chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: FLUKE HEART ATTACK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: Atrial fibrillation (AFIB), and dual ablation, and concurrent conditions included: asthma, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fluke heart attack. The patient also said that he started getting a tickle in the back of the throat which was normal and by monday it did not got worse but he did lost his sense of smell and he got tested which was positive (suspected covid-19 infection and suspected clinical vaccination failure). The patient also stated that he had congestion and cough but never had fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluke heart attack, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000196328. This case, from the same reporter is linked to 20211007486.; Sender's Comments: V0: 20211007273-covid-19 vaccine ad26.cov2.s-fluke heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211007273-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Muscle spasms, Ophthalmic migraine, Tension headache
Clinical narrative: HEAD TENSION; NUMBNESS IN ARMS AND LEGS; OCULAR MIGRAINE; LEG CRAMPS/MUSCLE ACHES IN LEGS; IMMEDIATE PAINFUL REACTION AT INJECTION SITE (PAINFUL INJECTION); This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker. 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 23-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-SEP-2021, the patient experienced immediate painful reaction at injection site (painful injection). On 24-SEP-2021, the patient experienced ocular migraine. On 24-SEP-2021, the patient experienced leg cramps/muscle aches in legs. On 01-OCT-2021, the patient experienced head tension. On 01-OCT-2021, the patient experienced numbness in arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ocular migraine on 24-SEP-2021, leg cramps/muscle aches in legs on 25-SEP-2021, and immediate painful reaction at injection site (painful injection) on 23-SEP-2021, and had not recovered from numbness in arms and legs, and head tension. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: SWEATING; CHEST TIGHTNESS; FATIGUE; JOINT ACHES; NUMBNESS IN BOTH HANDS; EXPLOSIVE DIARRHEA; VERY BAD FLU/FELT VERY SICK ALL DAY/FEVER/DIFFICULTY BREATHING/POUNDING HEADACHE/MUSCLE ACHES/ACHY ALL DAY; FELT WEIRD AND DIFFERENT; GUT STARTED RUMBLING; This spontaneous report received from a patient concerned a 43 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: 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced felt weird and different. On 30-SEP-2021, the patient experienced gut started rumbling. On 30-SEP-2021, the patient experienced very bad flu/felt very sick all day/fever/difficulty breathing/pounding headache/muscle aches/achy all day. On 30-SEP-2021, the patient experienced joint aches. On 30-SEP-2021, the patient experienced numbness in both hands. On 30-SEP-2021, the patient experienced explosive diarrhea. On 01-OCT-2021, the patient experienced fatigue. On an unspecified date, the patient experienced sweating, and chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gut started rumbling, and explosive diarrhea on 30-SEP-2021, joint aches on 02-OCT-2021, and numbness in both hands on 01-OCT-2021, was recovering from felt weird and different, had not recovered from chest tightness, very bad flu/felt very sick all day/fever/difficulty breathing/pounding headache/muscle aches/achy all day, and fatigue, and the outcome of sweating was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Hyperhidrosis, Hypoaesthesia, Influenza like illness
Clinical narrative: SWEATING; CHEST TIGHTNESS; FATIGUE; JOINT ACHES; NUMBNESS IN BOTH HANDS; EXPLOSIVE DIARRHEA; VERY BAD FLU/FELT VERY SICK ALL DAY/FEVER/DIFFICULTY BREATHING/POUNDING HEADACHE/MUSCLE ACHES/ACHY ALL DAY; FELT WEIRD AND DIFFERENT; GUT STARTED RUMBLING; This spontaneous report received from a patient concerned a 43 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: 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced felt weird and different. On 30-SEP-2021, the patient experienced gut started rumbling. On 30-SEP-2021, the patient experienced very bad flu/felt very sick all day/fever/difficulty breathing/pounding headache/muscle aches/achy all day. On 30-SEP-2021, the patient experienced joint aches. On 30-SEP-2021, the patient experienced numbness in both hands. On 30-SEP-2021, the patient experienced explosive diarrhea. On 01-OCT-2021, the patient experienced fatigue. On an unspecified date, the patient experienced sweating, and chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gut started rumbling, and explosive diarrhea on 30-SEP-2021, joint aches on 02-OCT-2021, and numbness in both hands on 01-OCT-2021, was recovering from felt weird and different, had not recovered from chest tightness, very bad flu/felt very sick all day/fever/difficulty breathing/pounding headache/muscle aches/achy all day, and fatigue, and the outcome of sweating was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Expired product administered, Myalgia, Pain in extremity, Syncope
Clinical narrative: FAINTING UPON RECEIPT; EXPIRED VACCINE ADMINISTERED; PERSISTENT CHEST PAIN; LEG PAIN; MUSCLE ACHES; This spontaneous report received from a patient concerned an adult male of unspecified age, race and ethnic origin 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: 21-SEP-2021) dose was not reported, 1 Total administered on 27-SEP-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient was administered expired vaccine and experienced fainting upon receipt. About 3-4 days later on an unspecified date the patient complained of persistent chest pain and leg pain described as muscle aches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered, fainting upon receipt, persistent chest pain, leg pain and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211009169-Covid-19 vaccine ad26.cov2.s- fainting upon receipt. 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). 20211009169-Covid-19 vaccine ad26.cov2.s-expired vaccine administered. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Impaired driving ability, Movement disorder, Muscle spasms, Paraesthesia
Clinical narrative: EXTREME MUSCLE CRAMPS; CAN'T SIT; CAN'T DRIVE; CAN'T GO TO BATHROOM; NEEDLES AND PINS IN THE FEET/LEGS; NEEDLES AND PINS IN THE SHOULDER/GROIN NECK; 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: arthritis, and other pre-existing medical conditions included: Patient was on some type of pain medication. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for arthritis, and gabapentin.  On 01-APR-2021, the patient experienced extreme muscle cramps. On 01-APR-2021, the patient experienced can't sit. On 01-APR-2021, the patient experienced can't drive. On 01-APR-2021, the patient experienced can't go to bathroom. On 01-APR-2021, the patient experienced needles and pins in the feet/legs. On 01-APR-2021, the patient experienced needles and pins in the shoulder/groin neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme muscle cramps, needles and pins in the feet/legs, can't sit, can't drive, can't go to bathroom and needles and pins in the shoulder/groin neck was not reported. This report was non-serious. This case, from the same reporter is linked to 20211009251.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Lethargy
Clinical narrative: VERY TIRED/LETHARGIC FOR NEXT 6-7 HOURS; ACHY; CHILLS; NOT FEELING WELL; LOW GRADE FEVER OF 100F; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 128 pounds, and height was 64 inches. The patient's past medical history included: ulcerative colitis, and concurrent conditions included: immunocompromised, and bactrim allergy/sensitive to sulfa drugs, and other pre-existing medical conditions included: Patient experienced anaphylactic reaction when treated with IV dyes. The patient experienced anaphylactic reaction when treated with promethazine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the patient experienced very tired/lethargic for next 6-7 hours. On 19-MAR-2021, the patient experienced achy. On 19-MAR-2021, the patient experienced chills. On 19-MAR-2021, the patient experienced not feeling well. On 19-MAR-2021, the patient experienced low grade fever of 100f. On 19-MAR-2021, the patient experienced headache. On 19-MAR-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very tired/lethargic for next 6-7 hours, achy, chills, not feeling well, low grade fever of 100f, headache, and fatigue on 21-MAR-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: VERY TIRED/LETHARGIC FOR NEXT 6-7 HOURS; ACHY; CHILLS; NOT FEELING WELL; LOW GRADE FEVER OF 100F; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 128 pounds, and height was 64 inches. The patient's past medical history included: ulcerative colitis, and concurrent conditions included: immunocompromised, and bactrim allergy/sensitive to sulfa drugs, and other pre-existing medical conditions included: Patient experienced anaphylactic reaction when treated with IV dyes. The patient experienced anaphylactic reaction when treated with promethazine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the patient experienced very tired/lethargic for next 6-7 hours. On 19-MAR-2021, the patient experienced achy. On 19-MAR-2021, the patient experienced chills. On 19-MAR-2021, the patient experienced not feeling well. On 19-MAR-2021, the patient experienced low grade fever of 100f. On 19-MAR-2021, the patient experienced headache. On 19-MAR-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very tired/lethargic for next 6-7 hours, achy, chills, not feeling well, low grade fever of 100f, headache, and fatigue on 21-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Tinnitus
Clinical narrative: INFLAMMATION; SEVERE EAR RINGING (TINNITUS); 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, and batch number were not reported) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On JUN-2021, the patient experienced inflammation. On JUN-2021, the patient experienced severe ear ringing (tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe ear ringing (tinnitus), and inflammation. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Influenza like illness, Laboratory test, Tinnitus
Clinical narrative: INFLAMMATION; SEVERE EAR RINGING (TINNITUS); 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, and batch number were not reported) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On JUN-2021, the patient experienced inflammation. On JUN-2021, the patient experienced severe ear ringing (tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe ear ringing (tinnitus), and inflammation. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pneumonia, Pulmonary embolism, Suspected COVID-19, Vaccination failure
Clinical narrative: PULMONARY EMBOLISM; ACUTE RESPIRATORY FAILURE; PNEUMONIA; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a parent concerned a male of unspecified age of unknown race and ethnicity. 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, expiry: Unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in JUN-2021 (in third week of the month), patient received the vaccine because patient was doing shows on ship in the second week of July and had to be vaccinated to do the cruise. On 10-SEP-2021, the patient passed away from a pulmonary embolism and lack of oxygen as per parent but patient's neurologist could not understand why patient died because the rest of organs were functioning well. On 10-SEP-2021, the patient died from pulmonary embolism, acute respiratory failure, pneumonia, and covid-19 (suspected clinical vaccination failure) as per the death certificate. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of pulmonary embolism, acute respiratory failure, pneumonia, suspected covid-19 infection on 10-SEP-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000196332.; Sender's Comments: V0 20211009924-COVID-19 VACCINE AD26.COV2.S-pulmonary embolism, acute respiratory failure, pneumonia, suspected covid-19 infection. 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). V0 20211009924-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: PULMONARY EMBOLISM; ACUTE RESPIRATORY FAILURE; PNEUMONIA; COVID-19
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 58 year old female of unspecified race and ethnicity. 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, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on MAR-2021 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 moderate to severe rheumatoid arthritis. No concomitant medications were reported. On SEP-2021, the patient felt like head cold. On 17 Sep 2021, the patient experienced Covid-19 (suspected covid-19, suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product compliant.; Sender's Comments: V0: 20211010186-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: VACCINE-RELATED BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned multiple patients of unknown ethnicity and race. No past medical history or concurrent conditions were reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 38 people had confirmed cases of the vaccine-related blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine-related blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211009193.; Sender's Comments: V0: 20211010279- Covid-19 vaccine ad26.cov2.s-Vaccine-related blood clot. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry eye, Eye irritation, Eye swelling, Ocular hyperaemia, Vomiting
Clinical narrative: OCCASIONAL EYE DRYNESS; EYES HAVE BEEN ON FIRE AND IRRITATED; EYES ARE RED; EYES ARE PUFFY; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine (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. Non-company suspect drugs included: dupilumab ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced occasional eye dryness, eyes have been on fire and irritated, eyes are red, eyes are puffy, and vomiting. Treatment medications (dates unspecified) included: alclometasone. The action taken with covid-19 vaccine was not applicable; and action taken with dupilumab was not reported. The outcome of the occasional eye dryness, eyes have been on fire and irritated, eyes are red, eyes are puffy and vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, fever, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigued, and the outcome of body aches and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: USE OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced use of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of use of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diplopia, Eye disorder, Fatigue, Lymphadenopathy
Clinical narrative: DOUBLE VISION; BLOOD SHOT EYES; DROOPY EYES; BAD MUSCLE ACHES; BAD CHILLS; FATIGUE; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 100 pounds, and height was 62 inches. The patient's concurrent conditions included: hypertension, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. Patient had taken multivitamin. 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 30-SEP-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included biotin for drug used for unknown indication, and hydrochlorothiazide for hypertension. On 01-OCT-2021, the patient experienced bad chills. On 01-OCT-2021, the patient experienced fatigue. On 01-OCT-2021, the patient experienced swollen lymph nodes. On 05-OCT-2021, the patient experienced blood shot eyes. On 05-OCT-2021, the patient experienced droopy eyes. On 05-OCT-2021, the patient experienced bad muscle aches. On 06-OCT-2021, the patient experienced double vision. Laboratory data (dates unspecified) included: SARS-CoV-2 PCR test (NR: not provided) Unknown, and SARS-CoV-2 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision on 06-OCT-2021, and swollen lymph nodes on 03-OCT-2021, and had not recovered from bad chills, fatigue, bad muscle aches, blood shot eyes, and droopy eyes. This report was non-serious. This case, from the same reporter is linked to 20211011585.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ocular hyperaemia, SARS-CoV-2 test
Clinical narrative: DOUBLE VISION; BLOOD SHOT EYES; DROOPY EYES; BAD MUSCLE ACHES; BAD CHILLS; FATIGUE; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 100 pounds, and height was 62 inches. The patient's concurrent conditions included: hypertension, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. Patient had taken multivitamin. 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 30-SEP-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included biotin for drug used for unknown indication, and hydrochlorothiazide for hypertension. On 01-OCT-2021, the patient experienced bad chills. On 01-OCT-2021, the patient experienced fatigue. On 01-OCT-2021, the patient experienced swollen lymph nodes. On 05-OCT-2021, the patient experienced blood shot eyes. On 05-OCT-2021, the patient experienced droopy eyes. On 05-OCT-2021, the patient experienced bad muscle aches. On 06-OCT-2021, the patient experienced double vision. Laboratory data (dates unspecified) included: SARS-CoV-2 PCR test (NR: not provided) Unknown, and SARS-CoV-2 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision on 06-OCT-2021, and swollen lymph nodes on 03-OCT-2021, and had not recovered from bad chills, fatigue, bad muscle aches, blood shot eyes, and droopy eyes. This report was non-serious. This case, from the same reporter is linked to 20211011585.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tremor, Vomiting, Weight decreased
Clinical narrative: EXCESSIVE SHAKING; WEIGHT LOSS; VOMITING; SEVERE MUSCLE PAIN; This spontaneous report received from a parent via a company representative concerned a 5 decade 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: 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 patient experienced excessive shaking, weight loss, vomiting, and severe muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the excessive shaking, severe muscle pain, weight loss and vomiting was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE TEMPERATURE EXCRUSION FROM 3.1 C TO 0.77 C TO 3.0 C WITHIN 30 MINUTES; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 40 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, and batch number were not reported) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855173.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: FEELING TIRED; BAD MUSCLES ACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-SEP-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 30-SEP-2021, the patient experienced bad muscles aches. On an unspecified date, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad muscles aches, and had not recovered from feeling tired. This report was non-serious. This case, from the same reporter is linked to 20211011458.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: VACCINE RELATED HEALTH ISSUES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was perfectly healthy person with an uneventful medical file before 07-MAR-2021. 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 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the patient experienced vaccine related health issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine related health issues. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 57 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 (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: DEEP MUSCLE PAIN PRIMARILY IN FLEXORS; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-OCT-2021, the patient experienced deep muscle pain primarily in flexors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep muscle pain primarily in flexors on 03-OCT-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE OF EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 59 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: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced dose of expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex and unknown race and ethnicity. 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 and expiry: Unknown) 1 total, dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-SEP-2021, the patient was tested positive for covid (suspected clinical vaccination failure and suspected covid-19 infection). The patient had all the symptoms but the worst was the cough and the symptom was like having a bad cold. The patient was feeling better after 10 days.  Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000196265.; Sender's Comments: V0: 20211011774-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE OF THE VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced expired dose of the vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of the vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211012114, 20211012141, 20211012209 and 20211012383.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211421A expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.9 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-OCT-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. 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, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211011936-Covid-19 vaccine ad26.cov2. s-Suspected immunological failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an 87 year old White and Non Hispanic or Latino 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: 1805029 and expiry: UNKNOWN) 1 total, dose was not reported, administered at right arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  Patient needed a blood test after she was vaccinated and patient asked the doctor to check for antibodies against covid-19. On 05-OCT-2021, it was reported that patient had less than 1 %, that means patient had no antibodies (Confirmed immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative, Less than 1% (No antibodies). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000196260.; Sender's Comments: V0:20211011984-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Headache
Clinical narrative: FELT FATIGUE; HEADACHE; EXPIRED DOSES OF THE VACCINE WERE ADMINISTERED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced expired doses of the vaccine were administered. On 28-SEP-2021, the patient experienced felt fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired doses of the vaccine were administered, felt fatigue and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211011801, 20211012141, 20211012383 and 20211012209. This report was associated with product quality complaint: 90000196311.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous, non-serious report received from a healthcare professional, concerned a patient, of unspecified age and sex. The patient's height, weight, medical history, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin: not reported, batch/lot# 201A21A, expiry: Sep 21, 2021), dose not reported, on Sep 23, 2021 for COVID-19 immunization. On Sep 23, 2021, patient administered expired vaccine. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of administered expired vaccine: not reported. This case (from the same reporter), linked to 20211012141, 20211011801, 20211012383 and 20211012114. The product quality complaint number was 90000196302.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE OF VACCINE WERE 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, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced expired dose of vaccine were administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of vaccine were administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211012114, 20211012141 and 20211012209.