chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: STROKE; MEMORY LOSS; CAN NOT SEE; COLD/FLU LIKE SYMPTOMS; SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, alcohol user (On Occasion), smoker (Half a pack a day or less), and blind (glaucoma). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 21-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the patient experienced stroke, memory loss and can not see. On same day, the patient was hospitalized for 15 days. On 15-AUG-2021, the patient discharged from hospital. On same day, patient visited emergency room and physician office for stroke, memory loss and can not see. The reporter stated, they went to the hospital, and they were told the patient was outside the window for administering anything for the stroke. The patient, couldn't tell what year it was (he said it was 1987) and also he doesn't remember his neighbors. One day, he didn't remember his girlfriend (reporter), and also he didn't remember his grown (38 year old) daughter. On an unspecified date, the patient experienced cold/flu like symptoms, sore arm and laboratory data included: Computed tomography (CAT) scan result was confirmed stroke. Treatment medications (dates unspecified) included: Plavix (clopidogrel bisulfate) for stroke and heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold/flu like symptoms on 26-JUN-2021, and sore arm, was recovering from stroke, had not recovered from memory loss and the outcome of could not see was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211240605-covid-19 vaccine ad26.cov2.s -Stroke, memory loss, cannot see. 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: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN LUNG; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, (dose number in series was 2), administered 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 blood clot in lung (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211240684-covid-19 vaccine ad26.cov2.s-blood clot in lung . 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: Abdominal pain upper, Heavy menstrual bleeding, Malaise
Clinical narrative: HEAVY MENSTRUAL BLEEDING; STOMACH WAS HURTING; NOT FEELING GREAT; This spontaneous report received from a consumer concerned a 28 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient menstrual cycle was ended 5 days ago. The patient was received with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received the Janssen COVID-19 vaccine booster recently (dose number in series 2). The patient's menstrual cycle ended 5 days ago. On 17-DEC-2021, the patient experienced heavy menstrual bleeding at morning, her stomach was hurting and was not feeling great (Dose number in series 2) but at work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes from heavy menstrual bleeding, stomach was hurting, and not feeling great were unknown. This report as non-serious. This case, from the same reporter is linked to 20211240616.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vision blurred
Clinical narrative: BLURRED VISION; TROUBLE BREATHING; This spontaneous report received from a patient concerned a 73 year old female. Initial information was processed along with additional information on 19-DEC-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung cancer, and breast cancer. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number not reported) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212D21A, and expiry: UNKNOWN) dose was not reported,1 total, administered on 12-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-DEC-2021, after the patient received booster, she experienced blurred vision. The patient had seen her health care professional (HCP) for blurred vision and the doctor prescribed her eye drops to relieve blurry vision but the blurred vision was not resolving. The patient did not know the name of eye-drops and could not read the name of the medication. On an unspecified date in DEC-2021, patient experienced trouble breathing but she does not believe that it was caused by the booster (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, and the outcome of trouble breathing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: NOW GONE FROM THE DEATH SHOT; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients of unspecified race and ethnicity. 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: unknown and expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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, patients were died from unknown cause. The reporter stated, "I know so many that were now gone from the death shot". It was unknown if autopsy is performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211242638.; Sender's Comments: V0: 20211242746-COVID-19 VACCINE AD26.COV2.S-Now gone from the death shot. 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.; Reported Cause(s) of Death: DEATH
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Illness, Suspected COVID-19, Vitamin B12, Vitamin D
Clinical narrative: GOT SICK AS A DOG; ALL THE SYMPTOMS OF COVID; 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 concurrent conditions included: feeding tube, skin cancers off nose, crohn's disease, sores on her back, low immune system, nausea, pain, diarrhea, gastroenteritis, no vitamin d, no vitamin b12, sleep apnea, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got sick as a dog, and all the symptoms of covid. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) High, Vitamin B12 (NR: not provided) No, and Vitamin D (NR: not provided) No. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got sick as a dog and all the symptoms of covid was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a male 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, batch number: unknown and expiry: unknown) dose, 1 total, dose number series of 1, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that "a friend of mine had JJ vaccine he got covid and he died 3 month ago" (suspected clinical vaccination failure). On SEP-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on SEP-2021, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000207827.; Sender's Comments: V0: 20211244971-COVID-19 VACCINE AD26.COV2.S-Death. 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. 20211244971-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Rhinorrhoea
Clinical narrative: SLIGHT RUNNY NOSE; ARM ACHE; SLIGHT HEADACHES; This spontaneous report received from a patient concerned a 79-year-old female. The patient's past medical history included lung cancer (the middle lobe of her lung removed), and concurrent conditions included Crohn's disease (her small and large intestines removed), chemo neuropathy, osteoarthritis. Allergies to NSAIDS, oxycontin, and gabapentin. The patient previously received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 213O21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-JUN-2021 to right arm for prophylactic vaccination (Dose number in series 1). The patient experienced arm ache with covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-DEC-2021 to right arm for prophylactic vaccination (Dose number in series 2). Concomitant medications included paracetamol for chemo neuropathy, tramadol for chemo neuropathy, ergocalciferol for unknown indication, metoprolol for unknown indication, and pyridoxine hydrochloride for unknown indication. The patient was on oxygen therapy for unknown indication at the time of vaccination. On an unspecified date in DEC-2021 after her booster dose, the patient experienced runny nose, arm ache (right arm but the ache somehow got to her left arm), and slight headache (dose number in series 2). The action taken with covid-19 vaccine was not applicable. The patient recovered from arm ache (also reported as unknown), and slight headache (also reported as unknown), and the outcome of runny nose was unknown. This report was non-serious. This case, involving the same patient is linked to 20211244413.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Pain
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COUGH; CHILLS THE DAY AFTER RECEIVING THE VACCINE; DRAINED/TIRED; HIGH FEVER; RUNNY NOSE; BODY ACHE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included: no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number series 1) (suspension for injection, intramuscular, batch number: 204A21A and expiry: unknown) dose was not reported, 1 total, administered on 19-AUG-2021 right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-AUG-2021, the patient experienced high fever 104.5 F (Fahrenheit) body ache, runny nose after receiving the vaccine, she was also drained and tired. On 20-AUG-2021, the patient experienced chills  and cough (lasted about a week). On 17-DEC-2021, the patient started getting cough. On 18-DEC-2021, the patients body was sore, had chills and a temperature of 102.8 F. On 19-DEC-2021, the patient tested positive for Covid-19 rapid test (suspected covid-19 infection, suspected clinical vaccination failure) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills the day after receiving the vaccine, and high fever on 22-AUG-2021, cough on 01-SEP-2021, and runny nose, and drained/tired on 21-AUG-2021, 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: 90000207849. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211245389- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COUGH; CHILLS THE DAY AFTER RECEIVING THE VACCINE; DRAINED/TIRED; HIGH FEVER; RUNNY NOSE; BODY ACHE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included: no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number series 1) (suspension for injection, intramuscular, batch number: 204A21A and expiry: unknown) dose was not reported, 1 total, administered on 19-AUG-2021 right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-AUG-2021, the patient experienced high fever 104.5 F (Fahrenheit) body ache, runny nose after receiving the vaccine, she was also drained and tired. On 20-AUG-2021, the patient experienced chills  and cough (lasted about a week). On 17-DEC-2021, the patient started getting cough. On 18-DEC-2021, the patients body was sore, had chills and a temperature of 102.8 F. On 19-DEC-2021, the patient tested positive for Covid-19 rapid test (suspected covid-19 infection, suspected clinical vaccination failure) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills the day after receiving the vaccine, and high fever on 22-AUG-2021, cough on 01-SEP-2021, and runny nose, and drained/tired on 21-AUG-2021, 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: 90000207849. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211245389- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination 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: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Haemothorax, Loss of consciousness, Pulmonary embolism
Clinical narrative: BLOOD CLOTS IN LUNGS AND AROUND HEART; LARGE HEMOTHORAX ON BACK AND HIP; PASSED OUT; UNPROVOKED PULMONARY EMBOLISM; FELL; This spontaneous report received from a parent concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, administered on 06-APR-2021 for prophylactic vaccination (dose number in series is 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient was at work when she passed and fell and as a result of the fall she had a large hemothorax on her back and hip. Patient did not remember what she hit when she fell and the patient was admitted to the hospital for unprovoked pulmonary embolisms and blood clots in her lungs and around her heart. The patient remained in the ICU for three days then was transferred to the cardiac wing where she remained for two additional days. Reporter stated that the patient was not sick in fact, she had just a physical and everything was good. Patient was seen by a hematologist, had several computerised tomogram (CT) scans, a neurologist, her primary doctor had her on blood thinners and said she may be on them the rest of her life. Reporter stated that doctor knew exactly what to do and acted fast in administering the appropriate medicine to break up the clots to prevent her from serious illness or death according to the doctor. The reporter also reported that since her discharge from the hospital, she has had many follow-up appointments with her physicians but no one knows why this has happened to her because she received her vaccine shot in April and the clots, embolisms happened in September, every doctor says it could not have been a result from the vaccine because it has been too long from the shot to the illness. The physicians said that it would have happened within a shorter time frame maybe a few days to a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unprovoked pulmonary embolism, blood clots in lungs and around heart, passed out, large hemothorax on back and hip and fell was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245486- COVID-19 VACCINE AD26.COV2.S- blood clots in lungs and around heart, large hemothorax on back and hip, passed out, unprovoked pulmonary embolism, fell. 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: Thrombosis
Clinical narrative: BLOOD CLOTS IN LUNGS AND AROUND HEART; LARGE HEMOTHORAX ON BACK AND HIP; PASSED OUT; UNPROVOKED PULMONARY EMBOLISM; FELL; This spontaneous report received from a parent concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, administered on 06-APR-2021 for prophylactic vaccination (dose number in series is 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient was at work when she passed and fell and as a result of the fall she had a large hemothorax on her back and hip. Patient did not remember what she hit when she fell and the patient was admitted to the hospital for unprovoked pulmonary embolisms and blood clots in her lungs and around her heart. The patient remained in the ICU for three days then was transferred to the cardiac wing where she remained for two additional days. Reporter stated that the patient was not sick in fact, she had just a physical and everything was good. Patient was seen by a hematologist, had several computerised tomogram (CT) scans, a neurologist, her primary doctor had her on blood thinners and said she may be on them the rest of her life. Reporter stated that doctor knew exactly what to do and acted fast in administering the appropriate medicine to break up the clots to prevent her from serious illness or death according to the doctor. The reporter also reported that since her discharge from the hospital, she has had many follow-up appointments with her physicians but no one knows why this has happened to her because she received her vaccine shot in April and the clots, embolisms happened in September, every doctor says it could not have been a result from the vaccine because it has been too long from the shot to the illness. The physicians said that it would have happened within a shorter time frame maybe a few days to a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unprovoked pulmonary embolism, blood clots in lungs and around heart, passed out, large hemothorax on back and hip and fell was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211245486- COVID-19 VACCINE AD26.COV2.S- blood clots in lungs and around heart, large hemothorax on back and hip, passed out, unprovoked pulmonary embolism, fell. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Suspected COVID-19, Vaccination failure
Clinical narrative: ATRIAL FIBRILLATION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer through a company representative concerned a 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 administration, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total, for prophylactic vaccination (dose number in series 1). 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 suspected Covid-19 infection due to which he almost died (bad Covid-19 infection) (suspected clinical vaccination failure) and atrial fibrillation. He was fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atrial fibrillation, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211245023 and 20211245964. This report was associated with a product quality complaint: 90000207820.; Sender's Comments: V0: 20211245900- COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. 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. 20211245900- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination 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: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a consumer through a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had any heart problems before vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that his girlfriend had heart problems and suddenly needed a triple bypass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211245023 and 20211245900.; Sender's Comments: V0: 20211245964-COVID-19 VACCINE AD26.COV2.S-Heart problems. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient concerned a male 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 previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, Expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (dose number in series 1).  The patient experienced tired when treated with covid-19 vaccine ad26. cov2. S (dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, Expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested.   No concomitant medications were reported.  On an unspecified date, the patient was tired (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case involving the same patient is linked to 20211244564.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's weight was 155 pounds, and height was 70 inches. The patient's concurrent conditions included: drink alcohol occasionally, cannabis use occasional, and smoker, and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar event and had no adverse event after any previous vaccination. The patient had no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days, with cause. It was unknown about the family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211246488, 20211246559, 20211246474, 20211246517, 20211246432, 20211246471, 20210955494, 20211246439 and 20211245708.; Reporter's Comments: This spontaneous report received from a health care professional concerned a 59 year old male. The patient's weight was 155 pounds, and height was 70 inches. The patient's concurrent conditions included: drink alcohol occasionally, cannabis use occasional, and smoke 1/2 packet per day, and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar event and had no adverse event after any previous vaccination. The patient had no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days, with cause. It was unknown about the family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211246488, 20211246559, 20211246474, 20211246517, 20211246432, 20211246471, 20210955494, 20211245708 and 20211246439,
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000208034.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: EYESIGHT IMPROVED TO A POINT THAT PATIENT DID NOT NEED TO WEAR GLASSES; 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. The patient's concurrent conditions included: patient was wearing glasses 15 years ago since the shot. The patient received covid-19 vaccine ad26.cov2.s (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 eyesight improved to a point that patient did not need to wear glasses. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eyesight improved to a point that patient did not need to wear glasses was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Cardiac disorder
Clinical narrative: HEART PROBLEM; ALLERGY FROM JANSSEN VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problem and allergy from janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart problem and allergy from janssen vaccine was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoporosis, 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, 01 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced breakthrough infection. The patient experienced symptoms included mild sore throat and felt tired and then first took coronavirus disease-19 (COVID-19) rapid point of care (POC) test that came back positive. Then on 01-NOV-2021, the patient again underwent laboratory test which included COVID-19 polymerase chain reaction (PCR) test that came out positive as well which resulted in confirmed clinical vaccination failure. She also visited to physician office. Reportedly, she received the monoclonal antibody treatment for COVID-19. Her symptoms were resolved more than a month ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208046.; Sender's Comments: V0:20211247875-covid-19 vaccine ad26.cov2.s- breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211247875-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Injection site pain, Pain, Pyrexia
Clinical narrative: FLU LIKE BODY ACHES THAT WAS REALLY BAD; CHILLS; MILD FEVER; SORE ARM ON INJECTION SITE FELT LIKE PUNCH IN THE ARM FELT LIKE SORE FOR A WHILE; DID NOT FEEL CLEAR HEADED AND FELT UNCOMFORTABLE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild asthma, and sulfonamide allergy, and other pre-existing medical conditions included: The patient's mother had pre-eclampsia. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient experienced did not feel clear headed and felt uncomfortable, mild fever, and sore arm on injection site felt like punch in the arm felt like sore for a while. On 13-APR-2021, the patient experienced flu like body aches that was really bad, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like body aches that was really bad, and chills on 13-APR-2021, did not feel clear headed and felt uncomfortable, and sore arm on injection site felt like punch in the arm felt like sore for a while on 19-APR-2021, and mild fever on 18-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient vvia 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 (dose number series-1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on NOV-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 DEC-2021, the patient reported that "The vaccine really works. patient had vaccine in NOV-2021 and now laying here in bed with covid (suspected clinical vaccination failure) waiting for appointment for an antibody transfusion at 2". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208134; Sender's Comments: V0:20211248388-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: Cardiomyopathy, Haemorrhage, Peripheral swelling
Clinical narrative: CARDIOMYOPATHY; BLEEDING ISSUES; SWELLING OF HANDS; This spontaneous report received from a consumer concerned a 50 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hepatitis b-cured, and other pre-existing medical conditions included: Patient had no previous heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported,1 total administered on 22-NOV-2021 at left arm for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 24-NOV-2021, two days later after receiving the vaccine, the patient started to have bleeding issues, swelling of hands and legs and was hospitalized (date unspecified) and was diagnosed with cardiomyopathy on the day of reporting. Consumer stated and would also like to know if the company would help pay for his bills and if he can be transferred to a research facility to study effects of post vaccine. Number of hospitalization days were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiomyopathy, bleeding issues and swelling of hands was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20211248452-covid-19 vaccine ad26.cov2.s -Cardiomyopathy, bleeding issue and swelling of hands. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: DIED OF COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "My Brother took your vaccine, he died of covid soon thereafter!" (Suspected vaccination failure). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0- 20211248611-Covid-19 vaccine ad26.CoV-2.s- Died of COVID. 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. :20211248611-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination 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; Reported Cause(s) of Death: COVID-19
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: LEFT HAND HAS TREMBLING SENSATION THAT COMES AND GOES AWAY; TINGLING SENSATION IN THE TIPS OF FINGERS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and ergocalciferol.  On an unspecified date, the patient experienced left hand fingers trembling sensation that comes and goes away, and tingling sensation in the tips of fingers. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in the tips of fingers, and had not recovered from left hand fingers trembling sensation that comes and goes away. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 74 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, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-NOV-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20211247645.