chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Erythema, Eye irritation, Injection site pain
Clinical narrative: BURNING AROUND THE EYES; IRRITATION IN BOTH EYES; BAD RASH AROUND BOTH EYES; ALLERGIC REACTION INCLUDING SNEEZING; ALLERGIC REACTION WITH COLD LIKE SYMPTOMS; ALLERGIC REACTION WITH EYE TEARING; REDNESS AROUND THE NECK; BODY PAINS; CHILLS; FEVER; NAUSEA; LEFT SHOULDER PAIN AT THE SITE OF INJECTION; 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: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body pains. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced left shoulder pain at the site of injection. On 12-MAR-2021, the subject experienced allergic reaction including sneezing. On 12-MAR-2021, the subject experienced allergic reaction with cold like symptoms. On 12-MAR-2021, the subject experienced allergic reaction with eye tearing. On 12-MAR-2021, the subject experienced redness around the neck. On 12-MAR-2021, the subject experienced bad rash around both eyes. On 13-MAR-2021, the subject experienced burning around the eyes. On 13-MAR-2021, the subject experienced irritation in both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction including sneezing, and allergic reaction with cold like symptoms on 14-MAR-2021, and body pains, chills, fever, nausea, and left shoulder pain at the site of injection on 12-MAR-2021, was recovering from redness around the neck, and had not recovered from burning around the eyes, allergic reaction with eye tearing, bad rash around both eyes, and irritation in both eyes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasopharyngitis, Nausea, Pain, Pyrexia
Clinical narrative: BURNING AROUND THE EYES; IRRITATION IN BOTH EYES; BAD RASH AROUND BOTH EYES; ALLERGIC REACTION INCLUDING SNEEZING; ALLERGIC REACTION WITH COLD LIKE SYMPTOMS; ALLERGIC REACTION WITH EYE TEARING; REDNESS AROUND THE NECK; BODY PAINS; CHILLS; FEVER; NAUSEA; LEFT SHOULDER PAIN AT THE SITE OF INJECTION; 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: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body pains. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced left shoulder pain at the site of injection. On 12-MAR-2021, the subject experienced allergic reaction including sneezing. On 12-MAR-2021, the subject experienced allergic reaction with cold like symptoms. On 12-MAR-2021, the subject experienced allergic reaction with eye tearing. On 12-MAR-2021, the subject experienced redness around the neck. On 12-MAR-2021, the subject experienced bad rash around both eyes. On 13-MAR-2021, the subject experienced burning around the eyes. On 13-MAR-2021, the subject experienced irritation in both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction including sneezing, and allergic reaction with cold like symptoms on 14-MAR-2021, and body pains, chills, fever, nausea, and left shoulder pain at the site of injection on 12-MAR-2021, was recovering from redness around the neck, and had not recovered from burning around the eyes, allergic reaction with eye tearing, bad rash around both eyes, and irritation in both eyes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sneezing
Clinical narrative: BURNING AROUND THE EYES; IRRITATION IN BOTH EYES; BAD RASH AROUND BOTH EYES; ALLERGIC REACTION INCLUDING SNEEZING; ALLERGIC REACTION WITH COLD LIKE SYMPTOMS; ALLERGIC REACTION WITH EYE TEARING; REDNESS AROUND THE NECK; BODY PAINS; CHILLS; FEVER; NAUSEA; LEFT SHOULDER PAIN AT THE SITE OF INJECTION; 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: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body pains. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced left shoulder pain at the site of injection. On 12-MAR-2021, the subject experienced allergic reaction including sneezing. On 12-MAR-2021, the subject experienced allergic reaction with cold like symptoms. On 12-MAR-2021, the subject experienced allergic reaction with eye tearing. On 12-MAR-2021, the subject experienced redness around the neck. On 12-MAR-2021, the subject experienced bad rash around both eyes. On 13-MAR-2021, the subject experienced burning around the eyes. On 13-MAR-2021, the subject experienced irritation in both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction including sneezing, and allergic reaction with cold like symptoms on 14-MAR-2021, and body pains, chills, fever, nausea, and left shoulder pain at the site of injection on 12-MAR-2021, was recovering from redness around the neck, and had not recovered from burning around the eyes, allergic reaction with eye tearing, bad rash around both eyes, and irritation in both eyes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Injection site pain, Nasopharyngitis, Nausea
Clinical narrative: COLD; CHEST TIGHTNESS; NAUSEA; FEVER; INJECTION SITE HURT ALOT; REALLY BAD 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, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced chest tightness. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced injection site hurt alot. On MAR-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, fever, chest tightness, injection site hurt alot, really bad headache and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COLD; CHEST TIGHTNESS; NAUSEA; FEVER; INJECTION SITE HURT ALOT; REALLY BAD 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, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced chest tightness. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced injection site hurt alot. On MAR-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, fever, chest tightness, injection site hurt alot, really bad headache and nausea was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Emotional disorder, Headache
Clinical narrative: VERY EMOTIONAL; SEVERE BODY ACHE; ANXIETY; SEVERE CHILLS; JOINT PAIN; HEADACHE; FELT FEVERISH; SLEPT MOST OF THE DAY; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, shoulder and hip issue, and 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: 1805029) dose was not reported, 1 total, administered on 12-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, after midnight the patient had chills and felt feverish. She was very emotional and had body aches, joint pain which was for about three hours. She had slept most of the day next day and had some body aches and headache. She felt better by Sunday 14-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very emotional, severe body ache, anxiety, severe chills, joint pain, headache, felt feverish and slept most of the day on 14-MAR-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache and anxiety as related and between covid-19 vaccine ad26.cov2.s and very emotional, joint pain and slept most of the day as possible. Company causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache, anxiety and slept most of the day was possible. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain, Pyrexia
Clinical narrative: VERY EMOTIONAL; SEVERE BODY ACHE; ANXIETY; SEVERE CHILLS; JOINT PAIN; HEADACHE; FELT FEVERISH; SLEPT MOST OF THE DAY; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, shoulder and hip issue, and 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: 1805029) dose was not reported, 1 total, administered on 12-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, after midnight the patient had chills and felt feverish. She was very emotional and had body aches, joint pain which was for about three hours. She had slept most of the day next day and had some body aches and headache. She felt better by Sunday 14-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very emotional, severe body ache, anxiety, severe chills, joint pain, headache, felt feverish and slept most of the day on 14-MAR-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache and anxiety as related and between covid-19 vaccine ad26.cov2.s and very emotional, joint pain and slept most of the day as possible. Company causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache, anxiety and slept most of the day was possible. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: ENLARGED LYMPH NODE IN ARMPIT, ENLARGED LYMPH NODE NECK; FLU-LIKE SYMPTOMS; This spontaneous report received from a health care professional 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 11-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 11-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced enlarged lymph node in armpit, enlarged lymph node neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 16-MAR-2021, and had not recovered from enlarged lymph node in armpit, enlarged lymph node neck. 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: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: 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 not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ALL OVER CHEST; 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 not reported and is requested) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced rash all over chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers The outcome of rash all over chest was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: BODY ACHES; FATIGUE; INJECTION SITE PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfite allergy, and other pre-existing medical conditions included patient have sulfate codeine allergy. The patient experienced drug allergy when treated with codeine. 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 13-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fatigue, injection site pain, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, injection site pain, headache, and nausea, and the outcome of fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; ACHES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 patients experienced fever, and aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and aches was not reported. This report was non-serious. This case, from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Myalgia
Clinical narrative: HEADACHE; CHILLS; SWEATING; HEART RACING; FELT HOT; MUSCLE PAINS; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced sweating. On 15-MAR-2021, the subject experienced heart racing. On 15-MAR-2021, the subject experienced felt hot. On 15-MAR-2021, the subject experienced muscle pains. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, and muscle pains, and was recovering from headache, chills, sweating, and heart racing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEADACHE; CHILLS; SWEATING; HEART RACING; FELT HOT; MUSCLE PAINS; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced sweating. On 15-MAR-2021, the subject experienced heart racing. On 15-MAR-2021, the subject experienced felt hot. On 15-MAR-2021, the subject experienced muscle pains. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, and muscle pains, and was recovering from headache, chills, sweating, and heart racing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain
Clinical narrative: FEVER; HEADACHE; CHILLS; BODY ACHE; MUSCLE ACHES; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and muscle aches, and the outcome of fever, chills and body ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; HEADACHE; CHILLS; BODY ACHE; MUSCLE ACHES; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and muscle aches, and the outcome of fever, chills and body ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-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 16-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.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a health care professional 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 was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: NAUSEA; DIZZINESS; FEVER; CHILLS; This spontaneous report received from a patient. 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, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced fever. On 12-MAR-2021, the patient experienced chills. On 13-MAR-2021, the patient experienced dizziness. On 14-MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 12-MAR-2021, and had not recovered from dizziness, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Pain in extremity
Clinical narrative: TEMP OF 101; AGRESSIVE CHILLS; ARM SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced temp of 101. On MAR-2021, the subject experienced aggressive chills. On MAR-2021, the subject experienced arm sore. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp of 101, aggressive chills and arm sore was not reported. This report was non-serious. This case, from the same reporter is linked to 20210331319, 20210331262, 20210331104, 20210332072 and 20210331202.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: SLIGHT BODY ACHE; SLIGHT CHILLS; SLIGHT 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 penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced slight body ache. On 14-MAR-2021, the subject experienced slight chills. On 14-MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight body ache, slight chills, and slight headache on 15-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included down syndrome. 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 15-MAR-2021 14:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.4 C, 98.9 C. 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.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Migraine
Clinical narrative: MIGRAINE; LETHARGY; TIRED; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, lethargy, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, tired and lethargy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210331319, 20210331262, 20210331801 and 20210331202. .
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: BODY ACHE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced body ache. On 16-MAR-2021, the subject experienced tiredness. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, tiredness, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; SHORTNESS OF BREATH; VOMITING; NAUSEA; FEVER; CHILLS; JOINT ACHES; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced joint aches. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, joint aches, fever, chills, nausea, shortness of breath, soreness at injection site and vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: SORENESS AT INJECTION SITE; SHORTNESS OF BREATH; VOMITING; NAUSEA; FEVER; CHILLS; JOINT ACHES; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced joint aches. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, joint aches, fever, chills, nausea, shortness of breath, soreness at injection site and vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: MILD BODY ACHES; 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, route of admin not reported, batch number: Unk and expiry: unknown) dose was not reported, administered on 15-MAR-2021 14:15 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced mild body aches. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild body aches, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: BODY ACHE; LEFT SHOULDER PAIN; HEADACHE; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, and left shoulder pain. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: DIZZINESS; ALL OVER BODY ACHE; SORE ARM; HEADACHE; 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 concurrent conditions included unspecified health issues, and other pre-existing medical conditions included the patient had no health history that would relate to the vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, batch number: 1805022, and 1005022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced all over body ache. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, all over body ache, and headache on 17-MAR-2021, and had not recovered from sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; 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: 1805025, and  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 12-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Migraine, Pain
Clinical narrative: MIGRAINE; SEVERE BACK PAIN; SEVERE BODY PAIN; 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 fibromyalgia, obese, obstructive airways, and sleep apnea, 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, and batch number: 180502 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 15:40 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced migraine. On 16-MAR-2021, the subject experienced severe back pain. On 16-MAR-2021, the subject experienced severe body pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, severe back pain, and severe body pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Feeling abnormal, Hypopnoea, Malaise, Myalgia
Clinical narrative: BREATHING SHALLOW; FEELING BAD; FEELING SICK; FEELS SOMETHING IN THE BACK WHEN TAKES A DEEP BREATH; MUSCLE ACHE; NAUSEA; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included stomach ulcers, and concurrent conditions included bad heart condition, and atrial fibrillation.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: not reported ) dose was not reported, administered on 15-MAR-2021 12:30 for prophylactic vaccination. Concomitant medications included apixaban for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 15-MAR-2021, the subject experienced breathing shallow. On 15-MAR-2021, the subject experienced feeling bad. On 15-MAR-2021, the subject experienced feeling sick. On 15-MAR-2021, the subject experienced feels something in the back when takes a deep breath. On 15-MAR-2021, the subject experienced muscle ache. On 15-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling bad, nausea, muscle ache, feeling sick, and breathing shallow, and the outcome of feels something in the back when takes a deep breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: BREATHING SHALLOW; FEELING BAD; FEELING SICK; FEELS SOMETHING IN THE BACK WHEN TAKES A DEEP BREATH; MUSCLE ACHE; NAUSEA; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included stomach ulcers, and concurrent conditions included bad heart condition, and atrial fibrillation.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: not reported ) dose was not reported, administered on 15-MAR-2021 12:30 for prophylactic vaccination. Concomitant medications included apixaban for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 15-MAR-2021, the subject experienced breathing shallow. On 15-MAR-2021, the subject experienced feeling bad. On 15-MAR-2021, the subject experienced feeling sick. On 15-MAR-2021, the subject experienced feels something in the back when takes a deep breath. On 15-MAR-2021, the subject experienced muscle ache. On 15-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling bad, nausea, muscle ache, feeling sick, and breathing shallow, and the outcome of feels something in the back when takes a deep breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SLIGHTLY SORE ARM 10 DAYS AFTER; 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 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 MAR-2021, the subject experienced slightly sore arm 10 days after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slightly sore arm 10 days after was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Heart rate increased, Pyrexia
Clinical narrative: FAST HEART RATE; FACE IS SWOLLEN; FEELING DIZZY; SHAKING UNCONTROLLABLY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced fast heart rate. On MAR-2021, the subject experienced face is swollen. On MAR-2021, the subject experienced feeling dizzy. On MAR-2021, the subject experienced shaking uncontrollably. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face is swollen, fever, headache, feeling dizzy, fast heart rate, chills and shaking uncontrollably was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor
Clinical narrative: FAST HEART RATE; FACE IS SWOLLEN; FEELING DIZZY; SHAKING UNCONTROLLABLY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced fast heart rate. On MAR-2021, the subject experienced face is swollen. On MAR-2021, the subject experienced feeling dizzy. On MAR-2021, the subject experienced shaking uncontrollably. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face is swollen, fever, headache, feeling dizzy, fast heart rate, chills and shaking uncontrollably was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: FREEZING/CHILLS; This spontaneous report received from a consumer concerned a 7 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: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced freezing/chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of freezing/chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 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, route of admin not reported, and batch number: 1803618 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 07:30 to right arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: GETTING CHILLS; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced getting chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the getting chills and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; LOW GRADE FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient medical history was unknown. the patient had no known allergy. 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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced low grade fever. On 17-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, low grade fever, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: VAGINAL ITCHING; DIARRHEA; LIGHT HEADED; CHILLS; FEVER; NAUSEA; HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a 72 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: 1805029 expiry: UNKNOWN) 1 in total, dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced light headed. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced exhaustion. On 14-MAR-2021, the subject experienced vaginal itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaginal itching, headache, fever, chills, diarrhea, nausea, light headed and exhaustion was not reported. This report was non-serious.