chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Feeling hot
Clinical narrative: MIGRAINE; MILD NAUSEA; HEADACHE; CHILLS; TIRED; FELT WARM; FELT COLD; DIZZY; SWEATING; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dizzy. On MAR-2021, the subject experienced sweating. On MAR-2021, the subject experienced felt warm. On MAR-2021, the subject experienced felt cold. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felt warm, and felt cold on 13-MAR-2021, and sweating, migraine, chills, tired, mild nausea, and headache. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Migraine, Nausea
Clinical narrative: MIGRAINE; MILD NAUSEA; HEADACHE; CHILLS; TIRED; FELT WARM; FELT COLD; DIZZY; SWEATING; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dizzy. On MAR-2021, the subject experienced sweating. On MAR-2021, the subject experienced felt warm. On MAR-2021, the subject experienced felt cold. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felt warm, and felt cold on 13-MAR-2021, and sweating, migraine, chills, tired, mild nausea, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Pain, Rash pruritic
Clinical narrative: ITCHY RASH ON BOTH ARMS, THIGHS,  CHEST, AND UPPER BACK; 2 ITCHY BUMPS EITHER SIDE OF  INJECTION SITE; HEADACHE; 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 concurrent conditions included pollen allergy. The patient was previously treated with loratadine for pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol. On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced 2 itchy bumps either side of injection site. On 12-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced itchy rash on both arms, thighs, chest, and upper back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 13-MAR-2021, was recovering from 2 itchy bumps either side of injection site, and had not recovered from itchy rash on both arms, thighs, chest, and upper back. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 migraine. The patient was previously treated with acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Dysarthria, Eye pain
Clinical narrative: SWOLLEN EYES; SLURRED SPEECH; SHAKING; COLD; DECREASED MOTOR ABILITY; EYE PAIN; CHILLS; TIREDNESS; FEVER; MILD HEADACHE; LOWER BACK PAIN; This spontaneous report received from a patient 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, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swollen eyes, slurred speech, shaking, cold, decreased motor ability, eye pain, tiredness, fever, chills, mild headache, and lower back pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes, slurred speech, shaking, cold, decreased motor ability, tiredness, fever, chills, mild headache, and lower back pain, and the outcome of eye pain was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Motor dysfunction, Nasopharyngitis
Clinical narrative: SWOLLEN EYES; SLURRED SPEECH; SHAKING; COLD; DECREASED MOTOR ABILITY; EYE PAIN; CHILLS; TIREDNESS; FEVER; MILD HEADACHE; LOWER BACK PAIN; This spontaneous report received from a patient 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, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swollen eyes, slurred speech, shaking, cold, decreased motor ability, eye pain, tiredness, fever, chills, mild headache, and lower back pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes, slurred speech, shaking, cold, decreased motor ability, tiredness, fever, chills, mild headache, and lower back pain, and the outcome of eye pain was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SWOLLEN EYES; SLURRED SPEECH; SHAKING; COLD; DECREASED MOTOR ABILITY; EYE PAIN; CHILLS; TIREDNESS; FEVER; MILD HEADACHE; LOWER BACK PAIN; This spontaneous report received from a patient 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, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swollen eyes, slurred speech, shaking, cold, decreased motor ability, eye pain, tiredness, fever, chills, mild headache, and lower back pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes, slurred speech, shaking, cold, decreased motor ability, tiredness, fever, chills, mild headache, and lower back pain, and the outcome of eye pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough, Fatigue
Clinical narrative: COUGH; BACK ACHE; CHILLS; HIPS ACHE; LEG PAIN; MUSCLE ACHES; NAUSEA; BODY ACHES; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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: 09-MAR-2021) dose was not reported, administered on 09-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced back ache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced hips ache. On MAR-2021, the subject experienced leg pain. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, body aches, nausea, cough, fatigue, chills, hips ache, leg pain and back ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: COUGH; BACK ACHE; CHILLS; HIPS ACHE; LEG PAIN; MUSCLE ACHES; NAUSEA; BODY ACHES; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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: 09-MAR-2021) dose was not reported, administered on 09-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced back ache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced hips ache. On MAR-2021, the subject experienced leg pain. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, body aches, nausea, cough, fatigue, chills, hips ache, leg pain and back ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: STING TO INJECTION SITE; LITTLE SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included tetanus shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOW) dose was not reported, administered on 13-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 sting to injection site. On MAR-2021, the subject experienced little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting to injection site on MAR-2021, and the outcome of little sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS NO JOKE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced side effects no joke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects no joke was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent 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 13-MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Dysphagia, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Mild shortness of breath; mild taste in mouth; mild swallowing difficulty; faster heartbeat; WEAKNESS IN LEGS; feeling of tiredness; This spontaneous report received from a patient concerned a 66 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, route of admin, and batch number were not reported) dose was not reported, 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 mild shortness of breath. On MAR-2021, the subject experienced mild taste in mouth. On MAR-2021, the subject experienced mild swallowing difficulty. On MAR-2021, the subject experienced faster heartbeat. On MAR-2021, the subject experienced weakness in legs. On MAR-2021, the subject experienced feeling of tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild shortness of breath, mild taste in mouth, mild swallowing difficulty, faster heartbeat, weakness in legs, and feeling of tiredness on MAR-2021. This report was non-serious.
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Mild shortness of breath; mild taste in mouth; mild swallowing difficulty; faster heartbeat; WEAKNESS IN LEGS; feeling of tiredness; This spontaneous report received from a patient concerned a 66 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, route of admin, and batch number were not reported) dose was not reported, 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 mild shortness of breath. On MAR-2021, the subject experienced mild taste in mouth. On MAR-2021, the subject experienced mild swallowing difficulty. On MAR-2021, the subject experienced faster heartbeat. On MAR-2021, the subject experienced weakness in legs. On MAR-2021, the subject experienced feeling of tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild shortness of breath, mild taste in mouth, mild swallowing difficulty, faster heartbeat, weakness in legs, and feeling of tiredness on MAR-2021. This report was non-serious.
Age: 66.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Mild shortness of breath; mild taste in mouth; mild swallowing difficulty; faster heartbeat; WEAKNESS IN LEGS; feeling of tiredness; This spontaneous report received from a patient concerned a 66 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, route of admin, and batch number were not reported) dose was not reported, 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 mild shortness of breath. On MAR-2021, the subject experienced mild taste in mouth. On MAR-2021, the subject experienced mild swallowing difficulty. On MAR-2021, the subject experienced faster heartbeat. On MAR-2021, the subject experienced weakness in legs. On MAR-2021, the subject experienced feeling of tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild shortness of breath, mild taste in mouth, mild swallowing difficulty, faster heartbeat, weakness in legs, and feeling of tiredness on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN UNDER THE ARM WHERE THE  VACCINE WAS ADMINISTERED; 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 10-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 11-MAR-2021, the subject experienced pain under the arm where the vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain under the arm where the vaccine was administered. This report was non-serious.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: SORE ARM FOR 30 MINUTES; KNEES ACHED; This spontaneous report received from a patient via a company representative concerned a 75 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, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm for 30 minutes, and knees ached. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for 30 minutes, and the outcome of knees ached 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Pain in extremity
Clinical narrative: This spontaneous report received from a consumer concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease., 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: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 in the right 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 chest pain. On 10-MAR-2021, the subject experienced elevated heart rate. On 10-MAR-2021, the subject experienced occasional shortness of breath. On 10-MAR-2021, the subject experienced soreness throughout legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain, soreness throughout legs and arms, and elevated heart rate, and the outcome of occasional shortness of breath. was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: LITTLE ITCHY BUMP BELOW THE INJECTION SITE; LITTLE ITCHY BUMP BELOW THE INJECTION SITE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced little itchy bump below the injection site, and little itchy bump below the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little itchy bump below the injection site and little itchy bump below the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: FULL BODY RASH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-MAR-2021, the subject experienced full body rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full body rash was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: COULD NOT SLEEP; HEADACHE FOR TWO DAYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced could not sleep, and headache for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache for two days, and the outcome of could not sleep was not reported. This report was non-serious.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: FATIGUE; MUSCLE PAIN; CHILLS; This spontaneous report received from a patient concerned a 70 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue, muscle pain, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, muscle pain, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site nodule
Clinical narrative: HARD KNOT ON LEFT ARM; CHILLS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once total administered on 03-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAR-2021, the subject experienced chills. On 03-MAR-2021, the subject experienced slight headache. On 05-MAR-2021, the subject experienced hard knot on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight headache on 04-MAR-2021, and had not recovered from hard knot on left arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Pyrexia
Clinical narrative: BEDRIDDEN FOR LAST 3 HOURS; WAVES OF CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 bedridden for last 3 hours, waves of chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the waves of chills, fever and bedridden for last 3 hours was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Pyrexia
Clinical narrative: FEVER; SENSITIVITY TO LIGHT; This spontaneous report received from a consumer via a company representative concerned a 5 decade old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced sensitivity to light. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and sensitivity to light was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pyrexia
Clinical narrative: BACK PAIN; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On an unspecified date, the subject experienced back pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Unevaluable event
Clinical narrative: REACTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from reaction. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Vertigo
Clinical narrative: FELT LITTLE TIRED; DIZZINESS; VERTIGO; MILD HEADACHE; chills; This spontaneous report received from a patient concerned a 75 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, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 10:30 for prophylactic vaccination. Batch number was not reported and has been requested, No concomitant medications were reported. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced vertigo. On 13-MAR-2021, the subject experienced mild headache. On 13-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced felt little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and mild headache on 13-MAR-2021, was recovering from dizziness, and the outcome of chills and felt little tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: RAPID HEART PALPITATIONS (PRE VENTRICULAR PALPITATIONS); This spontaneous report received from a health care professional via a company representative concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-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 08-MAR-2021, the subject experienced rapid heart palpitations (pre ventricular palpitations). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart palpitations (pre ventricular palpitations) on 08-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029,  expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: PAINFUL AND BODY ACHE; CHILLS; FEVER; 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: Unk, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced painful and body ache, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the painful and body ache, fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Pain, Pyrexia
Clinical narrative: BODY PAIN; HIGH HEART RATE; 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 random and spontaneous allergy caused, mast cell activation syndrome, postural orthostatic tachycardia, ehlers danlos syndrome, non smoker, and alcohol user, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5, and (NR: not provided) 102.6. On an unspecified date, the subject experienced body pain, and high heart rate. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 90-115. 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 pain, and high heart rate. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: MILD HEADACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the subject experienced mild headache. On 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 MAR-2021, and was recovering from mild headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Expired product administered, Pain, Pyrexia
Clinical narrative: ACHINESS; CHILLS (COLD SWEATS LEADING TO SOAKING WET); HIGH FEVER RANGING FROM 99.7 TO 101.8.; EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 13-MAR-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced expired product administered. On 14-MAR-2021, the subject experienced achiness. On 14-MAR-2021, the subject experienced chills (cold sweats leading to soaking wet). On 14-MAR-2021, the subject experienced high fever ranging from 99.7 to 101.8. Laboratory data included: Body temperature (NR: not provided) 99.7 to 101.8 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever ranging from 99.7 to 101.8., chills (cold sweats leading to soaking wet), achiness and expired product administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORENESS; 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: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and chills was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: RASH ALL OVER FACE ONLY; SLIGHT FEVER; CHILLS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included Asian flu, and concurrent conditions included GERD, high blood pressure, arthritis in hands, gout, tuna fish allergy, allergic to tarte/acidic foods., allergic to bread, and no alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:00 for prophylactic vaccination on left deltoid. Concomitant medications included allopurinol for gout, and atenolol for high blood pressure.  On 12-MAR-2021 21:00, the subject experienced chills. On 12-MAR-2021 21:00, the subject experienced slight fever. On 13-MAR-2021, the subject experienced rash all over face only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight fever on 13-MAR-2021, and had not recovered from rash all over face only. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: ICK FEELING; ARM SORENESS; TIREDNESS; 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: Unk) 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 ick feeling, arm soreness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, tiredness and ick feeling was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Nasopharyngitis, Pruritus, Sinus pain
Clinical narrative: COLD SORES IN NASAL CAVITY; PAINFUL IN NASAL CAVITY; BUTTOCK CHEEK BURNING SENSATION; BUTTOCK CHEEK ITCHING SENSATION; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold sores in nose.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, once a total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced buttock cheek burning sensation. On 05-MAR-2021, the subject experienced buttock cheek itching sensation. On 10-MAR-2021, the subject experienced cold sores in nasal cavity. On 10-MAR-2021, the subject experienced painful in nasal cavity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from buttock cheek burning sensation, and buttock cheek itching sensation on 05-MAR-2021, and had not recovered from cold sores in nasal cavity, and painful in nasal cavity. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; HIGH FEVER DURING THE NIGHT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, once a total 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 flu-like symptoms, and high fever during the night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever during the night and flu-like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: HEADACHE; FEVER; WEAKNESS; SORE ARM; CHILLS; BODY ACHES; 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 09-MAR-2021 for prophylactic vaccination. Unable to follow the reporter hence batch number could not be requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache, fever, weakness, sore arm, chills, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fever, weakness, sore arm, chills, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE; FEVER; WEAKNESS; SORE ARM; CHILLS; BODY ACHES; 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 09-MAR-2021 for prophylactic vaccination. Unable to follow the reporter hence batch number could not be requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache, fever, weakness, sore arm, chills, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fever, weakness, sore arm, chills, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia, Tremor
Clinical narrative: DIZZINESS; SHAKY; CHILLS; HEADACHE; FEVER; 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: 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 dizziness. On 2021, the subject experienced shaky. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, shaky, chills, headache, and fever on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: ACHY; FEELING WEAK; CHILLS; HEADACHE; DISCOMFORT AT SITE OF INJECTION; RAPID HEART BEAT OF 120; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) 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 10-MAR-2021, the subject experienced discomfort at site of injection. On 10-MAR-2021, the subject experienced rapid heart beat of 120. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 120 (units unspecified). On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort at site of injection, rapid heart beat of 120, chills, and headache on 11-MAR-2021, and achy, and feeling weak on MAR-2021. This report was non-serious.