chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Pneumonia
Clinical narrative: PNEUMONIA; FELT IT DOWN HER HAND, BACK UP HER ARM AND HEAD; NAUSEA; DIZZY SPELLS; 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 administration was not reported, batch number: unknown) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient's injection site did not hurt but she felt it down her hand, back up her arm and her head. On an unspecified date, in MAR-2021, the patient experienced dizzy spells, nausea and pneumonia. Two weeks after vaccination, in MAR-2021, she was hospitalized for pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy spells, nausea, pneumonia, and felt it down her hand, back up her arm and head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210422308- Covid-19 vaccine ad26.cov2.s- pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event..
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Hypertension, Laboratory test
Clinical narrative: PNEUMONIA; FELT IT DOWN HER HAND, BACK UP HER ARM AND HEAD; NAUSEA; DIZZY SPELLS; 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 administration was not reported, batch number: unknown) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient's injection site did not hurt but she felt it down her hand, back up her arm and her head. On an unspecified date, in MAR-2021, the patient experienced dizzy spells, nausea and pneumonia. Two weeks after vaccination, in MAR-2021, she was hospitalized for pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy spells, nausea, pneumonia, and felt it down her hand, back up her arm and head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210422308- Covid-19 vaccine ad26.cov2.s- pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event..
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: PNEUMONIA; FELT IT DOWN HER HAND, BACK UP HER ARM AND HEAD; NAUSEA; DIZZY SPELLS; 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 administration was not reported, batch number: unknown) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient's injection site did not hurt but she felt it down her hand, back up her arm and her head. On an unspecified date, in MAR-2021, the patient experienced dizzy spells, nausea and pneumonia. Two weeks after vaccination, in MAR-2021, she was hospitalized for pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy spells, nausea, pneumonia, and felt it down her hand, back up her arm and head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210422308- Covid-19 vaccine ad26.cov2.s- pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event..
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Rash, Swelling face
Clinical narrative: SWOLLEN FACE; BAD RASH ALL OVER BODY; PASSED OUT; This spontaneous report received from a patient concerned a 38 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, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient passed out and had no symptoms until seven days. On 07-APR-2021, the patient experienced pretty bad rash. On 08-APR-2021, the patient experienced swollen face and rash all over body which made him to visit an urgency clinic where he was prescribed with prednisone for rash. The patient visited doctor or healthcare professional office for events passed out, swollen face, and bad rash all over body and emergency room or department or urgent care for events swollen face, and bad rash all over body. It was reported that, the medication had not eradicated the symptoms but only calmed them down. According to the patient, if he had stop taking the medications the symptoms would go back to the same intensity as before.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 01-APR-2021, and had not recovered from swollen face, and bad rash all over body. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422310-covid-19 vaccine ad26.cov2.s -Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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: 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 an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: ACHE; CHILLS; 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, 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 ache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210420123.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Headache, Injection site pain
Clinical narrative: INCREASING CHILLS; MILD PAIN AT INJECTION SITE; UNUSUALLY INTENSE TIREDNESS; LOW GRADE FEVER; HEADACHE; NAUSEA; UNABLE TO SLEEP; UNABLE TO EAT; VOMITING; This spontaneous report received from a patient concerned a 27 year old. 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 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced low grade fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced increasing chills. On 10-APR-2021, the subject experienced mild pain at injection site. On 10-APR-2021, the subject experienced unusually intense tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increasing chills, unusually intense tiredness, low grade fever, headache, nausea, vomiting, unable to sleep, and unable to eat, and had not recovered from mild pain at injection site. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pyrexia, Vomiting
Clinical narrative: INCREASING CHILLS; MILD PAIN AT INJECTION SITE; UNUSUALLY INTENSE TIREDNESS; LOW GRADE FEVER; HEADACHE; NAUSEA; UNABLE TO SLEEP; UNABLE TO EAT; VOMITING; This spontaneous report received from a patient concerned a 27 year old. 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 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced low grade fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced increasing chills. On 10-APR-2021, the subject experienced mild pain at injection site. On 10-APR-2021, the subject experienced unusually intense tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increasing chills, unusually intense tiredness, low grade fever, headache, nausea, vomiting, unable to sleep, and unable to eat, and had not recovered from mild pain at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Myalgia, Nausea
Clinical narrative: LITTLE SORE IN LEG MUSCLES; METALLIC TASTE IN MOUTH; SICK STOMACH; TIRED; 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 09-APR-2021 for prophylactic vaccination.  Batch number was not reported has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced sick stomach. On 09-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced metallic taste in mouth. On an unspecified date, the subject experienced little sore in leg muscles. Treatment medications (dates unspecified) included: povidone-iodine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick stomach, tired, little sore in leg muscles and metallic taste in mouth was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: SWEATING; FEELING OF WARMTH; FEVER; TIREDNESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 19 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 01-APR-2021 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 chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced feeling of warmth. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, feeling of warmth, chills, headache, fever, and tiredness on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SWEATING; FEELING OF WARMTH; FEVER; TIREDNESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 19 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 01-APR-2021 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 chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced feeling of warmth. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, feeling of warmth, chills, headache, fever, and tiredness on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PRETTY HIGH FEVER; TThis spontaneous report received from a patient via a company representative concerned a 30 year old female. 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: Unk) 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 pretty high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty high fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Dyspepsia, Dyspnoea, Feeling abnormal
Clinical narrative: RASHES ON FACE AND BODY; FELT OFF BALANCE; COULD BARELY KEEP AWAKE; FEELING BAD; FELT A WARM SENSATION TO MOVE UP SHOULDER; PAIN AT INJECTION SITE; HEADACHE; FEVER; NEEDLE LIKE FEELING IN FEET,RIGHT ARM AND HANDS; SORE THROAT; STUFFY NOSE; KNUCKLES IN FINGER FELT STIFF; VERY ACHY; HEARTBURN LIKE PAINS; SLIGHT HEAVY BREATHING; VERY RAPID HEART RATE; 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: unk) dose was not reported, administered on 10-APR-2021 10:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight heavy breathing. On 10-APR-2021, the subject experienced very rapid heart rate. On 10-APR-2021, the subject experienced needle like feeling in feet, right arm and hands. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced stuffy nose. On 10-APR-2021, the subject experienced knuckles in finger felt stiff. On 10-APR-2021, the subject experienced very achy. On 10-APR-2021, the subject experienced heartburn like pains. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 102 beats/min. Treatment medications included: paracetamol. On 10-APR-2021 10:45, the subject experienced pain at injection site. On 10-APR-2021 11:00, the subject experienced felt a warm sensation to move up shoulder. On 10-APR-2021 20:00, the subject experienced feeling bad. On 11-APR-2021, the subject experienced felt off balance. On 11-APR-2021, the subject experienced could barely keep awake. Laboratory data included: Body temperature (NR: not provided) 101.1-101.4. On 12-APR-2021, the subject experienced rashes on face and body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very rapid heart rate on 11-APR-2021, and fever on 12-APR-2021, had not recovered from headache, sore throat, and stuffy nose, and the outcome of pain at injection site, felt a warm sensation to move up shoulder, feeling bad, slight heavy breathing, needle like feeling in feet,right arm and hands, knuckles in finger felt stiff, rashes on face and body, very achy, heartburn like pains, felt off balance and could barely keep awake was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate, Heart rate increased, Injection site pain
Clinical narrative: RASHES ON FACE AND BODY; FELT OFF BALANCE; COULD BARELY KEEP AWAKE; FEELING BAD; FELT A WARM SENSATION TO MOVE UP SHOULDER; PAIN AT INJECTION SITE; HEADACHE; FEVER; NEEDLE LIKE FEELING IN FEET,RIGHT ARM AND HANDS; SORE THROAT; STUFFY NOSE; KNUCKLES IN FINGER FELT STIFF; VERY ACHY; HEARTBURN LIKE PAINS; SLIGHT HEAVY BREATHING; VERY RAPID HEART RATE; 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: unk) dose was not reported, administered on 10-APR-2021 10:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight heavy breathing. On 10-APR-2021, the subject experienced very rapid heart rate. On 10-APR-2021, the subject experienced needle like feeling in feet, right arm and hands. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced stuffy nose. On 10-APR-2021, the subject experienced knuckles in finger felt stiff. On 10-APR-2021, the subject experienced very achy. On 10-APR-2021, the subject experienced heartburn like pains. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 102 beats/min. Treatment medications included: paracetamol. On 10-APR-2021 10:45, the subject experienced pain at injection site. On 10-APR-2021 11:00, the subject experienced felt a warm sensation to move up shoulder. On 10-APR-2021 20:00, the subject experienced feeling bad. On 11-APR-2021, the subject experienced felt off balance. On 11-APR-2021, the subject experienced could barely keep awake. Laboratory data included: Body temperature (NR: not provided) 101.1-101.4. On 12-APR-2021, the subject experienced rashes on face and body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very rapid heart rate on 11-APR-2021, and fever on 12-APR-2021, had not recovered from headache, sore throat, and stuffy nose, and the outcome of pain at injection site, felt a warm sensation to move up shoulder, feeling bad, slight heavy breathing, needle like feeling in feet,right arm and hands, knuckles in finger felt stiff, rashes on face and body, very achy, heartburn like pains, felt off balance and could barely keep awake was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nasal congestion, Oropharyngeal pain, Pain, Paraesthesia
Clinical narrative: RASHES ON FACE AND BODY; FELT OFF BALANCE; COULD BARELY KEEP AWAKE; FEELING BAD; FELT A WARM SENSATION TO MOVE UP SHOULDER; PAIN AT INJECTION SITE; HEADACHE; FEVER; NEEDLE LIKE FEELING IN FEET,RIGHT ARM AND HANDS; SORE THROAT; STUFFY NOSE; KNUCKLES IN FINGER FELT STIFF; VERY ACHY; HEARTBURN LIKE PAINS; SLIGHT HEAVY BREATHING; VERY RAPID HEART RATE; 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: unk) dose was not reported, administered on 10-APR-2021 10:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight heavy breathing. On 10-APR-2021, the subject experienced very rapid heart rate. On 10-APR-2021, the subject experienced needle like feeling in feet, right arm and hands. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced stuffy nose. On 10-APR-2021, the subject experienced knuckles in finger felt stiff. On 10-APR-2021, the subject experienced very achy. On 10-APR-2021, the subject experienced heartburn like pains. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 102 beats/min. Treatment medications included: paracetamol. On 10-APR-2021 10:45, the subject experienced pain at injection site. On 10-APR-2021 11:00, the subject experienced felt a warm sensation to move up shoulder. On 10-APR-2021 20:00, the subject experienced feeling bad. On 11-APR-2021, the subject experienced felt off balance. On 11-APR-2021, the subject experienced could barely keep awake. Laboratory data included: Body temperature (NR: not provided) 101.1-101.4. On 12-APR-2021, the subject experienced rashes on face and body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very rapid heart rate on 11-APR-2021, and fever on 12-APR-2021, had not recovered from headache, sore throat, and stuffy nose, and the outcome of pain at injection site, felt a warm sensation to move up shoulder, feeling bad, slight heavy breathing, needle like feeling in feet,right arm and hands, knuckles in finger felt stiff, rashes on face and body, very achy, heartburn like pains, felt off balance and could barely keep awake was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: RASHES ON FACE AND BODY; FELT OFF BALANCE; COULD BARELY KEEP AWAKE; FEELING BAD; FELT A WARM SENSATION TO MOVE UP SHOULDER; PAIN AT INJECTION SITE; HEADACHE; FEVER; NEEDLE LIKE FEELING IN FEET,RIGHT ARM AND HANDS; SORE THROAT; STUFFY NOSE; KNUCKLES IN FINGER FELT STIFF; VERY ACHY; HEARTBURN LIKE PAINS; SLIGHT HEAVY BREATHING; VERY RAPID HEART RATE; 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: unk) dose was not reported, administered on 10-APR-2021 10:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight heavy breathing. On 10-APR-2021, the subject experienced very rapid heart rate. On 10-APR-2021, the subject experienced needle like feeling in feet, right arm and hands. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced stuffy nose. On 10-APR-2021, the subject experienced knuckles in finger felt stiff. On 10-APR-2021, the subject experienced very achy. On 10-APR-2021, the subject experienced heartburn like pains. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 102 beats/min. Treatment medications included: paracetamol. On 10-APR-2021 10:45, the subject experienced pain at injection site. On 10-APR-2021 11:00, the subject experienced felt a warm sensation to move up shoulder. On 10-APR-2021 20:00, the subject experienced feeling bad. On 11-APR-2021, the subject experienced felt off balance. On 11-APR-2021, the subject experienced could barely keep awake. Laboratory data included: Body temperature (NR: not provided) 101.1-101.4. On 12-APR-2021, the subject experienced rashes on face and body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very rapid heart rate on 11-APR-2021, and fever on 12-APR-2021, had not recovered from headache, sore throat, and stuffy nose, and the outcome of pain at injection site, felt a warm sensation to move up shoulder, feeling bad, slight heavy breathing, needle like feeling in feet,right arm and hands, knuckles in finger felt stiff, rashes on face and body, very achy, heartburn like pains, felt off balance and could barely keep awake was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient's 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: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Fall, Fatigue, Headache
Clinical narrative: SWELLING IN FILLER LIP ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; BURNING PAIN ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; HEADACHE; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; DIZZINESS; FELL DOWN; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included panic attacks. The patient was previously treated with hyaluronic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for panic attacks. On APR-2021, the subject experienced fell down. Laboratory data included: Body temperature increased (NR: not provided) 99.5 F. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced swelling in filler lip on left side of upper lip from middle of lip to end of top lip. On 12-APR-2021, the subject experienced burning pain on left side of upper lip from middle of lip to end of top lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and low grade fever on 08-APR-2021, was recovering from muscle aches, and fatigue, had not recovered from burning pain on left side of upper lip from middle of lip to end of top lip., dizziness, and swelling in filler lip on left side of upper lip from middle of lip to end of top lip., and the outcome of fell down was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling, Myalgia, Pyrexia
Clinical narrative: SWELLING IN FILLER LIP ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; BURNING PAIN ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; HEADACHE; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; DIZZINESS; FELL DOWN; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included panic attacks. The patient was previously treated with hyaluronic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for panic attacks. On APR-2021, the subject experienced fell down. Laboratory data included: Body temperature increased (NR: not provided) 99.5 F. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced swelling in filler lip on left side of upper lip from middle of lip to end of top lip. On 12-APR-2021, the subject experienced burning pain on left side of upper lip from middle of lip to end of top lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and low grade fever on 08-APR-2021, was recovering from muscle aches, and fatigue, had not recovered from burning pain on left side of upper lip from middle of lip to end of top lip., dizziness, and swelling in filler lip on left side of upper lip from middle of lip to end of top lip., and the outcome of fell down was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE PAIN; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle pain was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypopnoea, Lacrimation increased, Nausea
Clinical narrative: This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Tremor
Clinical narrative: This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: BODY ACHES; FEELING HOT; BAD HEADACHE; his 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, 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, feeling hot, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, feeling hot and bad headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420044 and 20210421304.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate irregular, Insomnia, Pain, Pyrexia
Clinical narrative: COULDN'T SLEEP AT NIGHT; ACHES; CHILLS; FEVER; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical conditions, not on any medications. no history of irregular heart beat.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced irregular heart beat. On an unspecified date, the subject experienced couldn't sleep at night, aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and fever, had not recovered from irregular heart beat, and the outcome of couldn't sleep at night was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Pain, Pain in extremity, Pyrexia
Clinical narrative: NOSEBLEEDS; SORE ARM; CHILLS; FEVER; BODY ACHES; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional nosebleeds, migraine, seasonal allergy, allergic reaction to steroids, and concerned about citric acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nosebleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleeds on 11-APR-2021, chills on 07-APR-2021, and fever on 10-APR-2021, and the outcome of sore arm and body aches was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Headache, Malaise, Pyrexia
Clinical narrative: CRYING; NOT FEELING GOOD; CHILLS; SEVERE HEADACHE; FEVER; This spontaneous report received from a parent concerned a 24 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, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced crying, not feeling good, chills, severe headache, and fever.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, severe headache, and fever, and the outcome of crying and not feeling good was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number and expiry date was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: INSOMNIA; SORE ARM; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy and also was an active runner and taking vitamins.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from insomnia, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422183.
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Hypophagia, Nausea
Clinical narrative: DIZZINESS; COLD SWEATS; CAN'T EAT MUCH; NAUSEA; VERY DRAINED; 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: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, cold sweats, can't eat much, nausea, and very drained. Treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, nausea, cold sweats, can't eat much, and very drained. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: ADMINISTERED VACCINE TWICE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported.  On 12-APR-2021, the subject experienced administered vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine twice was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site pain, Sinus headache
Clinical narrative: DISCOMFORT; SINUS HEADACHE; INJECTION SITE PAIN AND SORE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, asthma, and sarcoidosis, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse / illicit drug use. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site pain and sore. On 11-APR-2021, the subject experienced sinus headache. On an unspecified date, the subject experienced discomfort. 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 injection site pain and sore, and sinus headache, and the outcome of discomfort was not reported. This report was non-serious.