chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT THE SHOTS AND STILL GOT COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) 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 got the shots and still got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got the shots and still got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000216213. The suspected product quality complaint has been confirmed to be the reported event is not associated with a product defect or product performance issue. this customer preference case has been assessed and does not represent a product quality complaint. the disposition/root cause determination was documented properly and the product record closed. based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 08-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injury, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; INJURIES; CHRONIC  FATIGUE; This spontaneous report received from a patient via social media via a company representative concerned multiple patients. It concerned two patients of unspecified age, gender, race and ethnicity. The patients' height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients 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. 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 the patients had experienced pulmonary embolism after the vaccination and had chronic fatigue since their vaccination. On an unspecified date, the patients also had injuries. On an unspecified date, it was reported "I refuse to take any of the vaccines, 2 of my friends had pulmonary embolisms after their shots and have had chronic fatigue since their''. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, chronic fatigue and injuries was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220217362.  Version created to amend previously reported information on 04-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220213367-COVID-19 VACCINE AD26.COV2.S-pulmonary embolism. 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: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: LITTLE SIDE EFFECTS; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, 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 previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown), dose was not reported, 1 total administered for prophylactic vaccination.  On an unspecified date, the patient experienced little side effects following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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 had little side effects following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series:2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20220210428 (Dose number in series: 1). This case, from the same reporter is linked to 20220216041 and 20220210047.  Version created to amend previously reported information on 03-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH (5 PEOPLE KILLED); This spontaneous report received from a consumer via a social media via a company representative concerned multiple patients (5 people) of unspecified age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total 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 patients experienced death (5 people killed). On an unspecified date, the patients died from unknown cause of death. It was unknown whether an autopsy performed. It was reported that "I know 5. Should be pulled immediately J&J Stop killing people". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 05-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220216228 -COVID-19 VACCINE AD26.COV2.S-Death(5 people killed). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Swelling
Clinical narrative: SWOLLEN KNEES; SWOLLEN FEET; SWOLLEN WRISTS; SWOLLEN NECK; This spontaneous report received from a consumer via a company representative concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced swollen knees, swollen feet, swollen wrists, and swollen neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen knees, swollen feet, swollen wrists and swollen neck was not reported. This report was non-serious.  Version created to amend previously reported information on 06-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN EACH LUNG; This spontaneous report received from a consumer via social media through a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, 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 clots in each lung. It was reported by reporter that, "Cousin has blood clots in each lung." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in each lung was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220161645.  Version created to amend previously reported information on 06-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid); Sender's Comments: V1- Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220217296-covid-19 vaccine ad26.cov2.s-Blood clots in each 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: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEM CAUSED BY THE VACCINE; This spontaneous report received from a consumer via a social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problem caused by the vaccine. On an unspecified date, the patient died from heart problem caused by the vaccine. It was unknown if an autopsy was performed. The reporter stated, " I have a relative who has passed away of heart problem caused by the vaccine as the forense reported". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 08-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1 - Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events  20220220915 -COVID-19 VACCINE AD26.COV2.S- Heart problem caused by the vaccine. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: HEART PROBLEM CAUSED BY THE VACCINE
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Mobility decreased
Clinical narrative: BACK SORE; CAN BARELY GET OUT OF BED; ALL JOINTS SORE; This spontaneous report received from a patient via a 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. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series: 1) (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination. No adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (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, and batch number were not reported) dose, 1 total, 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, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2), the patient experienced back sore, all joints sore, and can barely get out of bed. The reporter stated that "I work construction. since my booster my back is sore along with all my joints. And i can barely get out of bed. I have not missed a day in over a year so iam not a whiner. And for those who say believe in science. Its not a vaccine by definition. Vaccines you get once". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back sore, all joints sore and can barely get out of bed was not reported. This report was non-serious.  Version created to amend previously reported information on 09-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: CHANGED SINCE GETTING JAB (VACCINE); This spontaneous report received from a consumer via a company representative concerned a male 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, and batch number were not reported) 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 changed since getting jab (vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of changed since getting jab (vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220224739 and 20220227232.  Version created to amend previously reported information on 09-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea
Clinical narrative: DEAD; COULD NOT BREATHE; This spontaneous report received from a consumer via social media via a company representative concerned a 67 year old female of unspecified race and ethnicity. 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, and batch number were not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  The reporter stated, "My 67 year old mother in law took the shot and 15 minutes later could not breathe, 5 days later she was dead, so git you some shot". 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 dead on an unspecified date, and the outcome of could not breathe was not reported. This report was serious (Death).  Version created to amend previously reported information on 10-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220227565-covid-19 vaccine ad26.cov2.s -Dead. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via Social media concerned a female of an unspecified age, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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 JAN-2022 (a month ago from the reporting date), the patient got covid and was sick (suspected vaccination failure and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality complaint number: 90000217265. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220230241.  Version created to amend previously reported information on 24-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of  non-valid and LLT of event suspected covid-19 infection was updated from covid-19 to suspected covid-19).; Sender's Comments: V3:Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid and LLT of event suspected covid-19 infection was updated from covid-19 to suspected covid-19). This updated information does not change the causality of the previously reported events. 20220230287-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Cerebrovascular accident, Death
Clinical narrative: DEATH; HAD A STROKE; SAME PROBLEM; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered 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, consumer posted " my friend had same problem after shot and then had a stroke and died. Doctors just said health great including heart ". On an unspecified date, 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 outcome of same problem and had a stroke was not reported. This report was serious (Death, and Other Medically Important Condition).  Version created to amend previously reported information on 11-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220230403-covid-19 vaccine ad26.cov2.s -Death, Had a stroke. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a social media via a company representative 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. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. It was reported that, "that is was they want. These people are killing us. Lost my sister in law who was fully vaxed, lost a friend also vaxed, and an uncle who is critical fully vaxed. These people are playing you very badly. I am sorry you live in fear. I am not vaxed had covid it sucked but dr. Prescribed hydroxychlorquin and I took zinc and vitamin d3 felt great in 30 hrs. No hospital required. I am 43. You do not deserve this". It was unknown if an autopsy was performed. 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 20220231552 and 20220232101.  Version created to amend previously reported information on 13-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220231819-COVID-19 VACCINE AD26.COV2.S-Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; FLU; This spontaneous report received from a patient via social media 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: sensitive to new products, and other pre-existing medical conditions included: The patient had no heart problem with other vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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 suspected covid-19, and flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, and the outcome of suspected covid-19 was not reported. This report was non-serious. This case was associated with a product quality complaint: 90000217339. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 24-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) 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 covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217341. This case, from the same reporter is linked to 20220235393. The suspected product quality complaint has been confirmed that the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 28-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, 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, and batch number: unknown, expiry: unknown) dose, 1 total, 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 death, and blood clots. On an unspecified date, the patient died from unknown cause of death. The reporter stated that "blood clots is what Covid is all about and other stuff. My friend died after taking one of the other. Not Covid". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient died of death on an unspecified date, and the outcome of blood clots was not reported. This report was serious (Death, Other Medically Important Condition).  Version created to amend previously reported information on 13-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220232663- covid-19 vaccine ad26.cov2.s-Death, Blood Clots. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY; This spontaneous report received from a parent via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose, start therapy date were not reported administered 1 in total 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, exactly 1 week before surgery the patient experienced bell's palsy. The reporter stated that daughter got her vaccine a few weeks before the start of treatment for breast cancer. The patient was recently done with chemo after several month. The patient has been in therapy for it for months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 13-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Additional information received is regarding amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).. This follow up information received does not alter the assessment of prior company causality of previously reported events.  20220232686-COVID-19 VACCINE AD26.COV2.S- Bell's palsy. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative 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. 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, 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 died from unknown cause of death. The reporter stated that "My sister's coworker dropped dead at work the next morning after her shot". It was unspecified if an autopsy was performed. 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 20220233703.  Version created to amend previously reported information on 14-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220233788-Covid-19 vaccine ad26.cov2.s-Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via a social media, by a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 stroke, blood clots, and was hospitalized (date unspecified) and still in ICU (intensive care unit). It was reported that "Just had 2 coworkers in 3 weeks of each other got strokes and blood clots one is still in ICU (intensive care unit)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220234166.  Version created to amend previously reported information on 14-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events  20220234488-covid-19 vaccine ad26.cov2.s-Stroke, Blood clots. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED 4 DAYS AFTER THE VACCINATION; This spontaneous report received from a consumer via social media concerned a young female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had no pre-existing medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose and 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 died 4 days after the vaccination from an unknown cause of death. It was unspecified if an autopsy was performed. The consumer reported as "Doctors are threatened with having their licences cancelled if they represent adverse reactions and self reporting of adverse reactions is not considered reliable. A young, healthy, active mother was dead 4 days after the vax and no connection was found to the vax. She just died. No pre existing conditions."  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 20220316156.  Version created to amend previously reported information on 07-MAR-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of invalid).; Sender's Comments: V1. This follow-up version was created to amend following information: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of invalid). This amended information doesn't alter previous causality assessment made for the events in the case.  20220316497-covid-19 vaccine ad26.cov2.s-died 4 days after the vaccination. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: JOHNSON & JOHNSON COVID-19 VACCINE KILLS WOMAN; This spontaneous report received from a consumer via a company representative via social media concerned a 52 year adult 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, expiry: unknown) dose was not reported, 1 total, therapy start 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 died from unknown cause of death. As per reporter "Johnson and Johnson COVID-19 (coronavirus disease) vaccine kills woman, 52, two weeks after jab". It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 03-MAR-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend previously reported information on 03-MAR-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid). This updated information does not alter the causality of previously reported events. 20220323554-COVID-19 VACCINE AD26.COV2.S -Johnson and Johnson COVID-19 vaccine kills woman. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: BAD COVID VACCINE REACTIONS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 09-DEC-2021, the patient experienced bad covid vaccine reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad covid vaccine reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220306273, 20210333455 and 20210308223.  Version created to amend previously reported information on 10-DEC-2021. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Adverse event, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: MAJOR ADVERSE REACTION; FEELS LIKE THE WALKING  DEAD; WORSE ADVERSE REACTION; CHRONIC FATIGUE; INSOMNIA; MENOPAUSE; This spontaneous report received from a patient via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, within two weeks after receiving the vaccine, the patient experienced insomnia, and chronic fatigue (dose number in series: 1). On an unspecified date, the patient experienced major adverse reaction feels like the walking dead, (dose number in series: 1) and it was reported as Woman Feels Like the Walking Dead' After COVID9Vaccine Injuries 1st JandJ jab caused major adverse reaction" and " I went to a couple of doctors and they just said it was menopause that was causing it."  The patient received, Non-company suspect vaccine tozinameran (pfizer) (dose number in series: 2) ( form of admin, route of admin, and batch number, expiry were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis.  On an unspecified date, following vaccination with tozinameran (pfizer), the patient experienced worse adverse reaction (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the major adverse reaction, chronic fatigue, insomnia, menopause, feels like the walking dead and worse adverse reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menopause
Clinical narrative: MAJOR ADVERSE REACTION; FEELS LIKE THE WALKING  DEAD; WORSE ADVERSE REACTION; CHRONIC FATIGUE; INSOMNIA; MENOPAUSE; This spontaneous report received from a patient via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, within two weeks after receiving the vaccine, the patient experienced insomnia, and chronic fatigue (dose number in series: 1). On an unspecified date, the patient experienced major adverse reaction feels like the walking dead, (dose number in series: 1) and it was reported as Woman Feels Like the Walking Dead' After COVID9Vaccine Injuries 1st JandJ jab caused major adverse reaction" and " I went to a couple of doctors and they just said it was menopause that was causing it."  The patient received, Non-company suspect vaccine tozinameran (pfizer) (dose number in series: 2) ( form of admin, route of admin, and batch number, expiry were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis.  On an unspecified date, following vaccination with tozinameran (pfizer), the patient experienced worse adverse reaction (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the major adverse reaction, chronic fatigue, insomnia, menopause, feels like the walking dead and worse adverse reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a patient via a company representative via social media concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had seizures in 65 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total start therapy date were not reported for covid-19 prophylaxis. 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 seizures. As per reporter, "covi vaccine caused me seizures l never had seizures in 65 years But after covi vaccine l had 4 " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220863804- Covid-19 vaccine ad26.cov2.s- Seizures. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.