chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: MIGRAINE HEADACHE; BODY PAIN HEAD TO TOE; LOST APPETITE/COULDN'T EAT; STOMACH PAIN; RIB PAIN; CHILLS; WEAKNESS; FEVER; NAUSEA; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no past medical history of migraine disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 12/APR/2021) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced couldn't sleep. On 12-APR-2021, the subject experienced migraine headache. On 12-APR-2021, the subject experienced body pain head to toe. On 12-APR-2021, the subject experienced lost appetite/couldn't eat. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced rib pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) No temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on APR-2021, had not recovered from migraine headache, body pain head to toe, lost appetite/couldn't eat, weakness, stomach pain, and rib pain, and the outcome of couldn't sleep was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Musculoskeletal chest pain, Nausea, Pain
Clinical narrative: MIGRAINE HEADACHE; BODY PAIN HEAD TO TOE; LOST APPETITE/COULDN'T EAT; STOMACH PAIN; RIB PAIN; CHILLS; WEAKNESS; FEVER; NAUSEA; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no past medical history of migraine disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 12/APR/2021) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced couldn't sleep. On 12-APR-2021, the subject experienced migraine headache. On 12-APR-2021, the subject experienced body pain head to toe. On 12-APR-2021, the subject experienced lost appetite/couldn't eat. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced rib pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) No temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on APR-2021, had not recovered from migraine headache, body pain head to toe, lost appetite/couldn't eat, weakness, stomach pain, and rib pain, and the outcome of couldn't sleep was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MIGRAINE HEADACHE; BODY PAIN HEAD TO TOE; LOST APPETITE/COULDN'T EAT; STOMACH PAIN; RIB PAIN; CHILLS; WEAKNESS; FEVER; NAUSEA; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no past medical history of migraine disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 12/APR/2021) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced couldn't sleep. On 12-APR-2021, the subject experienced migraine headache. On 12-APR-2021, the subject experienced body pain head to toe. On 12-APR-2021, the subject experienced lost appetite/couldn't eat. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced rib pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) No temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on APR-2021, had not recovered from migraine headache, body pain head to toe, lost appetite/couldn't eat, weakness, stomach pain, and rib pain, and the outcome of couldn't sleep was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: WEAKNESS; SEVERE FATIGUE; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative bone disease, and osteoporosis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and severe fatigue. This report was non-serious. This case, from the same reporter is linked to 20210427584.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: BUMP ON TOP OF RIGHT INDEX FINGER; HEADACHE; This spontaneous report received from a consumer. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced bump on top of right index finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from bump on top of right index finger. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Fatigue, Headache, Injection site pain
Clinical narrative: ABDOMINAL PAIN; ARM SORENESS; FEVER; FATIGUE; NAUSEA; HEADACHE; INJECTION SITE SORENESS (RIGHT DELTOID); This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was taking unspecified name of medication for birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced abdominal pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced injection site soreness (right deltoid). Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, fatigue, nausea, headache, arm soreness, abdominal pain, and injection site soreness (right deltoid). This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: ABDOMINAL PAIN; ARM SORENESS; FEVER; FATIGUE; NAUSEA; HEADACHE; INJECTION SITE SORENESS (RIGHT DELTOID); This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was taking unspecified name of medication for birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced abdominal pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced injection site soreness (right deltoid). Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, fatigue, nausea, headache, arm soreness, abdominal pain, and injection site soreness (right deltoid). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: PRESSURE HEADACHE (POTENTIALLY SINUS HEADACHE); BODY ACHES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 14-APR-2021, the subject experienced sinus headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and had not recovered from sinus headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 110 pounds, and height was 63 inches. The patient's concurrent conditions included seasonal allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-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 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and sore arm on 13-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: ITCHING AT SITE OF INJECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-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 15-MAR-2021, the subject experienced itching at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching at site of injection on 29-MAR-2021. This report was non-serious.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: SEVERE ITCHINESS; HIVES; This spontaneous report received from a patient concerned a 46 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced severe itchiness. On 13-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itchiness, and hives. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Skin discolouration
Clinical narrative: BLUISH, BLACKISH RIGHT THUMB; CHILLS; TIREDNESS; LETHARGY; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced lethargy. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced bluish, blackish right thumb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy on 25-MAR-2021, and bluish, blackish right thumb on 05-APR-2021, and was recovering from chills, and tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea exertional, Limb discomfort
Clinical narrative: LEGS FEEL WEAK; WEAKNESS; NAUSEA; FEELING DIZZY AND DIZZINESS GOT WORSE; MEDICINAL SMELL IN NOSE; BODY ACHE; CHILLS; STANDS AND WALKS AROUND FELT WINDED; LEGS FEELS HEAVY; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stands and walks around felt winded. On APR-2021, the subject experienced legs feels heavy. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced feeling dizzy and dizziness got worse. On 12-APR-2021, the subject experienced medicinal smell in nose. On 13-APR-2021, the subject experienced legs feel weak. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-APR-2021, had not recovered from feeling dizzy and dizziness got worse, medicinal smell in nose, legs feel weak, nausea, body ache, and weakness, and the outcome of stands and walks around felt winded and legs feels heavy was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Pain, Parosmia
Clinical narrative: LEGS FEEL WEAK; WEAKNESS; NAUSEA; FEELING DIZZY AND DIZZINESS GOT WORSE; MEDICINAL SMELL IN NOSE; BODY ACHE; CHILLS; STANDS AND WALKS AROUND FELT WINDED; LEGS FEELS HEAVY; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stands and walks around felt winded. On APR-2021, the subject experienced legs feels heavy. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced feeling dizzy and dizziness got worse. On 12-APR-2021, the subject experienced medicinal smell in nose. On 13-APR-2021, the subject experienced legs feel weak. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-APR-2021, had not recovered from feeling dizzy and dizziness got worse, medicinal smell in nose, legs feel weak, nausea, body ache, and weakness, and the outcome of stands and walks around felt winded and legs feels heavy was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) with unspecified dose, 1 total, administered on 12-MAR-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 14-MAR-2021, 2 days after administration of vaccine, the patient had stroke, and the patient was hospitalized on an unspecified date for unspecified duration and had since made a full recovery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428874-Covid-19 vaccine ad26.cov2.s -Stroke. 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: Muscle spasms
Clinical narrative: LEG CRAMPS; 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 hospitalization.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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps. This report was non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid portion/without reconstituting with accompanying antigen; administered only the liquid portion/without reconstituting with accompanying antigen; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that, the temporary medical assistants did not follow instructions for Shingrix and administered only the liquid portion to several different patients without reconstituting with accompanying antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not recall many details. The reporter agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on chest; This case was reported by a consumer  and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient received a dose of shingrix and experienced rash on chest. The patient enquired if it was a normal side effect. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via ( interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088501:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088497:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088501:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088531:Original Case : US2021AMR088476
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088497:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088501:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088531:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088531:Original Case : US2021AMR088476
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088497:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088501:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088531:Original Case : US2021AMR088476
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088497:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; very painful; had three shingles shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had three shingles shots, which led to  extra dose administered. The patient still experienced shingles. It was reported as shingles shot was very painful every time. This case was reported as suspected vaccination failure since the details regarding time to onset and laboratory confirmation were not reported.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on Jan 7yh 2020 but he never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020, Batch no-3EC24, Expiry date-10th May2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis, Pain, Pyrexia, X-ray
Clinical narrative: INFECTED MOUTH SORE, TUBULAR GUM SWELLING, STRANGE YELLOWISH PUS, INFECTION IN GUMS; MILD BODY ACHES; FEVERISH; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and anxiety, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. the patient had no previous gum/mouth condition.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety. On 12-MAR-2021, the subject experienced mild body aches. On 12-MAR-2021, the subject experienced feverish. On 03-APR-2021, the subject experienced infected mouth sore, tubular gum swelling, strange yellowish pus, infection in gums. On 07-APR-2021, Laboratory data included: X-ray (NR: not provided) unknown. On 08-APR-2021, treatment medications included: azithromycin. Laboratory data (dates unspecified) included: X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild body aches, and feverish on 14-MAR-2021, and was recovering from infected mouth sore, tubular gum swelling, strange yellowish pus, infection in gums. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Mobility decreased
Clinical narrative: SWELLING BEHIND HER KNEE, CALF AND THIGH; PAIN BEHIND HER KNEE, CALF AND THIGH; CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; DIZZINESS; DIFFICULT TIME GETTING UP AND MOVING; HEADACHE/COULD NOT MOVE OR TALK; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficult time getting up and moving. On APR-2021, the subject experienced headache/could not move or talk. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced swelling behind her knee, calf and thigh. On 11-APR-2021, the subject experienced pain behind her knee, calf and thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, injection site pain on 03-APR-2021, and headache/could not move or talk on APR-2021, was recovering from nausea, and dizziness, had not recovered from pain behind her knee, calf and thigh, and swelling behind her knee, calf and thigh, and the outcome of difficult time getting up and moving was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: SWELLING BEHIND HER KNEE, CALF AND THIGH; PAIN BEHIND HER KNEE, CALF AND THIGH; CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; DIZZINESS; DIFFICULT TIME GETTING UP AND MOVING; HEADACHE/COULD NOT MOVE OR TALK; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficult time getting up and moving. On APR-2021, the subject experienced headache/could not move or talk. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced swelling behind her knee, calf and thigh. On 11-APR-2021, the subject experienced pain behind her knee, calf and thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, injection site pain on 03-APR-2021, and headache/could not move or talk on APR-2021, was recovering from nausea, and dizziness, had not recovered from pain behind her knee, calf and thigh, and swelling behind her knee, calf and thigh, and the outcome of difficult time getting up and moving was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Cough, Dyspnoea, Injection site scar, Nausea
Clinical narrative: PAINS IN NECK; LOW BODY TEMPERATURE; COUGHING; SCAR LIKE NEXT TO VACCINE SITE; SORE ARM; FEVER; EXTREME SHORTNESS OF BREATH; NAUSEA; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced extreme shortness of breath. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced pains in neck. On 11-APR-2021, the subject experienced low body temperature. On 11-APR-2021, the subject experienced coughing. On 11-APR-2021, the subject experienced scar like next to vaccine site. Laboratory data included: Body temperature decreased (NR: not provided) 94-95 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, was recovering from low body temperature, had not recovered from extreme shortness of breath, nausea, pains in neck, sore arm, and coughing, and the outcome of scar like next to vaccine site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425534 and 20210423876.