chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SLIGHT 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  (suspension for injection, route of admin not reported, batch number: Unknown dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced slight sore arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from slight sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness
Clinical narrative: STOMACH DISCOMFORT; WEAKNESS; LIGHTHEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced lightheaded. On 01-MAY-2021, the subject experienced weakness. On 03-MAY-2021, the subject experienced stomach discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lightheaded, and had not recovered from weakness, and stomach discomfort. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: ARM WEAKNESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm weakness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza, Visual impairment
Clinical narrative: MILD FLU SYMPTOMS; VISUAL DISRUPTION; SWEATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mild flu symptoms, visual disruption, and sweating. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild flu symptoms, visual disruption, and sweating. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; MILD FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and mild fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the mild fever and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: SHAKING; FEVER; HEADACHES; 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, 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 shaking, fever, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headaches and shaking was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site reaction
Clinical narrative: INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021 11:09, Laboratory data included: Body temperature (NR: not provided) 98.1 F. On an unspecified date, the subject experienced injection site reaction. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from injection site reaction. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDERDOSE; This spontaneous report received from a parent concerned a 19 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: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested . No concomitant medications were reported. On 03-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of underdose was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Dizziness, Muscular weakness
Clinical narrative: DIZZY; TEMPERATURE; LEG MUSCLES REMAIN WEEK; This spontaneous report received from a patient concerned a 61 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: Unk) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced dizzy. On 02-MAY-2021, the subject experienced temperature. On 02-MAY-2021, the subject experienced leg muscles remain week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and temperature on MAY-2021, and had not recovered from leg muscles remain week. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM HURT ( FROM THE ELBOW DOWN); 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) dose was not reported, administered on 16-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 patient experienced arm hurt ( from the elbow down). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurt ( from the elbow down) was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: DULL HEADACHE; INJECTION SITE ARM PAIN; FATIGUE; ACHY; DIZZY; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced injection site arm pain. On 09-APR-2021, the subject experienced felt fatigued. On an unspecified date, the subject experienced dull headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine  was not applicable. The patient recovered from achy, dizzy, injection site arm pain, and felt fatigued on APR-2021, and had not recovered from dull headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report received from social media from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, 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 15-APR-2021, the patient passed away due to unknown cause. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 15-APR-2021. This report was serious (Death).; Sender's Comments: -Covid-19 vaccine ad26.cov2.s -PASSED AWAY. 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: PASSED AWAY
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and the patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Nausea, Pain
Clinical narrative: CRAMPS; BODY ACHES; WARM TO TOUCH; FEELS WIPED OUT; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 54 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced cramps. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced warm to touch. On 03-MAY-2021, the subject experienced feels wiped out. On 03-MAY-2021, the subject experienced nausea. On 03-MAY-2021, the subject experienced fever. On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, cramps, body aches, nausea, headache, feels wiped out, and warm to touch. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: CRAMPS; BODY ACHES; WARM TO TOUCH; FEELS WIPED OUT; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 54 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced cramps. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced warm to touch. On 03-MAY-2021, the subject experienced feels wiped out. On 03-MAY-2021, the subject experienced nausea. On 03-MAY-2021, the subject experienced fever. On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, cramps, body aches, nausea, headache, feels wiped out, and warm to touch. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Ageusia, Back pain, Chest X-ray, Chills
Clinical narrative: LOWER BACK PAIN IN BOTH SIDES; BLOATING; COUGH; THROAT TICKLISH; MUCOUS; SWOLLEN ANKLE IN RIGHT LEG; NUMB TONGUE; LOSS OF TASTE; WHITE COAT ON THE TONGUE; RIGHT ARM SWOLLEN; CHILLS; TIRED; HOT FLUSHES; THIRSTY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hot flushes. On 31-MAR-2021, the subject experienced thirsty. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced lower back pain in both sides. On APR-2021, the subject experienced bloating. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced throat ticklish. On APR-2021, the subject experienced mucous. On APR-2021, the subject experienced swollen ankle in right leg. On APR-2021, the subject experienced numb tongue. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced white coat on the tongue. On APR-2021, the subject experienced right arm swollen. Laboratory data included: Chest X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes, thirsty, throat ticklish, chills, and tired on APR-2021, was recovering from numb tongue, and loss of taste, had not recovered from lower back pain in both sides, bloating, cough, mucous, swollen ankle in right leg, and white coat on the tongue, and the outcome of right arm swollen was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hot flush, Hypoaesthesia oral, Joint swelling
Clinical narrative: LOWER BACK PAIN IN BOTH SIDES; BLOATING; COUGH; THROAT TICKLISH; MUCOUS; SWOLLEN ANKLE IN RIGHT LEG; NUMB TONGUE; LOSS OF TASTE; WHITE COAT ON THE TONGUE; RIGHT ARM SWOLLEN; CHILLS; TIRED; HOT FLUSHES; THIRSTY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hot flushes. On 31-MAR-2021, the subject experienced thirsty. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced lower back pain in both sides. On APR-2021, the subject experienced bloating. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced throat ticklish. On APR-2021, the subject experienced mucous. On APR-2021, the subject experienced swollen ankle in right leg. On APR-2021, the subject experienced numb tongue. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced white coat on the tongue. On APR-2021, the subject experienced right arm swollen. Laboratory data included: Chest X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes, thirsty, throat ticklish, chills, and tired on APR-2021, was recovering from numb tongue, and loss of taste, had not recovered from lower back pain in both sides, bloating, cough, mucous, swollen ankle in right leg, and white coat on the tongue, and the outcome of right arm swollen was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mucosal disorder, Peripheral swelling, Thirst, Throat irritation, Tongue coated
Clinical narrative: LOWER BACK PAIN IN BOTH SIDES; BLOATING; COUGH; THROAT TICKLISH; MUCOUS; SWOLLEN ANKLE IN RIGHT LEG; NUMB TONGUE; LOSS OF TASTE; WHITE COAT ON THE TONGUE; RIGHT ARM SWOLLEN; CHILLS; TIRED; HOT FLUSHES; THIRSTY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hot flushes. On 31-MAR-2021, the subject experienced thirsty. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced lower back pain in both sides. On APR-2021, the subject experienced bloating. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced throat ticklish. On APR-2021, the subject experienced mucous. On APR-2021, the subject experienced swollen ankle in right leg. On APR-2021, the subject experienced numb tongue. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced white coat on the tongue. On APR-2021, the subject experienced right arm swollen. Laboratory data included: Chest X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes, thirsty, throat ticklish, chills, and tired on APR-2021, was recovering from numb tongue, and loss of taste, had not recovered from lower back pain in both sides, bloating, cough, mucous, swollen ankle in right leg, and white coat on the tongue, and the outcome of right arm swollen was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: VACCINE WAS OUT FROM SATURDAY AND IT WAS ADMINISTERED ON MONDAY; VACCINE ADMINISTERED AT EXPIRATION TEMPERATURE; This spontaneous report received from a health care professional concerned a 47 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: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 09:19 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced vaccine was out from saturday and it was administered on monday. On 03-MAY-2021, the subject experienced vaccine administered at expiration temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was out from saturday and it was administered on monday and vaccine administered at expiration temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503927.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain
Clinical narrative: SEVERE BODY PAIN; NERVE ISSUES; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced severe body pain, and nerve issues. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from severe body pain, and nerve issues. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site bruising
Clinical narrative: DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus issues.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for sinuses. On 07-APR-2021, the subject experienced bruised arm at injection site. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from bruised arm at injection site, and sore arm on 09-APR-2021, and had not recovered from tired, feverish, dizzy, headache, run down, and weak. This report was non-serious. This case, from the same reporter is linked to.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus issues.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for sinuses. On 07-APR-2021, the subject experienced bruised arm at injection site. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from bruised arm at injection site, and sore arm on 09-APR-2021, and had not recovered from tired, feverish, dizzy, headache, run down, and weak. This report was non-serious. This case, from the same reporter is linked to.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia oral, Therapeutic response unexpected
Clinical narrative: WARMTH AND TINGLING ON LIPS; WARMTH AND TINGLING ON LIPS; HEALED COLD SORE; 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: 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 APR-2021, the subject experienced healed cold sore. On 08-APR-2021, the subject experienced warmth and tingling on lips. On 08-APR-2021, the subject experienced warmth and tingling on lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth and tingling on lips, and warmth and tingling on lips on 08-APR-2021, and the outcome of healed cold sore was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious. This parent/child case is linked to 20210503989.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Throat irritation
Clinical narrative: MIGRAINE; SCRATCHY THROAT; 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 pre-existing medical conditions included 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 2020 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 2020, the subject experienced migraine. On 2020, the subject experienced scratchy throat. On 2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, fatigue and scratchy throat was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 test
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, shellfish allergy, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 12:50 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 03-MAY-2021 22:00, the subject experienced chest pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chest pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; 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: 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 requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced 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: COVID-19
Clinical narrative: COVID; This spontaneous report received from a consumer via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced covid. The action taken with covid-19 vaccine  was not applicable. The outcome of covid was not reported. This report was non-serious. This report was associated with product quality complaint:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY VACCINE  ADMINISTERED; This spontaneous report received from a health care professional 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 and batch number: 180897 expiry: 13-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VIAL LEFT OUTSIDE OF THE FRIDGE FOR MORE THAN 2 HOURS; ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 37 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: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vial left outside of the fridge for more than 2 hours, and administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial left outside of the fridge for more than 2 hours and administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210507453 and 20210507559.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Extra dose administered, Nasal discomfort, Off label use, SARS-CoV-2 test
Clinical narrative: DRUG EXPOSURE DURING PREGNANCY; MULTIPLE VACCINE DOSES; OFF LABEL USE; SKIN DARKENING; BURNING NOSE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.The batch number was not reported and has been requested.  On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. On an unspecified date, the subject experienced drug exposure during pregnancy, multiple vaccine doses, off label use, skin darkening, and burning nose. The date of the subject's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin darkening, and burning nose, and the outcome of multiple vaccine doses, off label use and drug exposure during pregnancy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: DRUG EXPOSURE DURING PREGNANCY; MULTIPLE VACCINE DOSES; OFF LABEL USE; SKIN DARKENING; BURNING NOSE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.The batch number was not reported and has been requested.  On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. On an unspecified date, the subject experienced drug exposure during pregnancy, multiple vaccine doses, off label use, skin darkening, and burning nose. The date of the subject's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin darkening, and burning nose, and the outcome of multiple vaccine doses, off label use and drug exposure during pregnancy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE FEELING AT INJECTION SITE; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore feeling at injection site. The action taken with covid-19 vaccine  was not applicable. The outcome of sore feeling at injection site was not reported. This report was non-serious. This case, from the same reporter is linked to .
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: BLOOD VESSEL IN THE RETINA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, batch number: Unknown) dose was not reported, administered on 05-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 blood vessel in the retina. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from blood vessel in the retina. This report was non-serious. This case, from the same reporter is linked to.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: ACHY; SWEATING; CHILLS; SORE LEFT ARM; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 100 pounds, and height was 63 inches. The patient's concurrent conditions included auto immune disease, no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies reported. no drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26/MAY/2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for auto immune disease. On 2021, Laboratory data included: Antibody test (NR: not provided) SARS-CO-2 IGG Antibody result 0.2 (negative per doctor). On an unspecified date, the subject experienced achy, sweating, chills, sore left arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, sweating, chills, sore left arm, and headache on 17-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ACHY; SWEATING; CHILLS; SORE LEFT ARM; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 100 pounds, and height was 63 inches. The patient's concurrent conditions included auto immune disease, no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies reported. no drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26/MAY/2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for auto immune disease. On 2021, Laboratory data included: Antibody test (NR: not provided) SARS-CO-2 IGG Antibody result 0.2 (negative per doctor). On an unspecified date, the subject experienced achy, sweating, chills, sore left arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, sweating, chills, sore left arm, and headache on 17-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and back pain, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 09:30 for prophylactic vaccination. Concomitant medications included atorvastatin for diabetes, metformin for diabetes, and saxagliptin for diabetes. On 04-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: BURNING SENSATION; ARM PAIN; This spontaneous report received from a consumer concerned a 63 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: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced burning sensation. On 04-MAY-2021, the subject experienced arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, and burning sensation. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: CHILLS; JOINT PAIN; FATIGUE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was on cholesterol medication and had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced chills. On 04-MAY-2021, the subject experienced joint pain. On 04-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chills, joint pain, and fatigue. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: MILD CRAMPS; SEVERE DIARRHEA; This spontaneous report received from a patient concerned a 78 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 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced severe diarrhea. On 04-MAY-2021, the subject experienced mild cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe diarrhea and mild cramps was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: SORE THROAT; HEADACHE; FEVER; FATIGUE; STOMACH PAIN; BODY ACHES; RIGHT LEG SORE AROUND KNEE; LEFT ARM SORE; This spontaneous report received from a patient concerned a 23 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced left arm sore. On 30-APR-2021, the subject experienced stomach pain. On 30-APR-2021, the subject experienced body aches. On 30-APR-2021, the subject experienced right leg sore around knee. On 30-APR-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced sore throat. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm sore, fatigue, headache, right leg sore around knee, body aches, fever, sore throat and stomach pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Skin injury
Clinical narrative: SORE THROAT; HEADACHE; FEVER; FATIGUE; STOMACH PAIN; BODY ACHES; RIGHT LEG SORE AROUND KNEE; LEFT ARM SORE; This spontaneous report received from a patient concerned a 23 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced left arm sore. On 30-APR-2021, the subject experienced stomach pain. On 30-APR-2021, the subject experienced body aches. On 30-APR-2021, the subject experienced right leg sore around knee. On 30-APR-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced sore throat. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm sore, fatigue, headache, right leg sore around knee, body aches, fever, sore throat and stomach pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES ON SKIN; 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced hives on skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives on skin was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: ACHY; SWEATING; ARM PAIN; CHILLS; HEADACHE; This spontaneous report received from a parent concerned a 20 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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced achy. On 2021, the subject experienced sweating. On 2021, the subject experienced arm pain. On 2021, the subject experienced chills. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy, arm pain, headache and sweating was not reported. This report was non-serious.