chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: CHEST SORENESS; OCCASIONAL COUGH; MILD LABORED BREATHING; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 or 1855018 - she cant tell, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on Right arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 21-MAR-2021, the subject experienced mild labored breathing. On 21-MAR-2021, the subject experienced chest soreness. On 21-MAR-2021, the subject experienced occasional cough. 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 fever, occasional cough, body aches, chills, chest soreness, and mild labored breathing. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: CHEST SORENESS; OCCASIONAL COUGH; MILD LABORED BREATHING; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 or 1855018 - she cant tell, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on Right arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 21-MAR-2021, the subject experienced mild labored breathing. On 21-MAR-2021, the subject experienced chest soreness. On 21-MAR-2021, the subject experienced occasional cough. 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 fever, occasional cough, body aches, chills, chest soreness, and mild labored breathing. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pain in extremity
Clinical narrative: MIGRAINE; CHILLS; SORE ARM; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on right arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced migraine. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced sore arm. On 21-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, migraine, and sore arm, and the outcome of headaches was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Headache, Injection site rash
Clinical narrative: ACHE (ACHIE); DECREASED APPETITE; HEADACHE; NAUSEA; FEVER; RASH ON INJECTION SITE; WARM INJECTION SITE; DIARRHEA; STOMACH PAIN; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient didn't had any pre-existing medical conditions and no known allergies. The patient was previously treated with paracetamol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced rash on injection site. On 21-MAR-2021, the subject experienced warm injection site. On 21-MAR-2021, the subject experienced diarrhea. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced stomach pain. On 21-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced ache.  On 22-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from rash on injection site, and warm injection site on 22-MAR-2021, was recovering from headache, and had not recovered from diarrhea, fever, stomach pain, nausea, ache, and decreased appetite. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: ACHE (ACHIE); DECREASED APPETITE; HEADACHE; NAUSEA; FEVER; RASH ON INJECTION SITE; WARM INJECTION SITE; DIARRHEA; STOMACH PAIN; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient didn't had any pre-existing medical conditions and no known allergies. The patient was previously treated with paracetamol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced rash on injection site. On 21-MAR-2021, the subject experienced warm injection site. On 21-MAR-2021, the subject experienced diarrhea. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced stomach pain. On 21-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced ache.  On 22-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from rash on injection site, and warm injection site on 22-MAR-2021, was recovering from headache, and had not recovered from diarrhea, fever, stomach pain, nausea, ache, and decreased appetite. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Pain
Clinical narrative: ACHES/PAIN; FEELING TERRIBLE; DIARRHEA; 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced aches/pain. On 19-MAR-2021, the subject experienced feeling terrible. On 19-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches/pain, feeling terrible, and diarrhea. This report was non-serious.  Additional information was received from patient on 24-Mar-2021, following information was incorporated into case: Other AE characteristics added (Physicians/HCP office).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHE; SORE TEETH; CHILLS; HIGH FEVER TEMPERATURE/103.2 FEVER FOR 4 HOURS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced body ache. On 21-MAR-2021, the subject experienced sore teeth. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced high fever temperature/103.2 fever for 4 hours. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 103.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore teeth, and high fever temperature/103.2 fever for 4 hours, and was recovering from body ache, headache, chills, and fatigue. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: BODY ACHE; SORE TEETH; CHILLS; HIGH FEVER TEMPERATURE/103.2 FEVER FOR 4 HOURS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced body ache. On 21-MAR-2021, the subject experienced sore teeth. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced high fever temperature/103.2 fever for 4 hours. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 103.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore teeth, and high fever temperature/103.2 fever for 4 hours, and was recovering from body ache, headache, chills, and fatigue. 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 was not reported, administered on 18-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 18-MAR-2021, 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Decreased appetite, Diarrhoea, Pain
Clinical narrative: STOMACH PAIN; COUGH; DIARRHEA; BODY ACHES; LOSS OF APPETITE; LOW FEVER; This spontaneous report received from a patient concerned a 74 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, cough, diarrhea, low fever, body aches and loss of appetite was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: STOMACH PAIN; COUGH; DIARRHEA; BODY ACHES; LOSS OF APPETITE; LOW FEVER; This spontaneous report received from a patient concerned a 74 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, cough, diarrhea, low fever, body aches and loss of appetite was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: LOSS OF APPETITE; MALAISE; CHILLS; TIRED; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, penicillin allergy, alcohol use, and nonsmoker, and other pre-existing medical conditions included patients was not pregnant at the time of reporting. patient had no history of illicit drug use or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNWON) dose was not reported, administered on 10-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included metoprolol for hypertension.  On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced loss of appetite. On 11-MAR-2021, the subject experienced malaise. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 16-MAR-2021, malaise, chills, nausea, fever, and headache on 12-MAR-2021, and tired on 15-MAR-2021. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: LOSS OF APPETITE; MALAISE; CHILLS; TIRED; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, penicillin allergy, alcohol use, and nonsmoker, and other pre-existing medical conditions included patients was not pregnant at the time of reporting. patient had no history of illicit drug use or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNWON) dose was not reported, administered on 10-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included metoprolol for hypertension.  On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced loss of appetite. On 11-MAR-2021, the subject experienced malaise. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 16-MAR-2021, malaise, chills, nausea, fever, and headache on 12-MAR-2021, and tired on 15-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Tenderness
Clinical narrative: TENDERNESS; SORENESS; CHILLS; HEADACHE; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced tenderness, soreness, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness, headache, chills and tenderness was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: CHILLS; JOINT PAIN IN ANKLES, KNEES, FINGERS; FATIGUE; HEADACHE; ARM PAIN AT INJECTION SITE; DIZZINESS LIKE MIGHT PASS OUT; BACK PAIN; LACK OF ENERGY; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, latex allergy, and sulfa allergy. The patient experienced drug allergy when treated with erythromycin, and tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018) dose was not reported, administered on 19-MAR-2021 18:30 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced lack of energy. On 20-MAR-2021, the subject experienced dizziness like might pass out. On 20-MAR-2021, the subject experienced back pain. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced joint pain in ankles, knees, fingers. On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced arm pain at injection site. On 20-MAR-2021 02:00, treatment medications included: paracetamol. On 20-MAR-2021 19:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in ankles, knees, fingers, arm pain at injection site, back pain, and lack of energy, and the outcome of fatigue, headache, dizziness like might pass out and chills was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: CHILLS; JOINT PAIN IN ANKLES, KNEES, FINGERS; FATIGUE; HEADACHE; ARM PAIN AT INJECTION SITE; DIZZINESS LIKE MIGHT PASS OUT; BACK PAIN; LACK OF ENERGY; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, latex allergy, and sulfa allergy. The patient experienced drug allergy when treated with erythromycin, and tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018) dose was not reported, administered on 19-MAR-2021 18:30 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced lack of energy. On 20-MAR-2021, the subject experienced dizziness like might pass out. On 20-MAR-2021, the subject experienced back pain. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced joint pain in ankles, knees, fingers. On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced arm pain at injection site. On 20-MAR-2021 02:00, treatment medications included: paracetamol. On 20-MAR-2021 19:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in ankles, knees, fingers, arm pain at injection site, back pain, and lack of energy, and the outcome of fatigue, headache, dizziness like might pass out and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; TIREDNESS; 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 company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT VERY SICK THE NEXT DAY AND FOR 4 DAYS THERE AFTER; 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 MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced i felt very sick the next day and for 4 days thereafter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt very sick the next day and for 4 days thereafter was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: RASH ON WRIST; TIREDNESS; This spontaneous report received from a patient via a company representative concerned an elderly female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced rash on wrist. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on wrist on MAR-2021, and the outcome of tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: MILD DISCOMFORT; 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, expiry: 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 mild discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of mild discomfort was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: HIP PAIN; ANKLE PAIN; INJECTION SITE PAIN; NAUSEA; VOMITING; DIARRHEA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has had asthma as a child, and concurrent conditions included alphagal allergy, food allergy, alcoholic, and cigarette smoker. 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 20-MAR-2021 17:55 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced hip pain. On 21-MAR-2021, the subject experienced ankle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, diarrhea, hip pain, ankle pain, injection site pain, and nausea on 22-MAR-2021. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Headache, Hypoaesthesia
Clinical narrative: SEVERE NAUSEA; MYALGIA OF LOWER EXTREMITIES; FEVER; DROWSINESS; DIARRHEA  ALL DAY; LOSS OF APPETITE (ATE BREAKFAST AND LUNCH, THEN NOTHING ELSE); HIVES WHICH WERE SHORT-LIVED; DEAD ARM FEELING; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered in left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dead arm feeling. On MAR-2021, the subject experienced diarrhea all day. On MAR-2021, the subject experienced loss of appetite (ate breakfast and lunch, then nothing else). On MAR-2021, the subject experienced hives which were short-lived. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 19-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 20-MAR-2021 17:00, the subject experienced drowsiness. On 20-MAR-2021 21:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 21-MAR-2021, the subject experienced severe nausea. On 21-MAR-2021, the subject experienced myalgia of lower extremities. On 21-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 103.5 F. On 21-MAR-2021 16:00, treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from myalgia of lower extremities, and headache, and the outcome of drowsiness, severe nausea, hives which were short-lived, dead arm feeling, diarrhea all day and loss of appetite (ate breakfast and lunch, then nothing else) 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.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: SEVERE NAUSEA; MYALGIA OF LOWER EXTREMITIES; FEVER; DROWSINESS; DIARRHEA  ALL DAY; LOSS OF APPETITE (ATE BREAKFAST AND LUNCH, THEN NOTHING ELSE); HIVES WHICH WERE SHORT-LIVED; DEAD ARM FEELING; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered in left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dead arm feeling. On MAR-2021, the subject experienced diarrhea all day. On MAR-2021, the subject experienced loss of appetite (ate breakfast and lunch, then nothing else). On MAR-2021, the subject experienced hives which were short-lived. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 19-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 20-MAR-2021 17:00, the subject experienced drowsiness. On 20-MAR-2021 21:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 21-MAR-2021, the subject experienced severe nausea. On 21-MAR-2021, the subject experienced myalgia of lower extremities. On 21-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 103.5 F. On 21-MAR-2021 16:00, treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from myalgia of lower extremities, and headache, and the outcome of drowsiness, severe nausea, hives which were short-lived, dead arm feeling, diarrhea all day and loss of appetite (ate breakfast and lunch, then nothing else) 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.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SEVERE NAUSEA; MYALGIA OF LOWER EXTREMITIES; FEVER; DROWSINESS; DIARRHEA  ALL DAY; LOSS OF APPETITE (ATE BREAKFAST AND LUNCH, THEN NOTHING ELSE); HIVES WHICH WERE SHORT-LIVED; DEAD ARM FEELING; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered in left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dead arm feeling. On MAR-2021, the subject experienced diarrhea all day. On MAR-2021, the subject experienced loss of appetite (ate breakfast and lunch, then nothing else). On MAR-2021, the subject experienced hives which were short-lived. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 19-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 20-MAR-2021 17:00, the subject experienced drowsiness. On 20-MAR-2021 21:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 21-MAR-2021, the subject experienced severe nausea. On 21-MAR-2021, the subject experienced myalgia of lower extremities. On 21-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 103.5 F. On 21-MAR-2021 16:00, treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from myalgia of lower extremities, and headache, and the outcome of drowsiness, severe nausea, hives which were short-lived, dead arm feeling, diarrhea all day and loss of appetite (ate breakfast and lunch, then nothing else) 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: F
Vaccine: COVID19
Symptoms: Gastric disorder, Headache
Clinical narrative: SEVERE HEADACHE; COULDN'T KEEP ANYTHING IN STOMACH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced couldn't keep anything in stomach. Treatment medications included: paracetamol. On 14-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't keep anything in stomach, and severe headache on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: CONSUMER RECEIVED 1ML DOSE OF VACCINE; OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 1 ml, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced consumer received 1ml dose of vaccine. On 22-MAR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the consumer received 1ml dose of vaccine and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Feeling of body temperature change, Headache
Clinical narrative: FEVER; HEADACHE; SHAKING CHILLS; FEELING HOT AND COLD; SWEATY; BODY CRAMPS; This spontaneous report received from a patient concerned a 50 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: 1805020 expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot and cold. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced shaking chills. On 16-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature increased (NR: not provided) High. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling hot and cold, fever, headache, sweaty, body cramps, and shaking chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscle spasms, Pyrexia
Clinical narrative: FEVER; HEADACHE; SHAKING CHILLS; FEELING HOT AND COLD; SWEATY; BODY CRAMPS; This spontaneous report received from a patient concerned a 50 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: 1805020 expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot and cold. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced shaking chills. On 16-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature increased (NR: not provided) High. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling hot and cold, fever, headache, sweaty, body cramps, and shaking chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Musculoskeletal chest pain
Clinical narrative: RIB CAGE PAIN FRONT AND BACK; DIFFICULTY BREATHING; FEVER; CHILLS; HEADACHE; ACHEY; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included broken ribs, and concurrent conditions included migraines.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:30 for prophylactic vaccination on left arm . No concomitant medications were reported. On 21-MAR-2021 22:30, the subject experienced achey. On 22-MAR-2021, the subject experienced rib cage pain front and back. On 22-MAR-2021, the subject experienced difficulty breathing. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 99.5 F. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from achey, fever, and chills, and the outcome of rib cage pain front and back, difficulty breathing and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: RIB CAGE PAIN FRONT AND BACK; DIFFICULTY BREATHING; FEVER; CHILLS; HEADACHE; ACHEY; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included broken ribs, and concurrent conditions included migraines.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:30 for prophylactic vaccination on left arm . No concomitant medications were reported. On 21-MAR-2021 22:30, the subject experienced achey. On 22-MAR-2021, the subject experienced rib cage pain front and back. On 22-MAR-2021, the subject experienced difficulty breathing. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 99.5 F. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from achey, fever, and chills, and the outcome of rib cage pain front and back, difficulty breathing and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: SORE THROAT; SNIFFLES; COUGH; BODY ACHES; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore throat. On 12-MAR-2021, the subject experienced sniffles. On 12-MAR-2021, the subject experienced cough. On 12-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAR-2021, and had not recovered from sore throat, sniffles, and cough. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: SWEATING; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 2021, the subject experienced sweating. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and sweating was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: ICKY FEELING; DIGESTIVE UPSET; CHILLS; NAUSEA; SORENESS OF INJECTION SITE; TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced icky feeling. On MAR-2021, the subject experienced digestive upset. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced soreness of injection site. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, icky feeling, soreness of injection site, tiredness, digestive upset, chills and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: ICKY FEELING; DIGESTIVE UPSET; CHILLS; NAUSEA; SORENESS OF INJECTION SITE; TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced icky feeling. On MAR-2021, the subject experienced digestive upset. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced soreness of injection site. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, icky feeling, soreness of injection site, tiredness, digestive upset, chills and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 190 pounds, and height was 65 inches. The patient's concurrent conditions included hereditary hypertension, seasonal allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage and uses cbd edibles for sleep. 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 15-MAR-2021 10:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced elevated temperature. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fatigue (conked/worn out). Laboratory data included: Body temperature (NR: not provided) 99 to 99.2 F, 99 to 101.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from elevated temperature, and fatigue (conked/worn out). This report was non-serious.