chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram ST-T change, Heart rate, Magnetic resonance imaging heart
Clinical narrative: ACUTE MYOCARDITIS; This spontaneous report was received from literature: Myocarditis Temporally Associated with COVID-19 Vaccination. Rosner et al.: Myocarditis after COVID-19 Vaccination. This report concerned a 28 year old male. The patient's height, and weight were not reported. The patient had no history of prior covid19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, 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 (3-7 days post vaccination), the patient was hospitalized for acute myocarditis-like illness. The patient also experienced acute onset chest pain and biochemical evidence of myocardial injury, by cardiac troponin I. The patient was hemodynamically stable and had no pericardial friction rub or rash. Electrocardiogram (ECG) patterns varied from normal to ST segment elevation. Echocardiograms showed left ventricular ejection fraction (LVEF) ranging from 35% to 62% with 5/7 having some degree of hypokinesis. The patient hospitalized for 2 days and symptoms resolved by hospital discharge. Treatment medication included beta-blocker, unspecified anti-inflammatory medication, aspirin, angiotensin converting Enzyme-Inhibitor(ACE-I) and clopidogrel (2 doses, stopped on discharge). Laboratory data (dates unspecified) included: ANA (NR: not provided) Negative, Blood pressure (NR: not provided) 145/82 mmHg, Body temperature (NR: not provided) 37 C, C-reactive protein (NR: not provided) 1.3 mg/dL, Cardiac MRI (NR: not provided) LVEF-50% (no regional wall motion abnormalities), Cardiac troponin I (NR: not provided) mean peak = 15.77ng/mL, median peak = 12.01ng/mL, Chest X-ray (NR: not provided) No acute pulmonary disease, Coronary angiograph (NR: not provided) No evidence of CAD, Echocardiogram (NR: not provided) LVEF-50%, LVIDd-4.8cm, IVS-1.0cm, RWMA-Mild global HKN, Electrocardiogram ST-T change (NR: not provided) 1mm ST elevation in II, V5-V6, Erythrocyte sedimentation rate (NR: not provided) 8 mm/h, Heart rate (NR: not provided) 70 bpm, PCR (NR: not provided) Negative, Respiratory viral panel (NR: not provided) Testing not obtained, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and WBC (NR: not provided) 8.08 (unit not reported).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute myocarditis. This case was reported to the vaccine adverse event reporting system (VAERS) and the CDC. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210650174- covid-19 vaccine ad26.cov2.s-Acute Myocarditis, . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I, White blood cell count
Clinical narrative: ACUTE MYOCARDITIS; This spontaneous report was received from literature: Myocarditis Temporally Associated with COVID-19 Vaccination. Rosner et al.: Myocarditis after COVID-19 Vaccination. This report concerned a 28 year old male. The patient's height, and weight were not reported. The patient had no history of prior covid19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, 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 (3-7 days post vaccination), the patient was hospitalized for acute myocarditis-like illness. The patient also experienced acute onset chest pain and biochemical evidence of myocardial injury, by cardiac troponin I. The patient was hemodynamically stable and had no pericardial friction rub or rash. Electrocardiogram (ECG) patterns varied from normal to ST segment elevation. Echocardiograms showed left ventricular ejection fraction (LVEF) ranging from 35% to 62% with 5/7 having some degree of hypokinesis. The patient hospitalized for 2 days and symptoms resolved by hospital discharge. Treatment medication included beta-blocker, unspecified anti-inflammatory medication, aspirin, angiotensin converting Enzyme-Inhibitor(ACE-I) and clopidogrel (2 doses, stopped on discharge). Laboratory data (dates unspecified) included: ANA (NR: not provided) Negative, Blood pressure (NR: not provided) 145/82 mmHg, Body temperature (NR: not provided) 37 C, C-reactive protein (NR: not provided) 1.3 mg/dL, Cardiac MRI (NR: not provided) LVEF-50% (no regional wall motion abnormalities), Cardiac troponin I (NR: not provided) mean peak = 15.77ng/mL, median peak = 12.01ng/mL, Chest X-ray (NR: not provided) No acute pulmonary disease, Coronary angiograph (NR: not provided) No evidence of CAD, Echocardiogram (NR: not provided) LVEF-50%, LVIDd-4.8cm, IVS-1.0cm, RWMA-Mild global HKN, Electrocardiogram ST-T change (NR: not provided) 1mm ST elevation in II, V5-V6, Erythrocyte sedimentation rate (NR: not provided) 8 mm/h, Heart rate (NR: not provided) 70 bpm, PCR (NR: not provided) Negative, Respiratory viral panel (NR: not provided) Testing not obtained, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and WBC (NR: not provided) 8.08 (unit not reported).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute myocarditis. This case was reported to the vaccine adverse event reporting system (VAERS) and the CDC. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210650174- covid-19 vaccine ad26.cov2.s-Acute Myocarditis, . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oropharyngeal pain, Pain, Sinus congestion
Clinical narrative: SINUS CONGESTION; BODY ACHES; SORE THROAT; COUGHING; TIREDNESS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, administered on 31-MAR-2021 20:00 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced tiredness. On 22-JUN-2021, the subject experienced sinus congestion. On 22-JUN-2021, the subject experienced body aches. On 22-JUN-2021, the subject experienced sore throat. On 22-JUN-2021, the subject experienced coughing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 02-APR-2021, and had not recovered from sinus congestion, body aches, sore throat, and coughing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Sciatica
Clinical narrative: SCIATICA PAIN (BACK AND LEG PAIN, CAN'T WALK AND STAND); CAN'T SLEEP WITHOUT PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sciatica pain (back and leg pain, can't walk and stand), and can't sleep without pain. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sciatica pain (back and leg pain, can't walk and stand), and can't sleep without pain. 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF VACCINE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS FOR POSSIBLY HUNDREDS; This spontaneous report received from a pharmacist concerned multiple patients of unspecified age and sex. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, the patients experienced administration of vaccine outside of recommended storage conditions for possibly hundreds. The patients were vaccinated with punctured vials that had been left at room temperature for over 2 hours. It was reported that, this involves hundreds of patients dating from as early as 15-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine outside of recommended storage conditions for possibly hundreds was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210653950- Covid-19 vaccine ad26.cov2.s- Administration of vaccine outside of recommended storage conditions for possibly hundreds. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: COUGH; SORE THROAT; RUNNY NOSE; MUSCLE PAIN; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced cough. On 19-JUN-2021, the subject experienced sore throat. On 19-JUN-2021, the subject experienced runny nose. On 19-JUN-2021, the subject experienced muscle pain. On 19-JUN-2021, the subject experienced severe headache. On 20-JUN-2021, treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, fexofenadine, ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, cough, sore throat, runny nose, and muscle pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: EXTREME HEADACHE; EXTREME NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age  The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 an unspecified date, the subject experienced extreme headache, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme headache and extreme nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: PERSISTING BODYACHE; PERSISTING FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Body temperature (NR: not provided) 98.5F to 101F. On 20-JUN-2021, the subject experienced persisting bodyache. On 20-JUN-2021, the subject experienced persisting fever. On 20-JUN-2021, the subject experienced headache. On 24-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from persisting fever, and persisting bodyache. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: FLARE UP ON HIS LOWER BACK/SEVERE LOWER BACK PAIN,LEFT LUMBAR SIDE; LEGS HURTING; FELT QUITE TIRED; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 85 kilograms, and height was 186 centimeters. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 201A21A, expiry: 07-AUG-2021) dose was not reported, administered on 22-JUN-2021 15:14 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced flare up on his lower back/severe lower back pain, left lumbar side. On 23-JUN-2021, the subject experienced legs hurting. On 23-JUN-2021, the subject experienced felt quite tired. Treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare up on his lower back/severe lower back pain, left lumbar side, felt quite tired, and legs hurting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: RASH (IN CREASES OF HIS ARM, BUTTOCK AND GROIN AREA); MILD FEVER; BODY ACHES (SORENESS); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced body aches (soreness). On 22-JUN-2021, the subject experienced mild fever. On 23-JUN-2021, the subject experienced rash (in creases of his arm, buttock and groin area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash (in creases of his arm, buttock and groin area), and the outcome of mild fever and body aches (soreness) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Myocardial infarction
Clinical narrative: SEVERAL HEART ATTACKS; FREEZING ALL THE TIME; This spontaneous report received from a patient via a company representative concerned an adult male in late thirties to forties. The patient's height was given as average and weight was not reported. The patient was average to slight build. The patient was a healthy person previously with no significant medical conditions or 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, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Three days after receiving the vaccine, the patient had several heart attacks. The patient had stents placed and was given medicine to thin the blood and since then was freezing all of the time. The patient seemed angry. The patient definitely attributed his experience to the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the several heart attacks and freezing all the time was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660367- covid-19 vaccine ad26.cov2.s-Several Heart attacks. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES TO THE NECK, BILATERALLY; JOINT AND MUSCLE PAIN; LOW ENERGY; MORE TIRED THAN USUAL; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mixed connective tissue disease, lupus, latex allergy, and sulphate allergy, and other pre-existing medical conditions included patient had allergies to sulphate. The patient experienced drug allergy when treated with levofloxacin, omeprazole, and omeprazole for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced swollen lymph nodes to the neck, bilaterally. On 06-JUN-2021, the subject experienced joint and muscle pain. On 06-JUN-2021, the subject experienced low energy. On 06-JUN-2021, the subject experienced more tired than usual. On 06-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low energy, joint and muscle pain, more tired than usual, headache, and swollen lymph nodes to the neck, bilaterally. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; 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 difficulty in hearing, and difficulty in communication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2068219, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 23-JUN-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE 30 MINS AFTER EXPIRATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 administration of expired vaccine 30 mins after expiration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine 30 mins after expiration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: LITTLE PAIN IN BODY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-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 APR-2021, the subject experienced little pain in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain in body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Headache, Muscle spasms, Paraesthesia
Clinical narrative: TINGLING ALL OVER BODY; CHEST PAINS; MUSCLE SPASMS; WEIRD HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 07-APR-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 APR-2021, the subject experienced tingling all over body. On APR-2021, the subject experienced chest pains. On APR-2021, the subject experienced muscle spasms. On APR-2021, the subject experienced weird headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling all over body, weird headaches, chest pains, and muscle spasms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Somnolence
Clinical narrative: SLEEPINESS; STOMACH HURTS; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 710127, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced sleepiness. On 26-JUN-2021, the subject experienced stomach hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepiness, and stomach hurts. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeling cold, Pyrexia
Clinical narrative: COUGHING; FREEZING; FEVER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included liver transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A2IA, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUN-2021 09:00, the subject experienced coughing. On 25-JUN-2021 09:00, the subject experienced freezing. On 25-JUN-2021 09:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 97.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, coughing, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION OF 4 UNPUNCTURED VIALS AT 19.4 DEGREES FOR PERIOD OF 2 HOURS; 8 DOSES GIVEN FROM THOSE INCORRECTLY STORED VIALS; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced 8 doses given from those incorrectly stored vials. On 03-JUN-2021, the subject experienced temperature excursion of 4 unpunctured vials at 19.4 degrees for period of 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of 4 unpunctured vials at 19.4 degrees for period of 2 hours and 8 doses given from those incorrectly stored vials was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Chills, Headache
Clinical narrative: PAIN IN LOWER BACK; CHILLS; FEVER; HEADACHE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, no any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced pain in lower back. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced nausea. On 25-JUN-2021, the subject experienced overall weakness. Laboratory data included: Body temperature (NR: not provided) 102.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, nausea, chills, pain in lower back, and overall weakness. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: PAIN IN LOWER BACK; CHILLS; FEVER; HEADACHE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, no any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced pain in lower back. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced nausea. On 25-JUN-2021, the subject experienced overall weakness. Laboratory data included: Body temperature (NR: not provided) 102.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, nausea, chills, pain in lower back, and overall weakness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability, Insomnia, Sciatica
Clinical narrative: CAN NOT WALK; CAN NOT STAND; CAN NOT SLEEP; SCIATICA; This spontaneous report received from a patient via a company representative . 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 APR-2021 for prophylactic vaccination.Batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced sciatica. On JUN-2021, the subject experienced can not walk. On JUN-2021, the subject experienced can not stand. On JUN-2021, the subject experienced can not sleep. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not walk, can not stand, can not sleep, and sciatica. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 01-AUG-2021) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced partial dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Neck pain, Periorbital pain
Clinical narrative: NECK PAIN; OCCASIONAL BACK PAIN; PAIN AROUND LEFT EYE; PAIN IN MUSCLE FROM NECK TO SHOULDER WHILE TURNING HEAD TO LEFT AND RIGHT (MORE TO THE RIGHT); This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced occasional back pain. On APR-2021, the subject experienced pain around left eye. On APR-2021, the subject experienced pain in muscle from neck to shoulder while turning head to left and right (more to the right). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, occasional back pain, pain around left eye and pain in muscle from neck to shoulder while turning head to left and right (more to the right) was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue, Nausea
Clinical narrative: LOOSE BOWEL MOVEMENTS; UPSET STOMACH; ACHY; TIRED; FEVER; NAUSEA; WEAKNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced loose bowel movements. On 18-JUN-2021, the subject experienced upset stomach. On 18-JUN-2021, the subject experienced achy. On 18-JUN-2021, the subject experienced tired. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced nausea. On 18-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, achy, fever, nausea, upset stomach, and weakness, and the outcome of loose bowel movements was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LOOSE BOWEL MOVEMENTS; UPSET STOMACH; ACHY; TIRED; FEVER; NAUSEA; WEAKNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced loose bowel movements. On 18-JUN-2021, the subject experienced upset stomach. On 18-JUN-2021, the subject experienced achy. On 18-JUN-2021, the subject experienced tired. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced nausea. On 18-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, achy, fever, nausea, upset stomach, and weakness, and the outcome of loose bowel movements was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: SOME CHILLS; SLIGHT FEVER; EXHAUSTED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced some chills, slight fever, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, some chills and exhausted was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity, Rash, Tenderness
Clinical narrative: Cellulitis; right wrist area started swelling; painful to touch; Tender; bit of a rash; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OEDEMA PERIPHERAL (right wrist area started swelling), PAIN IN EXTREMITY (painful to touch), TENDERNESS (Tender) and RASH (bit of a rash). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), OEDEMA PERIPHERAL (right wrist area started swelling), PAIN IN EXTREMITY (painful to touch), TENDERNESS (Tender) and RASH (bit of a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment information was not provided. For event of Cellulitis, the reporter assessed causality as not related. For events, right wrist area started swelling, painful to touch, tender and bit of rash, the reporter did not provide any causality assessments.  Company Comment  Based on reporter's causality of recent hospitalization for the event of cellulitis in the non-vaccinated upper limb, is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Turns out it was cellulitis from a recent hospital visit and not related to the vaccine at all.; Sender's Comments: Based on reporter's causality of recent hospitalization for the event of cellulitis in the non-vaccinated upper limb, is assessed as unlikely related to mRNA-1273.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Chills, Physiotherapy
Clinical narrative: had COVID-19 in October; had a stroke; has been receiving therapy, physical therapy; Chills/it throw him in a hard loop of chills.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Stroke in 2020. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills/it throw him in a hard loop of chills.). On an unknown date, the patient experienced COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant) and PHYSIOTHERAPY (has been receiving therapy, physical therapy). On 26-Jan-2021, CHILLS (Chills/it throw him in a hard loop of chills.) had resolved. At the time of the report, COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) and PHYSIOTHERAPY (has been receiving therapy, physical therapy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Headache, Myalgia
Clinical narrative: covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (seven and half years ago).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (covid) (seriousness criterion hospitalization). The patient was hospitalized for 24 days due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid), COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.3 °F (High) 100.3°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant products included blood pressure medicine (unspecified).  Reportedly, the patient had COVID five days after the first shot of vaccine. The patient had to stay three and a half weeks in hospital that destroyed her immune system and she said that it was coming back after medications.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Case upgraded to serious, includes- serious event of covid-19 (hospitalization) and historical condition of cancer and had chemotherapy.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (seven and half years ago).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (covid) (seriousness criterion hospitalization). The patient was hospitalized for 24 days due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid), COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.3 °F (High) 100.3°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant products included blood pressure medicine (unspecified).  Reportedly, the patient had COVID five days after the first shot of vaccine. The patient had to stay three and a half weeks in hospital that destroyed her immune system and she said that it was coming back after medications.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Case upgraded to serious, includes- serious event of covid-19 (hospitalization) and historical condition of cancer and had chemotherapy.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Pneumonia, SARS-CoV-2 test
Clinical narrative: Pneumonia; Did not get second dose within 36 days; Tested positive for COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after 1st dose). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose within 36 days). At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 after 1st dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose within 36 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Based on the mechanism of action of mRNA-1273, a causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. The COVID-19 infection could be a possible confounding factor for the event of Pneumonia. Very limited information regarding the pneumonia event  and hospitalization have been provided. No further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-Jun-2021 and had significant information. Updated event Pneumonia.Case Upgraded to serious.; Sender's Comments: Based on the mechanism of action of mRNA-1273, a causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. The COVID-19 infection could be a possible confounding factor for the event of Pneumonia. Very limited information regarding the pneumonia event  and hospitalization have been provided. No further information is expected.