness, Pain
Clinical narrative: SICK; CHEST PAINS; HURTING ALL OVER; NO ENERGY; This spontaneous report received from a consumer via social media (Facebook) concerned a male 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, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No adverse events reported after vaccination.  The patient received non-company suspect booster vaccine included: BNT 162 (Pfizer) (form of admin, route of admin, and batch number were not reported), dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On an unspecified date following BNT 162 (Pfizer) vaccination, the patient got really sick. The patient had chest pains within 10 minutes and within half hour it was hurting all over and had no energy (dose number in series 2).   It was reported that "my husband and I took the Pfizer (however it is spelled) booster after we had the J&J and we both got really sick. My husband had chest pains within 10 minutes and within half hour was hurting all over and no energy. Mine started the next day and I was in bed for 7 days with joint pain, nausea, dizziness and no appetite. I will never take another vaccine"  The action taken withcovid-19 vaccine ad26.cov2.s  was not applicable.  The outcome of the sick, chest pains, hurting all over and no energy was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211229790.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: COVID SHOT MURDERED THREE PEOPLE I KNOW; This spontaneous report received from a consumer via a company representative via social media concerned 3 patients of unspecified age, sex, race and ethnic origin.  No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the reporter stated that, the J&J (Johnson and Johnson) covid shot murdered three people I know. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211230706-COVID-19 VACCINE AD26.COV2.S- covid shot murdered three people I know. This event(s) is considered unassessable. The event(s) has 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: Suspected COVID-19, Vaccination failure
Clinical narrative: BAD CASE OF COVID AND REFUSED TO GO THE HOSPITAL; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a regulatory authority through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, weight and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. The dose number in series was 1. No concomitant medications were reported.  On an unspecified date, the patient had a bad case of covid and refused to go the hospital, and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad case of covid and refused to go the hospital and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested. This case, from the same reporter is linked to 20211230489.; Sender's Comments: V0.20211230784-covid-19 vaccine ad26.cov2.s -Bad covid 19. 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).  20211230784-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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000206831.; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: LOOKING ROUGH; This spontaneous report received from a consumer via a company representative via social media concerned a male of 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 (Janssen series 1) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose not reported,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 was looking rough, and was hospitalized (date unspecified). Consumer reported that patient still in hospital, nine weeks, still looking rough. Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from looking rough. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211230904-Covid-19 vaccine ad26.cov2.s  Looking rough. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Groin pain
Clinical narrative: GROIN PAIN; This spontaneous report received from a consumer concerned a 6 decade old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-infectious intermediate, posterior and panuveitis. The patient was previously treated with covid-19 vaccine ad26. cov2. (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 in total, administered on 21-APR-2021 for prophylactic vaccination. (Dose number in series was 1). On an unspecified date, the patient experienced groin pain (Dose number in series was 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: Unknown) dose was not reported,1 total administered on 31-OCT-2021 for prophylactic vaccination. (Dose number in series was 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate, posterior and panuveitis. No concomitant medications were reported. On an unspecified date, following vaccination with booster dose covid-19 vaccine ad26.cov2.s the patient experienced groin pain (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from groin pain. This report was non-serious. This case, involving the same patient is linked to 20211221612.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 INFECTION; SUSPECTED VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a 33 year old male of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of administration was not reported, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total, 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.  On an unspecified date, it was reported that, "the patient died due to coronavirus disease-19 (covid-19), even though he was vaccinated (suspected vaccination failure)". It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event covid-19 was fatal and outcome of the suspected vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000207040.; Sender's Comments: V0. 20211232923-covid-19 vaccine ad26.cov2.s -Died of Covid 19. 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).  20211232923-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; Reported Cause(s) of Death: COVID-19 INFECTION
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a company representative via social media (twitter) concerned a patient of unspecified age, race, ethnicity 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, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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 myocarditis. The action taken with covid-19 vaccine  was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211233715-COVID-19 VACCINE -myocarditis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: DIED; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch numbers were not reported) dose was not reported, 1 total, therapy start dates were not reported for prophylactic vaccination. The batch numbers were not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified dates, after the vaccination, the multiple patients caught Covid-19 and died (dates unspecified) (suspected covid-19 infection and suspected clinical vaccination failure). The cause of death was unknown. As per the reporter, "I also know a couple of people that were vaxxed, caught covid and died". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The multiple patients died on an unspecified date, and the outcome for suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000207068. This case, from the same reporter is linked to 20211233027.; Sender's Comments: V0: 20211233833 -Covid-19 vaccine ad26.cov2.s-Died, Suspected COVID-19 infection. 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).   20211233833-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccine 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nonspecific reaction
Clinical narrative: MUSCLE ACHES; MINOR REACTIONS; This spontaneous report received from a pharmacist 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 (Dose number in series: 1) (suspension for injection, route of admin was not reported, and batch number: UNKNOWN) dose was not reported, administered on 21-MAY-2021 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 minor reactions and muscle aches (Dose number in series: 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minor reactions and muscle aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20211233514 (Dose number in series: 2, Booster dose) This case, from the same reporter is linked to 20211233321 and 20211233061.
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis
Clinical narrative: INFLAMMATION OF THE OPTIC NERVE; 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, and batch number were not reported) 1 total, dose (Dose series number : 1) and 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.  The reporter stated that, on an unspecified date, the "patient lost sight completely in her right eye, and 3 days later, inflammation of the optic nerve. Doctor said fault of the vaccine 100 percent." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of the optic nerve (lost sight completely in right eye) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211234734 -COVID-19 VACCINE AD26.COV2.S- inflammation of optic nerve. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 40 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000207303.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: anaphylactic reactions to many medications. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on MAY-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 anaphylactic reaction specifically lips swelled, throat swelled, and stabbing in chest when first go it .The reactions lasted for two weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211234835-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Death
Clinical narrative: DEATH; ADVERSE REACTION; This spontaneous report received from a consumer via social media via a company representative concerned a 29-year-old male of unknown 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, and batch number were not reported)1 total, dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that ""The Johnson and Johnson vaccine contributed to the death of my grandson only 29 adverse reaction to a mandated vaccine to keep his new job." On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was serious (Death).; Sender's Comments: V0 20211234915- COVID-19 VACCINE AD26.COV2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Hypokinesia, Inflammation
Clinical narrative: NOT BE ABLE TO WALK FOR 7 WEEKS; COULD NOT BEND LEGS; ALL THE INFLAMMATION; 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, 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced not be able to walk for 7 weeks, could not bend legs, and all the inflammation. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not be able to walk for 7 weeks, and the outcome of all the inflammation and could not bend legs was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal
Clinical narrative: NO ENERGY; FEEL BAD; EXTREME FATIGUE/SO TIRED; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: uterine cancer, anemia, and diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the patient experienced extreme fatigue/so tired. On an unspecified date, the patient experienced no energy, and feel bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue/so tired on 23-MAY-2021, and no energy, and the outcome of feel bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electric shock sensation, Hypertension, Hypoaesthesia, Insomnia
Clinical narrative: EXTREME PAIN; CAN NOT SLEEP AT NIGHT; BLOOD PRESSURE HIGH; ELECTRIC SHOCKS FROM KNEE TO UPPER THIGH; NUMBNESS ON LEFT THIGH; PINCH NERVE; This spontaneous report received from a patient concerned a 67 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and orthropaedic procedure, and concurrent conditions included: herniated disc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2C6A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced pinch nerve. On 16-JUL-2021, the patient experienced numbness on left thigh. On an unspecified date, the patient experienced extreme pain, can not sleep at night, blood pressure high, and electric shocks from knee to upper thigh. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on left thigh, pinch nerve, and extreme pain, and the outcome of can not sleep at night, blood pressure high and electric shocks from knee to upper thigh was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nerve compression, Pain
Clinical narrative: EXTREME PAIN; CAN NOT SLEEP AT NIGHT; BLOOD PRESSURE HIGH; ELECTRIC SHOCKS FROM KNEE TO UPPER THIGH; NUMBNESS ON LEFT THIGH; PINCH NERVE; This spontaneous report received from a patient concerned a 67 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and orthropaedic procedure, and concurrent conditions included: herniated disc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2C6A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced pinch nerve. On 16-JUL-2021, the patient experienced numbness on left thigh. On an unspecified date, the patient experienced extreme pain, can not sleep at night, blood pressure high, and electric shocks from knee to upper thigh. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on left thigh, pinch nerve, and extreme pain, and the outcome of can not sleep at night, blood pressure high and electric shocks from knee to upper thigh was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: FREEZING FOR A GOOD HOUR; 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, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced freezing for a good hour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing for a good hour on 10-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Asthenia, Body temperature, Diarrhoea, Dizziness
Clinical narrative: DID NOT HAVE MENSTRUAL CYCLE FOR A PERIOD OF 6 MONTHS; DIZZINESS; FEVER; DIARRHEA; SWOLLEN LYMPH NODES; WEAKNESS; EXTREME HEADACHE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced did not have menstrual cycle for a period of 6 months, dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) between 10 and 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache, and the outcome of did not have menstrual cycle for a period of 6 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235952.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: DID NOT HAVE MENSTRUAL CYCLE FOR A PERIOD OF 6 MONTHS; DIZZINESS; FEVER; DIARRHEA; SWOLLEN LYMPH NODES; WEAKNESS; EXTREME HEADACHE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced did not have menstrual cycle for a period of 6 months, dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) between 10 and 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache, and the outcome of did not have menstrual cycle for a period of 6 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235952.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; PUNCTURED VACCINE THAT WAS LEFT AT ROOM TEMPERATURE FOR 5 HOURS WAS 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced incorrect product storage, and punctured vaccine that was left at room temperature for 5 hours was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and punctured vaccine that was left at room temperature for 5 hours was administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS GIVEN FROM A PUNCTURED VIAL; KEPT AT FRIDGE TEMPERATURE, A FEW DAYS AFTER INITIAL PUNCTURE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine was given from a punctured vial, and kept at fridge temperature, a few days after initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given from a punctured vial and kept at fridge temperature, a few days after initial puncture was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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, 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiovascular disorder
Clinical narrative: CARDIOVASCULAR HEALTH HAS DETERIORATED; 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 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.  On an unspecified date, the patient experienced cardiovascular health has deteriorated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiovascular health has deteriorated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: FLU LIKE SIDE EFFECT; ARM HURT FOR OVER A WEEK; 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, 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 flu like side effect, and arm hurt for over a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt for over a week, and the outcome of flu like side effect was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID FIVE MONTHS AFTER THE SHOT; This spontaneous report received from a patient via a company representative concerned an 86 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 got covid five months after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid five months after the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20211238440. This report was associated with product quality complaint: 90000207487.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bone pain, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: UPSET STOMACH/FEELING SICK TO STOMACH; PAIN IN BONES; SWEATS; THROWING UP BILE; DIARRHEA; FEELING TIRED; This spontaneous report received from a patient concerned a 70 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: 213021A expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced upset stomach/feeling sick to stomach. On 03-DEC-2021, the patient experienced pain in bones. On 03-DEC-2021, the patient experienced sweats. On 03-DEC-2021, the patient experienced throwing up bile. On 03-DEC-2021, the patient experienced diarrhea. On 03-DEC-2021, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upset stomach/feeling sick to stomach, throwing up bile, diarrhea, pain in bones, sweats, and feeling tired. This report was non-serious. This case, from the same reporter is linked to 20211238076.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: UPSET STOMACH/FEELING SICK TO STOMACH; PAIN IN BONES; SWEATS; THROWING UP BILE; DIARRHEA; FEELING TIRED; This spontaneous report received from a patient concerned a 70 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: 213021A expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced upset stomach/feeling sick to stomach. On 03-DEC-2021, the patient experienced pain in bones. On 03-DEC-2021, the patient experienced sweats. On 03-DEC-2021, the patient experienced throwing up bile. On 03-DEC-2021, the patient experienced diarrhea. On 03-DEC-2021, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upset stomach/feeling sick to stomach, throwing up bile, diarrhea, pain in bones, sweats, and feeling tired. This report was non-serious. This case, from the same reporter is linked to 20211238076.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: PRETTY SERIOUS REACTION TO THE VACCINE; 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  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUL-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 pretty serious reaction to the vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of pretty serious reaction to the vaccine was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).