chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
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 60 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: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date patient had no complaints except fatigue. On 01-AUG-2021, the patient had COVID-19 antigen test which resulted in positive (suspected clinical vaccination failure and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not 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 report was associated with product quality complaint:90000189953.; Sender's Comments: V0- 20210834806-  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: Injection site discomfort
Clinical narrative: SMALL AMOUNT OF DISCOMFORT AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced small amount of discomfort at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small amount of discomfort at injection site. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19 pneumonia, Coma, Dehydration, Multiple organ dysfunction syndrome
Clinical narrative: COMA; COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; MULTIPLE ORGAN FAILURE; SUSPECTED COVID-19; ACUTE KIDNEY INJURY; THROMBOCYTOPENIA; SEVERELY DEHYDRATED; This spontaneous report received from a consumer concerned a 62 year old White, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol user. The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis.  On 17-JUL-2021, the patient started feeling chills, fever and throwing up. The oximeter showed that his oxygen levels were low. On The patient was admitted to the hospital and on 18-JUL-2021 the patient was diagnosed with covid-19 related pneumonia. On an unspecified date in JUL-2021, it was reported that the patient was severely dehydrated and had an intravenous (IV), had thrombocytopenia and acute kidney injury. The reporter (spouse) stated that the patient was given 4 liters of oxygen but was not getting better, and hence was put on the ventilator. On JUL-2021, the patient experienced suspected covid-19, multiple organ failure. Laboratory data included: covid-19 antigen test (NR: not provided) positive to Covid-19. On an unspecified date, the patient experienced coma. On 25-JUL-2021, the patient died from covid-19 related pneumonia, severe sepsis, acute respiratory syndrome, suspected covid-19, and multiple organ failure. An autopsy was not performed. The duration of hospitalization was unspecified. The death certificate of the patient had severe sepsis, acute respiratory syndrome and covid-19 related pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coma, thrombocytopenia, acute kidney injury, and severely dehydrated. This report was serious (Death and Hospitalization Caused / Prolonged). This case is associated with a Product Quality Complaint.; Sender's Comments: V0;20210834830; Covid-19 vaccine ad26.cov2. s, Suspected covid-19, Covid-19 related pneumonia, Acute respiratory syndrome, Severe sepsis, Coma, Thrombocytopenia, Multiple organ failure, Acute kidney injury and Severely dehydrated. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; SUSPECTED COVID-19; MULTIPLE ORGAN FAILURE
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test, Sepsis, Severe acute respiratory syndrome, Suspected COVID-19
Clinical narrative: COMA; COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; MULTIPLE ORGAN FAILURE; SUSPECTED COVID-19; ACUTE KIDNEY INJURY; THROMBOCYTOPENIA; SEVERELY DEHYDRATED; This spontaneous report received from a consumer concerned a 62 year old White, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol user. The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis.  On 17-JUL-2021, the patient started feeling chills, fever and throwing up. The oximeter showed that his oxygen levels were low. On The patient was admitted to the hospital and on 18-JUL-2021 the patient was diagnosed with covid-19 related pneumonia. On an unspecified date in JUL-2021, it was reported that the patient was severely dehydrated and had an intravenous (IV), had thrombocytopenia and acute kidney injury. The reporter (spouse) stated that the patient was given 4 liters of oxygen but was not getting better, and hence was put on the ventilator. On JUL-2021, the patient experienced suspected covid-19, multiple organ failure. Laboratory data included: covid-19 antigen test (NR: not provided) positive to Covid-19. On an unspecified date, the patient experienced coma. On 25-JUL-2021, the patient died from covid-19 related pneumonia, severe sepsis, acute respiratory syndrome, suspected covid-19, and multiple organ failure. An autopsy was not performed. The duration of hospitalization was unspecified. The death certificate of the patient had severe sepsis, acute respiratory syndrome and covid-19 related pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coma, thrombocytopenia, acute kidney injury, and severely dehydrated. This report was serious (Death and Hospitalization Caused / Prolonged). This case is associated with a Product Quality Complaint.; Sender's Comments: V0;20210834830; Covid-19 vaccine ad26.cov2. s, Suspected covid-19, Covid-19 related pneumonia, Acute respiratory syndrome, Severe sepsis, Coma, Thrombocytopenia, Multiple organ failure, Acute kidney injury and Severely dehydrated. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; SUSPECTED COVID-19; MULTIPLE ORGAN FAILURE
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: COMA; COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; MULTIPLE ORGAN FAILURE; SUSPECTED COVID-19; ACUTE KIDNEY INJURY; THROMBOCYTOPENIA; SEVERELY DEHYDRATED; This spontaneous report received from a consumer concerned a 62 year old White, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol user. The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis.  On 17-JUL-2021, the patient started feeling chills, fever and throwing up. The oximeter showed that his oxygen levels were low. On The patient was admitted to the hospital and on 18-JUL-2021 the patient was diagnosed with covid-19 related pneumonia. On an unspecified date in JUL-2021, it was reported that the patient was severely dehydrated and had an intravenous (IV), had thrombocytopenia and acute kidney injury. The reporter (spouse) stated that the patient was given 4 liters of oxygen but was not getting better, and hence was put on the ventilator. On JUL-2021, the patient experienced suspected covid-19, multiple organ failure. Laboratory data included: covid-19 antigen test (NR: not provided) positive to Covid-19. On an unspecified date, the patient experienced coma. On 25-JUL-2021, the patient died from covid-19 related pneumonia, severe sepsis, acute respiratory syndrome, suspected covid-19, and multiple organ failure. An autopsy was not performed. The duration of hospitalization was unspecified. The death certificate of the patient had severe sepsis, acute respiratory syndrome and covid-19 related pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coma, thrombocytopenia, acute kidney injury, and severely dehydrated. This report was serious (Death and Hospitalization Caused / Prolonged). This case is associated with a Product Quality Complaint.; Sender's Comments: V0;20210834830; Covid-19 vaccine ad26.cov2. s, Suspected covid-19, Covid-19 related pneumonia, Acute respiratory syndrome, Severe sepsis, Coma, Thrombocytopenia, Multiple organ failure, Acute kidney injury and Severely dehydrated. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; SUSPECTED COVID-19; MULTIPLE ORGAN FAILURE
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nonspecific reaction, Pain, Yawning
Clinical narrative: GENERAL ACHES/FEELS GENERALLY ACHY ALL OVER; TROUBLE GETTING OUT OF BED; YAWNING A LOT; FATIGUE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: normal allergies, sinus, non alcohol user, non-smoker, and arthritis, and other pre-existing medical conditions included: The patient had high blood and that doesn't have anything to do with the shot and had no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for sinus, and allergies. On 17-AUG-2021, the patient experienced general aches/feels generally achy all over. On 17-AUG-2021, the patient experienced trouble getting out of bed. On 17-AUG-2021, the patient experienced yawning a lot. On 17-AUG-2021, the patient experienced fatigue. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general aches/feels generally achy all over, fatigue, trouble getting out of bed, and yawning a lot. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and fatigue. 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 female of an 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 and expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient was asking about the need of a booster of covid-19 vaccine or getting another vaccine brand after testing negative for antibodies (confirmed immunological vaccine failure) and the patient had visited physician/healthcare professional office. Laboratory data included: COVID-19 antibody test (NR: not provided) negative for 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).; Sender's Comments: V0-20210834860-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
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Inguinal hernia, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INGUINAL HERNIA; This spontaneous report received from a patient concerned a 55 year old of mixed race, not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes mellitus 1 (DM1), hypertension (HTN), alcohol user (less than occasionally/rarely) and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the patient was diagnosed with inguinal hernia. On 04-AUG-2021, The primary doctor ordered antibody test (SARS-CoV-2 IgG spike semi quantitative antibody test) and the result found to be negative (confirmed immunological vaccine failure). On 12-AUG-2021, the cardiologist ordered antibody test which came negative as well. The patient was scheduled for surgery on 18-AUG-2021 for inguinal hernia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and inguinal hernia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210834862- 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 20210834862- Covid-19 vaccine ad26.cov2.s- Inguinal hernia. 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery in right side, and concurrent conditions included heart issue, cancer, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021 and, on 11-AUG-2021 the patient was exposed to life covid-19 cases and hence on 14-AUG-2021 her doctor ordered her to take titer test (antibody test) to check for protection and the result came out to be negative (confirmed immunological vaccine failure). The patent said that she did not know the type of test that the doctor ordered her to take and what she knew was that they drew blood from her in the doctor's office. The patient said that she feels she was not protected. 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).; Sender's Comments: V0:20210834896-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
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED BEYOND THE TWO HOUR RECOMMENDED STORAGE WINDOW AT ROOM TEMPERATURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 20 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced vaccine administered beyond the two hour recommended storage window at room temperature. On 17-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered beyond the two hour recommended storage window at room temperature and incorrect product storage was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: ACHINESS; COLD IN THE MIDDLE OF THE NIGHT; FEVER OF 100F; This spontaneous report received from a parent concerned a 20 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: 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 achiness, cold in the middle of the night, and fever of 100f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, cold in the middle of the night, and fever of 100f. This report was non-serious. This case, from the same reporter is linked to 20210834795.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac imaging procedure, Fatigue, Injection site swelling, Pain
Clinical narrative: WEIGHT GAIN; PAIN IN BODY; SYMPTOMS OF LUPUS; SWELLING INJECTION SITE; TIRED FEELING; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On MAR-2021, the patient experienced short term reaction: swelling injection site and tired feeling for 3 to 4 days. Approximately 30 days later, On APR-2021, the patient experienced significant swelling in both legs and feet. The patient stated that he never had edema prior to that date and it persisted since then. Laboratory data included: Cardiac imaging procedure (NR: not provided) not reported, blood test (NR: not provided) positive/high RNP Antibodies, and Renal function test (NR: not provided) not reported. Doctor has ruled out other organ issues. On an unspecified date, the physician indicated symptoms of lupus and had referred to a specialist. Doctor has started diuretics once per day as the patient gained 20 pounds in 4 weeks period. The patient had gained weight of 20 pounds. Swelling has reduced in legs but feet remain swollen. On 17-AUG-2021, the patient had pain in body and not relieved on over the counter (OTC).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling injection site, and tired feeling on MAR-2021, had not recovered from pain in body, and symptoms of lupus/swelling in both legs and feet/edema, and the outcome of weight gain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210834929-COVID-19 VACCINE AD26.COV2.S -SYMPTOMS OF LUPUS. 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.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test, Systemic lupus erythematosus, Weight, Weight increased
Clinical narrative: WEIGHT GAIN; PAIN IN BODY; SYMPTOMS OF LUPUS; SWELLING INJECTION SITE; TIRED FEELING; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On MAR-2021, the patient experienced short term reaction: swelling injection site and tired feeling for 3 to 4 days. Approximately 30 days later, On APR-2021, the patient experienced significant swelling in both legs and feet. The patient stated that he never had edema prior to that date and it persisted since then. Laboratory data included: Cardiac imaging procedure (NR: not provided) not reported, blood test (NR: not provided) positive/high RNP Antibodies, and Renal function test (NR: not provided) not reported. Doctor has ruled out other organ issues. On an unspecified date, the physician indicated symptoms of lupus and had referred to a specialist. Doctor has started diuretics once per day as the patient gained 20 pounds in 4 weeks period. The patient had gained weight of 20 pounds. Swelling has reduced in legs but feet remain swollen. On 17-AUG-2021, the patient had pain in body and not relieved on over the counter (OTC).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling injection site, and tired feeling on MAR-2021, had not recovered from pain in body, and symptoms of lupus/swelling in both legs and feet/edema, and the outcome of weight gain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210834929-COVID-19 VACCINE AD26.COV2.S -SYMPTOMS OF LUPUS. 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER  FOR 3 DAYS BETWEEN 102 F TO100.5; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: deaf, eye disease, and penicillin allergy. The patient experienced drug allergy when treated with vancomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever for 3 days between 102 f to100.5. Laboratory data included: Body temperature (NR: not provided) 102 to 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for 3 days between 102 f to100.5 on AUG-2021, and had not recovered from chills. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: BAD BODY ACHES; TIREDNESS/FELT EXHAUSTED; NAUSEA; FEVER; HEADACHE; TENSION HEADACHE; DID NOT FEEL LIKE MY NORMAL SELF; TOOK 2 DAYS OFF WORK BECAUSE COULD NOT GET UP; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced did not feel like my normal self. On AUG-2021, the patient experienced took 2 days off work because could not get up. On AUG-2021, the patient experienced tension headache. On 09-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced bad body aches. On 10-AUG-2021, the patient experienced tiredness/felt exhausted. On 10-AUG-2021, the patient experienced nausea. On 10-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 11-AUG-2021, and fever on 12-AUG-2021, had not recovered from headache, bad body aches, and tiredness/felt exhausted, and the outcome of took 2 days off work because could not get up, did not feel like my normal self and tension headache was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tension headache
Clinical narrative: BAD BODY ACHES; TIREDNESS/FELT EXHAUSTED; NAUSEA; FEVER; HEADACHE; TENSION HEADACHE; DID NOT FEEL LIKE MY NORMAL SELF; TOOK 2 DAYS OFF WORK BECAUSE COULD NOT GET UP; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced did not feel like my normal self. On AUG-2021, the patient experienced took 2 days off work because could not get up. On AUG-2021, the patient experienced tension headache. On 09-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced bad body aches. On 10-AUG-2021, the patient experienced tiredness/felt exhausted. On 10-AUG-2021, the patient experienced nausea. On 10-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 11-AUG-2021, and fever on 12-AUG-2021, had not recovered from headache, bad body aches, and tiredness/felt exhausted, and the outcome of took 2 days off work because could not get up, did not feel like my normal self and tension headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; ARM SORENESS; LOW GRADE FEVER; FATIGUE; This spontaneous pregnancy report received from a patient via a company representative 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 was pregnant at the time of vaccination. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: 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 vaccine exposure during pregnancy, arm soreness, low grade fever, and fatigue. The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, fatigue, arm soreness and vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown.  The Company is unable to perform follow-up to request batch number) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age who experienced Guillain Barre syndrome (GBS) an unknown time after vaccine. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced GBS. No other details regarding symptoms, diagnostics, treatment, or outcome were provided. Information is limited in this case, and the occurrence of GBS could represent background incidence of such events in the general population. Therefore, the relationship of GBS to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested if contact information becomes available.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood glucose, Blood test, Body temperature
Clinical narrative: HIGH LIVER ENZYMES; LETHARGIC; SORE ARM; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included: kidney disease, and fatty liver disease, and concurrent conditions included: penicillin allergy, non-smoker, non-alcohol user, and autistic, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was on a very restricted diet, no sugar, no potassium, no red meat and very low salt intake. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, Laboratory data included: Magnetic resonance elastography (NR: not provided) Fine, SGOT (NR: not provided) 31, and SGPT (NR: not provided) 41. On AUG-2021, the patient experienced lethargic. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 16-AUG-2021, the patient experienced high liver enzymes. Laboratory data included: Blood test (NR: not provided) Not specified, Glucose (NR: not provided) 144, Hepatic enzyme (NR: not provided) High, SGOT (NR: not provided) 80, and SGPT (NR: not provided) 108. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, had not recovered from fatigue, lethargic, and headache, and the outcome of sore arm and high liver enzymes was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hepatic enzyme, Hepatic enzyme increased, Lethargy
Clinical narrative: HIGH LIVER ENZYMES; LETHARGIC; SORE ARM; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included: kidney disease, and fatty liver disease, and concurrent conditions included: penicillin allergy, non-smoker, non-alcohol user, and autistic, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was on a very restricted diet, no sugar, no potassium, no red meat and very low salt intake. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, Laboratory data included: Magnetic resonance elastography (NR: not provided) Fine, SGOT (NR: not provided) 31, and SGPT (NR: not provided) 41. On AUG-2021, the patient experienced lethargic. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 16-AUG-2021, the patient experienced high liver enzymes. Laboratory data included: Blood test (NR: not provided) Not specified, Glucose (NR: not provided) 144, Hepatic enzyme (NR: not provided) High, SGOT (NR: not provided) 80, and SGPT (NR: not provided) 108. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, had not recovered from fatigue, lethargic, and headache, and the outcome of sore arm and high liver enzymes was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance elastography, Pain in extremity, Pyrexia
Clinical narrative: HIGH LIVER ENZYMES; LETHARGIC; SORE ARM; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included: kidney disease, and fatty liver disease, and concurrent conditions included: penicillin allergy, non-smoker, non-alcohol user, and autistic, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was on a very restricted diet, no sugar, no potassium, no red meat and very low salt intake. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, Laboratory data included: Magnetic resonance elastography (NR: not provided) Fine, SGOT (NR: not provided) 31, and SGPT (NR: not provided) 41. On AUG-2021, the patient experienced lethargic. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 16-AUG-2021, the patient experienced high liver enzymes. Laboratory data included: Blood test (NR: not provided) Not specified, Glucose (NR: not provided) 144, Hepatic enzyme (NR: not provided) High, SGOT (NR: not provided) 80, and SGPT (NR: not provided) 108. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, had not recovered from fatigue, lethargic, and headache, and the outcome of sore arm and high liver enzymes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an adult white male of unspecified 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) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-AUG-2021, the patient got sick and developed Covid after receiving the Covid-19 vaccine, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210835110-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
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthropathy, Blood test, Chills, Cold sweat
Clinical narrative: BLURRY VISION; JOINT ISSUES; SORE THROAT; BREAKING OUT IN COLD SWEAT (MOSTLY HER HEAD); CHILLS; LOW GRADE FEVER; FEET HURT; SHORTNESS OF BREATH; HIGH HEART RATE; FELT LIKE GOING TO FAINT; MUSCLE ACHE; BAD HEADACHE; VOMITING; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 67 inches. The patient's past medical history included: flu, and concurrent conditions included: hashimoto's disease, sjogren's disease, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced vomiting. On MAR-2021, the patient experienced muscle ache. On MAR-2021, the patient experienced bad headache. On 17-AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced high heart rate. On 17-AUG-2021, the patient experienced felt like going to faint. Laboratory data included: Heart rate (NR: not provided) 117 {beats}/min, 83 {beats}/min, leveled off. On an unspecified date, the patient experienced blurry vision, joint issues, sore throat, breaking out in cold sweat (mostly her head), chills, low grade fever, and feet hurt. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 180, Titer 640, Blood test (NR: not provided) Something was low but not sure what it was, COVID-19 virus test (NR: not provided) Negative, Negative, and Hepatic enzyme (NR: not provided) Have been different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart rate on 17-AUG-2021, and vomiting, had not recovered from bad headache, muscle ache, joint issues, breaking out in cold sweat (mostly her head), and feet hurt, and the outcome of blurry vision, chills, sore throat, low grade fever, shortness of breath and felt like going to faint was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate, Heart rate increased, Hepatic enzyme
Clinical narrative: BLURRY VISION; JOINT ISSUES; SORE THROAT; BREAKING OUT IN COLD SWEAT (MOSTLY HER HEAD); CHILLS; LOW GRADE FEVER; FEET HURT; SHORTNESS OF BREATH; HIGH HEART RATE; FELT LIKE GOING TO FAINT; MUSCLE ACHE; BAD HEADACHE; VOMITING; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 67 inches. The patient's past medical history included: flu, and concurrent conditions included: hashimoto's disease, sjogren's disease, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced vomiting. On MAR-2021, the patient experienced muscle ache. On MAR-2021, the patient experienced bad headache. On 17-AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced high heart rate. On 17-AUG-2021, the patient experienced felt like going to faint. Laboratory data included: Heart rate (NR: not provided) 117 {beats}/min, 83 {beats}/min, leveled off. On an unspecified date, the patient experienced blurry vision, joint issues, sore throat, breaking out in cold sweat (mostly her head), chills, low grade fever, and feet hurt. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 180, Titer 640, Blood test (NR: not provided) Something was low but not sure what it was, COVID-19 virus test (NR: not provided) Negative, Negative, and Hepatic enzyme (NR: not provided) Have been different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart rate on 17-AUG-2021, and vomiting, had not recovered from bad headache, muscle ache, joint issues, breaking out in cold sweat (mostly her head), and feet hurt, and the outcome of blurry vision, chills, sore throat, low grade fever, shortness of breath and felt like going to faint was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Presyncope, Pyrexia
Clinical narrative: BLURRY VISION; JOINT ISSUES; SORE THROAT; BREAKING OUT IN COLD SWEAT (MOSTLY HER HEAD); CHILLS; LOW GRADE FEVER; FEET HURT; SHORTNESS OF BREATH; HIGH HEART RATE; FELT LIKE GOING TO FAINT; MUSCLE ACHE; BAD HEADACHE; VOMITING; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 67 inches. The patient's past medical history included: flu, and concurrent conditions included: hashimoto's disease, sjogren's disease, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced vomiting. On MAR-2021, the patient experienced muscle ache. On MAR-2021, the patient experienced bad headache. On 17-AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced high heart rate. On 17-AUG-2021, the patient experienced felt like going to faint. Laboratory data included: Heart rate (NR: not provided) 117 {beats}/min, 83 {beats}/min, leveled off. On an unspecified date, the patient experienced blurry vision, joint issues, sore throat, breaking out in cold sweat (mostly her head), chills, low grade fever, and feet hurt. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 180, Titer 640, Blood test (NR: not provided) Something was low but not sure what it was, COVID-19 virus test (NR: not provided) Negative, Negative, and Hepatic enzyme (NR: not provided) Have been different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart rate on 17-AUG-2021, and vomiting, had not recovered from bad headache, muscle ache, joint issues, breaking out in cold sweat (mostly her head), and feet hurt, and the outcome of blurry vision, chills, sore throat, low grade fever, shortness of breath and felt like going to faint was not reported. This report was non-serious.