chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Dyspepsia
Clinical narrative: FREEZING COLD; FEVER; DIGESTIVE ISSUES; VOMITED; SEVERE DIARRHEA; SHAKING AND CRAZY CHILLS; SWEATING ON HER FACE DURING LUNCH; EYE ISSUE; GUM ISSUE; NOSTRIL ISSUE; FEEL SICK; VERY TIRED; MUSCLE ACHES; NAUSEA; SWOLLEN LYMPH NODES IN HER NECK; SEVERE HEADACHE; SKIN FEELS WEIRD (LIKE EEL SKIN, HEAVY AND THICK); NO APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced eye issue. On SEP-2021, the patient experienced gum issue. On SEP-2021, the patient experienced nostril issue. On SEP-2021, the patient experienced skin feels weird (like eel skin, heavy and thick). On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced feel sick. On SEP-2021, the patient experienced very tired. On SEP-2021, the patient experienced muscle aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced swollen lymph nodes in her neck. On SEP-2021, the patient experienced severe headache. Treatment medications included: acetylsalicylic acid, ibuprofen, and ibuprofen/pseudoephedrine hydrochloride. On 09-SEP-2021, the patient experienced sweating on her face during lunch. On 09-SEP-2021, the patient experienced shaking and crazy chills. On 16-SEP-2021, the patient experienced digestive issues. On 16-SEP-2021, the patient experienced vomited. On 16-SEP-2021, the patient experienced severe diarrhea. On 21-SEP-2021, the patient experienced freezing cold. On 21-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye issue, gum issue, and nostril issue on 21-SEP-2021, and severe headache on 20-SEP-2021, had not recovered from sweating on her face during lunch, skin feels weird (like eel skin, heavy and thick), no appetite, and freezing cold, and the outcome of very tired, muscle aches, nausea, swollen lymph nodes in her neck, digestive issues, vomited, severe diarrhea, shaking and crazy chills, fever and feel sick was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Fatigue, Feeling cold, Gingival disorder, Headache
Clinical narrative: FREEZING COLD; FEVER; DIGESTIVE ISSUES; VOMITED; SEVERE DIARRHEA; SHAKING AND CRAZY CHILLS; SWEATING ON HER FACE DURING LUNCH; EYE ISSUE; GUM ISSUE; NOSTRIL ISSUE; FEEL SICK; VERY TIRED; MUSCLE ACHES; NAUSEA; SWOLLEN LYMPH NODES IN HER NECK; SEVERE HEADACHE; SKIN FEELS WEIRD (LIKE EEL SKIN, HEAVY AND THICK); NO APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced eye issue. On SEP-2021, the patient experienced gum issue. On SEP-2021, the patient experienced nostril issue. On SEP-2021, the patient experienced skin feels weird (like eel skin, heavy and thick). On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced feel sick. On SEP-2021, the patient experienced very tired. On SEP-2021, the patient experienced muscle aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced swollen lymph nodes in her neck. On SEP-2021, the patient experienced severe headache. Treatment medications included: acetylsalicylic acid, ibuprofen, and ibuprofen/pseudoephedrine hydrochloride. On 09-SEP-2021, the patient experienced sweating on her face during lunch. On 09-SEP-2021, the patient experienced shaking and crazy chills. On 16-SEP-2021, the patient experienced digestive issues. On 16-SEP-2021, the patient experienced vomited. On 16-SEP-2021, the patient experienced severe diarrhea. On 21-SEP-2021, the patient experienced freezing cold. On 21-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye issue, gum issue, and nostril issue on 21-SEP-2021, and severe headache on 20-SEP-2021, had not recovered from sweating on her face during lunch, skin feels weird (like eel skin, heavy and thick), no appetite, and freezing cold, and the outcome of very tired, muscle aches, nausea, swollen lymph nodes in her neck, digestive issues, vomited, severe diarrhea, shaking and crazy chills, fever and feel sick was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lymphadenopathy, Malaise, Myalgia, Nausea
Clinical narrative: FREEZING COLD; FEVER; DIGESTIVE ISSUES; VOMITED; SEVERE DIARRHEA; SHAKING AND CRAZY CHILLS; SWEATING ON HER FACE DURING LUNCH; EYE ISSUE; GUM ISSUE; NOSTRIL ISSUE; FEEL SICK; VERY TIRED; MUSCLE ACHES; NAUSEA; SWOLLEN LYMPH NODES IN HER NECK; SEVERE HEADACHE; SKIN FEELS WEIRD (LIKE EEL SKIN, HEAVY AND THICK); NO APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced eye issue. On SEP-2021, the patient experienced gum issue. On SEP-2021, the patient experienced nostril issue. On SEP-2021, the patient experienced skin feels weird (like eel skin, heavy and thick). On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced feel sick. On SEP-2021, the patient experienced very tired. On SEP-2021, the patient experienced muscle aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced swollen lymph nodes in her neck. On SEP-2021, the patient experienced severe headache. Treatment medications included: acetylsalicylic acid, ibuprofen, and ibuprofen/pseudoephedrine hydrochloride. On 09-SEP-2021, the patient experienced sweating on her face during lunch. On 09-SEP-2021, the patient experienced shaking and crazy chills. On 16-SEP-2021, the patient experienced digestive issues. On 16-SEP-2021, the patient experienced vomited. On 16-SEP-2021, the patient experienced severe diarrhea. On 21-SEP-2021, the patient experienced freezing cold. On 21-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye issue, gum issue, and nostril issue on 21-SEP-2021, and severe headache on 20-SEP-2021, had not recovered from sweating on her face during lunch, skin feels weird (like eel skin, heavy and thick), no appetite, and freezing cold, and the outcome of very tired, muscle aches, nausea, swollen lymph nodes in her neck, digestive issues, vomited, severe diarrhea, shaking and crazy chills, fever and feel sick was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinitis, Skin hypertrophy, Vomiting
Clinical narrative: FREEZING COLD; FEVER; DIGESTIVE ISSUES; VOMITED; SEVERE DIARRHEA; SHAKING AND CRAZY CHILLS; SWEATING ON HER FACE DURING LUNCH; EYE ISSUE; GUM ISSUE; NOSTRIL ISSUE; FEEL SICK; VERY TIRED; MUSCLE ACHES; NAUSEA; SWOLLEN LYMPH NODES IN HER NECK; SEVERE HEADACHE; SKIN FEELS WEIRD (LIKE EEL SKIN, HEAVY AND THICK); NO APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced eye issue. On SEP-2021, the patient experienced gum issue. On SEP-2021, the patient experienced nostril issue. On SEP-2021, the patient experienced skin feels weird (like eel skin, heavy and thick). On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced feel sick. On SEP-2021, the patient experienced very tired. On SEP-2021, the patient experienced muscle aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced swollen lymph nodes in her neck. On SEP-2021, the patient experienced severe headache. Treatment medications included: acetylsalicylic acid, ibuprofen, and ibuprofen/pseudoephedrine hydrochloride. On 09-SEP-2021, the patient experienced sweating on her face during lunch. On 09-SEP-2021, the patient experienced shaking and crazy chills. On 16-SEP-2021, the patient experienced digestive issues. On 16-SEP-2021, the patient experienced vomited. On 16-SEP-2021, the patient experienced severe diarrhea. On 21-SEP-2021, the patient experienced freezing cold. On 21-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye issue, gum issue, and nostril issue on 21-SEP-2021, and severe headache on 20-SEP-2021, had not recovered from sweating on her face during lunch, skin feels weird (like eel skin, heavy and thick), no appetite, and freezing cold, and the outcome of very tired, muscle aches, nausea, swollen lymph nodes in her neck, digestive issues, vomited, severe diarrhea, shaking and crazy chills, fever and feel sick was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Heart rate, Hypertension, Overdose
Clinical narrative: ELEVATED BLOOD PRESSURE; RECEIVED AN ENTIRE VIAL OF THE JANSSEN COVID 19 VACCINE INSTEAD OF ONLY ONE DOSE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a health care professional concerned a 36 year. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, non-smoker, and non-alcohol user, and the patient had no health conditions. The patient experienced drug allergy when treated with cefalexin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, 1 total administered to right arm on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient was accidently given an entire vial of the Janssen COVID-19 Vaccine instead of only one dose at the vaccination facility (overdose). The patient had not experienced any side effects at the time of reporting. On the same day, the patient had visited Emergency Department (ER) and her vitals were monitored at ER. Her blood pressure was found to be 190/70 mmHg (elevated blood pressure), Heart rate was 83 bpm (beats per minute), and Oxygen saturation was 98%. The Patient was discharged from the Emergency Department on the same day and experienced a low grade fever (no Temperature recorded) and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure, and the outcome of received an entire vial of the janssen covid 19 vaccine instead of only one dose, low grade fever and chills was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000194469.  Initial information was processed with additional information received on 23-SEP-2021.The following information was updated and incorporated into the case narrative: Reporter(Pharmacist) added as contact, events(low grade fever, chills) were added, labelling, causality and narrative were updated.; Sender's Comments: 20210943963-COVID-19 VACCINE AD26.COV2.S-elevated blood pressure. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia
Clinical narrative: ELEVATED BLOOD PRESSURE; RECEIVED AN ENTIRE VIAL OF THE JANSSEN COVID 19 VACCINE INSTEAD OF ONLY ONE DOSE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a health care professional concerned a 36 year. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, non-smoker, and non-alcohol user, and the patient had no health conditions. The patient experienced drug allergy when treated with cefalexin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, 1 total administered to right arm on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient was accidently given an entire vial of the Janssen COVID-19 Vaccine instead of only one dose at the vaccination facility (overdose). The patient had not experienced any side effects at the time of reporting. On the same day, the patient had visited Emergency Department (ER) and her vitals were monitored at ER. Her blood pressure was found to be 190/70 mmHg (elevated blood pressure), Heart rate was 83 bpm (beats per minute), and Oxygen saturation was 98%. The Patient was discharged from the Emergency Department on the same day and experienced a low grade fever (no Temperature recorded) and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure, and the outcome of received an entire vial of the janssen covid 19 vaccine instead of only one dose, low grade fever and chills was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000194469.  Initial information was processed with additional information received on 23-SEP-2021.The following information was updated and incorporated into the case narrative: Reporter(Pharmacist) added as contact, events(low grade fever, chills) were added, labelling, causality and narrative were updated.; Sender's Comments: 20210943963-COVID-19 VACCINE AD26.COV2.S-elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a male of unspecified age, race and ethnic origin The patient's height, and weight were not reported. No medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 total administered on 12-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient did an antibody test for the Covid-19 spike protein (Beckman Coulter test) and resulted as negative (none detected) (confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210944113-Covid-19 vaccine ad26.cov2.s- Confirmed immunological 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.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT GIVEN TO PATIENT; This spontaneous report received from a health care professional concerned a 55 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired product given to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product given to patient was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID 19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 26 year old White 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: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient tested Covid-19 positive using the Rapid antigen test. It was reported that the patient had breakthrough Covid-19 and the symptoms were low fever, scratchy throat, and congestion and he took Tylenol (suspected Covid-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194298.; Sender's Comments: V0: 20210944277-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dermatitis contact, Diarrhoea, Expired product administered
Clinical narrative: JOINT ACHE; HEADACHE; FEVER OF 101.2 F; FATIGUE; NUMBING OF HAND; TINGLING OF HAND; DIARRHEA; SORE ARM AT THE INJECTION SITE; MUSCLE ACHE; BODY ACHE; RASH/ REDNESS AROUND THE TAPE; PALE; FEELING COLD BUT WHEN TOUCH FEELS HOT; EYE IS SO HOT; EXPIRED VACCINE USED; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no health conditions. The patient experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine used. On 22-SEP-2021, the patient experienced body ache. On 22-SEP-2021, the patient experienced rash/ redness around the tape. On 22-SEP-2021, the patient experienced pale. On 22-SEP-2021, the patient experienced feeling cold but when touch feels hot. On 22-SEP-2021, the patient experienced eye is so hot. On 22-SEP-2021, the patient experienced joint ache. On 22-SEP-2021, the patient experienced headache. On 22-SEP-2021, the patient experienced fever of 101.2 f. On 22-SEP-2021, the patient experienced fatigue. On 22-SEP-2021, the patient experienced numbing of hand. On 22-SEP-2021, the patient experienced tingling of hand. On 22-SEP-2021, the patient experienced diarrhea. On 22-SEP-2021, the patient experienced sore arm at the injection site. On 22-SEP-2021, the patient experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.2 f, headache, fatigue, diarrhea, body ache, sore arm at the injection site, rash/ redness around the tape, pale, numbing of hand, muscle ache, joint ache, tingling of hand, eye is so hot, and feeling cold but when touch feels hot, and the outcome of expired vaccine used was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Feeling of body temperature change, Headache, Hypoaesthesia
Clinical narrative: JOINT ACHE; HEADACHE; FEVER OF 101.2 F; FATIGUE; NUMBING OF HAND; TINGLING OF HAND; DIARRHEA; SORE ARM AT THE INJECTION SITE; MUSCLE ACHE; BODY ACHE; RASH/ REDNESS AROUND THE TAPE; PALE; FEELING COLD BUT WHEN TOUCH FEELS HOT; EYE IS SO HOT; EXPIRED VACCINE USED; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no health conditions. The patient experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine used. On 22-SEP-2021, the patient experienced body ache. On 22-SEP-2021, the patient experienced rash/ redness around the tape. On 22-SEP-2021, the patient experienced pale. On 22-SEP-2021, the patient experienced feeling cold but when touch feels hot. On 22-SEP-2021, the patient experienced eye is so hot. On 22-SEP-2021, the patient experienced joint ache. On 22-SEP-2021, the patient experienced headache. On 22-SEP-2021, the patient experienced fever of 101.2 f. On 22-SEP-2021, the patient experienced fatigue. On 22-SEP-2021, the patient experienced numbing of hand. On 22-SEP-2021, the patient experienced tingling of hand. On 22-SEP-2021, the patient experienced diarrhea. On 22-SEP-2021, the patient experienced sore arm at the injection site. On 22-SEP-2021, the patient experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.2 f, headache, fatigue, diarrhea, body ache, sore arm at the injection site, rash/ redness around the tape, pale, numbing of hand, muscle ache, joint ache, tingling of hand, eye is so hot, and feeling cold but when touch feels hot, and the outcome of expired vaccine used was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain, Pallor, Paraesthesia
Clinical narrative: JOINT ACHE; HEADACHE; FEVER OF 101.2 F; FATIGUE; NUMBING OF HAND; TINGLING OF HAND; DIARRHEA; SORE ARM AT THE INJECTION SITE; MUSCLE ACHE; BODY ACHE; RASH/ REDNESS AROUND THE TAPE; PALE; FEELING COLD BUT WHEN TOUCH FEELS HOT; EYE IS SO HOT; EXPIRED VACCINE USED; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no health conditions. The patient experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine used. On 22-SEP-2021, the patient experienced body ache. On 22-SEP-2021, the patient experienced rash/ redness around the tape. On 22-SEP-2021, the patient experienced pale. On 22-SEP-2021, the patient experienced feeling cold but when touch feels hot. On 22-SEP-2021, the patient experienced eye is so hot. On 22-SEP-2021, the patient experienced joint ache. On 22-SEP-2021, the patient experienced headache. On 22-SEP-2021, the patient experienced fever of 101.2 f. On 22-SEP-2021, the patient experienced fatigue. On 22-SEP-2021, the patient experienced numbing of hand. On 22-SEP-2021, the patient experienced tingling of hand. On 22-SEP-2021, the patient experienced diarrhea. On 22-SEP-2021, the patient experienced sore arm at the injection site. On 22-SEP-2021, the patient experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.2 f, headache, fatigue, diarrhea, body ache, sore arm at the injection site, rash/ redness around the tape, pale, numbing of hand, muscle ache, joint ache, tingling of hand, eye is so hot, and feeling cold but when touch feels hot, and the outcome of expired vaccine used was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: JOINT ACHE; HEADACHE; FEVER OF 101.2 F; FATIGUE; NUMBING OF HAND; TINGLING OF HAND; DIARRHEA; SORE ARM AT THE INJECTION SITE; MUSCLE ACHE; BODY ACHE; RASH/ REDNESS AROUND THE TAPE; PALE; FEELING COLD BUT WHEN TOUCH FEELS HOT; EYE IS SO HOT; EXPIRED VACCINE USED; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no health conditions. The patient experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine used. On 22-SEP-2021, the patient experienced body ache. On 22-SEP-2021, the patient experienced rash/ redness around the tape. On 22-SEP-2021, the patient experienced pale. On 22-SEP-2021, the patient experienced feeling cold but when touch feels hot. On 22-SEP-2021, the patient experienced eye is so hot. On 22-SEP-2021, the patient experienced joint ache. On 22-SEP-2021, the patient experienced headache. On 22-SEP-2021, the patient experienced fever of 101.2 f. On 22-SEP-2021, the patient experienced fatigue. On 22-SEP-2021, the patient experienced numbing of hand. On 22-SEP-2021, the patient experienced tingling of hand. On 22-SEP-2021, the patient experienced diarrhea. On 22-SEP-2021, the patient experienced sore arm at the injection site. On 22-SEP-2021, the patient experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.2 f, headache, fatigue, diarrhea, body ache, sore arm at the injection site, rash/ redness around the tape, pale, numbing of hand, muscle ache, joint ache, tingling of hand, eye is so hot, and feeling cold but when touch feels hot, and the outcome of expired vaccine used was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Blood pressure increased, Blood pressure measurement, Chest pain
Clinical narrative: BELL'S PALSY; SUDDEN ONSET OF CHEST PAIN; DIAPHORESIS; SKIN COLOR GRAY; BLOOD PRESSURE ELEVATED; RIGHT LEG WEAKNESS; PAIN IN MULTIPLE AREAS OF HIS BODY; REMAINS WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no history of strokes or Bell's Palsy and also had no prior history of blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered, 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 numbness to right side of face, asymmetrical smile, high blood pressure, also during admission patient had sudden onset of chest pain, diaphoresis, skin color gray. After the patient got discharged from the hospital diagnosed with bell's palsy and developed right leg weakness ,facial palsy also moved to left side of face. The patient stayed in hospital for another three days and got discharged with multispecialty follow ups, and also remained weak along with pain in multiple areas of patient body. On an unspecified date patient hospitalized for bell's palsy, chest pain, diaphoresis, skin color gray, blood pressure elevated and right leg weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) with reported result as elevated, and Stroke work up (NR: not provided) result unknown. Treatment medications (dates unspecified) included: glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sudden onset of chest pain, diaphoresis, and skin color gray, had not recovered from right leg weakness, pain in multiple areas of his body, and remains weak, and the outcome of blood pressure elevated and bell's palsy was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0-20210944356-Covid-19 vaccine ad26.cov2.s- Bell's palsy,  sudden onset of chest pain, diaphoresis, skin color gray, blood pressure elevated .This event(s) is considered unassessable. The event(s) has an 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).  20210944356-Covid-19 vaccine ad26.cov2.s-Right leg weakness. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Investigation, Muscular weakness, Pain, Skin discolouration
Clinical narrative: BELL'S PALSY; SUDDEN ONSET OF CHEST PAIN; DIAPHORESIS; SKIN COLOR GRAY; BLOOD PRESSURE ELEVATED; RIGHT LEG WEAKNESS; PAIN IN MULTIPLE AREAS OF HIS BODY; REMAINS WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no history of strokes or Bell's Palsy and also had no prior history of blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered, 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 numbness to right side of face, asymmetrical smile, high blood pressure, also during admission patient had sudden onset of chest pain, diaphoresis, skin color gray. After the patient got discharged from the hospital diagnosed with bell's palsy and developed right leg weakness ,facial palsy also moved to left side of face. The patient stayed in hospital for another three days and got discharged with multispecialty follow ups, and also remained weak along with pain in multiple areas of patient body. On an unspecified date patient hospitalized for bell's palsy, chest pain, diaphoresis, skin color gray, blood pressure elevated and right leg weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) with reported result as elevated, and Stroke work up (NR: not provided) result unknown. Treatment medications (dates unspecified) included: glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sudden onset of chest pain, diaphoresis, and skin color gray, had not recovered from right leg weakness, pain in multiple areas of his body, and remains weak, and the outcome of blood pressure elevated and bell's palsy was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0-20210944356-Covid-19 vaccine ad26.cov2.s- Bell's palsy,  sudden onset of chest pain, diaphoresis, skin color gray, blood pressure elevated .This event(s) is considered unassessable. The event(s) has an 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).  20210944356-Covid-19 vaccine ad26.cov2.s-Right leg weakness. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 58 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 allergies and the patient was doing well and had no adverse event. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944479.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a female patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-Hodgkin's lymphoma, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In SEP-2021 (About 3 weeks ago from the date of report), the patient had a blood test which showed no antibodies (Confirmed Immunological vaccine failure). And she also reported that the vaccine gave her nothing but protection. Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834803. This report was associated with a product quality complaint.; Sender's Comments: 20210945348-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Drug eruption, Fear, Laboratory test, Mass, Ultrasound scan
Clinical narrative: DRUG ERUPTION (GENERALIZED ITCHINESS ALL OVER BODY WHICH INTENSIFIED, RASH ALL OVER BODY, LEGS, STOMACH, BACK, AND THEN ALL TORSO); LUMP ON RIGHT ARM (FEEL LIKE A KNOT IN MUSCLE); GOT SCARED; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included: several surgeries, and steroid shots, and concurrent conditions included: slightly elevated cholesterol, acid reflux, and blood pressure, and other pre-existing medical conditions included: Patient was taking blood pressure medications and statins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced drug eruption (generalized itchiness all over body which intensified, rash all over body, legs, stomach, back, and then all torso). On MAR-2021, the patient experienced lump on right arm (feel like a knot in muscle). On MAR-2021, the patient experienced got scared. On 22-SEP-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) not provided. Laboratory data (dates unspecified) included: Lab test (NR: not provided) diagnosis: drug eruption. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump on right arm (feel like a knot in muscle), had not recovered from drug eruption (generalized itchiness all over body which intensified, rash all over body, legs, stomach, back, and then all torso), and the outcome of got scared was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hypothyroidism
Clinical narrative: HYPOTHYRODISM; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient had no previous health issues other than 3 herniated discs. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, and expiry: unknown) dose was not reported, 1 total administered on right deltoid at  24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-OCT-2020, the patient underwent test for thyroid stimulating hormone (TSH) which was found to be 2.2 and on 26-JAN-2021, the TSH was 3.2. On 27-APR-2021, the patient was diagnosed with hypothyroidism with TSH level of 12.2. After rechecking on 05-MAY-2021, the TSH was found to be 10.7 and the patient was put on levothyroxine 0.5% from mid MAY-2021 to JUL-2021. On 29-JUL-2021,the patient's blood work showed a TSH level of 2.1 and her medication was stopped. On 09-SEP-2021, the patient's TSH level was 3.2 (normal level is 4).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothyrodism. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210945397-Covid-19 vaccine ad26.cov2.s-Hypothyroidism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 antibody test positive
Clinical narrative: SARS-COV-2 ANTIBODY TEST NEGATIVE; SARS-COV-2 ANTIBODY TEST POSITIVE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non smoker, and ventricular hypertrophy, and other pre-existing medical conditions included: The patient did not have drug abuse or illicit drug usage and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) 9.77 H. On 13-SEP-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and SARS-CoV-2 IgM antibody test (NR: not provided) Negative. On an unspecified date, the patient experienced sars-cov-2 antibody test negative, and sars-cov-2 antibody test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 antibody test negative and sars-cov-2 antibody test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000193355. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this record indicates results to an antibody test for previous covid infection were negative while the antibody test for immunity after vaccination were positive. there is no product quality issue reported as the response to the test for vaccine antibodies is positive.) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210926264.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: PAINFUL LYMPH NODES AT ARMPIT; ENLARGED LYMPH NODES AT ARMPIT; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced painful lymph nodes at armpit, and enlarged lymph nodes at armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the painful lymph nodes at armpit and enlarged lymph nodes at armpit was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943896 and 20210849152.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Hunger, Somnolence
Clinical narrative: FEELING HUNGRY; SLEEPY; FELT REALLY TIRED; FELT NOT HUNGRY; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (hay fever), and diabetic, and other pre-existing medical conditions included: Patient had not taken insulin and he was taking BP pill, Cholesterol pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, and acetylsalicylic acid.  On 03-JUL-2021, the patient experienced felt not hungry. On 03-JUL-2021, the patient experienced felt really tired. On 04-JUL-2021, the patient experienced feeling hungry. On 04-JUL-2021, the patient experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt not hungry, feeling hungry, sleepy, and felt really tired on 05-JUL-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. On 22-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: OFF LABEL USE WITHOUT ADVERSE EVENT; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned an adult 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 (suspension for injection, route of admin not reported, and batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced off label use without adverse event. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of the off label use without adverse event and expired vaccine administered was not reported. This report was non-serious.