chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arterial rupture, Catheterisation cardiac, Myocardial infarction, Myocarditis, Reproductive tract disorder
Clinical narrative: APPARENT HEART ATTACK; MYOPERICARDITIS AND INFLAMED HEART; CORONARY TEAR; GYNECOLOGICAL PROBLEMS; This spontaneous report received from a Company representative concerned a 34 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient had no pre-existing conditions. The patient never had coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  No concomitant medications were reported.  The patient did not notice complications until three months later on 09-JUL-2021 the pain started with what felt like heartburn or indigestion, but three days later on 12-JUL-2021 pain intensified to the point that she was breathing into a paper bag for relief and body aches kept her up at night. After three days on 12-JUL-2021, the patient experienced apparent heart attack. By the time patient went to an emergency room, where the amount of troponin in her blood was 7.3 nanograms per milliliter (normal range between 0 to 0.04.), which indicates heart injury. They asked her to get done cardiac catheterization. They sent her by ambulance to hospital for treatment. Catheterization was done and they did not find any blockages and it was normal. The patient also experienced inflamed heart (myopericarditis and inflamed heart) and a coronary tear that will take six to eight months to heal. She met the next day with an infectious diseases team, which recommended additional testing before noting on her admissions paperwork. In addition to continuing to heal, she said she has also developed gynecological problems and her doctors have mentioned the potential for a hysterectomy. On an unspecified date patient was hospitalized. Number of days hospitalized was unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myopericarditis and inflamed heart and coronary tear and the outcome of apparent heart attack, gynecological problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953564.; Sender's Comments: V0: 20210953105 -COVID-19 VACCINE AD26.COV2.S-Apparant Heart attack, Myopericarditis and inflamed heart ,Coronary tear. 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
Symptoms: Troponin
Clinical narrative: APPARENT HEART ATTACK; MYOPERICARDITIS AND INFLAMED HEART; CORONARY TEAR; GYNECOLOGICAL PROBLEMS; This spontaneous report received from a Company representative concerned a 34 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient had no pre-existing conditions. The patient never had coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  No concomitant medications were reported.  The patient did not notice complications until three months later on 09-JUL-2021 the pain started with what felt like heartburn or indigestion, but three days later on 12-JUL-2021 pain intensified to the point that she was breathing into a paper bag for relief and body aches kept her up at night. After three days on 12-JUL-2021, the patient experienced apparent heart attack. By the time patient went to an emergency room, where the amount of troponin in her blood was 7.3 nanograms per milliliter (normal range between 0 to 0.04.), which indicates heart injury. They asked her to get done cardiac catheterization. They sent her by ambulance to hospital for treatment. Catheterization was done and they did not find any blockages and it was normal. The patient also experienced inflamed heart (myopericarditis and inflamed heart) and a coronary tear that will take six to eight months to heal. She met the next day with an infectious diseases team, which recommended additional testing before noting on her admissions paperwork. In addition to continuing to heal, she said she has also developed gynecological problems and her doctors have mentioned the potential for a hysterectomy. On an unspecified date patient was hospitalized. Number of days hospitalized was unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myopericarditis and inflamed heart and coronary tear and the outcome of apparent heart attack, gynecological problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953564.; Sender's Comments: V0: 20210953105 -COVID-19 VACCINE AD26.COV2.S-Apparant Heart attack, Myopericarditis and inflamed heart ,Coronary tear. 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
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 consumer via a company representative 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 was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In late AUG-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Unknown. Patient had a mild case but symptoms lasted 1 weeks longer although patient was not hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered 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 case, from the same reporter is linked to 20210952846.; Sender's Comments: V0. 20210953291-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: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer (patient's spouse) via company representative concerned a male of an 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, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in MAR-2021 (reported as approximately 14-MAR-2021) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-SEP-2021, the patient had PCR test (polymerase chain reaction test) which revealed a confirmed breakthrough infection (confirmed clinical vaccination failure and confirmed covid-19 infection). It was reported that currently, the patient had mild case with reoccurring fever and minimal congestion. The patient was quarantine at home and had contacted his physician for any additional or needed monitoring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with RA: 90000194837; Sender's Comments: V0 20210953404-COVID-19 VACCINE AD26.COV2.S-confirmed 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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inhibitory drug interaction, Psoriatic arthropathy
Clinical narrative: INHIBITORY DRUG INTERACTION; PSORIATIC ARTHRITIS AGGRAVATED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination, and psoriatic arthritis. The batch number was not reported. Per procedure, no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for psoriatic arthritis. Concomitant medications included prednisone. On an unspecified date, the patient experienced inhibitory drug interaction, and psoriatic arthritis aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was increased. The outcome of the inhibitory drug interaction and psoriatic arthritis aggravated was not reported. This report was non-serious.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Blood culture, Epstein-Barr virus test, Heart rate, Myalgia, Oropharyngeal pain
Clinical narrative: IN FULL SEPSIS; SORENESS IN THROAT; MUSCLE PAIN; This spontaneous report received from a patient concerned a 35 year old white patient of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no medical history. The patient had no known allergies. The patient did not had any drug abuse or illicit drug use. Patient had no respiratory condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered on 02-SEP-2021 at left arm for prophylactic vaccination. Concomitant medications included probiotics, and fish oil.  On 23-SEP-2021, patient started having muscle pain and soreness in the throat. On 25-SEP-2021, saturday morning, patient woke up with fever, night sweats and also reported was losing a lot of water. By midday patient experienced nausea and vomiting. On Sep-2021, patient decided to go to urgent care as could not keep any food or water down. In the emergency room (ER), they told patient had sepsis. Patient reported resting heart rate was 119 and white blood cell count was 21,000. They had a covid test done that was negative, a streptococcus test that was negative, Epstein Barr test that was negative, urinalyses that was negative and blood culture tests were not reported. Patient reported no changes were made to diet, or exposure to anything. The discharge professional stated this was most likely related to the vaccine. In ER, patient was given broad spectrum antibiotic and IV (intravenous) fluids. Patient did not feel better at all and no symptoms had gone away or gotten any better since they started except for dehydration because patient received 4 IV bags in the ER, still had a fever and increased heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, soreness in throat, and in full sepsis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210953480-covid-19 vaccine ad26.cov2.s-in full sepsis. 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: 35.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sepsis, Streptococcus test, Urine analysis, White blood cell count
Clinical narrative: IN FULL SEPSIS; SORENESS IN THROAT; MUSCLE PAIN; This spontaneous report received from a patient concerned a 35 year old white patient of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no medical history. The patient had no known allergies. The patient did not had any drug abuse or illicit drug use. Patient had no respiratory condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered on 02-SEP-2021 at left arm for prophylactic vaccination. Concomitant medications included probiotics, and fish oil.  On 23-SEP-2021, patient started having muscle pain and soreness in the throat. On 25-SEP-2021, saturday morning, patient woke up with fever, night sweats and also reported was losing a lot of water. By midday patient experienced nausea and vomiting. On Sep-2021, patient decided to go to urgent care as could not keep any food or water down. In the emergency room (ER), they told patient had sepsis. Patient reported resting heart rate was 119 and white blood cell count was 21,000. They had a covid test done that was negative, a streptococcus test that was negative, Epstein Barr test that was negative, urinalyses that was negative and blood culture tests were not reported. Patient reported no changes were made to diet, or exposure to anything. The discharge professional stated this was most likely related to the vaccine. In ER, patient was given broad spectrum antibiotic and IV (intravenous) fluids. Patient did not feel better at all and no symptoms had gone away or gotten any better since they started except for dehydration because patient received 4 IV bags in the ER, still had a fever and increased heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, soreness in throat, and in full sepsis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210953480-covid-19 vaccine ad26.cov2.s-in full sepsis. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: SEVERE ANAPHYLACTIC ALLERGIC REACTION; This spontaneous report received from a patient concerned a 69-year-old, white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805018, and expiry: Unknown) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 12-MAR-2021, 18 minutes after vaccination the patient experienced severe anaphylactic allergic reaction and they called code blue. The patient received epipen and they kept the patient for 4 to 5 hours after in emergency department. The patient received the shot in a Hospital as patient had allergic reactions previously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe anaphylactic allergic reaction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210953617-COVID-19 VACCINE AD26.COV2.S-Severe  anaphylactic allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS, FAVORING, VOMITING, SHORTNESS OF BREATH, WORST BODY PAIN, NAUSEA, SHIVERS; SHINGLES, RED DOTS, HURT ITCHY LEGS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no past episode. The patient tried steroids for couple of weeks but did not work and followed up with doctor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included sertraline.  On APR-2021, the patient experienced shingles, red dots, hurt itchy legs. On 07-APR-2021, the patient experienced flu like symptoms, favoring, vomiting, shortness of breath, worst body pain, nausea, shivers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, favoring, vomiting, shortness of breath, worst body pain, nausea, shivers, and shingles, red dots, hurt itchy legs. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Diplopia, Headache, Hypoaesthesia
Clinical narrative: DOUBLE VISION; VERTIGO (DIZZINESS); FEELS NAUSEA; DIARRHEA; SEVERE HEADACHES; CANNOT DO DAILY ACTIVITIES(LIFTING OBJECTS, COOKING, AND PICKING UP 4 YEAR OLD GRANDDAUGHTER); CANNOT DRIVE AND IS HOME BOUND; FEELING VERY ILL; COULDN'T USE ARM DUE TO NUMBNESS; NUMBNESS IN ARM AFTER INJECTION/NUMBNESS TRAVELED TO HANDS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, and thyroid, and other pre-existing medical conditions included: The patient does not have any other known conditions. The patient takes vitamins. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis.  On 16-MAR-2021, the patient experienced couldn't use arm due to numbness. On 16-MAR-2021, the patient experienced feeling very ill. On 16-MAR-2021, the patient experienced numbness in arm after injection/numbness traveled to hands. On SEP-2021, the patient experienced cannot do daily activities (lifting objects, cooking, and picking up 4 year old granddaughter). On SEP-2021, the patient experienced cannot drive and is home bound. On 24-SEP-2021, Laboratory data included: Blood test (NR: not provided) Results not reported. On an unspecified date, the patient experienced double vision, vertigo (dizziness), feels nausea, diarrhea, and severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't use arm due to numbness, and numbness in arm after injection/numbness traveled to hands, had not recovered from diarrhea, double vision, cannot drive and is home bound, and cannot do daily activities(lifting objects, cooking, and picking up 4 year old granddaughter), and the outcome of vertigo (dizziness), severe headaches, feels nausea and feeling very ill was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Malaise, Movement disorder, Nausea
Clinical narrative: DOUBLE VISION; VERTIGO (DIZZINESS); FEELS NAUSEA; DIARRHEA; SEVERE HEADACHES; CANNOT DO DAILY ACTIVITIES(LIFTING OBJECTS, COOKING, AND PICKING UP 4 YEAR OLD GRANDDAUGHTER); CANNOT DRIVE AND IS HOME BOUND; FEELING VERY ILL; COULDN'T USE ARM DUE TO NUMBNESS; NUMBNESS IN ARM AFTER INJECTION/NUMBNESS TRAVELED TO HANDS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, and thyroid, and other pre-existing medical conditions included: The patient does not have any other known conditions. The patient takes vitamins. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis.  On 16-MAR-2021, the patient experienced couldn't use arm due to numbness. On 16-MAR-2021, the patient experienced feeling very ill. On 16-MAR-2021, the patient experienced numbness in arm after injection/numbness traveled to hands. On SEP-2021, the patient experienced cannot do daily activities (lifting objects, cooking, and picking up 4 year old granddaughter). On SEP-2021, the patient experienced cannot drive and is home bound. On 24-SEP-2021, Laboratory data included: Blood test (NR: not provided) Results not reported. On an unspecified date, the patient experienced double vision, vertigo (dizziness), feels nausea, diarrhea, and severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't use arm due to numbness, and numbness in arm after injection/numbness traveled to hands, had not recovered from diarrhea, double vision, cannot drive and is home bound, and cannot do daily activities(lifting objects, cooking, and picking up 4 year old granddaughter), and the outcome of vertigo (dizziness), severe headaches, feels nausea and feeling very ill was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: DOUBLE VISION; VERTIGO (DIZZINESS); FEELS NAUSEA; DIARRHEA; SEVERE HEADACHES; CANNOT DO DAILY ACTIVITIES(LIFTING OBJECTS, COOKING, AND PICKING UP 4 YEAR OLD GRANDDAUGHTER); CANNOT DRIVE AND IS HOME BOUND; FEELING VERY ILL; COULDN'T USE ARM DUE TO NUMBNESS; NUMBNESS IN ARM AFTER INJECTION/NUMBNESS TRAVELED TO HANDS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, and thyroid, and other pre-existing medical conditions included: The patient does not have any other known conditions. The patient takes vitamins. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis.  On 16-MAR-2021, the patient experienced couldn't use arm due to numbness. On 16-MAR-2021, the patient experienced feeling very ill. On 16-MAR-2021, the patient experienced numbness in arm after injection/numbness traveled to hands. On SEP-2021, the patient experienced cannot do daily activities (lifting objects, cooking, and picking up 4 year old granddaughter). On SEP-2021, the patient experienced cannot drive and is home bound. On 24-SEP-2021, Laboratory data included: Blood test (NR: not provided) Results not reported. On an unspecified date, the patient experienced double vision, vertigo (dizziness), feels nausea, diarrhea, and severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't use arm due to numbness, and numbness in arm after injection/numbness traveled to hands, had not recovered from diarrhea, double vision, cannot drive and is home bound, and cannot do daily activities(lifting objects, cooking, and picking up 4 year old granddaughter), and the outcome of vertigo (dizziness), severe headaches, feels nausea and feeling very ill was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 asymptomatic covid-19. 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 asymptomatic covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210424495.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FEVER; FATIGUE; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 74 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 administration not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  Patient took an antibody test as directed by health care physician on 15-SEP-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative (no antibodies). Patient also went to her heart doctor to understand the test results and he explained results to patient. 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 product quality complaint: Sender's Comments: V0: 20210955430-COVID-19 VACCINE AD26.COV2.S -Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Organ failure
Clinical narrative: DEATH; STROKE; MASSIVE ORGAN FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a two elderly patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. Both patients were healthy and had full physical before taking vaccination. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. The reporter reported that, know of two over 65 folks who died two weeks after Johnson and Johnson shot. Stroke and massive organ failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of unknown cause on an unspecified date and the outcome of stroke and massive organ failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210955453-Covid-19 vaccine ad26.cov2.s- Death, Stroke, Massive organ failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE TO 3 FEMALES; 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: 207A21A, 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 administration of expired vaccine to 3 females. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine to 3 females was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 47 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administration of an expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955892.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Suspected COVID-19
Clinical narrative: MILD COVID-LIKE SYMPTOMS/  FELT ALMOST LIKE A  LITTLE TOUCH OF COVID AGAIN; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 135 pounds, and height was 60.5 inches. The patient's past medical history included: covid-19, and concurrent conditions included: panic attacks, and hormone replacement therapy. The patient experienced drug allergy when treated with prednisone 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: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for panic attack. On an unspecified date, the patient experienced mild covid-like symptoms/ felt almost like a little touch of covid again, sore arm, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild covid-like symptoms/ felt almost like a little touch of covid again, sore arm, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: BREAKTHROUGH INFECTION; 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 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine was not applicable. The outcome of breakthrough infection was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 6 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: 202A21A, 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 administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 54 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 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administered an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered an expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: FAST HEART RATE; DIZZINESS; SHORTNESS OF BREATH; BLURRED VISION; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 SEP-2021, the patient experienced fast heart rate. On SEP-2021, the patient experienced dizziness. On SEP-2021, the patient experienced shortness of breath. On SEP-2021, the patient experienced blurred vision. On SEP-2021, the patient experienced weakness. On SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heart rate, dizziness, weakness, blurred vision, headache, and shortness of breath. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: FAST HEART RATE; DIZZINESS; SHORTNESS OF BREATH; BLURRED VISION; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 SEP-2021, the patient experienced fast heart rate. On SEP-2021, the patient experienced dizziness. On SEP-2021, the patient experienced shortness of breath. On SEP-2021, the patient experienced blurred vision. On SEP-2021, the patient experienced weakness. On SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heart rate, dizziness, weakness, blurred vision, headache, and shortness of breath. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Muscular weakness, Pain in extremity
Clinical narrative: RIGHT LOWER ABDOMINAL DISCOMFORT; PERSISTENT LEFT ANTERIOR ARM PAIN; DIFFICULTY RAISING ARM OVER HEAD AND BEHIND BACK; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: gall bladder removal, and right lower abdominal pain, and concurrent conditions included: latex allergy, celiac disease, gerd, low blood pressure, and lightheadedness, and other pre-existing medical conditions included: The patient had an allergy to IV contrast and Vitamin D (unspecified), had no adverse events following any previous vaccinations, had no history of left arm or shoulder problems and was not pregnant during vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204B21A, and batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 13:00:00 for prophylactic vaccination. Concomitant medications included ascorbic acid for drug used for unknown indication, and folic acid for drug used for unknown indication. On SEP-2021, the patient experienced persistent left anterior arm pain. On SEP-2021, the patient experienced difficulty raising arm over head and behind back. On 20-SEP-2021, the patient experienced right lower abdominal discomfort. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from persistent left anterior arm pain, and difficulty raising arm over head and behind back, and had not recovered from right lower abdominal discomfort. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Illness
Clinical narrative: SHINGLES; VERY SICK FOR TWO MONTHS; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced very sick for two months. On an unspecified date, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sick for two months, and the outcome of shingles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pain
Clinical narrative: ACHES; BEING TOO HOT; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced aches, being too hot, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches and being too hot was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 50 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-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: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE TO 9 MALES; 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: 207A21A, 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 administration of expired vaccine to 9 males. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine to 9 males was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955494.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: POTENTIAL ADMINISTRATION ERROR - EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced potential administration error - expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration error - expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955936, 20210955892, 20210955498 and 20210955712.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 61 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced administered expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955498, 20210955712, 20210955936 and 20210955852.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 45 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine 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 20210955892.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: COLD SYMPTOMS (A LITTLE BIT SORE THROAT, SNEEZING); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had fever. 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-SEP-2021, the patient experienced cold symptoms (a little bit sore throat, sneezing). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms (a little bit sore throat, sneezing) was not reported. This report was non-serious.