chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19 pneumonia, Cardiac disorder, Gait disturbance, Inappropriate schedule of product administration
Clinical narrative: This spontaneous report received from a patient concerned a 53 year old female. Initial information was processed along with additional information received on 10-FEB-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 01-MAY-2021 for prophylactic vaccination and also received additional dose of Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date in DEC-2021, the patient experienced COVID-19 and was hospitalized for six days due to being sick with COVID, low oxygen levels (oxygen saturation low), double pneumonia (bilateral pneumonia, coded as Covid-19 pneumonia), difficulty in walking and breathing and was prescribed steroids. On an unspecified date, the patient experienced asthma, ongoing heart condition (heart disorder) and tachycardia. The date of hospitalization was not reported. The patient had occasional pain, muscle aches, headaches and tiredness and was prescribed amitriptyline (dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The patient was recovering from Covid-19 pneumonia, had not recovered from asthma, heart disorder, and tachycardia, and the outcome of difficulty in walking, inappropriate schedule of vaccine administered and off label use was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000217009. This case, involving the same patient is linked to 20220225398 and 20220235226. Sender's Comments: V0:20220222411-COVID-19 VACCINE AD26.COV2.S- Covid-19 pneumonia, difficulty in walking, asthma, heart disorder, tachycardia. 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Oxygen saturation, Tachycardia
Clinical narrative: This spontaneous report received from a patient concerned a 53 year old female. Initial information was processed along with additional information received on 10-FEB-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 01-MAY-2021 for prophylactic vaccination and also received additional dose of Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date in DEC-2021, the patient experienced COVID-19 and was hospitalized for six days due to being sick with COVID, low oxygen levels (oxygen saturation low), double pneumonia (bilateral pneumonia, coded as Covid-19 pneumonia), difficulty in walking and breathing and was prescribed steroids. On an unspecified date, the patient experienced asthma, ongoing heart condition (heart disorder) and tachycardia. The date of hospitalization was not reported. The patient had occasional pain, muscle aches, headaches and tiredness and was prescribed amitriptyline (dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The patient was recovering from Covid-19 pneumonia, had not recovered from asthma, heart disorder, and tachycardia, and the outcome of difficulty in walking, inappropriate schedule of vaccine administered and off label use was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000217009. This case, involving the same patient is linked to 20220225398 and 20220235226. Sender's Comments: V0:20220222411-COVID-19 VACCINE AD26.COV2.S- Covid-19 pneumonia, difficulty in walking, asthma, heart disorder, tachycardia. 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: M
Vaccine: COVID19
Symptoms: Gait inability, Inappropriate schedule of product administration, Off label use, Pain in extremity
Clinical narrative: COULD NOT WALK; LEGS HURT SO BAD FOR 3 DAYS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from social media a patient via a company representative concerned a male of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: a medical condition on the spine (spinal arteriovenous malformation (AVM)). On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s, (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, (Dose number in series: 1) 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced legs hurt so bad for 3 days and couldn't walk (Dose number in series: 1). The patient recovered from legs hurt so bad for 3 days and outcome of couldn't walk was not reported. On an unspecified date after series 1, the patient had received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, (Dose number in series: 2) 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced legs hurt so bad for 3 days and couldn't walk (Dose number in series: 2). The patient recovered from legs hurt so bad for 3 days and outcome of couldn't walk was 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, 1 total administered for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (Dose number in series: 3). 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 could not walk, and legs hurt so bad for 3 days (Dose number in series: 3). As per reporter it was reported that "I have taken all three doses. I have a medical condition on the spine (AVM). With each dose my legs hurt so bad for 3 days I couldn't walk. Not sure I want to go thru it again." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs hurt so bad for 3 days, and the outcome of could not walk, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220220578 (Dose series 1) and 20220222825 (Dose series 2).
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via media via a company representative 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event following vaccination with covid-19 vaccine (dose number series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that I know of a person that got the booster and died that night from blood clots. I have no reason to lie, everyone that works with this person knows what happened and why. It was the 3rd shot. This person was a supervisor, got his shot and didn't come back to work ever again. On an unspecified date, the patient experienced blood clots (dose number in series 2). On an unspecified date, the patient died from blood clots. 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).; Sender's Comments: V0:20220224715-COVID-19 VACCINE AD26.COV2.S-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: BLOOD CLOTS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with MRNA 1273 (Dose Number in Series 1) (Moderna vaccine, route of administration, dose, batch number 039B21A,expiry 02-OCT-2021 (first shot) and received the second dose on 12-MAY-2021 (batch number 022C21A, expiry 23-DEC-2021 (second shot). The patient had a reaction to both the shots.(dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2)(suspension for injection, intramuscular, batch number:213D21A, expiry: UNKNOWN) dose not reported, 1 total administered on 15-DEC-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 10-FEB-2022, the patient experienced confirmed clinical vaccination failure, and confirmed covid-19 infection. (Dose number in series 2). The patient did two rapid tests at home, one was negative and one was positive. As per the advice of her doctor she got tested again at the county testing site on 10-FEB-2022 for a Covid test, and they contacted her back with a positive test result. They had done a rapid test and a PCR (polymerase chain reaction) test. The patient did not specify any symptoms but reported that she does not have a fever. The patient also enquired if there was a problem with asthma and the Janssen booster. Laboratory data included: On 10-FEB-2022, COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive, and COVID-19 rapid POC test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) positive, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report is associated with a product quality complaint number 90000217187.; Sender's Comments: V0:20220230227-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination 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: COVID-19
Clinical narrative: This spontaneous report received from a patient through 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 past medical history included: Covid-19. 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. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced have Covid-19 again presently. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have Covid-19 again presently was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217338. The suspected product quality complaint has been confirmed to be voided (reported complaints were adverse events, hence was confirmed as voided. based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: MYSTERIOUSLY DIED AFTER GETTING VACCINATED; This spontaneous report received from a consumer via a company representative concerned multiple patients (2 patients) of unknown 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, batch number and expiry date were not reported) dose not reported, 1 total, 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.  It was reported that "I know 2 different people who mysteriously died after getting vaccinated. I just hope we all live". On an unspecified date, the patient mysteriously died after getting vaccinated. On an unspecified date, two patient's died from unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220231988-COVID-19 VACCINE AD26.COV2.S- mysteriously died after getting vaccinated. 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: Herpes zoster
Clinical narrative: This spontaneous report received from a consumer via company representative through social media (J&J Corporate) concerned a patient of unspecified age and sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 shingles. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20220231933.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media through company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. It was unspecified whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1).  The patient received booster 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, 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, 4 hours after taking the booster shot the patient died (dose number in series 2). The patient died from unknown cause of death. It was unspecified if an autopsy was performed. It was reported that "My friend's mom dropped dead 4 hours after taking the booster. I refuse to take it." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death).; Sender's Comments: V0: 20220234178-COVID-19 VACCINE AD26.COV2.S-Death. 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. Therefore, this event is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Bacterial infection, Suspected COVID-19, Vaccination failure
Clinical narrative: SECONDARY BACTERIAL INFECTION IN NECK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient 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 admin not reported, batch number: unknown, expiry date: 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 secondary bacterial infection in neck, suspected clinical vaccination failure, and suspected covid-19 infection. It was reported that, "I caught covid from someone who had vaccine and all booster shots. I contracted it from him. Covid caused a secondary bacterial infection in my neck which I had to go through two operations while under the effects of covid. No doubt covid caused my secondary bacterial infection. I am lucky to still be alive and if the vaccine worked all that would have never happened."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, secondary bacterial infection in neck and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217483. This case, from the same reporter is linked to 20220234118.; Sender's Comments: V0: 20220234819-COVID-19 VACCINE AD26.COV2.S- secondary bacterial infection in neck. 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. 20220234819-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination 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: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: This spontaneous report received from a consumer concerned a 64 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously treated with Covid-19 vaccine ad26.cov2.s (dose number in series:1) (suspension for injection, intramuscular, batch number and expiry date not reported) dose was not reported, 1 total administered on 01-MAR-2021 for prophylactic vaccination. The patient experienced headache and sinus disorder when treated 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, intramuscular, batch number and expiry date not reported) dose was not reported, 1 total administered (off label use, and inappropriate schedule of vaccine administered) on 01-OCT-2021 for prophylactic vaccination.(dose number in series: 2).The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to JAN-2022 for psoriasis. No concomitant medications were reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220228734.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via 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 were not reported) 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 experienced blood clots, and covid-19 (suspected clinical vaccination failure and suspected covid-19 infection). The reporter stated, "Got blood clots after Vax. Then covid19, out of work 18 days". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, 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 a product quality complaint.; Sender's Comments: V0 20220236442-COVID-19 VACCINE AD26.COV2.S-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. V0 20220236442-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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient via social media via a company representative concerned a patient 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, 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 got Covid (suspected covid-19) and reported that none of the vaccines worked (suspected clinical vaccination failure). Patient stated that, "None of the vaccines are working. It is simply a moneymaker for those in power who want to stay in power. I got JnJ then got Covid. My mum died and I could not go to her funeral. I also missed my uncle's funeral. People will not easily forgot how much pain has been inflicted by these lies and corruption. It will all come out one day." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217704.; Sender's Comments: V0: 20220236761-COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination 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: M
Vaccine: COVID19
Symptoms: Cardiac failure, Death, Renal failure, Thrombosis
Clinical narrative: DIED; HEART FAILURE; KIDNEY FAILURE; BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned a 20 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 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 experienced heart failure due to blood clots, kidney failure due to blood clots, and blood clots. On APR-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated, "My nephew died after receiving the vaccine. Heart and kidney failure due to blood, he just turned 20 in JAN-2021. he died APR-2021". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on APR-2021, and the outcome of heart failure, kidney failure and blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220236791-Covid-19 vaccine ad26.cov2.s-Died, heart failure, kidney failure and 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: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: 11 INCH BLOOD CLOT IN LUNG; This spontaneous report received from a consumer via a company representative via social media concerned a male patient 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 and expiry were not reported) 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 11 inch blood clot in lung. The reporter stated that, "My good friend took the shot and a week later almost died with a 11 inch blood clot in his lung". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 11 inch blood clot in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220236850-covid-19 vaccine ad26.cov2.s- 11 inch blood clot in lung. 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: M
Vaccine: COVID19
Symptoms: Back pain, Catheterisation cardiac, Chest pain, Computerised tomogram, Heart rate
Clinical narrative: This spontaneous report received from a consumer concerned a 55 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: 206A21A and expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel, colecalciferol, and metoprolol succinate.  On an unspecified date, the patient experienced swelling left leg, skin irritation on legs, occasional charlie horses in legs, knots in calves, back pain, chest pain, rapid pulse elevated to 20 bpm for over an hour to two hours, edema, calf pain, and pain left shoulder blade. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative, Cardiac catheterization (NR: not provided) fine, Diagnostic ultrasound (NR: not provided) detected no clots, and Pulse rate (NR: not provided) rapid. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from edema, had not recovered from pain left shoulder blade, back pain, chest pain, and rapid pulse elevated to 20 bpm for over an hour to two hours, and the outcome of calf pain, swelling left leg, skin irritation on legs, occasional charlie horses in legs and knots in calves was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Muscle spasms, Musculoskeletal pain, Nodule, Oedema
Clinical narrative: This spontaneous report received from a consumer concerned a 55 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: 206A21A and expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel, colecalciferol, and metoprolol succinate.  On an unspecified date, the patient experienced swelling left leg, skin irritation on legs, occasional charlie horses in legs, knots in calves, back pain, chest pain, rapid pulse elevated to 20 bpm for over an hour to two hours, edema, calf pain, and pain left shoulder blade. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative, Cardiac catheterization (NR: not provided) fine, Diagnostic ultrasound (NR: not provided) detected no clots, and Pulse rate (NR: not provided) rapid. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from edema, had not recovered from pain left shoulder blade, back pain, chest pain, and rapid pulse elevated to 20 bpm for over an hour to two hours, and the outcome of calf pain, swelling left leg, skin irritation on legs, occasional charlie horses in legs and knots in calves was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin irritation, Ultrasound scan
Clinical narrative: This spontaneous report received from a consumer concerned a 55 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: 206A21A and expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel, colecalciferol, and metoprolol succinate.  On an unspecified date, the patient experienced swelling left leg, skin irritation on legs, occasional charlie horses in legs, knots in calves, back pain, chest pain, rapid pulse elevated to 20 bpm for over an hour to two hours, edema, calf pain, and pain left shoulder blade. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative, Cardiac catheterization (NR: not provided) fine, Diagnostic ultrasound (NR: not provided) detected no clots, and Pulse rate (NR: not provided) rapid. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from edema, had not recovered from pain left shoulder blade, back pain, chest pain, and rapid pulse elevated to 20 bpm for over an hour to two hours, and the outcome of calf pain, swelling left leg, skin irritation on legs, occasional charlie horses in legs and knots in calves was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS (HAS TO SEE A CARDIOLOGIST AFTER GETTING THE BOOSTER); This spontaneous report received from a consumer 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. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, one total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s.  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, one 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 adverse event nos (has to see a cardiologist after getting the booster) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos (has to see a cardiologist after getting the booster) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT VERY SICK; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got very sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220236638 and 20220236731.
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: DEATH; HEART ATTACK; This spontaneous report received from a patient via a company representative 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, 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, after two days of vaccination, the patient experienced heart attack then slowly went down hill and died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated that  "Hey Johnson and Johnson my dad got the shot and 2 days later had a heart attack. Then slowly went down hill and died. Thanks a lot for killing my dad. You will pay for what you've done." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date,  and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-20220237253 -COVID-19 VACCINE AD26.COV2.S-Death, Heart attack. 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: Headache, Pain in extremity
Clinical narrative: PAIN IN ARM; BAD HEADACHES; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced pain in arm, and bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and bad headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON FACE AND NECK; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (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 on 08-MAR-2021 for prophylactic vaccination. On an unspecified date, she then felt her face and neck were sore (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 05-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-NOV-2021, the patient experienced rash on her whole face down to the chin, and neck (dose number in series 2). Patient consulted her MD (doctor of medicine) who said that this rash would go, but as per the patient it was still there. Patient also consulted a dermatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on face and neck. This report was non-serious. This case, involving the same patient is linked to 20220238207.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative from social media  concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer 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. 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 was sick and had suspected clinical vaccination failure, and suspected covid-19 infection. The reporter stated, "I had a niece and her family who had been vaccinated and caught COVID 3 times. The last time she was very sick". 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 a product quality complaint: 90000217868 This case, from the same reporter is linked to 20220239628.; Sender's Comments: V0. 20220239490-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: Abdominal pain, Death
Clinical narrative: ABDOMINAL PAIN; DIED; This spontaneous report received from a consumer via social media via a company representative concerned a 100 year old male of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was in good health prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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.  It was reporter that "My father 100 years old in good health and still driving was taken and coaxed by his neighbor for the one-time J&J COVIC vaccination shot. He developed abdominal pain. Hospital one month, nursing home one month, four months later at home, dead! End of health and life." The patient died of unknown cause on an unspecified date. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abdominal pain was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220239600- covid-19 vaccine ad26.cov2.s-died, abdominal pain. 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: COVID-19
Clinical narrative: CAUGHT COVID THREE TIMES; This spontaneous report received from a consumer via social media  via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 caught covid three times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of caught covid three times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000217865. This case, from the same reporter is linked to 20220239490.