chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Diarrhoea, Faeces hard, Haemorrhoids, Illness, Suspected COVID-19
Clinical narrative: REALLY SICK; DIARRHEA; SUSPECTED COVID-19; HEMORRHOID PROBLEM; BOWEL MOVEMENTS ARE MORE FIRM; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 103.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension, diarrhea, and change in her bowel movements. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number in this case. Non-company suspect drugs included: macitentan (oral, batch number: ZE019B0101 expiry: 31-JUL-2024, form of admin was not reported) 10 mg, 1 time every 1 day, therapy dates were not reported for an unspecified indication; and epoprostenol sodium (intravenous, batch number: MM254M0101 expiry: 31-JUL-2022, form of admin was not reported) 1.5 mg, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 2021, the subject experienced suspected covid-19. On 2021, the subject experienced hemorrhoid problem. On 2021, the subject experienced bowel movements are more firm. On 2021, the subject experienced diarrhea. On 26-APR-2021, the subject experienced really sick. The action taken with covid-19 vaccine  was not applicable; and dose of macitentan, and epoprostenol sodium was not changed. The patient recovered from really sick on 28-APR-2021, and the outcome of suspected covid-19, diarrhea, bowel movements are more firm and hemorrhoid problem was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and 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: Unknown) dose was not reported, 1 in total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. On an unspecified date, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint : 90000179522. The suspected product quality complaint has been confirmed to be voided: N based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210526646 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
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient got covid-19 (captured as suspected covid-19 infection, and suspected clinical vaccination failure). The action taken with covid-19 vaccine 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 reported was associated with product Quality complaint. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: covid-19 vaccine suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 VIRUS TEST POSITIVE.; This spontaneous report received from a physician concerned a male patient in his 40s (exact age unknown), of an other race and unknown ethnic origin. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  Four days after vaccination, the patient tested positive for covid-19 (covid-19 virus test positive).The doctor wanted to know if the vaccine could cause a positive test.  The action taken with covid-19 was not applicable. The outcome of covid-19 virus test positive. was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: BLAH; CHILLS; FEVER; HEADACHE; SIDE EFFECTS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 7/18O/U/V/8978 expiry: JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 12-MAY-2021, the subject experienced blah. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced side effects. The action taken with covid-19 vaccine  was not applicable. The patient recovered from blah, chills, fever, headache, and side effects on 14-MAY-2021. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BLAH; CHILLS; FEVER; HEADACHE; SIDE EFFECTS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 7/18O/U/V/8978 expiry: JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 12-MAY-2021, the subject experienced blah. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced side effects. The action taken with covid-19 vaccine  was not applicable. The patient recovered from blah, chills, fever, headache, and side effects on 14-MAY-2021. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN AREA BELOW THE SHOT/ SWELLING IN ARM; REDNESS IN PROXIMITY OF INJECTION SITE; SORE ARM; HEART FLUTTER; This spontaneous report received from a patient concerned a 68 year old White (Not Hispanic or Latino) female. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, heart flutter, and severe hives with antibiotics, and concurrent conditions included non-alcoholic, non-smoker, sulfer allergy, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, cefdinir, and ibuprofen. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 30-APR-2021 on left arm as prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the patient experienced heart flutter. On 01-MAY-2021, the patient experienced sore arm. On 15-MAY-2021, the patient experienced swollen area below the shot/swelling in arm. On 15-MAY-2021, the patient experienced redness in proximity of injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from heart flutter on 30-APR-2021, and had not recovered from sore arm, swollen area below the shot/swelling in arm, and redness in proximity of injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine heart flutter. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: ACHES EVERYWHERE; HORRIBLE CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches everywhere, horrible chills, and fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, horrible chills and aches everywhere was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Decreased appetite, Dyspnoea, Laboratory test
Clinical narrative: BLOOD CLOTS IN THE LEFT LUNG; SHORT IN BREATH/ BARELY BREATHING; MOVEMENT DISORDER (COULD NOT GET OUT OF THE CAR); CONFUSED; ZERO APPETITE; WEAKNESS AND ZERO ENERGY; This spontaneous report received from a parent (mother) concerned a 49 year old male. Initial information was processed with additional information received on 17-MAY-2021. The patient's weight was 200 pounds, and height was not reported. The patient's past medical history included asthma. He did not experience something like that for thirty years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient  got the Janssen Covid 19 vaccine on 02-APR-2021, nothing happened no side effects at all ,he didn't experience anything abnormal. On 06-MAY-2021 (four weeks later),patient drove for 22 miles, he didn't get enough drinks, short in breath, he could not get out of the car (coded as movement disorder), he was in the car since 11.30 am in the morning, remained in the car till 12 PM at night, leaning against the kitchen sink, he was barely breathing. The reporter called the ambulance, they came and transported the patient to the medical center, they admitted him on 07-MAY-2021, and they did tests, and x-rays, they confirmed that he had blood clots in the left lung. The hospital was full, they couldn't find a room for patient then they admitted him in to a room on second floor. The patient had no medical issues or problem before the vaccine The patient  got out of the hospital on 12-MAY-2021 (Wednesday). Patient was hospitalized for 6 days. During follow-up, reporter mentioned that on an unspecified date in MAY-2021, her son was weak and confused ,zero appetite ,zero energy, he was not the same person he was two weeks ago, he was going to take medications indefinitely its like a life sentence for him, and she also did not have an email address. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from movement disorder (could not get out of the car), had not recovered from blood clots in the left lung, and short in breath/ barely breathing, and the outcome of weakness and zero energy, confused and zero appetite was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210531244-covid-19 vaccine ad26.cov2.s -blood clots in the left lung, and short in breath ,weakness and zero energy, confused and zero appetite. 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: Movement disorder, Pulmonary thrombosis, X-ray
Clinical narrative: BLOOD CLOTS IN THE LEFT LUNG; SHORT IN BREATH/ BARELY BREATHING; MOVEMENT DISORDER (COULD NOT GET OUT OF THE CAR); CONFUSED; ZERO APPETITE; WEAKNESS AND ZERO ENERGY; This spontaneous report received from a parent (mother) concerned a 49 year old male. Initial information was processed with additional information received on 17-MAY-2021. The patient's weight was 200 pounds, and height was not reported. The patient's past medical history included asthma. He did not experience something like that for thirty years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient  got the Janssen Covid 19 vaccine on 02-APR-2021, nothing happened no side effects at all ,he didn't experience anything abnormal. On 06-MAY-2021 (four weeks later),patient drove for 22 miles, he didn't get enough drinks, short in breath, he could not get out of the car (coded as movement disorder), he was in the car since 11.30 am in the morning, remained in the car till 12 PM at night, leaning against the kitchen sink, he was barely breathing. The reporter called the ambulance, they came and transported the patient to the medical center, they admitted him on 07-MAY-2021, and they did tests, and x-rays, they confirmed that he had blood clots in the left lung. The hospital was full, they couldn't find a room for patient then they admitted him in to a room on second floor. The patient had no medical issues or problem before the vaccine The patient  got out of the hospital on 12-MAY-2021 (Wednesday). Patient was hospitalized for 6 days. During follow-up, reporter mentioned that on an unspecified date in MAY-2021, her son was weak and confused ,zero appetite ,zero energy, he was not the same person he was two weeks ago, he was going to take medications indefinitely its like a life sentence for him, and she also did not have an email address. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from movement disorder (could not get out of the car), had not recovered from blood clots in the left lung, and short in breath/ barely breathing, and the outcome of weakness and zero energy, confused and zero appetite was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210531244-covid-19 vaccine ad26.cov2.s -blood clots in the left lung, and short in breath ,weakness and zero energy, confused and zero appetite. 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: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: Suspected clinical vaccination failure; TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients. 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) 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, seven patient's ware tested positive for covid-19 (suspected clinical vaccination failure) after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210531848-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chromaturia, Pollakiuria
Clinical narrative: BATHROOM FREQUENCY/WENT TO BATHROOM ABOUT FOUR TIMES; URINE WAS LIKE A LIGHT PINK COLOR; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis.The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 03-MAY-2021, the subject experienced bathroom frequency/went to bathroom about four times. On 03-MAY-2021, the subject experienced urine was like a light pink color. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The outcome of the bathroom frequency/went to bathroom about four times and urine was like a light pink color was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Fatigue, Feeling hot, Malaise, Pain in extremity
Clinical narrative: FELT RUNDOWN; FELT TIRED; NO ERECTION; WARMTH SENSATION IN THE RIGHT ARM AND WRIST; PAIN IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 59-year old male. The patient's height and weight were not reported.  The patient's past medical history included open heart surgery in 2018, and he had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose was administered on 06-MAY-2021 on the right arm as prophylactic vaccination. Concomitant medications included Atorvastatin, Clopidogrel, Diltiazem, Losartan, and Pioglitazone.  On 6-MAY-2021 the patient felt a warm sensation of the vaccine when it was administered in the arm and wrist. He felt soreness in the Right arm that evening. On 7-MAY-2021 his arm felt achy but not as painful. He felt "rundown" until the date of May 10th, or the 11th. On 10-MAY-2021 he observed that he was not able to obtain an erection; however, he was able to ejaculate. From 10-MAY-2021 to 17-MAY-2021 the patient still is not able to obtain an erection.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth sensation in the right arm and wrist, pain in the right arm, felt rundown, and felt tired, and had not recovered from no erection. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210532159-covid-19 vaccine ad26.cov2.s-No erection. 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: Injection site pain
Clinical narrative: SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine  was not applicable. The outcome of sore arm at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: PRODUCT GIVEN PAST STABILITY DATA/DOSE ADMINISTERED FROM PUNCTURED VIAL; MEDICATION ERROR; PUNCTURED VIAL PLACED IN FRIDGE; This spontaneous report received from a physician concerned a 4 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced punctured vial placed in fridge. On 17-MAY-2021, the subject experienced product given past stability data/dose administered from punctured vial. On 17-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine  was not applicable. The outcome of the product given past stability data/dose administered from punctured vial, punctured vial placed in fridge and medication error was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence, Headache, Rhinorrhoea
Clinical narrative: UPSET BOWELS; INCREASED GASSINESS; DIARRHEA; RUNNY NOSE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with promethazine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced severe headache. On 14-MAY-2021, the subject experienced upset bowels. On 14-MAY-2021, the subject experienced increased gassiness. On 14-MAY-2021, the subject experienced diarrhea. On 14-MAY-2021, the subject experienced runny nose. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe headache, and the outcome of upset bowels, increased gassiness, diarrhea and runny nose 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Eating disorder, Headache, Taste disorder
Clinical narrative: DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have any known drug allergy. He had not taken any over-the-counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAY-2021, the patient experienced diarrhea. On 15-MAY-2021, the patient experienced throwing up. On 15-MAY-2021, the patient experienced mouth feels like garbage. On 15-MAY-2021, the patient experienced not eating. On 15-MAY-2021, the patient experienced headache. On 15-MAY-2021, the patient experienced weakness. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea, throwing up, mouth feels like garbage, headache, weakness, and not eating. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have any known drug allergy. He had not taken any over-the-counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAY-2021, the patient experienced diarrhea. On 15-MAY-2021, the patient experienced throwing up. On 15-MAY-2021, the patient experienced mouth feels like garbage. On 15-MAY-2021, the patient experienced not eating. On 15-MAY-2021, the patient experienced headache. On 15-MAY-2021, the patient experienced weakness. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea, throwing up, mouth feels like garbage, headache, weakness, and not eating. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT, NOS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included down syndrome. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 adverse event, nos. The action taken with covid-19 vaccine  was not applicable. The outcome of adverse event, nos was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 57 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 08-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 05-MAY-2021, Laboratory data included: Antibody test (NR: not provided) Negative Antibodies.  On an unspecified date, the patient experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210533620-covid-19 vaccine ad26.cov2.s-suspected 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
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Night sweats
Clinical narrative: EXTREME ACHES; NIGHT SWEATS; SEVERE CHILLS; FEVER 102; FATIGUE; THROBBING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extreme aches, night sweats, chills, fever 102, fatigue, and throbbing headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever 102, chills, night sweats, extreme aches, fatigue, and throbbing headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: EXTREME ACHES; NIGHT SWEATS; SEVERE CHILLS; FEVER 102; FATIGUE; THROBBING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extreme aches, night sweats, chills, fever 102, fatigue, and throbbing headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever 102, chills, night sweats, extreme aches, fatigue, and throbbing headache. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Thrombosis
Clinical narrative: BLOOD CLOT IN LEG; SWEATING; This spontaneous report received from a consumer concerned a 70 year old male of unspecified ethnicity. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced sweating which lasted about one day. It was stated that patient received vaccine around 18-APR-2021. It was also reported that actual date of vaccination may have been prior to 18-APR-2021 but definitely in April. On 17-MAY-2021, patient visited hospital and got diagnosed with blood clot in leg. The patient was on unspecified medications to dissolve clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 2021, and had not recovered from blood clot in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210534558-Covid 19 Vaccine- This case concerns a 70 yr old male. Blood clot in leg, Sweating. 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: Pain in extremity
Clinical narrative: PAIN IN THE ARM SINCE VACCINATED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  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-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced pain in the arm since vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the arm since vaccinated. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia
Clinical narrative: SHORTNESS OF BREATH; TINGLING/NUMBNESS ALL OVER THE ARM; 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced shortness of breath, and tingling/numbness all over the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and tingling/numbness all over the arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia
Clinical narrative: OUT SICK FOR TWO DAYS; ACHES; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced out sick for two days, aches, chills, and fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from out sick for two days, aches, chills, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Headache
Clinical narrative: BURNING PAIN UNDER UNDERARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine  (form of admin and route of admin were not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced burning pain under my underarm. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 09-APR-2021, and burning pain under underarm on 11-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: DIZZINESS; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness. On 2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness, and chills on 2021. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: PAIN BEGAN TO MOVE TO BACK; SHOCK LIKE PAIN IN RIGHT PECTORALIS; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced pain began to move to back, and shock like pain in right pectoralis. The action taken with covid-19 vaccine  was not applicable. The outcome of the shock like pain in right pectoralis and pain began to move to back was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anhidrosis, Body temperature, Body temperature increased
Clinical narrative: LOST ABILITY TO PERSPIRE; ELEVATED INTERNAL BODY TEMPERATURE (INTERNAL BODY TEMPERATURE THROUGH THE ROOF); This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies or illicit use of drugs and usually sweats normally. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost ability to perspire. On APR-2021, the subject experienced elevated internal body temperature (internal body temperature through the roof). Laboratory data included: Body temperature (NR: not provided) 98-99 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from lost ability to perspire, and elevated internal body temperature (internal body temperature through the roof). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Poor quality product administered, Pyrexia
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; HEADACHE; FEVER; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced poor quality vaccine administered. On 18-MAY-2021, the subject experienced headache. On 18-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the poor quality vaccine administered, headache and fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20210538801.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: TINGLING HANDS AND FEET; NUMBNESS HANDS AND FEET; PAIN WITH MOVEMENT; DROPPING THINGS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dropping things. On 28-APR-2021, the subject experienced tingling hands and feet. On 28-APR-2021, the subject experienced numbness hands and feet. On 28-APR-2021, the subject experienced pain with movement. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tingling hands and feet, numbness hands and feet, and pain with movement, and the outcome of dropping things was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: Polymerase chain reaction (NR: not provided) Positive. Treatment medications included: favipiravir. The action taken with covid-19 vaccine was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dehydration, Pleurisy, Ultrasound scan
Clinical narrative: DEHYDRATED; URINARY INCONTINENCE; PLEURISY; CHEST PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included neck surgery, back surgery, left knee replacement, and covid-19 infection, and concurrent conditions included alcohol consumer, non smoker, and heart patient, and other pre-existing medical conditions included the patient has no known drug allergies and drug illicit use. the patient also had 29 surgeries. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, apixaban, clopidogrel, lisinopril, metoprolol, ranolazine, rosuvastatin calcium, and . On 31-MAR-2021, the subject experienced pleurisy. On 31-MAR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced urinary incontinence. On an unspecified date, the subject experienced dehydrated. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Pleurisy on left lung, and Diagnostic ultrasound (NR: not provided) No abnormal finding. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pleurisy, chest pain on APR-2021, and urinary incontinence on 04-MAY-2021, and the outcome of dehydrated was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: DEHYDRATED; URINARY INCONTINENCE; PLEURISY; CHEST PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included neck surgery, back surgery, left knee replacement, and covid-19 infection, and concurrent conditions included alcohol consumer, non smoker, and heart patient, and other pre-existing medical conditions included the patient has no known drug allergies and drug illicit use. the patient also had 29 surgeries. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, apixaban, clopidogrel, lisinopril, metoprolol, ranolazine, rosuvastatin calcium, and . On 31-MAR-2021, the subject experienced pleurisy. On 31-MAR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced urinary incontinence. On an unspecified date, the subject experienced dehydrated. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Pleurisy on left lung, and Diagnostic ultrasound (NR: not provided) No abnormal finding. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pleurisy, chest pain on APR-2021, and urinary incontinence on 04-MAY-2021, and the outcome of dehydrated was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Fatigue, Nausea, Vomiting
Clinical narrative: VOMITING; NAUSEA; FATIGUE; SURGE OF ENERGY; 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 concurrent conditions included stage 4 prostate cancer, and sulfonamide allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAY-2021, the subject experienced surge of energy. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from surge of energy on 16-MAY-2021, and had not recovered from nausea, vomiting, and fatigue. This report was non-serious.