chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced serious reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious reaction was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: BODY ACHES IN LEGS; FULL BLOWN CHILLS/FREEZING; 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, expiry: 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 body aches in legs, and full blown chills/freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches in legs and full blown chills/freezing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Dysgeusia, Dyspnoea
Clinical narrative: EVERYTHING TASTES LIKE DIRT; COUGH; NAUSEA; BODY ACHES; SHORTNESS OF BREATH; LIGHTHEADED; JOINT PAIN; ARM PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included respiratory syncytial virus, and concurrent conditions included irritable bowel syndrome, fibromyalgia, osteoarthritis, osteoporosis, kidney tumor, duct closures in liver, penicillin allergy, Sulfonamide allergy, abstain from alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination in right arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced lightheaded. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced arm pain. On 14-MAR-2021, the subject experienced everything tastes like dirt. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from body aches, nausea, lightheaded, everything tastes like dirt, cough, and arm pain, and the outcome of joint pain was not reported. This report was non-serious.  Additional information was received from patient on 16-MAR-2021. the following information was updated and incorporated into the case narrative: Patient information (date of birth, age, age group, race and ethnicity) added, patient medical history was added, New events everything tastes like dirt,cough,body aches were added.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: EVERYTHING TASTES LIKE DIRT; COUGH; NAUSEA; BODY ACHES; SHORTNESS OF BREATH; LIGHTHEADED; JOINT PAIN; ARM PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included respiratory syncytial virus, and concurrent conditions included irritable bowel syndrome, fibromyalgia, osteoarthritis, osteoporosis, kidney tumor, duct closures in liver, penicillin allergy, Sulfonamide allergy, abstain from alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination in right arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced lightheaded. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced arm pain. On 14-MAR-2021, the subject experienced everything tastes like dirt. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from body aches, nausea, lightheaded, everything tastes like dirt, cough, and arm pain, and the outcome of joint pain was not reported. This report was non-serious.  Additional information was received from patient on 16-MAR-2021. the following information was updated and incorporated into the case narrative: Patient information (date of birth, age, age group, race and ethnicity) added, patient medical history was added, New events everything tastes like dirt,cough,body aches were added.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Stress
Clinical narrative: DIFFICULT TO BREATHE; STRESS; 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 04-MAR-2021 02:00 for prophylactic vaccination. he batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 04-MAR-2021, the subject experienced difficult to breathe. On 04-MAR-2021, the subject experienced stress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficult to breathe, and stress. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case is assessed as Non-serious. .
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: DIZZINESS; WEAKNESS; SEVERE HEADACHES; EXTREME FATIGUE; 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 high blood pressure, chronic sinusitus, and allergic to sulfa septra. 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 09-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced extreme fatigue. On 09-MAR-2021, the subject experienced severe headaches. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headaches, dizziness, and weakness, and the outcome of extreme fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Myalgia, Oedema peripheral, Pain
Clinical narrative: BRUISING ON RIGHT THIGH; SWOLLEN RIGHT THIGH; TENDER RIGHT THIGH; BODY ACHES, PAIN; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots in the neck. 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. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches, pain. On 08-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced bruising on right thigh. On 13-MAR-2021, the subject experienced swollen right thigh. On 13-MAR-2021, the subject experienced tender right thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, pain, and chills on MAR-2021, and the outcome of bruising on right thigh, swollen right thigh and tender right thigh was not reported. This report was non-serious.; Sender's Comments: MAC not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A DROP WENT ON THE PATIENT'S ARM AND IS CONCERNED  THE FULL DOSE WAS NOT ADMINISTERED.; This spontaneous report received from a pharmacist 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. No concomitant medications were reported. On 12-MAR-2021, the subject experienced a drop went on the subject's arm and is concerned the full dose was not administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a drop went on the patient's arm and is concerned the full dose was not administered. was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Possible extra 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced possible extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible extra dose administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: ALLERGIC TO VACCINE; 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 09-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 allergic to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to vaccine was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: REDNESS AT INJECTION SITE; LUMP AT INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non drug allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: 14-MAR-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced redness at injection site. On 11-MAR-2021, the subject experienced lump at injection site. On 11-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, redness at injection site, and lump at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Electrocardiogram, Heart rate abnormal
Clinical narrative: DIZZINESS; NOT ABLE TO SLEEP OVER NIGHT; HEART RATE WAS FLUCTUATING HIGH AND LOW; HIGH BLOOD PRESSURE; MIGRAINE AND SEVERE HEADACHE; FEVER; CHILLS; THROAT FEELS SORE; NECK FEELS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not had any history of blood pressure or heart rate issues. 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 to left arm 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 fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced throat feels sore. On MAR-2021, the subject experienced neck feels sore. Laboratory data included: ECG (NR: not provided) Normal. On 13-MAR-2021, the subject experienced heart rate was fluctuating high and low. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced migraine and severe headache. Laboratory data included: Blood pressure (NR: not provided) 141/ 93. On 14-MAR-2021, the subject experienced dizziness. On 14-MAR-2021, the subject experienced not able to sleep over night. Laboratory data included: Heart rate high (NR: not provided) 112. Treatment medications (dates unspecified) included: amitriptyline, erenumab, and ketorolac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, heart rate was fluctuating high and low, high blood pressure, throat feels sore, neck feels sore, dizziness, migraine and severe headache and not able to sleep over night was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Insomnia, Migraine, Neck pain
Clinical narrative: DIZZINESS; NOT ABLE TO SLEEP OVER NIGHT; HEART RATE WAS FLUCTUATING HIGH AND LOW; HIGH BLOOD PRESSURE; MIGRAINE AND SEVERE HEADACHE; FEVER; CHILLS; THROAT FEELS SORE; NECK FEELS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not had any history of blood pressure or heart rate issues. 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 to left arm 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 fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced throat feels sore. On MAR-2021, the subject experienced neck feels sore. Laboratory data included: ECG (NR: not provided) Normal. On 13-MAR-2021, the subject experienced heart rate was fluctuating high and low. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced migraine and severe headache. Laboratory data included: Blood pressure (NR: not provided) 141/ 93. On 14-MAR-2021, the subject experienced dizziness. On 14-MAR-2021, the subject experienced not able to sleep over night. Laboratory data included: Heart rate high (NR: not provided) 112. Treatment medications (dates unspecified) included: amitriptyline, erenumab, and ketorolac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, heart rate was fluctuating high and low, high blood pressure, throat feels sore, neck feels sore, dizziness, migraine and severe headache and not able to sleep over night was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: DIZZINESS; NOT ABLE TO SLEEP OVER NIGHT; HEART RATE WAS FLUCTUATING HIGH AND LOW; HIGH BLOOD PRESSURE; MIGRAINE AND SEVERE HEADACHE; FEVER; CHILLS; THROAT FEELS SORE; NECK FEELS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not had any history of blood pressure or heart rate issues. 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 to left arm 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 fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced throat feels sore. On MAR-2021, the subject experienced neck feels sore. Laboratory data included: ECG (NR: not provided) Normal. On 13-MAR-2021, the subject experienced heart rate was fluctuating high and low. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced migraine and severe headache. Laboratory data included: Blood pressure (NR: not provided) 141/ 93. On 14-MAR-2021, the subject experienced dizziness. On 14-MAR-2021, the subject experienced not able to sleep over night. Laboratory data included: Heart rate high (NR: not provided) 112. Treatment medications (dates unspecified) included: amitriptyline, erenumab, and ketorolac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, heart rate was fluctuating high and low, high blood pressure, throat feels sore, neck feels sore, dizziness, migraine and severe headache and not able to sleep over night was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZY; This spontaneous report received from a patient and 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 not reported, once a total administered, start therapy date was 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 MAR-2021, the patient experienced dizzy. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of dizzy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site mass
Clinical narrative: GOLF BALL SIZE PUFFED UP AREA WHERE THE INJECTION WAS; CHILLS; 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 was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced golf ball size puffed up area where the injection was, chills, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The outcome of the golf ball size puffed up area where the injection was, chills and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM WAS A LITTLE TENDER; 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) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm was a little tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm was a little tender was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Erythema, Feeling hot, Injection site reaction
Clinical narrative: REDNESS; WARMTH; SORENESS; ARM SWELING; FEVER; INJECTION SITE REACTION; EXPLOSIVE DIARRHEA; 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 on left arm, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced explosive diarrhea. On 13-MAR-2021, the subject experienced injection site reaction. On 14-MAR-2021, the subject experienced redness. On 14-MAR-2021, the subject experienced warmth. On 14-MAR-2021, the subject experienced soreness. On 14-MAR-2021, the subject experienced arm swelling. On 14-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from explosive diarrhea on 13-MAR-2021, and fever on 15-MAR-2021, had not recovered from arm swelling, redness, warmth, and soreness, and the outcome of injection site reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: REDNESS; WARMTH; SORENESS; ARM SWELING; FEVER; INJECTION SITE REACTION; EXPLOSIVE DIARRHEA; 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 on left arm, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced explosive diarrhea. On 13-MAR-2021, the subject experienced injection site reaction. On 14-MAR-2021, the subject experienced redness. On 14-MAR-2021, the subject experienced warmth. On 14-MAR-2021, the subject experienced soreness. On 14-MAR-2021, the subject experienced arm swelling. On 14-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from explosive diarrhea on 13-MAR-2021, and fever on 15-MAR-2021, had not recovered from arm swelling, redness, warmth, and soreness, and the outcome of injection site reaction was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: WEAK; TIRED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced weak. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weak, and tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle tightness, Neck pain
Clinical narrative: NECK PAIN; SWELLING OF LYMPH NODES ON LEFT  SIDE OF FACE UNDERNEATH EAR  NEAR JAW LINE; LITTLE BIT OF TENSION ON NECK; 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced little bit of tension on neck. On 13-MAR-2021, the subject experienced neck pain. On 13-MAR-2021, the subject experienced swelling of lymph nodes on left side of face underneath ear near jaw line. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, swelling of lymph nodes on left side of face underneath ear near jaw line and little bit of tension on neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a vaccine facility 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. 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS LASTED 24 HOURS; 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 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 MAR-2021, the subject experienced side effects lasted 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects lasted 24 hours on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT HEADED; 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, once a total administered on 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 light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light headed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; HEAD ACHE; FEVER LIKE SYMPTOMS; 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 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 MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced head ache. On MAR-2021, the subject experienced fever like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head ache, chills and fever like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210328755.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: JOINT PAIN; CHILLS; FEVER; FATIGUE; 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, and batch number were 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 14-MAR-2021, the subject experienced joint pain. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, fatigue and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: SORE ARM; ARM A LITTLE BRUISE; 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 sore arm, and arm a little bruise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm a little bruise and sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report received from a health care professional 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 batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test, Dizziness, Headache, Malaise, Nausea
Clinical narrative: ACHES; DIZZINESS; MALAISE; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) positive. On MAR-2021, the subject experienced aches. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced malaise. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, malaise, low grade fever, nausea, dizziness and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; DIZZINESS; MALAISE; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) positive. On MAR-2021, the subject experienced aches. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced malaise. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, malaise, low grade fever, nausea, dizziness and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: SEVERE BODY ACHE; JOINT PAIN; ARM PAIN; FEVER; NAUSEA; SEVERE HEADACHE; SEVERE FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 17:15, the subject experienced chills. On 12-MAR-2021 20:00, the subject experienced severe body ache. On 12-MAR-2021 20:00, the subject experienced joint pain. On 12-MAR-2021 20:00, the subject experienced arm pain. On 12-MAR-2021 20:00, the subject experienced fever. On 12-MAR-2021 20:00, the subject experienced nausea. On 12-MAR-2021 20:00, the subject experienced severe headache. On 12-MAR-2021 20:00, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. On 13-MAR-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body ache, and chills on 13-MAR-2021 19:30, and joint pain, arm pain, nausea, and severe fatigue on 12-MAR-2021 20:00, and was recovering from fever, and severe headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: SEVERE BODY ACHE; JOINT PAIN; ARM PAIN; FEVER; NAUSEA; SEVERE HEADACHE; SEVERE FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 17:15, the subject experienced chills. On 12-MAR-2021 20:00, the subject experienced severe body ache. On 12-MAR-2021 20:00, the subject experienced joint pain. On 12-MAR-2021 20:00, the subject experienced arm pain. On 12-MAR-2021 20:00, the subject experienced fever. On 12-MAR-2021 20:00, the subject experienced nausea. On 12-MAR-2021 20:00, the subject experienced severe headache. On 12-MAR-2021 20:00, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. On 13-MAR-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body ache, and chills on 13-MAR-2021 19:30, and joint pain, arm pain, nausea, and severe fatigue on 12-MAR-2021 20:00, and was recovering from fever, and severe headache. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: HEADACHE; DIZZY; MIGRAINE; MILD NAUSEA; CHILL; TIRED; SHIVERING; VERY WARM; SWEATING; COLD; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient experienced migraines and more rarely resulted in vomiting under normal circumstances. 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 15:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced shivering. On 12-MAR-2021, the subject experienced very warm. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021 19:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, shivering, very warm, sweating, cold, dizzy, migraine, chill, mild nausea, and headache. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Migraine, Nasopharyngitis, Nausea
Clinical narrative: HEADACHE; DIZZY; MIGRAINE; MILD NAUSEA; CHILL; TIRED; SHIVERING; VERY WARM; SWEATING; COLD; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient experienced migraines and more rarely resulted in vomiting under normal circumstances. 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 15:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced shivering. On 12-MAR-2021, the subject experienced very warm. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021 19:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, shivering, very warm, sweating, cold, dizzy, migraine, chill, mild nausea, and headache. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Feeling hot
Clinical narrative: HEADACHE; DIZZY; MIGRAINE; MILD NAUSEA; CHILL; TIRED; SHIVERING; VERY WARM; SWEATING; COLD; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient experienced migraines and more rarely resulted in vomiting under normal circumstances. 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 15:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced shivering. On 12-MAR-2021, the subject experienced very warm. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021 19:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, shivering, very warm, sweating, cold, dizzy, migraine, chill, mild nausea, and headache. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Migraine, Nausea
Clinical narrative: HEADACHE; DIZZY; MIGRAINE; MILD NAUSEA; CHILL; TIRED; SHIVERING; VERY WARM; SWEATING; COLD; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient experienced migraines and more rarely resulted in vomiting under normal circumstances. 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 15:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced shivering. On 12-MAR-2021, the subject experienced very warm. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced mild nausea. On 13-MAR-2021 19:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, shivering, very warm, sweating, cold, dizzy, migraine, chill, mild nausea, and headache. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Headache
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: Hyperhidrosis, Migraine, Nasopharyngitis, 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.