chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient is late for the second dose / First dose was / on January 2020.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was late for the second dose of Shingrix. No adverse events were reported. The details regarding patient's identifiers, vaccine lot number and expiration date and vaccination date were not provided. The reporter consented to follow up. This case has been linked with US2021034680, reported by same rporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034680:Same reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: HEADACHE; BODY ACHES; FEVER; SHAKINESS/TREMBLING; CHILLS; NAUSEA; TIRED; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 58.96 kilograms, and height was 158.49 centimeters. The patient's concurrent conditions included non alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no illicit drug usage. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:25 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 10-MAR-2021, the subject experienced shakiness/trembling. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 10-MAR-2021 22:48, the subject experienced body aches. On 10-MAR-2021 22:48, the subject experienced fever. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakiness/trembling, chills, fever, nausea, and tired on 12-MAR-2021, and the outcome of body aches and headache was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: HEADACHE; BODY ACHES; FEVER; SHAKINESS/TREMBLING; CHILLS; NAUSEA; TIRED; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 58.96 kilograms, and height was 158.49 centimeters. The patient's concurrent conditions included non alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no illicit drug usage. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:25 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 10-MAR-2021, the subject experienced shakiness/trembling. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 10-MAR-2021 22:48, the subject experienced body aches. On 10-MAR-2021 22:48, the subject experienced fever. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakiness/trembling, chills, fever, nausea, and tired on 12-MAR-2021, and the outcome of body aches and headache was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported.  On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Feeling abnormal, Feeling cold, Fibrin D dimer
Clinical narrative: SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported.  On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head, Memory impairment, Nausea, Neck pain
Clinical narrative: SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported.  On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Tinnitus, Urine abnormality, Urine odour abnormal
Clinical narrative: SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported.  On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY PAIN ESPECIALLY BACK PAIN, NECK PAIN AND JOINT PAIN; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 180 pounds, and height was 153.67 centimeters. The patient's past medical history included history of arthritis, heart attack, double hernia surgery, left knee fracture, right leg artery clot, and right toe gangrene, and concurrent conditions included shortness of breath, blood pressure, non alcohol user, non smoker, hay fever allergy, and sticky tape allergy, and other pre-existing medical conditions included no history of drug abuse. the patient had no history of vaccine allergy and no pre-existing acute illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 17:30 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for blood pressure, venlafaxine hydrochloride for blood thinner, calcium for drug used for unknown indication, clopidogrel bisulfate for drug used for unknown indication, losartan potassium for drug used for unknown indication, and oxybutynin hydrochloride for drug used for unknown indication.  On 12-MAR-2021, treatment medications included: acetylsalicylic acid.  On 12-MAR-2021 00:30, the subject experienced body pain especially back pain, neck pain and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body pain especially back pain, neck pain and joint pain. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcoholic (24 ounce cans of beer 2 per week), and non-smoker, and other pre-existing medical conditions included the patient had no known history of drug abuse. 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 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 102.2 F. On 16-MAR-2021, the subject experienced body aches. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 17-MAR-2021. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: NO ADVERSE REACTION ASSOCIATED WITH THE ERROR; PATIENT SAW MEDICINE GO DOWN HER ARM TO ELBOW/MEDICINE CAME OUT OF HER ARM; PATIENT DID NOT RECEIVE THE FULL AMOUNT (PARTIAL DOSE); This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 350 pounds, and height was 182.88 centimeters. The patient's concurrent conditions included latex allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of report and and had no history of drug abuse. 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 17-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced subject saw medicine go down her arm to elbow/medicine came out of her arm. On 17-MAR-2021, the subject experienced subject did not receive the full amount (partial dose). On an unspecified date, the subject experienced no adverse reaction associated with the error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient did not receive the full amount (partial dose), no adverse reaction associated with the error and patient saw medicine go down her arm to elbow/medicine came out of her arm was not reported. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Deafness, Ear infection
Clinical narrative: PATIENT LOST HEARING IN HER EAR; HAD A REALLY BAD EAR INFECTION; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30/NOV/2023) 10 mg, every 1 day, frequency, and therapy dates were not reported for primary pulmonary hypertension. 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. Concomitant medications included tadalafil. On an unspecified date, the subject experienced subject lost hearing in her ear, and had a really bad ear infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the patient lost hearing in her ear and had a really bad ear infection was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 16-Mar-2021: upon review Opsumit (macitentan) updated from concomitant to co-suspect, labeling and causality for co-suspect assessed.; Sender's Comments: V1 Additional information received in this version is regarding amendment of co-suspect.  20210341336-Covid-19 vaccine ad26.cov2.s -Hearing loss. 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: UNDERLYING DISEASE  20210341336-Macitentan -Hearing loss. Follow-up received regarding Other Information: Amended co-suspect. 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: UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pyrexia
Clinical narrative: NOSE BLEEDING; FEVER; This spontaneous report received from a parent concerned a 22 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nose bleeding. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and the outcome of nose bleeding 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: Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; 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: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced urinary tract infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210406945.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Hyperhidrosis, Strabismus
Clinical narrative: EYES WENT CROSSED; PERSPIREING; FELT LIKE SHE WAS GOING  TO PASS OUT; VISION BECAME BLURRY/COULD NOT SEE; STOMACH WAS WOOZY; FELT A LITTLE OFF; This spontaneous report received from a patient concerned a 69 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced vision became blurry/could not see.  On APR-2021, the subject experienced stomach was woozy. On APR-2021, the subject experienced felt a little off.  On APR-2021, the subject experienced felt like she was going to pass out.  On 02-APR-2021, the subject experienced eyes went crossed.  On 02-APR-2021, the subject experienced perspireing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from perspireing, and the outcome of eyes went crossed, vision became blurry/could not see, stomach was woozy, felt a little off and felt like she was going to pass out was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: EYES WENT CROSSED; PERSPIREING; FELT LIKE SHE WAS GOING  TO PASS OUT; VISION BECAME BLURRY/COULD NOT SEE; STOMACH WAS WOOZY; FELT A LITTLE OFF; This spontaneous report received from a patient concerned a 69 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced vision became blurry/could not see.  On APR-2021, the subject experienced stomach was woozy. On APR-2021, the subject experienced felt a little off.  On APR-2021, the subject experienced felt like she was going to pass out.  On 02-APR-2021, the subject experienced eyes went crossed.  On 02-APR-2021, the subject experienced perspireing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from perspireing, and the outcome of eyes went crossed, vision became blurry/could not see, stomach was woozy, felt a little off and felt like she was going to pass out was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Menstruation irregular, Muscle spasms, Pain
Clinical narrative: INTENSE CRAMP ON PELVIS AND LOWER BACK; BODY ACHE; INDUCED PERIODS; CHILLS; FEVER; HEADACHE; 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, and batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced intense cramp on pelvis and lower back, body ache, induced periods, chills, fever, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense cramp on pelvis and lower back, and the outcome of chills, fever, headache, body ache and induced periods was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: INTENSE CRAMP ON PELVIS AND LOWER BACK; BODY ACHE; INDUCED PERIODS; CHILLS; FEVER; HEADACHE; 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, and batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced intense cramp on pelvis and lower back, body ache, induced periods, chills, fever, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense cramp on pelvis and lower back, and the outcome of chills, fever, headache, body ache and induced periods was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Myalgia
Clinical narrative: SEVERE INCREASE IN HEART RATE; CHILLS; NAUSEA; HEADACHE; MUSCLE SORENESS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 01-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 severe increase in heart rate. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle soreness. Laboratory data included: Heart rate (NR: not provided) 150 bpm.  Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 55 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe increase in heart rate, and the outcome of nausea, headache, chills and muscle soreness 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: Nausea
Clinical narrative: SEVERE INCREASE IN HEART RATE; CHILLS; NAUSEA; HEADACHE; MUSCLE SORENESS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 01-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 severe increase in heart rate. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle soreness. Laboratory data included: Heart rate (NR: not provided) 150 bpm.  Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 55 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe increase in heart rate, and the outcome of nausea, headache, chills and muscle soreness 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Ear pain, Eye pain, Pain
Clinical narrative: EAR PAIN; EAR SQUEALING; SHARP PAIN ON NOSE; THROBBING PAIN BEHIND EYES; DRY MOUTH; SWOLLEN THROAT; DIZZINESS; BODY ACHES; This spontaneous report received from a patient concerned a 30 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, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced ear pain. On 25-MAR-2021, the subject experienced ear squealing. On 25-MAR-2021, the subject experienced sharp pain on nose. On 25-MAR-2021, the subject experienced throbbing pain behind eyes. On 25-MAR-2021, the subject experienced dry mouth. On 25-MAR-2021, the subject experienced swollen throat. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear pain, ear squealing, sharp pain on nose, throbbing pain behind eyes, dry mouth, swollen throat, dizziness, and body aches. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rhinalgia, Tinnitus
Clinical narrative: EAR PAIN; EAR SQUEALING; SHARP PAIN ON NOSE; THROBBING PAIN BEHIND EYES; DRY MOUTH; SWOLLEN THROAT; DIZZINESS; BODY ACHES; This spontaneous report received from a patient concerned a 30 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, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced ear pain. On 25-MAR-2021, the subject experienced ear squealing. On 25-MAR-2021, the subject experienced sharp pain on nose. On 25-MAR-2021, the subject experienced throbbing pain behind eyes. On 25-MAR-2021, the subject experienced dry mouth. On 25-MAR-2021, the subject experienced swollen throat. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear pain, ear squealing, sharp pain on nose, throbbing pain behind eyes, dry mouth, swollen throat, dizziness, and body aches. 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: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased
Clinical narrative: BLOOD SUGAR INCREASED; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 22-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAR-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 173.  On 22-MAR-2021, the subject experienced blood sugar increased. Laboratory data included: Blood sugar abnormal (NR: not provided) 140, 200.  On 23-MAR-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 148.  On 24-MAR-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 159. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar increased was not reported. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 155 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced covid-19 infection. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be void: y based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000175739
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a 60 year old African American, 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 as approximately on 26-Mar-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the patient died from unknown cause of death. It was reported that, the patient death occurred about 6-7 days after receiving the vaccine. It was unknown, if an autopsy was performed.  The patient death occurred about 6-7 days after receiving the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210416142-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: DIZZY; THROW UP; 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizzy. On 06-APR-2021, the subject experienced throw up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy and throw up was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420279.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypotension, Vomiting
Clinical narrative: ANAPHYLAXIS; HYPOTENSION; VOMITING; This spontaneous report received from a pharmacist concerned multiple patients (4 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) dose was not reported,1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, upon the vaccination patients had string of events among which the one patient experienced anaphylaxis, three patients have experienced hypotension and vomiting. And seven patients were taken for further review. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, hypotension and vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416852-Covid-19 vaccine ad26.cov2.s-anaphylaxis. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pallor, Palpitations, Pyrexia
Clinical narrative: PAINFUL HEADACHE; FAINTING/LOSS OF CONSCIOUSNESS; HEART RACING; APPEARED WHITE; FELT WARMTH IN EARS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 22 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, around eight hours later after vaccination, the patient felt a warm in her ears and her heart was racing. She appeared as white as a ghost and the patient fainted with complete loss of consciousness for approximately less than a minute. She had regained consciousness and still had accelerated heart rate until she ate and drank water and then calmed down. On 08-APR-2021, the patient had a very painful headache when she wake up and a low grade fever. She wanted to know if she can take Motrin or Tylenol for her events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling of warmth in ears, fainting, complete loss of consciousness, and heart racing on 07-APR-2021, had not recovered from very painful headache, and low grade fever, and the outcome of appeared white was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416890-JANSSEN COVID-19 VACCINE-Fainting. 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.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PAINFUL HEADACHE; FAINTING/LOSS OF CONSCIOUSNESS; HEART RACING; APPEARED WHITE; FELT WARMTH IN EARS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 22 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, around eight hours later after vaccination, the patient felt a warm in her ears and her heart was racing. She appeared as white as a ghost and the patient fainted with complete loss of consciousness for approximately less than a minute. She had regained consciousness and still had accelerated heart rate until she ate and drank water and then calmed down. On 08-APR-2021, the patient had a very painful headache when she wake up and a low grade fever. She wanted to know if she can take Motrin or Tylenol for her events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling of warmth in ears, fainting, complete loss of consciousness, and heart racing on 07-APR-2021, had not recovered from very painful headache, and low grade fever, and the outcome of appeared white was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416890-JANSSEN COVID-19 VACCINE-Fainting. 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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nervousness, Paraesthesia
Clinical narrative: TINGLING HAND; SHAKING INSIDE; NO ENERGY; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 64 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tingling hand. On 08-APR-2021, the subject experienced shaking inside. On 08-APR-2021, the subject experienced no energy. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tingling hand, fatigue, and no energy, and the outcome of shaking inside was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient 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) 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 02-APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious. This case is a duplicate of 20210417740.  Additional information was received from patient on 08-APR-2021. It was determined that Manufacturer Case Number 20210417740 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210417339.