chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: INSOMNIA X 1 NIGHT; LOSS OF TASTE X1 HOUR DURING BREAKFAST; STRANGE TASTE; DIZZINESS X8HOURS; SEVERE HEADACHE; NAUSEA; "DEEP STRETCH" SENSATION; LOSS OF APPETITE; VOMITING; DIAPHORETIC; SOUR FEELING IN THE STOMACH; 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 the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sour feeling in the stomach. On 07-MAR-2021, the subject experienced diaphoretic. On 07-MAR-2021, the subject experienced "deep stretch" sensation. On 07-MAR-2021, the subject experienced loss of appetite. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021 17:00, the subject experienced severe headache. On 09-MAR-2021, the subject experienced dizziness x8hours. On 09-MAR-2021, the subject experienced insomnia x 1 night. On 09-MAR-2021, the subject experienced loss of taste x1 hour during breakfast. On 09-MAR-2021, the subject experienced strange taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diaphoretic, "deep stretch" sensation, and vomiting on 08-MAR-2021, dizziness x8hours, insomnia x 1 night, and loss of taste x1 hour during breakfast on 09-MAR-2021, and severe headache on 08-MAR-2021 18:00, had not recovered from nausea, strange taste, and loss of appetite, and the outcome of sour feeling in the stomach was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: FEVER; CHILLS; TIREDNESS; JOINT ACHES; 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 concurrent conditions included diabetes, and amoxicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) .5 ml, administered on 07-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the patient experienced fever. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, and tiredness on 08-MAR-2021, and was recovering from joint aches. This report was non-serious. .
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Neck pain
Clinical narrative: NECK PAIN; DIZZINESS; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 06-MAR-2021, and had not recovered from neck pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: FEELING COLD; SHIVERING; FEVER; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced feeling cold. On 10-MAR-2021, the subject experienced shivering. On 10-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 feeling cold, shivering, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Tremor
Clinical narrative: EYES ROLLING; SHAKY; DIZZY; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced eyes rolling. On 10-MAR-2021, the subject experienced shaky. On 10-MAR-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyes rolling, shaky, and dizzy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Nausea, Pain, Pyrexia
Clinical narrative: NAUSEA; DIZZINESS; SLURRED SPEECH; DRY HEAVES; FEVER; BODY ACHES; 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 patient had no any medical history. The patient experienced drug allergy when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced slurred speech. On 09-MAR-2021, the subject experienced dry heaves. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness, slurred speech, dry heaves, fever and body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: NAUSEA; DIZZINESS; SLURRED SPEECH; DRY HEAVES; FEVER; BODY ACHES; 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 patient had no any medical history. The patient experienced drug allergy when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced slurred speech. On 09-MAR-2021, the subject experienced dry heaves. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness, slurred speech, dry heaves, fever and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: FEVER OF 98F; NAUSEA; GENERALLY TIRED; This spontaneous report received from a patient concerned a 55 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 10-MAR-2021 to Left Deltoid for prophylactic vaccination. the batch number and expiry date were not reported hence requested. No concomitant medications were reported. On 10-MAR-2021, the patient experienced fever of 98f. On 10-MAR-2021, the patient experienced nausea. On 10-MAR-2021, the patient experienced generally tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested.  The patient had not recovered from fever of 98f, nausea, and generally tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: SEVERE MUSCLE ACHES; PAIN AT INJECTION SITE; Headache; Fatigue; CHILLS; FEVER; This spontaneous report received from a pharmacist 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, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, headache, fatigue, and chills on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318167 and 20210320117.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SEVERE MUSCLE ACHES; PAIN AT INJECTION SITE; Headache; Fatigue; CHILLS; FEVER; This spontaneous report received from a pharmacist 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, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, headache, fatigue, and chills on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318167 and 20210320117.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; SYMPTOMS OF SEVERE CHILLS; FEVER (100-101F); HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, and hypothyroidism, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced symptoms of severe chills. On 10-MAR-2021, the subject experienced fever (100-101f). On 10-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from symptoms of severe chills, and headache on 11-MAR-2021, and was recovering from fever (100-101f), and body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: FEVER; HEADACHE; BODY ACHE; 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 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 06:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F, 101.6 F, 100 F. 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, body ache, and headache. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: HEADACHE; DIARRHEA; SWEATING; NAUSEA; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dust allergy, mite allergy, and pollen allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 07-MAR-2021, was recovering from fatigue, and had not recovered from nausea, diarrhea, and sweating. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: HEADACHE; DIARRHEA; SWEATING; NAUSEA; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dust allergy, mite allergy, and pollen allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 07-MAR-2021, was recovering from fatigue, and had not recovered from nausea, diarrhea, and sweating. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: IMMOBILE; This spontaneous report received from a consumer 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 was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced immobile. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from immobile. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: INJECTION SITE HARDNESS; FEVER; CHILLS; INJECTION SITE REDNESS; 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 pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced injection site redness. On 10-MAR-2021, the subject experienced injection site hardness. Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 11-MAR-2021, and the outcome of injection site redness and injection site hardness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain
Clinical narrative: CHILLS 3-4 HOURS AFTER THE SHOT, TEMP NOT TAKEN; FEELS VERY WEAK; ACHES ALL OVER THE BODY; This spontaneous report received from a consumer. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) .5 ml, administered on 10-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced chills 3-4 hours after the shot, temp not taken. On 10-MAR-2021, the subject experienced feels very weak. On 10-MAR-2021, the subject experienced aches all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills 3-4 hours after the shot, temp not taken, feels very weak, and aches all over the body. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A FEW SMALL ACHES; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown,  expiry: UNKNOWN) .5 ml, 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 a few small aches. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a few small aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Body temperature, Chills, Fatigue, Feeling jittery
Clinical narrative: CHILLS/ SHIVERING; FATIGUE; JITTERY; SHAKY; LOW  BLOOD SUGAR; MUSCLE CRAMPS  LIKE MENSTRUAL CRAMPS/ MUSCLE  CRAMPS CONSTANTLY ACHING; FEVER; EXTREME MUSCLE PAIN; VOMITING; NAUSEOUS/ NOT JUST  NAUSEA WANTED TO THROW UP AND  DID; This spontaneous report received from a patient concerned a 51 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 allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JANSSEN1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced nauseous/ not just nausea wanted to throw up and did. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced jittery. On 10-MAR-2021, the subject experienced shaky. On 10-MAR-2021, the subject experienced low blood sugar. On 10-MAR-2021, the subject experienced muscle cramps like menstrual cramps/ muscle cramps constantly aching. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced extreme muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.9. On an unspecified date, the subject experienced chills/ shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous/ not just nausea wanted to throw up and did, fatigue, jittery, shaky, low blood sugar, muscle cramps like menstrual cramps/ muscle cramps constantly aching, fever, and extreme muscle pain, and the outcome of chills/ shivering was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: CHILLS/ SHIVERING; FATIGUE; JITTERY; SHAKY; LOW  BLOOD SUGAR; MUSCLE CRAMPS  LIKE MENSTRUAL CRAMPS/ MUSCLE  CRAMPS CONSTANTLY ACHING; FEVER; EXTREME MUSCLE PAIN; VOMITING; NAUSEOUS/ NOT JUST  NAUSEA WANTED TO THROW UP AND  DID; This spontaneous report received from a patient concerned a 51 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 allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JANSSEN1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced nauseous/ not just nausea wanted to throw up and did. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced jittery. On 10-MAR-2021, the subject experienced shaky. On 10-MAR-2021, the subject experienced low blood sugar. On 10-MAR-2021, the subject experienced muscle cramps like menstrual cramps/ muscle cramps constantly aching. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced extreme muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.9. On an unspecified date, the subject experienced chills/ shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous/ not just nausea wanted to throw up and did, fatigue, jittery, shaky, low blood sugar, muscle cramps like menstrual cramps/ muscle cramps constantly aching, fever, and extreme muscle pain, and the outcome of chills/ shivering was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: CHILLS/ SHIVERING; FATIGUE; JITTERY; SHAKY; LOW  BLOOD SUGAR; MUSCLE CRAMPS  LIKE MENSTRUAL CRAMPS/ MUSCLE  CRAMPS CONSTANTLY ACHING; FEVER; EXTREME MUSCLE PAIN; VOMITING; NAUSEOUS/ NOT JUST  NAUSEA WANTED TO THROW UP AND  DID; This spontaneous report received from a patient concerned a 51 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 allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JANSSEN1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced nauseous/ not just nausea wanted to throw up and did. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced jittery. On 10-MAR-2021, the subject experienced shaky. On 10-MAR-2021, the subject experienced low blood sugar. On 10-MAR-2021, the subject experienced muscle cramps like menstrual cramps/ muscle cramps constantly aching. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced extreme muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.9. On an unspecified date, the subject experienced chills/ shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous/ not just nausea wanted to throw up and did, fatigue, jittery, shaky, low blood sugar, muscle cramps like menstrual cramps/ muscle cramps constantly aching, fever, and extreme muscle pain, and the outcome of chills/ shivering was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Nausea, Pain
Clinical narrative: BRUISING ON LEFT SIDE OF STOMACH, RIGHT SIDE OF CHEST, ON BACK, FOREHEAD ABOVE RIGHT EYE AND ON RIGHT WRIST; CHILLS; ACHY AND SORE TO TOUCH AREAS; NAUSEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cholesterol elevated, overweight, alcohol use, and nonsmoker, and other pre-existing medical conditions included patient had 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 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 08-MAR-2021, the subject experienced achy and sore to touch areas. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021 01:00, the subject experienced chills. On 09-MAR-2021, the subject experienced bruising on left side of stomach, right side of chest, on back, forehead above right eye and on right wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 09-MAR-2021, and nausea on 08-MAR-2021, and had not recovered from achy and sore to touch areas, and bruising on left side of stomach, right side of chest, on back, forehead above right eye and on right wrist. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: ASTHMA; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced asthma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asthma was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Ocular hyperaemia
Clinical narrative: TIREDNESS/TIRED; HEADACHES; CHILLS; RUNNY NOSE; RED EYE IN BOTH; COUGH; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced runny nose. On 08-MAR-2021, the subject experienced red eye in both. On 08-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced tiredness/tired. On 09-MAR-2021, the subject experienced headaches. On 09-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 09-MAR-2021, was recovering from headaches, and had not recovered from runny nose, cough, red eye in both, and tiredness/tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: TIREDNESS/TIRED; HEADACHES; CHILLS; RUNNY NOSE; RED EYE IN BOTH; COUGH; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced runny nose. On 08-MAR-2021, the subject experienced red eye in both. On 08-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced tiredness/tired. On 09-MAR-2021, the subject experienced headaches. On 09-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 09-MAR-2021, was recovering from headaches, and had not recovered from runny nose, cough, red eye in both, and tiredness/tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: CHILLS; BODY ACHES; SORE INJECTION SITE; 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 past medical history included supraventricular tachycardia (svt), and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, once a total administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced sore injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, and sore injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Movement disorder
Clinical narrative: TIREDNESS; HEADACHE; LEG DRAGGING; UNABLE TO MOVE; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been request.  No concomitant medications were reported. On an unspecified date, the patient experienced tiredness, headache, leg dragging, and unable to move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, headache, leg dragging, and unable to move. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Product administration error, Restlessness
Clinical narrative: ACHING JOINTS; RESTLESSNESS; SOLUTION DRIPPING DOWN ARM DURING ADMINISTRATION OF VACCINE; LOCALISED SORENESS AT INJECTION SITE; 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: Unkown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced aching joints. On 09-MAR-2021, the subject experienced restlessness. On 09-MAR-2021, the subject experienced solution dripping down arm during administration of vaccine. On 09-MAR-2021, the subject experienced localised soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aching joints, restlessness, solution dripping down arm during administration of vaccine and localised soreness at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: NAUSEA; FATIGUE/ TIREDNESS; CHILLS; SWEATING; HEADACHE; FELT MISERABLE; FEVER; ACHING BONES; This spontaneous report received from a patient via a company representative concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 06-MAR-2021 09:30 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 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.6 F. On 06-MAR-2021, treatment medications included: paracetamol. On 06-MAR-2021 17:00, the subject experienced aching bones. On 06-MAR-2021 18:30, the subject experienced fever. On 06-MAR-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 100.3 F. On 06-MAR-2021 22:00, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced felt miserable. On 06-MAR-2021 22:00, the subject experienced chills. On 06-MAR-2021 22:00, the subject experienced sweating. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 07-MAR-2021 04:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 07-MAR-2021 09:00, the subject experienced nausea. On 07-MAR-2021 09:00, the subject experienced fatigue/ tiredness. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, aching bones, felt miserable, fever, nausea, and fatigue/ tiredness on 08-MAR-2021, and chills, and sweating. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: NAUSEA; FATIGUE/ TIREDNESS; CHILLS; SWEATING; HEADACHE; FELT MISERABLE; FEVER; ACHING BONES; This spontaneous report received from a patient via a company representative concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 06-MAR-2021 09:30 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 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.6 F. On 06-MAR-2021, treatment medications included: paracetamol. On 06-MAR-2021 17:00, the subject experienced aching bones. On 06-MAR-2021 18:30, the subject experienced fever. On 06-MAR-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 100.3 F. On 06-MAR-2021 22:00, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced felt miserable. On 06-MAR-2021 22:00, the subject experienced chills. On 06-MAR-2021 22:00, the subject experienced sweating. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 07-MAR-2021 04:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 07-MAR-2021 09:00, the subject experienced nausea. On 07-MAR-2021 09:00, the subject experienced fatigue/ tiredness. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, aching bones, felt miserable, fever, nausea, and fatigue/ tiredness on 08-MAR-2021, and chills, and sweating. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER (101 F TEMPERATURE); BODY PAIN; HEADACHE; 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, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever (101 f temperature). On 09-MAR-2021, the subject experienced body pain. On 09-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body pain, and headache on MAR-2021, and the outcome of fever (101 f temperature) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: ELEVATED HEART RATE; 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, intramuscular and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced elevated heart rate. Laboratory data included: Heart rate (NR: not provided) under 100 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate on 09-MAR-2021. 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: Eye swelling, Tearfulness
Clinical narrative: PATIENT WAS TEARING; SWOLLEN EYES, WORSE LEFT EYE; 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included hydroxyzine. On 07-MAR-2021, the subject experienced swollen eyes, worse left eye. On an unspecified date, the subject experienced subject was tearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen eyes, worse left eye, and the outcome of patient was tearing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site pain, Rotator cuff syndrome, Ultrasound scan
Clinical narrative: TORN ROTATOR CUFF; VERY PAINFUL NEAR INJECTION SITE; BLACK AND BLUE AREA TO THE TIP OF THE SHOULDER; 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, intramuscular, batch number: Unknown, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced black and blue area to the tip of the shoulder. On 09-MAR-2021, the subject experienced very painful near injection site. On 10-MAR-2021, Laboratory data included: Sonogram (NR: not provided) NEGATIVE (units unspecified). On an unspecified date, the subject experienced torn rotator cuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very painful near injection site, and black and blue area to the tip of the shoulder, and the outcome of torn rotator cuff was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: SINUS HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was prone to sinus headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sinus headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus headache was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: CHILLS; ACHING BODY; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced aching body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and aching body was not reported. 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: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; 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: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2020, Laboratory data included: Body temperature (NR: not provided) 100.2 UNITS UNSPECIFIED. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced headache. On 10-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 headache, body aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: MYALGIA/MUSCLE PAIN; FEVER; NAUSEA; FATIGUE; INJECTION SITE PAIN; INJECTION SITE ITCHING; CHILLS; HEADACHE; BODY ACHE; This spontaneous report received from a patient via a company representative concerned a 35 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced injection site itching, myalgia/muscle pain, fever, nausea, fatigue, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, and fatigue, and the outcome of myalgia/muscle pain, chills, fever, injection site pain, injection site itching and body ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: MYALGIA/MUSCLE PAIN; FEVER; NAUSEA; FATIGUE; INJECTION SITE PAIN; INJECTION SITE ITCHING; CHILLS; HEADACHE; BODY ACHE; This spontaneous report received from a patient via a company representative concerned a 35 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced injection site itching, myalgia/muscle pain, fever, nausea, fatigue, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, and fatigue, and the outcome of myalgia/muscle pain, chills, fever, injection site pain, injection site itching and body ache was not reported. This report was non-serious.