chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Infarction, Magnetic resonance imaging
Clinical narrative: DOUBLE VISION; SHORT TERM MEMORY LOSS; LACK OF ATTENTION; COGNITIVE DEFICIENCIES; HEADACHE; POSSIBLE INFARCTION DUE TO RECENT EVENT; This spontaneous report received from a health care professional concerned a 67 year old white and not Hispanic or Latino male. 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) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced headache and dizziness. On 15-MAR-2021, patient had experienced double vision, trouble reading, lack of attention, short term memory loss and cognitive deficiency. One or two days later, (possibly on 16-MAR-2021), the patient visited emergency room and his computerized axial tomography (CAT) scan was normal. In MAR-2021 (a week after), the patient's symptoms got worsened and he consulted primary care physician. The patient underwent magnetic resonance imaging (MRI) scan which showed possible infarction due to recent event. It was reported that, the patient was yet to visit cardiologist and neurologist for follow up on the MRI scan.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, had not recovered from double vision, short term memory loss, lack of attention, and cognitive deficiencies, and the outcome of possible infarction due to recent event was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427306-covid-19 vaccine ad26.cov2.s-possible infarction due to recent event. 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: Cold sweat, Eating disorder, Headache, Myalgia, Nausea
Clinical narrative: COLD SWEATING; NOT ABLE TO EAT; VOMITING; FEVER; NAUSEA; HEADACHE; MUSCLE ACHE; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the subject experienced cold sweating. On APR-2021, the subject experienced not able to eat. On APR-2021, the subject experienced vomiting.  On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold sweating, nausea, headache, muscle ache, not able to eat and vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: COLD SWEATING; NOT ABLE TO EAT; VOMITING; FEVER; NAUSEA; HEADACHE; MUSCLE ACHE; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the subject experienced cold sweating. On APR-2021, the subject experienced not able to eat. On APR-2021, the subject experienced vomiting.  On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold sweating, nausea, headache, muscle ache, not able to eat and vomiting was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nasal congestion, Nausea, Pulmonary congestion
Clinical narrative: STUFFY NOSE; FELT TO THROW UP BUT SHE DID NOT; DIZZY; LUNG CONGESTION, COUGH; This spontaneous report received from a patient concerned a 57 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A,expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 12:30 p.m. in right arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 03:00 a.m., the patient experienced lung congestion, cough. On 09-APR-2021 11:00 a.m., the patient experienced dizzy, felt to throw up but she did not. On 11-APR-2021, the patient experienced stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and felt to throw up but she did not and was recovering from cough, lung congestion, and stuffy nose. This report was serious (Other Medically Important Condition).; Sender's Comments: V0--covid-19 vaccine ad26.cov2.s-Lung congestion. 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: Dizziness, Headache, Heart rate increased, Vision blurred
Clinical narrative: FAST HEARTBEAT; BLURRED VISION IN LEFT EYE; LIGHTHEADEDNESS; PRESSURE IN THE HEAD, HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced fast heartbeat. On 12-APR-2021, the subject experienced blurred vision in left eye. On 12-APR-2021, the subject experienced lightheadedness. On 12-APR-2021, the subject experienced pressure in the head, headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heartbeat, blurred vision in left eye, and lightheadedness on 12-APR-2021, and was recovering from pressure in the head, headache. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache
Clinical narrative: CHEST TIGHTNESS; INTERMITTENT HEADACHES; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included basilar artery thrombosis, and vertebral artery thrombosis, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no illicit use of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included . On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced intermittent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headaches, and chest tightness. This report was non-serious.; Sender's Comments: V0; MAC Comment  is not required for non serious case as per standard protocol.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hangover, Hot flush, Injection site pain
Clinical narrative: TROUBLE BREATHING/WHEEZING; HANGOVER; HOT FLASHES; CHILLS; SWOLLEN ARM MUSCLE; INJECTION SITE RED SCAB; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced trouble breathing/wheezing. On APR-2021, the subject experienced hangover. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced swollen arm muscle. On APR-2021, the subject experienced injection site red scab. On APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hangover, hot flashes, trouble breathing/wheezing, chills, injection site pain, swollen arm muscle and injection site red scab was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Scab
Clinical narrative: TROUBLE BREATHING/WHEEZING; HANGOVER; HOT FLASHES; CHILLS; SWOLLEN ARM MUSCLE; INJECTION SITE RED SCAB; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced trouble breathing/wheezing. On APR-2021, the subject experienced hangover. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced swollen arm muscle. On APR-2021, the subject experienced injection site red scab. On APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hangover, hot flashes, trouble breathing/wheezing, chills, injection site pain, swollen arm muscle and injection site red scab was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypertension, Myalgia
Clinical narrative: SORE THROAT; HIGH BLOOD PRESSURE; SEVERE DIZZINESS; WHOLE BODY MUSCLE PAIN; LITTLE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, and high blood pressure, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced whole body muscle pain. On 11-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021 06:30, treatment medications included: paracetamol. On 12-APR-2021 21:30, the subject experienced high blood pressure. On 12-APR-2021 21:30, the subject experienced severe dizziness. Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 12-APR-2021 22:30, Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 13-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 130/100 mmHg. On an unspecified date, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever, and headache on 12-APR-2021, was recovering from severe dizziness, and had not recovered from high blood pressure, whole body muscle pain, and sore throat. This report was non-serious. This parent/child case is linked to 20210432107.; Sender's Comments: V0;MAC is not required for non serious cases as per standard protocol
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; HIGH BLOOD PRESSURE; SEVERE DIZZINESS; WHOLE BODY MUSCLE PAIN; LITTLE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, and high blood pressure, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced whole body muscle pain. On 11-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021 06:30, treatment medications included: paracetamol. On 12-APR-2021 21:30, the subject experienced high blood pressure. On 12-APR-2021 21:30, the subject experienced severe dizziness. Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 12-APR-2021 22:30, Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 13-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 130/100 mmHg. On an unspecified date, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever, and headache on 12-APR-2021, was recovering from severe dizziness, and had not recovered from high blood pressure, whole body muscle pain, and sore throat. This report was non-serious. This parent/child case is linked to 20210432107.; Sender's Comments: V0;MAC is not required for non serious cases as per standard protocol
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Dizziness, Feeling abnormal, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: PASSED OUT; COULD HARDLY GET UP; TROUBLE WITH  LEFT HIP OR KNEE; LIGHT HEADED; NOT FEELING UP TO PAR; This spontaneous report received from a patient concerned an 85 year old male. 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 was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021,(on the night of vaccination) patient could hardly get up while he was putting some beer in refrigerator. Since then patient had trouble with his left hip or knee. Few days before 10-APR-2021, patient was light headed and not felt up to par. On 10-APR-2021, the patient was passed out which he never experienced before. On the same day, the patient was hospitalized and checked everything including blood clots in his leg. They did not found anything that could be causing problem. The patient was admitted to the hospital for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could hardly get up, trouble with left hip or knee, not feeling up to par, light headed, passed out was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This 85-year-old male patient of unknown ethnicity was admitted in a hospital after "passing out" 15 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient noted difficulty standing up on h the day of vaccination but attributed it to his hip or knee "trouble".  On the day of hospitalization, the patient complained of light headedness and was rushed to the hospital when he was found passed out.  The patient reported that the hospital checked everything including clots in his leg but did not found anything that could cause the problem.  No laboratory/diagnostic test results were reported; the treatment and outcome was not reported.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood test, Fatigue, Headache
Clinical narrative: HIGH BLOOD SUGAR READING; BLACK SPOTS ON BACK AND RIGHT LEG; BODY ACHES; THROAT TIGHTNESS; THROAT PAIN; SLIGHT HEADACHE; FATIGUE, TIREDNESS; This spontaneous report received from a consumer concerned a 57 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high cholesterol, and she was a non-smoker, and non-alcoholic. The patient had no known drug or non-drug allergies and had no drug abuse or illicit use. The patient's normal fasting blood sugar was around 120. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced body aches, felt very fatigued, tired, throat pain/tightness, and slight headache after vaccination. On 08-APR-2021, the patient experienced high blood sugar with reading of 290 and 340. On 08-APR-2021, the patient noticed black spots on back and right leg (4 black dime-sized spots on her back and it spread to her right leg). The lowest blood sugar reading she had since post vaccination was on 13- APR-2021 morning which was 190 fasting.  On unspecified date, Laboratory data included: Blood test (NR: not provided) normal, cholesterol was getting better, blood sugar was under control. She was advised to continue with her dietary restrictions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 10-APR-2021, was recovering from throat tightness, and throat pain, and had not recovered from high blood sugar reading, black spots on back and right leg, fatigue, tiredness, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood sugar increased. 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: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Skin discolouration, Throat tightness
Clinical narrative: HIGH BLOOD SUGAR READING; BLACK SPOTS ON BACK AND RIGHT LEG; BODY ACHES; THROAT TIGHTNESS; THROAT PAIN; SLIGHT HEADACHE; FATIGUE, TIREDNESS; This spontaneous report received from a consumer concerned a 57 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high cholesterol, and she was a non-smoker, and non-alcoholic. The patient had no known drug or non-drug allergies and had no drug abuse or illicit use. The patient's normal fasting blood sugar was around 120. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced body aches, felt very fatigued, tired, throat pain/tightness, and slight headache after vaccination. On 08-APR-2021, the patient experienced high blood sugar with reading of 290 and 340. On 08-APR-2021, the patient noticed black spots on back and right leg (4 black dime-sized spots on her back and it spread to her right leg). The lowest blood sugar reading she had since post vaccination was on 13- APR-2021 morning which was 190 fasting.  On unspecified date, Laboratory data included: Blood test (NR: not provided) normal, cholesterol was getting better, blood sugar was under control. She was advised to continue with her dietary restrictions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 10-APR-2021, was recovering from throat tightness, and throat pain, and had not recovered from high blood sugar reading, black spots on back and right leg, fatigue, tiredness, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood sugar increased. 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: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: BROKE OUT IN HIVES; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 61.8 kilograms, and height was not reported. The patient's concurrent conditions included terrible seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, frequency, and therapy dates were not reported for primary pulmonary hypertension. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included tadalafil.  On an unspecified date, the subject experienced broke out in hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of broke out in hives was not reported. This report was non-serious.  This case, involving the same patient is linked.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diverticulitis, Headache
Clinical narrative: DIVERTICULITIS; HEADACHE; This spontaneous report received from a patient concerned a 53 year old African American and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient was non alcohol user, non-smoker, and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use.   The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at unspecified time to left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of this report.  On 08-MAR-2021, the patient experienced headache. On 04-APR-2021 patient experienced unbearable abdominal cramps and went to emergency room on 08-APR-2021 where lab test of CAT scan was done and the patient diagnosed with diverticulitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and had not recovered from diverticulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210428413-covid-19 vaccine ad26.cov2.s-Diverticulitis. 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: Fatigue, Headache, Herpes zoster
Clinical narrative: SHINGLES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included shingles, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 10-MAR-2021, and had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Enlarged clitoris
Clinical narrative: CLITORIS THE SIZE OF A PINEAPPLE; 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. he 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 MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers."No concomitant medications were reported. On APR-2021, the subject experienced clitoris the size of a pineapple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clitoris the size of a pineapple. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate decreased, Syncope
Clinical narrative: PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Seizure, Vomiting
Clinical narrative: INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report received from a parent concerned a 43 years old white Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included cerebral palsy, mental retardation, and epilepsy, and concurrent conditions included seizures, cough, and phlegm. Patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced increased phlegm / increased coughing. On 07-APR-2021, the patient experienced increased seizures. On the same day, he experienced threw up. The patient usually had a cough and phlegm. On the following day of vaccination, the patient's amount of phlegm and cough was increased and he throw-up and had 2 seizures. On 08-Apr-2021, the patient had 10 seizures. The patient regularly had seizures but the number per day increased after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased seizures on 09-APR-2021, and threw up on 07-APR-2021, and had not recovered from increased phlegm / increased coughing. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428761-covid-19 vaccine ad26.cov2.s-increased seizures. 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: MEDICAL HISTORY
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Headache, Injection site pain
Clinical narrative: BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 year old male. 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, X-ray
Clinical narrative: BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 year old male. 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED IN SLEEP; 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. Patient had children. 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. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient died in her sleep from an unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210429895.; Sender's Comments: V0: 20210428967-COVID-19 VACCINE AD26.COV2.S- Died in sleep. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Postmenopausal haemorrhage
Clinical narrative: HAD PERIOD AGAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy, menopause, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total administered on 30-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included estradiol, progesterone, and testosterone. On 30-MAR-2021, the subject experienced flu-like symptoms.  On 30-MAR-2021, on the same day of vaccination the patient experienced symptoms such as flu-like symptoms, headache, extreme fatigue and runny nose that had lasted for 2 days. On 11-APR-2021, the patient started having period again. The last time she had period was 20 years ago. She was on natural hormone replacement therapy, a mixture of estrogen, progesterone and testosterone for the last six months from the time of this report and the patient was not sure if the period was side effect from the vaccination or from her hormone replacement therapy. The patient had notified her hormone replacement therapy physician and would be going for an ultrasound scan the day after this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 01-APR-2021, and had not recovered from menstruation. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s -Post menopausal bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: TIGHTNESS OF THROAT; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no known allergies, not on any chronic medications and is not allergic to any medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced allergic reaction. On APR-2021, the subject experienced tightness of throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and tightness of throat was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Haematochezia
Clinical narrative: POOPING BLOOD; REALLY BAD STOMACH PAIN; SHORTNESS OF BREATH; TIRED; This spontaneous report received from a consumer concerned a white 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: 043A21A, and expiry: UNKNOWN) dose was not reported, once total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient felt tired. On 10-APR-2021, the patient experienced really bad stomach pain. On 10-APR-2021, the patient experienced shortness of breath. On 13-APR-2021, the patient experienced pooping blood.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 11-APR-2021, and had not recovered from really bad stomach pain, shortness of breath, and pooping blood. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210429185-covid-19 vaccine ad26.cov2.s-pooping blood. 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: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSEBLEED; This spontaneous report received from a patient concerned a male 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: Unk) 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 nosebleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nosebleed was not reported. This report was non-serious.; Sender's Comments: :V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-APR-2021, the patient died due to unknown cause. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210429218 - COVID-19 VACCINE AD26.COV2.S- Died. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a consumer concerned a 24 year old male. 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 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: As per standard protocol, non-serious cases does not require comment
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Haemoptysis, Headache, Lacrimation increased
Clinical narrative: BLOWS  THE NOSE; SORE THROAT; LIKE I HAVE A COLD; WATER GETS OUT FROM EYES; LEG FELT ICKY; LEG HURTS ALL THE TIME; DIARRHEA; COUGH WAS WITH SPUTUM AND  BLOOD COMES; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 73 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included CHF, heart surgery, hospitalized for gall bladder issue, heart surgery for chronic AIFB, circulation problem, stomach issue, seasonal allergy, strawberry allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 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 chills. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Laboratory data included: Headache (NR: not provided). On 09-APR-2021, treatment medications included: guaifenesin. On 12-APR-2021, the subject experienced cough was with sputum and blood comes. On 14-APR-2021, Laboratory data included: Headache (NR: not provided) SCALE 2. On an unspecified date, the subject experienced diarrhea, blows the nose, sore throat, like I have a cold, water gets out from eyes, leg felt icky, and leg hurts all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and the outcome of diarrhea, headache, cough was with sputum and blood comes, blows the nose, sore throat, like i have a cold, water gets out from eyes, leg felt icky and leg hurts all the time was not reported. This report was non-serious.