chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Ophthalmological examination, Pain in extremity, Pyrexia, Thirst
Clinical narrative: EYE PAIN; SEVERE HEADACHE; FEVER; FEELING THIRSTY; FELT MASSIVE PAIN RADIATING IN BODY AND PAIN IN LEGS AND ARMS; BLURRY VISION AND WHITE CLOUD OVER EYES; FELT LIKE LOSING SIGHT; 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 non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did have no known drug allergies and no known health conditions and not on any medications. 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: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like losing sight. On 2021, the subject experienced blurry vision and white cloud over eyes. On 2021, the subject experienced felt massive pain radiating in body and pain in legs and arms. Laboratory data included: CAT scan (NR: not provided) couldn't diagnose, Electrocardiogram (NR: not provided) couldn't diagnose, Eye exam (NR: not provided) couldn't diagnose, Lab test (NR: not provided) didn't see any blockage and couldn't figure out, and MRI (NR: not provided) couldn't diagnose. On 08-MAR-2021, the subject experienced feeling thirsty. On 09-MAR-2021, the subject experienced eye pain. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: macrogol 400/propylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye pain, blurry vision and white cloud over eyes, and felt massive pain radiating in body and pain in legs and arms, and the outcome of feeling thirsty, severe headache, fever and felt like losing sight was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: EYE PAIN; SEVERE HEADACHE; FEVER; FEELING THIRSTY; FELT MASSIVE PAIN RADIATING IN BODY AND PAIN IN LEGS AND ARMS; BLURRY VISION AND WHITE CLOUD OVER EYES; FELT LIKE LOSING SIGHT; 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 non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did have no known drug allergies and no known health conditions and not on any medications. 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: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like losing sight. On 2021, the subject experienced blurry vision and white cloud over eyes. On 2021, the subject experienced felt massive pain radiating in body and pain in legs and arms. Laboratory data included: CAT scan (NR: not provided) couldn't diagnose, Electrocardiogram (NR: not provided) couldn't diagnose, Eye exam (NR: not provided) couldn't diagnose, Lab test (NR: not provided) didn't see any blockage and couldn't figure out, and MRI (NR: not provided) couldn't diagnose. On 08-MAR-2021, the subject experienced feeling thirsty. On 09-MAR-2021, the subject experienced eye pain. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: macrogol 400/propylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye pain, blurry vision and white cloud over eyes, and felt massive pain radiating in body and pain in legs and arms, and the outcome of feeling thirsty, severe headache, fever and felt like losing sight was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: VACCINE LEFT OUT OVER NIGHT ABOUT 12 HOURS BEFORE ADMINISTRATION; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-MAY-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 03-MAY-2021, the subject experienced left out over night about 12 hours. On 03-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and left out over night about 12 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210512313.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Echocardiogram, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: SEVERE PAIN ON LEFT LEG; SEVERE FATIGUE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and non smoker, and other pre-existing medical conditions included no known allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for high blood pressure. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 14-APR-2021, the subject experienced severe pain on left leg. Laboratory data included: Diagnostic ultrasound (NR: not provided) negative, and Echocardiogram (NR: not provided) negative. Treatment medications (dates unspecified) included: menthol/methyl salicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain on left leg, severe fatigue, and flu like symptoms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: SEVERE PAIN ON LEFT LEG; SEVERE FATIGUE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and non smoker, and other pre-existing medical conditions included no known allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for high blood pressure. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 14-APR-2021, the subject experienced severe pain on left leg. Laboratory data included: Diagnostic ultrasound (NR: not provided) negative, and Echocardiogram (NR: not provided) negative. Treatment medications (dates unspecified) included: menthol/methyl salicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain on left leg, severe fatigue, and flu like symptoms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tongue discomfort
Clinical narrative: TONGUE PROBLEMS-BURNS; LIGHT HEADED NOW AND THEN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 tongue problems- burns, and light headed now and then. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tongue problems-burns and light headed now and then was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia oral, Therapeutic response unexpected
Clinical narrative: TINGLING IN LIPS; LIPS GOT WARM; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included cold sores. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unexpected therapeutic benefit. On 08-APR-2021, the subject experienced tingling in lips. On 08-APR-2021, the subject experienced lips got warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, and the outcome of lips got warm and unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: BLURRED VISION; HEADACHE; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, back pain, anxiety, non alcohol user, and non smoker. The patient experienced drug allergy when treated with morphine, and tetracycline.  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 07-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone hydrochloride/paracetamol for back pain.  On 08-MAY-2021, the subject experienced blurred vision. On 08-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: LEGS SWELLING/ SWELLING IN CALF MUSCLE; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, atrial fibrillation (afib), non-smoker, and abstains from alcohol, 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced legs swelling/ swelling in calf muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs swelling/ swelling in calf muscle. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mouth haemorrhage
Clinical narrative: BLEEDING IN THE MOUTH; 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 cigarette smoker, and light bleeding in mouth, 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced bleeding in the mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in the mouth. This report was non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: CONSTANT DIZZINESS; WEAKNESS TO THE POINT OF CONCERN; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's past medical history included cardiac arrest, and concurrent conditions included chronic obstructive pulmonary disease, diabetes, high blood pressure, and henoch-schonlein purpura. The patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 19:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weak. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED WITH EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, 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 subject vaccinated with expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient vaccinated with expired product was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: THE VACCINATION SITE WAS WARM TO THE TOUCH; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, thyroid problems, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and not allergic to medication. The patient was not pregnant. 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 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced the vaccination site was warm to the touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site was warm to the touch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Gastric disorder
Clinical narrative: SEVERE STOMACH ISSUES; DIARRHEA; STOMACH CRAMPS; GAS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe stomach issues, diarrhea, stomach cramps, and gas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe stomach issues, diarrhea, stomach cramps and gas was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION (FLU SYMPTOMS); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced confirmed covid-19 infection (flu symptoms). Laboratory data included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection (flu symptoms) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: FLAT RED RASH AREAS ON BOTH ARMS AND ON THE BICEPS; HIVES; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced flat red rash areas on both arms and on the biceps. On 09-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, and chills on MAR-2021, and fever, and had not recovered from hives, and flat red rash areas on both arms and on the biceps. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS FROM TOP OF SHOULDER INTO CHEST ALONG THE COLLAR BONE ON SAME SIDE OF INJECTION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastrointestinal issues, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced numbness from top of shoulder into chest along the collar bone on same side of injection. The action taken with covid-19 vaccine was not applicable. The patient was recovering from numbness from top of shoulder into chest along the collar bone on same side of injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder
Clinical narrative: RED PIN LIKE DOTS UNDER SKIN; 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  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced red pin like dots under skin. The action taken with covid-19 vaccine was not applicable. The outcome of red pin like dots under skin was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MESS ME UP BIG TIME; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced mess me up big time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mess me up big time was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fibrin D dimer, Fibrin D dimer increased, Rash pruritic
Clinical narrative: ELEVATED D DIMER; ITCHY AND UNCOMFORTABLE RASH ( BOTH LEGS AND RIGHT FLANK); This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other pertinent medical history shared. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1805018 and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d dimer, and itchy and uncomfortable rash (both legs and right flank). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets, white blood cells and red blood cells are normal, and Fibrin D dimer (NR: not provided) weakly positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy and uncomfortable rash (both legs and right flank), and the outcome of elevated d dimer was not reported. 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: Gastric disorder, Pain
Clinical narrative: BODY ACHES; STOMACH WOES FLARED; 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 (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. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced stomach woes flared. The action taken with covid-19 vaccine was not applicable. The outcome of the body aches and stomach woes flared was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-2021 18:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: SHOOTING PAIN; PAIN IN LEFT SHOULDER THAT STARTS FROM END OF THE NECK AND GOES ALL THE WAY DOWN TO LEFT ARM AND ELBOW AND COMES BACK AND HARDLY COULD RAISE ARM UP; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included pain, and other pre-existing medical conditions included the patient had experienced something similar to the adverse event in past but that did not last long. The patient was previously treated with ibuprofen for pain.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206AZ1A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shooting pain. On MAY-2021, the subject experienced pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up. On 09-MAY-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up, and shooting pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Endotracheal intubation, Headache
Clinical narrative: BLEEDING IN BRAIN; INTUBATED; SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 45 year old female with unknown race and ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 17-MAR-2021, the patient experienced severe headache and went to the hospital and diagnosed with bleeding in brain. During hospitalization patient was intubated .On 18-Mar-2021,patient died  due to bleeding in brain. Patient was hospitalized for 1 day. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intubated and severe headache was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210517658- covid-19 vaccine ad26.cov2.s-Bleeding in brain, intubated. 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).; Reported Cause(s) of Death: BLEEDING IN BRAIN
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MILD ARM SORENESS THAT GOT SPIKED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: 23/JUN/2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced mild arm soreness that got spiked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm soreness that got spiked on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210518415.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Medication error, Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF EXPIRY SAFETY GUIDELINES; MEDICATION ERROR; VACCINE REMOVED FROM FRIDGE AT 09:40; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history on file with pharmacy. no known drug allergies on file with pharmacy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, expiry: 10-MAY-2021) dose was not reported, administered on 10-MAY-2021 17:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced vaccine administered outside of expiry safety guidelines. On 10-MAY-2021, the subject experienced medication error. On 10-MAY-2021, the subject experienced vaccine removed from fridge at 09:40. On 10-MAY-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of expiry safety guidelines, medication error, vaccine removed from fridge at 09:40 and incorrect storage of drug was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Hypersensitivity, Influenza like illness, Injection site pain
Clinical narrative: TREMENDOUS HEADACHE LIKE MIGRAINE; MILD PAIN IN THE INJECTION SITE; MILD ALLERGY; TIGHTNESS OF CHEST; FLU LIKE SYMPTOMS; THROAT FELT FUNNY; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to dust, and acid reflux. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tightness of chest. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced throat felt funny. On 08-APR-2021, the subject experienced mild pain in the injection site. On 08-APR-2021, the subject experienced mild allergy. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 09-APR-2021 03:00, the subject experienced tremendous headache like migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness of chest, throat felt funny, tremendous headache like migraine, mild pain in the injection site, and mild allergy on APR-2021, and flu like symptoms on 2021. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Oropharyngeal discomfort
Clinical narrative: TREMENDOUS HEADACHE LIKE MIGRAINE; MILD PAIN IN THE INJECTION SITE; MILD ALLERGY; TIGHTNESS OF CHEST; FLU LIKE SYMPTOMS; THROAT FELT FUNNY; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to dust, and acid reflux. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tightness of chest. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced throat felt funny. On 08-APR-2021, the subject experienced mild pain in the injection site. On 08-APR-2021, the subject experienced mild allergy. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 09-APR-2021 03:00, the subject experienced tremendous headache like migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness of chest, throat felt funny, tremendous headache like migraine, mild pain in the injection site, and mild allergy on APR-2021, and flu like symptoms on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE WAS ADMINISTERED TO A 16 YEARS OLD BY ACCIDENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine was administered to a 16 years old by accident, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was administered to a 16 years old by accident was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Chills, Decreased appetite, Headache
Clinical narrative: BLOATING; CRAMPS; CHILLS; FEVER; HEADACHE; LOSS OF APPETITE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcohol, and non smoker, and other pre-existing medical conditions included the patient has no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07/MAY/2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced cramps. On 08-MAY-2021, the subject experienced bloating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache, and had not recovered from abdominal pain, cramps, loss of appetite, and bloating. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: BLOATING; CRAMPS; CHILLS; FEVER; HEADACHE; LOSS OF APPETITE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcohol, and non smoker, and other pre-existing medical conditions included the patient has no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07/MAY/2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced cramps. On 08-MAY-2021, the subject experienced bloating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache, and had not recovered from abdominal pain, cramps, loss of appetite, and bloating. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Migraine, Pain in extremity
Clinical narrative: SEVERE MIGRAINE; LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial venous malformation in brain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: MVX1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg pain. On 14-MAR-2021, the subject experienced severe migraine. Laboratory data included: CT scan (NR: not provided) arterial venous malformation in brain, details of scan unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine, and leg pain. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Multiple allergies, Pain in extremity, Varicose vein
Clinical narrative: ALLERGIES; HEADACHE; GREEN VEIN UNDER ARM; SORE ARM; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced green vein under arm. On 09-MAY-2021, the subject experienced sore arm. Treatment medications included: paracetamol. On 09-MAY-2021 20:00, the subject experienced headache. On 10-MAY-2021, treatment medications included: cetirizine hydrochloride, and paracetamol. On an unspecified date, the subject experienced allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, headache, and green vein under arm, and the outcome of allergies was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: VERTIGO; 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) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination.  The Batch number was not reported and has been requested. Concomitant medications were reported. On 10-MAY-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test, Headache, Pain
Clinical narrative: BODY ACHES; HEADACHES; 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 non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. no medical history or diagnosis was reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced headaches. On 10-MAY-2021, Laboratory data included: Coronavirus test (NR: not provided) pending on results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and body aches. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RED RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. patient had no known medical condition. 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 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021 17:00, the subject experienced red rash all over body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: PAIN UNDER RIBS; FINGERS NUMB ON LEFT HAND; BLOOD PRESSURE 177/79; PAIN UNDER ARM; LEFT ARM HURTING; PAIN FROM SHOULDER TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included losartan. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 177/79 mmHg. On 07-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced pain under ribs. On 10-MAY-2021, the subject experienced fingers numb on left hand. On 10-MAY-2021, the subject experienced blood pressure 177/79. On 10-MAY-2021, the subject experienced pain under arm. On 10-MAY-2021, the subject experienced left arm hurting. On 10-MAY-2021, the subject experienced pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, left arm hurting, pain under ribs, pain from shoulder to elbow, fingers numb on left hand, blood pressure 177/79, and pain under arm. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: PAIN UNDER RIBS; FINGERS NUMB ON LEFT HAND; BLOOD PRESSURE 177/79; PAIN UNDER ARM; LEFT ARM HURTING; PAIN FROM SHOULDER TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included losartan. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 177/79 mmHg. On 07-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced pain under ribs. On 10-MAY-2021, the subject experienced fingers numb on left hand. On 10-MAY-2021, the subject experienced blood pressure 177/79. On 10-MAY-2021, the subject experienced pain under arm. On 10-MAY-2021, the subject experienced left arm hurting. On 10-MAY-2021, the subject experienced pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, left arm hurting, pain under ribs, pain from shoulder to elbow, fingers numb on left hand, blood pressure 177/79, and pain under arm. This report was non-serious.