chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Presyncope, Pyrexia, Rash
Clinical narrative: ARM FEELS LIKE HIT BY BASEBALL BAT; JUST ABOUT PASSED OUT; FELT FEELING HOT; DEVELOPED LACE TYPE RASH; PHYSICALLY EXHAUSTED, TIRED, FATIGUE; FEVER; FELT FREEZING COLD; SEIZURE LIKE TREMORS UNCONTROLLED; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included genetic liver mutation, and other pre-existing medical conditions included the patient had sensitivity to blood thinner product. 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 30-MAR-2021 16:00 on Right Arm 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 22-MAR-2021, Laboratory data included: Blood test (NR: not provided) negative. On 30-MAR-2021, the subject experienced pain at injection site. On 31-MAR-2021, the subject experienced seizure like tremors uncontrolled. On 31-MAR-2021, the subject experienced felt freezing cold. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2. On 01-APR-2021, the subject experienced felt feeling hot. On 01-APR-2021, the subject experienced developed lace type rash. On 01-APR-2021, the subject experienced physically exhausted, tired, fatigue. Laboratory data included: Body temperature (NR: not provided) 97.1. On 01-APR-2021 12:18, the subject experienced just about passed out. On 02-APR-2021, the subject experienced arm feels like hit by baseball bat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure like tremors uncontrolled, and fever on 2021, and developed lace type rash on APR-2021, had not recovered from pain at injection site, and physically exhausted, tired, fatigue, and the outcome of just about passed out, felt freezing cold, felt feeling hot and arm feels like hit by baseball bat was not reported. 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.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: ARM FEELS LIKE HIT BY BASEBALL BAT; JUST ABOUT PASSED OUT; FELT FEELING HOT; DEVELOPED LACE TYPE RASH; PHYSICALLY EXHAUSTED, TIRED, FATIGUE; FEVER; FELT FREEZING COLD; SEIZURE LIKE TREMORS UNCONTROLLED; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included genetic liver mutation, and other pre-existing medical conditions included the patient had sensitivity to blood thinner product. 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 30-MAR-2021 16:00 on Right Arm 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 22-MAR-2021, Laboratory data included: Blood test (NR: not provided) negative. On 30-MAR-2021, the subject experienced pain at injection site. On 31-MAR-2021, the subject experienced seizure like tremors uncontrolled. On 31-MAR-2021, the subject experienced felt freezing cold. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2. On 01-APR-2021, the subject experienced felt feeling hot. On 01-APR-2021, the subject experienced developed lace type rash. On 01-APR-2021, the subject experienced physically exhausted, tired, fatigue. Laboratory data included: Body temperature (NR: not provided) 97.1. On 01-APR-2021 12:18, the subject experienced just about passed out. On 02-APR-2021, the subject experienced arm feels like hit by baseball bat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure like tremors uncontrolled, and fever on 2021, and developed lace type rash on APR-2021, had not recovered from pain at injection site, and physically exhausted, tired, fatigue, and the outcome of just about passed out, felt freezing cold, felt feeling hot and arm feels like hit by baseball bat was not reported. 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.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hyperacusis, Hyperaesthesia
Clinical narrative: WOKE UP WITH SPLITTING HEADACHE MIDDLE OF NIGHT; INCREASED SKIN AND TOUCH SENSITIVITY; INCREASED LIGHT SENSITIVITY; INCREASED SOUND SENSITIVITY; NIGHT SWEATS, ABSOLUTELY DRENCHED; RESTLESSNESS; MUSCLE FATIGUE; PAIN IN ARM; SORENESS IN SHOULDER; TIREDNESS; NAUSEA; MUSCLE ACHE AND SORENESS SCAPULAR MUSCLES ON LEFT SIDE; 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, and batch number were not reported) dose was not reported, administered on 03-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 increased skin and touch sensitivity. On APR-2021, the subject experienced increased light sensitivity. On APR-2021, the subject experienced increased sound sensitivity. On APR-2021, the subject experienced night sweats, absolutely drenched. On APR-2021, the subject experienced restlessness. On APR-2021, the subject experienced muscle fatigue. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced soreness in shoulder. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced muscle ache and soreness scapular muscles on left side. On APR-2021, the subject experienced woke up with splitting headache middle of night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and the outcome of nausea, muscle ache and soreness scapular muscles on left side, woke up with splitting headache middle of night, increased skin and touch sensitivity, increased light sensitivity, increased sound sensitivity, night sweats, absolutely drenched, pain in arm, restlessness, soreness in shoulder and muscle fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle fatigue, Myalgia, Nausea, Night sweats, Pain in extremity
Clinical narrative: WOKE UP WITH SPLITTING HEADACHE MIDDLE OF NIGHT; INCREASED SKIN AND TOUCH SENSITIVITY; INCREASED LIGHT SENSITIVITY; INCREASED SOUND SENSITIVITY; NIGHT SWEATS, ABSOLUTELY DRENCHED; RESTLESSNESS; MUSCLE FATIGUE; PAIN IN ARM; SORENESS IN SHOULDER; TIREDNESS; NAUSEA; MUSCLE ACHE AND SORENESS SCAPULAR MUSCLES ON LEFT SIDE; 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, and batch number were not reported) dose was not reported, administered on 03-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 increased skin and touch sensitivity. On APR-2021, the subject experienced increased light sensitivity. On APR-2021, the subject experienced increased sound sensitivity. On APR-2021, the subject experienced night sweats, absolutely drenched. On APR-2021, the subject experienced restlessness. On APR-2021, the subject experienced muscle fatigue. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced soreness in shoulder. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced muscle ache and soreness scapular muscles on left side. On APR-2021, the subject experienced woke up with splitting headache middle of night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and the outcome of nausea, muscle ache and soreness scapular muscles on left side, woke up with splitting headache middle of night, increased skin and touch sensitivity, increased light sensitivity, increased sound sensitivity, night sweats, absolutely drenched, pain in arm, restlessness, soreness in shoulder and muscle fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Photophobia, Restlessness
Clinical narrative: WOKE UP WITH SPLITTING HEADACHE MIDDLE OF NIGHT; INCREASED SKIN AND TOUCH SENSITIVITY; INCREASED LIGHT SENSITIVITY; INCREASED SOUND SENSITIVITY; NIGHT SWEATS, ABSOLUTELY DRENCHED; RESTLESSNESS; MUSCLE FATIGUE; PAIN IN ARM; SORENESS IN SHOULDER; TIREDNESS; NAUSEA; MUSCLE ACHE AND SORENESS SCAPULAR MUSCLES ON LEFT SIDE; 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, and batch number were not reported) dose was not reported, administered on 03-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 increased skin and touch sensitivity. On APR-2021, the subject experienced increased light sensitivity. On APR-2021, the subject experienced increased sound sensitivity. On APR-2021, the subject experienced night sweats, absolutely drenched. On APR-2021, the subject experienced restlessness. On APR-2021, the subject experienced muscle fatigue. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced soreness in shoulder. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced muscle ache and soreness scapular muscles on left side. On APR-2021, the subject experienced woke up with splitting headache middle of night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and the outcome of nausea, muscle ache and soreness scapular muscles on left side, woke up with splitting headache middle of night, increased skin and touch sensitivity, increased light sensitivity, increased sound sensitivity, night sweats, absolutely drenched, pain in arm, restlessness, soreness in shoulder and muscle fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Myalgia
Clinical narrative: LOWER BACK PAIN; LEG MUSCLE PAIN; HEADACHE; This spontaneous report received from a consumer concerned an 18 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, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced lower back pain. On 03-APR-2021, the subject experienced leg muscle pain. On 03-APR-2021 02:00, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, headache, and leg muscle pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate affect
Clinical narrative: LAUGHING 10 HOURS AFTER THE SHOT WHICH LASTED MORE THEN 10 MINS AND WAS UNCONTROLLABLE; This spontaneous report received from a vaccine facility 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced laughing 10 hours after the shot which lasted more then 10 mins and was uncontrollable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from laughing 10 hours after the shot which lasted more then 10 mins and was uncontrollable. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN IT WAS LIKE A MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included active chemo therapy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) once a total dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain it was like a muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain it was like a muscle pain. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: L SORE ARM AT INJECTION SITE; INTERMITTENT HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808607, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced l sore arm at injection site. On 02-APR-2021, the subject experienced intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headache, and l sore arm at injection site. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Scab, Therapeutic response unexpected
Clinical narrative: SCABS; ABSCESSES ON SKIN CLOSED (UNEXPECTED THERAPEUTIC EFFECT); This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included insect bite, and concurrent conditions included high blood pressure, and skin abscesses, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced scabs. On 09-MAR-2021, the subject experienced abscesses on skin closed (unexpected therapeutic effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scabs and abscesses on skin closed (unexpected therapeutic effect) was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight was 100 pounds, and height was 162 centimeters. The patient's concurrent conditions included osteoporosis, hypothyroid, pollen allergy, alcoholic, and cigarette smoker, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. patient had healthy appetite.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus infection. 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. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On an unspecified date, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low grade fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE IN ARM; Headache; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and marijuana use, and other pre-existing medical conditions included the patient had no medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced sore in arm. On 02-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and was recovering from sore in arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in jaw
Clinical narrative: BODY ACHES; JAW PAIN; CHILL; HEAVY WAVES OF HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non smoker, and non alcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced jaw pain. On 01-APR-2021, the subject experienced chill. On 01-APR-2021, the subject experienced heavy waves of headaches. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heavy waves of headaches, nausea, chill, body aches, and jaw pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Chills, Cough
Clinical narrative: CONGESTION; DIZZY; COUGHING; RUNNY NOSE; VOMITING; TEMPERATURE 101; DIARRHEA; WEAKNESS; NAUSEA; COULD NOT EAT/BARELY EATING; ITCHING LIKE CRAZY; HOT TO TOUCH; CHILLS; INJECTION SITE REDNESS; SORENESS TO SITE; DID NOT FEEL WELL; MUSCLE ACHES; FELT THIRSTY LIKE DEHYDRATED; FELT AWFUL/DID NOT FEEL RIGHT; ITS LIKE HAVING COVID; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included thyroid disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:15 on left arm for prophylactic vaccination. Other concomitant medications were reported. On APR-2021, the subject experienced felt awful/did not feel right. On APR-2021, the subject experienced its like having covid. On APR-2021, the subject experienced felt thirsty like dehydrated. On APR-2021, the subject experienced did not feel well. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced soreness to site. On 01-APR-2021, the subject experienced itching like crazy. On 01-APR-2021, the subject experienced hot to touch. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced could not eat/barely eating. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced coughing. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced temperature 101. On 03-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful/did not feel right, and the outcome of vomiting, chills, could not eat/barely eating, did not feel well, temperature 101, diarrhea, congestion, dizzy, weakness, coughing, runny nose, its like having covid, nausea, muscle aches, injection site redness, itching like crazy, hot to touch, soreness to site and felt thirsty like dehydrated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Eating disorder, Feeling abnormal, Feeling hot
Clinical narrative: CONGESTION; DIZZY; COUGHING; RUNNY NOSE; VOMITING; TEMPERATURE 101; DIARRHEA; WEAKNESS; NAUSEA; COULD NOT EAT/BARELY EATING; ITCHING LIKE CRAZY; HOT TO TOUCH; CHILLS; INJECTION SITE REDNESS; SORENESS TO SITE; DID NOT FEEL WELL; MUSCLE ACHES; FELT THIRSTY LIKE DEHYDRATED; FELT AWFUL/DID NOT FEEL RIGHT; ITS LIKE HAVING COVID; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included thyroid disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:15 on left arm for prophylactic vaccination. Other concomitant medications were reported. On APR-2021, the subject experienced felt awful/did not feel right. On APR-2021, the subject experienced its like having covid. On APR-2021, the subject experienced felt thirsty like dehydrated. On APR-2021, the subject experienced did not feel well. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced soreness to site. On 01-APR-2021, the subject experienced itching like crazy. On 01-APR-2021, the subject experienced hot to touch. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced could not eat/barely eating. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced coughing. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced temperature 101. On 03-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful/did not feel right, and the outcome of vomiting, chills, could not eat/barely eating, did not feel well, temperature 101, diarrhea, congestion, dizzy, weakness, coughing, runny nose, its like having covid, nausea, muscle aches, injection site redness, itching like crazy, hot to touch, soreness to site and felt thirsty like dehydrated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: CONGESTION; DIZZY; COUGHING; RUNNY NOSE; VOMITING; TEMPERATURE 101; DIARRHEA; WEAKNESS; NAUSEA; COULD NOT EAT/BARELY EATING; ITCHING LIKE CRAZY; HOT TO TOUCH; CHILLS; INJECTION SITE REDNESS; SORENESS TO SITE; DID NOT FEEL WELL; MUSCLE ACHES; FELT THIRSTY LIKE DEHYDRATED; FELT AWFUL/DID NOT FEEL RIGHT; ITS LIKE HAVING COVID; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included thyroid disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:15 on left arm for prophylactic vaccination. Other concomitant medications were reported. On APR-2021, the subject experienced felt awful/did not feel right. On APR-2021, the subject experienced its like having covid. On APR-2021, the subject experienced felt thirsty like dehydrated. On APR-2021, the subject experienced did not feel well. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced soreness to site. On 01-APR-2021, the subject experienced itching like crazy. On 01-APR-2021, the subject experienced hot to touch. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced could not eat/barely eating. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced coughing. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced temperature 101. On 03-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful/did not feel right, and the outcome of vomiting, chills, could not eat/barely eating, did not feel well, temperature 101, diarrhea, congestion, dizzy, weakness, coughing, runny nose, its like having covid, nausea, muscle aches, injection site redness, itching like crazy, hot to touch, soreness to site and felt thirsty like dehydrated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rhinorrhoea, Sinus congestion, Suspected COVID-19, Thirst
Clinical narrative: CONGESTION; DIZZY; COUGHING; RUNNY NOSE; VOMITING; TEMPERATURE 101; DIARRHEA; WEAKNESS; NAUSEA; COULD NOT EAT/BARELY EATING; ITCHING LIKE CRAZY; HOT TO TOUCH; CHILLS; INJECTION SITE REDNESS; SORENESS TO SITE; DID NOT FEEL WELL; MUSCLE ACHES; FELT THIRSTY LIKE DEHYDRATED; FELT AWFUL/DID NOT FEEL RIGHT; ITS LIKE HAVING COVID; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included thyroid disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:15 on left arm for prophylactic vaccination. Other concomitant medications were reported. On APR-2021, the subject experienced felt awful/did not feel right. On APR-2021, the subject experienced its like having covid. On APR-2021, the subject experienced felt thirsty like dehydrated. On APR-2021, the subject experienced did not feel well. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced soreness to site. On 01-APR-2021, the subject experienced itching like crazy. On 01-APR-2021, the subject experienced hot to touch. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced could not eat/barely eating. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced coughing. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced temperature 101. On 03-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful/did not feel right, and the outcome of vomiting, chills, could not eat/barely eating, did not feel well, temperature 101, diarrhea, congestion, dizzy, weakness, coughing, runny nose, its like having covid, nausea, muscle aches, injection site redness, itching like crazy, hot to touch, soreness to site and felt thirsty like dehydrated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: CONGESTION; DIZZY; COUGHING; RUNNY NOSE; VOMITING; TEMPERATURE 101; DIARRHEA; WEAKNESS; NAUSEA; COULD NOT EAT/BARELY EATING; ITCHING LIKE CRAZY; HOT TO TOUCH; CHILLS; INJECTION SITE REDNESS; SORENESS TO SITE; DID NOT FEEL WELL; MUSCLE ACHES; FELT THIRSTY LIKE DEHYDRATED; FELT AWFUL/DID NOT FEEL RIGHT; ITS LIKE HAVING COVID; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included thyroid disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:15 on left arm for prophylactic vaccination. Other concomitant medications were reported. On APR-2021, the subject experienced felt awful/did not feel right. On APR-2021, the subject experienced its like having covid. On APR-2021, the subject experienced felt thirsty like dehydrated. On APR-2021, the subject experienced did not feel well. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced soreness to site. On 01-APR-2021, the subject experienced itching like crazy. On 01-APR-2021, the subject experienced hot to touch. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced could not eat/barely eating. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced coughing. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced temperature 101. On 03-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful/did not feel right, and the outcome of vomiting, chills, could not eat/barely eating, did not feel well, temperature 101, diarrhea, congestion, dizzy, weakness, coughing, runny nose, its like having covid, nausea, muscle aches, injection site redness, itching like crazy, hot to touch, soreness to site and felt thirsty like dehydrated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Pain, Pain in extremity
Clinical narrative: BODY ACHES; FROZEN ARM; SORE ARM; 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 not reported, batch number: 1808980, and batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021. At 13:10 vaccinated at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, frozen arm, sore arm, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache, and had not recovered from sore arm, and frozen arm. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; EXTREMELY LOW BLOOD PRESSURE; POSITIVE DIAGNOSTIC TEST FOR COVID; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported.  The patient's past medical history included gastrointestinal infection, and concurrent conditions included dialysis. The patient was hospitalized on an unspecified date in MAR-2021, (a week before vaccination) due to gastrointestinal infection and was discharged approximately on 29-MAR-2021 or 30-MAR-2021. On 31-MAR-2021, the patient had dialysis and was administered the vaccine as well in the dialysis center. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered to left arm on 31-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 experienced extremely low blood pressure and was taken to the emergency room. On the same day, the patient was admitted to the hospital and was diagnosed with a urinary tract infection. The patient took the quick COVID-19 test which was negative. The patient took another unspecified diagnostic test for COVID-19 on the same day which was positive. It was reported that, the patient did not have COVID-19 related symptoms (or previous symptoms) and was asymptomatic.  Laboratory data included: Blood pressure (NR: not provided) Extremely low, COVID-19 antigen test (NR: not provided) Negative, and COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the urinary tract infection, extremely low blood pressure and positive diagnostic test for COVID was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with Product Quality Complaint number # 90000175206. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210407177 -covid-19 vaccine ad26.cov2.s-extremely low blood pressure, urinary tract infection. 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: Fatigue, Pain
Clinical narrative: BODY ACHES; EXTREME FATIGUE; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue and body aches was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: HEADACHE; NAUSEA; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to allergy shots, abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 01-APR-2021 09:30 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.6 F. 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 chills on 01-APR-2021, and had not recovered from fever, body aches, headache, and nausea. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE; NAUSEA; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to allergy shots, abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 01-APR-2021 09:30 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.6 F. 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 chills on 01-APR-2021, and had not recovered from fever, body aches, headache, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: FLU; This spontaneous report received from a patient via a company representative 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: HEART RACING; BODY ACHES; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unk) dose was not reported, administered on 31-MAR-2021 08:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced heart racing. On 31-MAR-2021, the subject experienced body aches. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue on 01-APR-2021, and chills, and fever on 31-MAR-2021, and was recovering from heart racing. This report was non-serious.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: VERY MILD SORENESS FOR A VERY SHORT TIME; This spontaneous report received from a patient concerned a 69 year old of unspecified sex.; The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 on an unspecified site at 10:20 am 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 31-MAR-2021 10:20, the patient experienced very mild soreness for a very short time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very mild soreness for a very short time on 31-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Insomnia
Clinical narrative: TIREDNESS; HEADACHE; FEVER; BODY ACHES; SHE DIDN'T SLEEP WELL; CHILLS; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 150 pounds, and height was 67 inches. The patient's concurrent conditions included seasonal allergy, non-smoker, and alcoholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) once a total dose was not reported, administered on 01-APR-2021 approximately at 09:30 to 09:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced she didn't sleep well. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced did not feel well. On 01-APR-2021 18:00, the subject experienced body aches. On 01-APR-2021 18:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.7 F. On 01-APR-2021 22:00, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 02-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, was recovering from fever, and body aches, had not recovered from headache, and tiredness, and the outcome of she didn't sleep well and did not feel well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: TIREDNESS; HEADACHE; FEVER; BODY ACHES; SHE DIDN'T SLEEP WELL; CHILLS; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 150 pounds, and height was 67 inches. The patient's concurrent conditions included seasonal allergy, non-smoker, and alcoholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) once a total dose was not reported, administered on 01-APR-2021 approximately at 09:30 to 09:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced she didn't sleep well. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced did not feel well. On 01-APR-2021 18:00, the subject experienced body aches. On 01-APR-2021 18:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.7 F. On 01-APR-2021 22:00, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 02-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, was recovering from fever, and body aches, had not recovered from headache, and tiredness, and the outcome of she didn't sleep well and did not feel well was not reported. This report was non-serious.