chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; 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: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611858, 20210612779 and 20210614876.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Injection site rash, Pyrexia, Toothache
Clinical narrative: TEETH PAIN; JAW-LINE ON FIRE; RING-WORM LIKE RASH AROUND INJECTION SITE; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever  (genetic variant). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUN-2021, the subject experienced ring-worm like rash around injection site. On 06-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced severe headache. On 07-JUN-2021, the subject experienced teeth pain. On 07-JUN-2021, the subject experienced jaw-line on fire. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, severe headache, ring-worm like rash around injection site, jaw-line on fire and teeth pain was not reported. This report was non-serious.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Respiratory tract congestion
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; CHILLS; TIRED; CHEST CONGESTION; This spontaneous report received from a patient concerned a 41 year old of unspecified 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, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced chest congestion. On 29-MAY-2021, the subject experienced chills. On 29-MAY-2021, the subject experienced tired. On 05-JUN-2021, the subject experienced loss of taste. On 05-JUN-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, chills, and chest congestion, and had not recovered from loss of taste and loss of smell. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF PUNCTURED VIAL VACCINE STORED AT UNKNOWN AMOUNT OF TIME AT REFRIGERATED TEMPERATURE, NOT IN ORIGINAL PACKAGING; DOSE PREVIOUSLY LEFT IN THE REFRIGERATOR WITH NO INDICATION ON THE VIAL HOW LONG IT HAD BEEN STORED THAT WAY; This spontaneous report received from a pharmacist 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: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced administration of punctured vial vaccine stored at unknown amount of time at refrigerated temperature, not in original packaging. On 05-JUN-2021, the subject experienced dose previously left in the refrigerator with no indication on the vial how long it had been stored that way. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of punctured vial vaccine stored at unknown amount of time at refrigerated temperature, not in original packaging and dose previously left in the refrigerator with no indication on the vial how long it had been stored that way was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Tinnitus
Clinical narrative: TINNITUS STOPPED( HAD COMPLETELY DISAPPEARED FOR MORE THAN 04 DAYS); TINNITUS RECURRENCE (GRADUALLY RETURNING FROM PAST WEEK); This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. The patient's concurrent conditions included neurological disabilities, and tinnitus. 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. Concomitant medications included vilazodone hydrochloride for neurological disabilities.  On an unspecified date, the subject experienced tinnitus stopped ( had completely disappeared for more than 04 days), and tinnitus recurrence (gradually returning from past week). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from tinnitus stopped( had completely disappeared for more than 04 days), and the outcome of tinnitus recurrence (gradually returning from past week) was not reported. This report was non-serious.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a physician concerned a 12 year old of unspecified 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 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced off label use. On 08-JUN-2021, the subject experienced drug administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Miliaria, Platelet count, Platelet count decreased, Sinusitis
Clinical narrative: PLATELETS WERE REALLY LOW DOWN TO 6; COUGHING SPOTTY BLOOD/COUGHED UP A MOUTH FULL OF BLOOD; SINUS INFECTION; BUNCH OF RED LITTLE DOTS ALL OVER BODY/WORSE ON RIGHT LEG/LIKE HEAT RASH; This spontaneous report received from a patient concerned a 61-year-old white and not Hispanic or Latino 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: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced bunch of red little dots all over body which was worse on right leg like a heat rash. On 29-MAY-2021, patient thought he had sinus infection and started coughing spotty blood and then coughed up a mouth full of blood on 30-MAY-2021, went to emergency room because he was still coughing out blood. Patient's doctor found that patient's platelets were really low down to 6. Patient's doctor gave him bunch of steroid and platelets. Patient was hospitalized on 30-MAY-2021 and discharged on 01-Jun-2021 and was given a steroid 40 mg a day.  The patient recovered from coughing spotty blood/coughed up a mouth full of blood on 01-JUN-2021, and sinus infection, recovered with sequelae from platelets were really low down to 6 on 01-JUN-2021, and was recovering from bunch of red little dots all over body/worse on right leg/like heat rash. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210616684- JANSSEN COVID-19 VACCINE-Coughing spotty blood , platelet were really low below 6. 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).
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; TEMPERATURE EXCURSION (INCORRECT STORAGE OF DRUG); This spontaneous report received from a physician 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: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced poor quality vaccine administered. On 07-JUN-2021, the subject experienced temperature excursion (incorrect storage of drug). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and temperature excursion (incorrect storage of drug) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210616693 and 20210617020.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Migraine, Thrombosis
Clinical narrative: THROMBOSIS OF THE CLOT; INCREASED FREQUENCY OF MIGRAINES/VERTIGO; STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and concurrent conditions included lupus antiphospholipid syndrome, and migraine. 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 APR-2021, 1 total dose for prophylactic vaccination. Concomitant medications included Xarelto (rivaroxaban) for lupus antiphospholipid syndrome.  On APR-2021, the patient developed thrombosis of the clot and increased frequency of migraines/vertigo (over the past month or two). On 04-JUN-2021 (3 night ago), she was diagnosed with stroke. Later, she underwent procedure for thrombosis of the clot and she was stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and thrombosis of the clot, and the outcome of increased frequency of migraines/vertigo was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210617520-covid-19 vaccine ad26.cov2.s-Stroke, Thrombosis Of The Clot. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial septal defect, COVID-19, Cerebral artery occlusion, Cerebrovascular accident, Chills
Clinical narrative: THROMBOSIS OF THE CLOT; INCREASED FREQUENCY OF MIGRAINES/VERTIGO; STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and concurrent conditions included lupus antiphospholipid syndrome, and migraine. 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 APR-2021, 1 total dose for prophylactic vaccination. Concomitant medications included Xarelto (rivaroxaban) for lupus antiphospholipid syndrome.  On APR-2021, the patient developed thrombosis of the clot and increased frequency of migraines/vertigo (over the past month or two). On 04-JUN-2021 (3 night ago), she was diagnosed with stroke. Later, she underwent procedure for thrombosis of the clot and she was stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and thrombosis of the clot, and the outcome of increased frequency of migraines/vertigo was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210617520-covid-19 vaccine ad26.cov2.s-Stroke, Thrombosis Of The Clot. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test positive, Thrombectomy
Clinical narrative: THROMBOSIS OF THE CLOT; INCREASED FREQUENCY OF MIGRAINES/VERTIGO; STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and concurrent conditions included lupus antiphospholipid syndrome, and migraine. 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 APR-2021, 1 total dose for prophylactic vaccination. Concomitant medications included Xarelto (rivaroxaban) for lupus antiphospholipid syndrome.  On APR-2021, the patient developed thrombosis of the clot and increased frequency of migraines/vertigo (over the past month or two). On 04-JUN-2021 (3 night ago), she was diagnosed with stroke. Later, she underwent procedure for thrombosis of the clot and she was stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and thrombosis of the clot, and the outcome of increased frequency of migraines/vertigo was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210617520-covid-19 vaccine ad26.cov2.s-Stroke, Thrombosis Of The Clot. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Pyrexia
Clinical narrative: HEAVY HEAD; FEVER; 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: 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 heavy head, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever and heavy head was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: PAIN DOWN  LEFT SIDE OF BODY FROM NECK TO WAIST; PAIN LOCALISED; PAIN ON LEFT UPPER ARM WHERE RECEIVED VACCINE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced pain down left side of body from neck to waist, pain localised, and pain on left upper arm where received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain down left side of body from neck to waist, pain localised, and pain on left upper arm where received vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: LIGHT HEADEDNESS; DIZZINESS; BLURRED VISION; NAUSEA; FATIGUES; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 239 pounds, and height was 66 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced light headedness. On 09-JUN-2021, the subject experienced dizziness. On 09-JUN-2021, the subject experienced blurred vision. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fatigues. On 09-JUN-2021, the subject experienced muscle aches. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, light headedness, dizziness, blurred vision, fatigues, muscle aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: LIGHT HEADEDNESS; DIZZINESS; BLURRED VISION; NAUSEA; FATIGUES; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 239 pounds, and height was 66 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced light headedness. On 09-JUN-2021, the subject experienced dizziness. On 09-JUN-2021, the subject experienced blurred vision. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fatigues. On 09-JUN-2021, the subject experienced muscle aches. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, light headedness, dizziness, blurred vision, fatigues, muscle aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: LIGHT HEADEDNESS; DIZZINESS; BLURRED VISION; NAUSEA; FATIGUES; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 239 pounds, and height was 66 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced light headedness. On 09-JUN-2021, the subject experienced dizziness. On 09-JUN-2021, the subject experienced blurred vision. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fatigues. On 09-JUN-2021, the subject experienced muscle aches. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, light headedness, dizziness, blurred vision, fatigues, muscle aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: LIGHT HEADEDNESS; DIZZINESS; BLURRED VISION; NAUSEA; FATIGUES; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 239 pounds, and height was 66 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced light headedness. On 09-JUN-2021, the subject experienced dizziness. On 09-JUN-2021, the subject experienced blurred vision. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fatigues. On 09-JUN-2021, the subject experienced muscle aches. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, light headedness, dizziness, blurred vision, fatigues, muscle aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Vision blurred, Vomiting
Clinical narrative: LIGHT HEADEDNESS; DIZZINESS; BLURRED VISION; NAUSEA; FATIGUES; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 239 pounds, and height was 66 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced light headedness. On 09-JUN-2021, the subject experienced dizziness. On 09-JUN-2021, the subject experienced blurred vision. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fatigues. On 09-JUN-2021, the subject experienced muscle aches. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, light headedness, dizziness, blurred vision, fatigues, muscle aches, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AT THE RANGE FROM 1.6 TO 2.0 CELSIUS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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, and batch number: 1808980 expiry: 22-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced vaccine administered at the range from 1.6 to 2.0 celsius. On 09-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered at the range from 1.6 to 2.0 celsius and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210620305.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: SLEEPINESS; SORE ARM; TIREDNESS; 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: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced sore arm. On 24-MAR-2021, the subject experienced sleepiness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, sleepiness, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210619315, 20210619408 and 20210619407.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pyrexia
Clinical narrative: COULDN'T SLEEP; CHILLS; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 08-JUN-2021, the subject experienced couldn't sleep. On 08-JUN-2021, the subject experienced chills. On 08-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and couldn't sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: NO RAYNAUD'S SYMPTOMS IN HANDS SINCE VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud's symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) 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 no raynaud's symptoms in hands since vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no raynaud's symptoms in hands since vaccination was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Vision blurred
Clinical narrative: BLURRED VISION IN AND OUT; WEAKNESS ALL OVER; PAIN ON BOTH HANDS; BODY IS DRAINED; SUPER BAD HEADACHE; This spontaneous report received from a patient concerned a 52 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, batch number: Unknown) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced blurred vision in and out. On 08-JUN-2021, the subject experienced weakness all over. On 08-JUN-2021, the subject experienced pain on both hands. On 08-JUN-2021, the subject experienced body is drained. On 08-JUN-2021, the subject experienced super bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super bad headache, blurred vision in and out, weakness all over, body is drained and pain on both hands was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: COMA; 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date (after vaccination), the patient had 22 days of coma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of coma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210619921-Covid-19 vaccine ad26.cov2.s-COMA. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; 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: 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 adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from adverse event nos. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Prostatic operation
Clinical narrative: surgery on prostate; clotting issues; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PROSTATIC OPERATION (surgery on prostate) in a male 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.     Concurrent medical conditions included Blood disorder NOS.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROSTATIC OPERATION (surgery on prostate) (seriousness criterion hospitalization) and COAGULOPATHY (clotting issues). At the time of the report, PROSTATIC OPERATION (surgery on prostate) and COAGULOPATHY (clotting issues) outcome was unknown.            Reportedly, as of 16-MAR-2021 the patient was in the hospital for a surgery on his prostate. The reporter stated that he has been having clotting issues since the surgery.  Based on current available information and the temporal association between product use and the start date of the events the Company believes a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events the Company believes a causal relationship is unlikely.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disabled child and Epilepsy.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant). At the time of the report, SEIZURE (Seizures) outcome was unknown.            The patient's seizures have been under control at the time of report. Concomitant product use was not reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the previous history of epilepsy is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the previous history of epilepsy is a confounder.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary infarction, X-ray
Clinical narrative: Pulmonary infarction; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY INFARCTION (Pulmonary infarction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY INFARCTION (Pulmonary infarction) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY INFARCTION (Pulmonary infarction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: (abnormal) revealed he had more than 100 blood clots in his lungs..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized with a pulmonary infarction and had lost permanently about a quarter of his lung. Discharged and was in stable condition.  Company comment  Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthiritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthiritis flare up) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthiritis flare up) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Rheumatoid arthritis flare up, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthiritis flare up) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Very limited information regarding this event has been provided at this time. No further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Concomitant drug was changed as the treatment drug.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pneumonia, Viral titre decreased
Clinical narrative: pneumonia; less than 60 of titer in blood; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONIA (pneumonia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and VIRAL TITRE DECREASED (less than 60 of titer in blood). At the time of the report, PNEUMONIA (pneumonia) and VIRAL TITRE DECREASED (less than 60 of titer in blood) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. On unknown date an antibody test performed and showed less than 60 of titers in blood after Covid vaccine shots.  Very limited information regarding these events has been provided at this time. No further information is expected.   This case was linked to MOD-2021-198113 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome
Clinical narrative: Face paralyzed; Guillain barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Face paralyzed) and GUILLAIN-BARRE SYNDROME (Guillain barre syndrome) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Face paralyzed) (seriousness criterion medically significant) and GUILLAIN-BARRE SYNDROME (Guillain barre syndrome) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Face paralyzed) and GUILLAIN-BARRE SYNDROME (Guillain barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment for the events were not provided. The caller stated he knows another person who had his face paralyzed due to Guillain barre syndrome 2 weeks after the shot.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Myalgia, Pneumonia
Clinical narrative: Pneumonia; cough; headache; chills; fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia and Fibromyalgia. Concomitant products included DULOXETINE, METHOCARBAMOL, AMITRIPTYLINE and GABAPENTIN for Fibromyalgia, VERAPAMIL and GLUCAGON for Hypoglycemia.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On 21-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Pneumonia, at a dose of 1 dosage form. On 19-Apr-2021, COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. On 30-Apr-2021, PNEUMONIA (Pneumonia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The other concomitant medication provided by the reporter was Rescue inhaler, Epi pen and Air duo Inhaler. It was reported that the consumer took allergy shot about 1.5 weeks after receiving the first dose. Treatment medication provided was antibiotics.  Company comment: 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.   This case was linked to MOD-2021-200079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Non-significant Follow up appended for AE Doc Attachment.; Sender's Comments: 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pneumonia; cough; headache; chills; fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia and Fibromyalgia. Concomitant products included DULOXETINE, METHOCARBAMOL, AMITRIPTYLINE and GABAPENTIN for Fibromyalgia, VERAPAMIL and GLUCAGON for Hypoglycemia.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On 21-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Pneumonia, at a dose of 1 dosage form. On 19-Apr-2021, COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. On 30-Apr-2021, PNEUMONIA (Pneumonia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The other concomitant medication provided by the reporter was Rescue inhaler, Epi pen and Air duo Inhaler. It was reported that the consumer took allergy shot about 1.5 weeks after receiving the first dose. Treatment medication provided was antibiotics.  Company comment: 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.   This case was linked to MOD-2021-200079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Non-significant Follow up appended for AE Doc Attachment.; Sender's Comments: 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.