chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Eye pain, Haematuria, Headache
Clinical narrative: BLURRY EYE; DIZZY; PAIN IN HEAD; NAUSEA; VOMITING; BURNING UP; NERVE PAIN; ABOUT TO PASS OUT; PINS STICKING IN HER EYES; BLOOD/TISSUE IN URINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included copd, neuropathy in feet, diabetes, and heart problem.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood/tissue in urine. Laboratory data included: Urine analysis (NR: not provided) Blood/tissue in urine. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced burning up. On 09-MAR-2021, the subject experienced nerve pain. On 09-MAR-2021, the subject experienced about to pass out. On 09-MAR-2021, the subject experienced pins sticking in her eyes. On 09-MAR-2021, the subject experienced dizzy. On 09-MAR-2021, the subject experienced pain in head. On 09-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced blurry eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, pain in head, blurry eye, burning up, about to pass out, and blood/tissue in urine, and the outcome of nerve pain, pins sticking in her eyes and dizzy was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review, the following information was amended: Medical history hear problem updated to heart problem.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuralgia, Presyncope, Urine analysis, Vision blurred
Clinical narrative: BLURRY EYE; DIZZY; PAIN IN HEAD; NAUSEA; VOMITING; BURNING UP; NERVE PAIN; ABOUT TO PASS OUT; PINS STICKING IN HER EYES; BLOOD/TISSUE IN URINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included copd, neuropathy in feet, diabetes, and heart problem.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood/tissue in urine. Laboratory data included: Urine analysis (NR: not provided) Blood/tissue in urine. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced burning up. On 09-MAR-2021, the subject experienced nerve pain. On 09-MAR-2021, the subject experienced about to pass out. On 09-MAR-2021, the subject experienced pins sticking in her eyes. On 09-MAR-2021, the subject experienced dizzy. On 09-MAR-2021, the subject experienced pain in head. On 09-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced blurry eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, pain in head, blurry eye, burning up, about to pass out, and blood/tissue in urine, and the outcome of nerve pain, pins sticking in her eyes and dizzy was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review, the following information was amended: Medical history hear problem updated to heart problem.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BLURRY EYE; DIZZY; PAIN IN HEAD; NAUSEA; VOMITING; BURNING UP; NERVE PAIN; ABOUT TO PASS OUT; PINS STICKING IN HER EYES; BLOOD/TISSUE IN URINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included copd, neuropathy in feet, diabetes, and heart problem.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood/tissue in urine. Laboratory data included: Urine analysis (NR: not provided) Blood/tissue in urine. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced burning up. On 09-MAR-2021, the subject experienced nerve pain. On 09-MAR-2021, the subject experienced about to pass out. On 09-MAR-2021, the subject experienced pins sticking in her eyes. On 09-MAR-2021, the subject experienced dizzy. On 09-MAR-2021, the subject experienced pain in head. On 09-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced blurry eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, pain in head, blurry eye, burning up, about to pass out, and blood/tissue in urine, and the outcome of nerve pain, pins sticking in her eyes and dizzy was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review, the following information was amended: Medical history hear problem updated to heart problem.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Initial insomnia, Muscle spasms
Clinical narrative: MUSCLE SPASMS IN BACK; HIP PAIN; EXHAUSTION; LIGHT HEADACHE; DIFFICULT TIME FALLING ASLEEP; VERY RESTLESS; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was not reported and height was 162.56 centimeters. The patient's past medical history included reaction to vaccine, and other pre-existing medical conditions included patient weight v1 118. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021 23:00, the subject experienced very restless. On 10-MAR-2021 23:00, the subject experienced difficult time falling asleep. On 11-MAR-2021, the subject experienced muscle spasms in back. On 11-MAR-2021, the subject experienced hip pain. On 11-MAR-2021, the subject experienced exhaustion. On 11-MAR-2021, the subject experienced light headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very restless, muscle spasms in back, difficult time falling asleep, hip pain, and light headache on 11-MAR-2021, and had not recovered from exhaustion. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: MUSCLE SPASMS IN BACK; HIP PAIN; EXHAUSTION; LIGHT HEADACHE; DIFFICULT TIME FALLING ASLEEP; VERY RESTLESS; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was not reported and height was 162.56 centimeters. The patient's past medical history included reaction to vaccine, and other pre-existing medical conditions included patient weight v1 118. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021 23:00, the subject experienced very restless. On 10-MAR-2021 23:00, the subject experienced difficult time falling asleep. On 11-MAR-2021, the subject experienced muscle spasms in back. On 11-MAR-2021, the subject experienced hip pain. On 11-MAR-2021, the subject experienced exhaustion. On 11-MAR-2021, the subject experienced light headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very restless, muscle spasms in back, difficult time falling asleep, hip pain, and light headache on 11-MAR-2021, and had not recovered from exhaustion. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; 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: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body aches. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 132 and height was 64 inches. The patient's concurrent conditions included penicillin allergy, sulfa drug allergy, alcohol use(3-4 glasses of wine), non smoker, and rash, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 14:13 on right (site unspecified) for prophylactic vaccination. Concomitant medications included atorvastatin calcium.  On 10-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-MAR-2021. This report was non-serious.  Additional information was received from physician on 30-MAR-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight), concurrent conditions (penicillin allergy, sulfa drug allergy, alcohol use, non smoker, and rash), covid-19 vaccine therapy details (batch number, therapy start date and vaccination site), concomitant medication (lipitor), reporter details was added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Incorrect route of product administration
Clinical narrative: INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Tremor
Clinical narrative: INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: LUMP AT INJECTION SITE; 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 11-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 lump at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lump at injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Heart rate, Heart rate increased
Clinical narrative: FASTER HEART BEAT; MORE ENERGY AND INCREASED STRENGTH; This spontaneous report received from a patient concerned a 72 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 and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced faster heart beat. On 13-MAR-2021, the subject experienced more energy and increased strength. On 15-MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 85 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faster heart beat on 13-MAR-2021, and more energy and increased strength on 16-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Pruritus, Swelling
Clinical narrative: LEFT EYE ITCHING; HAND ITCHING; SWELLING; FINGERTIPS HARD AND RED IN COLOR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 12-MAR-2021 approximately at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced hand itching. On 16-MAR-2021, the subject experienced swelling. On 16-MAR-2021, the subject experienced fingertips hard and red in color. On an unspecified date, the subject experienced left eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hand itching, and swelling, and the outcome of fingertips hard and red in color and left eye itching was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Migraine, Nausea, Pain
Clinical narrative: BODY ACHES; DIZZY; MIGRAINE; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 35 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021 20:00, the subject experienced body aches. On 15-MAR-2021 20:00, the subject experienced dizzy. On 15-MAR-2021 20:00, the subject experienced migraine. On 15-MAR-2021 20:00, the subject experienced chills. On 15-MAR-2021 20:00, the subject experienced nausea. On 15-MAR-2021 20:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 16-MAR-2021, and had not recovered from chills, body aches, migraine, fever, and dizzy. This report was non-serious. This parent/child case is linked to 20210336338.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; DIZZY; MIGRAINE; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 35 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021 20:00, the subject experienced body aches. On 15-MAR-2021 20:00, the subject experienced dizzy. On 15-MAR-2021 20:00, the subject experienced migraine. On 15-MAR-2021 20:00, the subject experienced chills. On 15-MAR-2021 20:00, the subject experienced nausea. On 15-MAR-2021 20:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 16-MAR-2021, and had not recovered from chills, body aches, migraine, fever, and dizzy. This report was non-serious. This parent/child case is linked to 20210336338.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: EXPOSURE DURING BREASTFEEDING; This spontaneous report received from a patient concerned a bay of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the baby experienced exposure during breastfeeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure during breastfeeding was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 200 pounds, and height was 182 centimeters. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies (food vaccine and drug). No history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:30 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness on 11-MAR-2021. This report was non-serious.  Additional information was received from reporter on follow up 23-MAR-2021 following information was amended into case:  The patient details (height, weight, sex and age), concurrent conditions (alcohol use, non-smoker), vaccination time, route and vaccination site.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious.  Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome  was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pain, Musculoskeletal chest pain, Nausea, Nightmare
Clinical narrative: RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious.  Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome  was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious.  Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome  was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: BAD REACTION; 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, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction 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: Myalgia
Clinical narrative: MUSCLE SORENESS FOR 6 HOURS FOLLOWING THE INJECTION; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight was not reported and height was 182.88 centimeters. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient did not have any history of allergies to vaccine, drug or food nor any drug abuse.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced muscle soreness for 6 hours following the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness for 6 hours following the injection on 06-MAR-2021. This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter details (patient), patient demographics (patient initials), height, patient history including pre-existing medical conditions, medical history, event and event details (outcome, onset and cessation date), product and product details (route of administration, therapy start and end date, batch number) and case level outcome.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: CANNOT RISE UP THE LEFT ARM; LEFT ARM HURTS; This spontaneous report received from a patient 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 on right arm (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cannot rise up the left arm. On 19-MAR-2021, the subject experienced left arm hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot rise up the left arm, and left arm hurts. This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into case narrative. Reporter details (address, city, zip code) and due diligence.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Injection site swelling
Clinical narrative: RAPID HEARTBEAT; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 165 pounds, and height was not reported. The patient's pre-existing medical conditions included the patient had no known allergies illness at the time of vaccination: no past history of similar event? no pre-existing acute illness 30 days prior to vaccination? no family history of any disease (relevant to vaccination) or allergy? no. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced rapid heartbeat. On 20-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Heart rate (NR: not provided) 100 beats per min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, and rapid heartbeat. This report was non-serious.  Additional information received from patient on 31-march-2021 The following information was updated and incorporated into the case: patient weight added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis.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 flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative 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, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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: 180503, expiry: 30-DEC-2069) 1 ml, administered on 22-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced off label use. On 22-MAR-2021, the subject experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 22-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.  Additional information was received from physician on 29 /mar/2021 following information was updated and incorporated into case narrative: patinets date of birth, age group, age, unit dose, reporters details.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Needle issue, Product administration error, Syringe issue
Clinical narrative: MEDICATION CAME OUT OF BASE OF NEEDLE; INAPPROPRIATE ADMINISTRATION; MEDICATION RAN DOWN THE PATIENT'S ARM; SYRINGE SYSTEM USED FOR VACCINE ADMINISTRATION WAS DEFECTIVE; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609, G200714 and expiry: 09-JUN-2021) 0.5 ml, administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced medication came out of base of needle. On 23-MAR-2021, the subject experienced inappropriate administration. On 23-MAR-2021, the subject experienced medication ran down the subject's arm. On 23-MAR-2021, the subject experienced syringe system used for vaccine administration was defective. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from medication came out of base of needle, and the outcome of inappropriate administration, medication ran down the patient's arm and syringe system used for vaccine administration was defective was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Feeling abnormal, Nausea
Clinical narrative: FEVER; NAUSEA; FELT NOT NORMAL; STOMACH ACHE; SORE ARM AND SHOULDER; CHILLS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 21-MAR-2021 11:30 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced felt not normal. On 21-MAR-2021, the subject experienced stomach ache. On 21-MAR-2021, the subject experienced sore arm and shoulder. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.9 F. On 21-MAR-2021 20:00, the subject experienced fever. On 21-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 103.2 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, stomach ache, nausea, chills, sore arm and shoulder, and felt not normal. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FEVER; NAUSEA; FELT NOT NORMAL; STOMACH ACHE; SORE ARM AND SHOULDER; CHILLS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 21-MAR-2021 11:30 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced felt not normal. On 21-MAR-2021, the subject experienced stomach ache. On 21-MAR-2021, the subject experienced sore arm and shoulder. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.9 F. On 21-MAR-2021 20:00, the subject experienced fever. On 21-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 103.2 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, stomach ache, nausea, chills, sore arm and shoulder, and felt not normal. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cystitis, Fatigue, Nausea, Pyrexia
Clinical narrative: FEVER; NAUSEA; BLADDER INFECTION; 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 concurrent conditions included allergy of antibiotic .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 19-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced bladder infection. On 21-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bladder infection, fever, and fatigue, and the outcome of nausea 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.