chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; This spontaneous report received from a patient concerned a 34-year-old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced joint pain, and fever (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and joint pain was not reported. On an unspecified date, the patient received booster dose of covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported (dose number in series: 2) to left arm for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2). This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Balance disorder, Blood pressure increased, Blood pressure measurement, Feeling abnormal
Clinical narrative: This spontaneous report received from a patient concerned a 73-year-old white and non-Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 19-SEP-2021) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included chewable airborne. Ascorbicacid/herbalnos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc).  On an unspecified date, laboratory data included: Blood pressure 105/60 millimetres of mercury. On 07-APR-2021, the patient did not feel well within minutes after vaccination. The patient asked a nurse to check her after the 15-minute wait. The emergency medical technician checked blood pressure of patient and it was elevated to 190/80 millimetres of mercury. The emergency medical technician checked blood pressure of patient again, after about 15 minutes and it was 180/70 millimetres of mercury at 17:20. When patient was walking to her car to leave her nostrils closed, lips itched, eyeballs felt funny. The patient was still trying to get home with her special needs child. The patient did not feel it effect lungs. The feeling wore off in approximately five hours. Blood pressure of patient was 137/68 millimetres of mercury at 23:00 that night. Next morning (08-DEC-2021) patient felt wobbly, shaky and felt like she was coming down with something. The patient lost her zip lock bag with all the cards and could not find it in the car, so she drove back to the vaccination site to try and find the bag with the cards. Did not find them there. Patient then drove home, and, in the morning, patient called the vaccination site gymnasium to try and locate the cards. The patient found the cards at the vaccination site. The patient recovered from blood pressure increased, nostrils closed, lips itched, eyeballs felt funny, shaky, wobbly, felt like coming down with something, and did not feel well on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260647-COVID-19 VACCINE blood pressure increased. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Malaise, Nasal congestion, Tremor
Clinical narrative: This spontaneous report received from a patient concerned a 73-year-old white and non-Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 19-SEP-2021) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included chewable airborne. Ascorbicacid/herbalnos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc).  On an unspecified date, laboratory data included: Blood pressure 105/60 millimetres of mercury. On 07-APR-2021, the patient did not feel well within minutes after vaccination. The patient asked a nurse to check her after the 15-minute wait. The emergency medical technician checked blood pressure of patient and it was elevated to 190/80 millimetres of mercury. The emergency medical technician checked blood pressure of patient again, after about 15 minutes and it was 180/70 millimetres of mercury at 17:20. When patient was walking to her car to leave her nostrils closed, lips itched, eyeballs felt funny. The patient was still trying to get home with her special needs child. The patient did not feel it effect lungs. The feeling wore off in approximately five hours. Blood pressure of patient was 137/68 millimetres of mercury at 23:00 that night. Next morning (08-DEC-2021) patient felt wobbly, shaky and felt like she was coming down with something. The patient lost her zip lock bag with all the cards and could not find it in the car, so she drove back to the vaccination site to try and find the bag with the cards. Did not find them there. Patient then drove home, and, in the morning, patient called the vaccination site gymnasium to try and locate the cards. The patient found the cards at the vaccination site. The patient recovered from blood pressure increased, nostrils closed, lips itched, eyeballs felt funny, shaky, wobbly, felt like coming down with something, and did not feel well on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260647-COVID-19 VACCINE blood pressure increased. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Death
Clinical narrative: DIED AFTER RECEIVING THE JAB; HEART DAMAGE; This spontaneous report received from a consumer via social media  from 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 (Dose number in series 1) (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. 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 patient (reporter's great aunt) experienced " heart damage and died after receiving the jab". On an unspecified date, the patient died from unknown cause of death and it was unspecified whether an autopsy was performed.(Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of heart damage was not reported. This report was serious (Death). This case, from the same reporter is linked to 20211260953, 20211261664  and 20211261168.; Sender's Comments:  20211260743 -covid-19 vaccine ad26.cov2.s- Died after receiving the jab. 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: U
Vaccine: COVID19
Symptoms: Retinal tear
Clinical narrative: This spontaneous report received from a patient via a 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 (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, 1 total, administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced torn retina for which patient had surgery. The reporter stated that, "I just read your post 2 to 3 weeks after shot torn retina. One-week later 2d torn retina. Same eye different location. 4th surgery coming 1 by 4." The action taken with covid-19 vaccine was not applicable. The outcome of torn retina was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260786-COVID-19 VACCINE Torn retina. 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: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients (5 patients) of unspecified age, race and ethnicity.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 in 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, five patients died from unknown cause of death. As per the report, it was stated as "I know 5 who have died from the jab too. its terrible the info we are fed" (Dose number in series 1). 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).; Sender's Comments: V0: 20211260837-COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm recurrence
Clinical narrative: CANCER HAD COME BACK MUCH WORSE AND HAD RAPIDLY SPREAD; This spontaneous report received from a consumer via social media from a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: cancer, for which the patient was declared cancer free. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (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 numbers. No concomitant medications were reported.  The reporter stated that "My niece had cancer and beat it, she was declared cancer free. She received the shot two weeks later and a month later at a check-up they discovered the cancer had come back much worse and had rapidly spread. Her doctor verified the covid shot had caused it to come back. She is again fighting for her life because it came back so fast and with a vengeance". (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer had come back much worse and had rapidly spread was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260912-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cancer had come back much worse and had rapidly spread. 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: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; MILDLY TIRED; This spontaneous report received from a patient 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. On an unspecified date, the patient was previously treated with non-company vaccine BNT162 (Pfizer) (dose number in series: 1) (Form of admin, route of admin, batch number and expiry were Unknown) dose was not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series: 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: Unknown) dose, start therapy date were not reported, administered 1 in 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 sore arm and mildly tired (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm and mildly tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Disability
Clinical narrative: PERMANENT DISABILITY; SERIOUS HEART PROBLEMS AND PERMANENT HEART DAMAGE; This spontaneous report received from a patient via social media through 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 administration not reported, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered start therapy date were not reported for prophylactic vaccination (Dose number in series was 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient reported that "Thanks for the Covid Vaccine that caused serious heart problems, permanent heart damage and heart medication oh and permanent disability." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the serious heart problems and permanent heart damage and permanent disability was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0:20211260942-Covid-19 vaccine ad26.cov2.s-Permanent disability. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: ARM SORENESS; SLIGHT HEADACHE; SLIGHT MUSCLE SORENESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: contrast dye allergy. The patient experienced drug allergy when treated with ampicillin, clindamycin, and gemifloxacin mesilate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced arm soreness, slight headache, and slight muscle soreness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and slight headache, and slight muscle soreness on 19-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned an 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 not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: ALMOST KILLED ME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 almost killed me. Laboratory data (dates unspecified) included: Lab test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost killed me was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Peripheral swelling, Restlessness, Swollen tongue
Clinical narrative: WEDDING RING WOULD NOT GO ON; FACE FELT LIKE IT WAS DIFFERENT BUT DOSE NOT LOOK DIFFERENT; FELT TIRED; RESTLESS THROUGHOUT THE NIGHT; AFTER ABOUT 2 HOURS HER TONGUE STARTED TO SWELL; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-DEC-2021, the patient experienced after about 2 hours her tongue started to swell, and restless throughout the night. On 28-DEC-2021, the patient experienced wedding ring would not go on, face felt like it was different but dose not look different, and felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from after about 2 hours her tongue started to swell, felt tired, and face felt like it was different but dose not look different, and the outcome of wedding ring would not go on and restless throughout the night was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old White female of unspecified ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: shingles disease.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204AZ1A or 204A21A and expiry: unknown) dose was not reported, 1 total was administered to left arm on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that since 15-NOV-2021, the patient has been working from home. On an unspecified date, the patient had tested negative with the rapid home kit test (covid-19 rapid POC (point of care) test). On 27-DEC-2021, the patient started experiencing covid-19 symptoms of sore throat, tiredness, achiness, a little fever, runny nose, fatigue, headache and loss of smell (coded as suspected clinical vaccination failure, and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211263758. This report was associated with product quality complaint: 90000209256.; Sender's Comments: V0; 20211261116-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: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a parent via a 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) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number.  No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection (Dose number in series 1) (reported as "had it"). The mother reported, "three in my family chose to get the J and J vax. I know you get "no love". I have been exposed multiple times. Daughter had it, hubby and I did not. We all boosted with J and J too".  The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series was 2). It was unknown whether patient had any adverse event following vaccination with 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 covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000209140. This case, from the same reporter is linked to 20211261133 and 20211261154.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, reporter reported that "My great aunt's daughter also suffered the jab damage, blood clots in the brain massive stroke. She had not recovered. Unfortunately, they did not get the placebo or the saline jab, they got the actual experimental drug." The action taken with covid-19 vaccine was not applicable. The patient had not recovered from blood clots in brain and massive stroke. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211260743 and 20211260953.; Sender's Comments: V0: 20211261168-covid-19 vaccine Blood clots in brain, massive stroke. 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: Blindness unilateral, Eye haemorrhage
Clinical narrative: This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, gender, 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 (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination (Dose number series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, patient reported that "My eye was hemorrhaging, leaving me legally blind in one eye, very soon after the shot. I am going for a second opinion on the treatment and dismal outcome." The action taken with covid-19 vaccine was not applicable. The outcome of the hemorrhage eye and legally blind in one eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211261203-COVID-19 VACCINE hemorrhage eye, legally blind in one eye -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: Dyspnoea, Respiratory tract congestion
Clinical narrative: SHORTNESS OF BREATH; CHEST CONGESTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 shortness of breath, and chest congestion. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, oxymetazoline hydrochloride, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest congestion and shortness of breath was not reported. This report was non-serious. This case, from the same reporter is linked to 20211258792.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Death, Vertigo
Clinical narrative: DIED; BRAIN FILLED WITH BLOOD CLOTS; VERTIGO LIKE SYMPTOMS; This spontaneous report received from a consumer 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 not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced brain filled with blood clots, vertigo like symptoms and died from unknown cause of death. Reporter Stated as " My brother died after receiving the jab! He developed Vertigo like Systems. His brain was filled with Blood clots" It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo like symptoms and brain filled with blood clots was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211260953 and 20211260743.; Sender's Comments: V0:  20211261664-covid-19 vaccine ad26.cov2.s- Died, Brain filled with blood clots. 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: Death, Myocardial infarction
Clinical narrative: DEATH; HEART ATTACK; This spontaneous report received from a patient via social 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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 attack and the patient died". It was unspecified if an autopsy was performed. Cause of death was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died 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: 20211261673 -COVID-19 VACCINE AD26.COV2.S-Death, Heart attack. 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
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: SORE ARM; STARTED TO GET WEAK; TIRED FEELING; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, started to get weak, and tired feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, started to get weak, and tired feeling. This report was non-serious. This case, from the same reporter is linked to 20211261150.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pyrexia, Suicidal ideation
Clinical narrative: CONTEMPLATING SEPPUKU; SHOOK UNCONTROLLABLY; DID NOT GET TO SLEEP UNTIL LIKE 8 AM; CHILLS; 103 FEVER; This spontaneous report received from a patient via 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 not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, dose number in series 1, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, patient had 103 degrees Fahrenheit fever and chills so bad that patient get shook uncontrollably after moved an inch and touched the cooler part of the sheets (shaking). Patient did not get to sleep until like 8 am (difficulty sleeping) and also stated about contemplated seppuku to be honest (Suicidal ideation) (dose number In Series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 103 fever, chills, shook uncontrollably, did not get to sleep until like 8 am and contemplating seppuku was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211261770-COVID-19 VACCINE AD26.COV2.S-Contemplated seppuku (Suicidal ideation). This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: CONTEMPLATING SEPPUKU; SHOOK UNCONTROLLABLY; DID NOT GET TO SLEEP UNTIL LIKE 8 AM; CHILLS; 103 FEVER; This spontaneous report received from a patient via 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 not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, dose number in series 1, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, patient had 103 degrees Fahrenheit fever and chills so bad that patient get shook uncontrollably after moved an inch and touched the cooler part of the sheets (shaking). Patient did not get to sleep until like 8 am (difficulty sleeping) and also stated about contemplated seppuku to be honest (Suicidal ideation) (dose number In Series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 103 fever, chills, shook uncontrollably, did not get to sleep until like 8 am and contemplating seppuku was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211261770-COVID-19 VACCINE AD26.COV2.S-Contemplated seppuku (Suicidal ideation). This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: SHARP PAIN; HAVE NOT FELT QUITE RIGHT SINCE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sharp pain, and have not felt quite right since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have not felt quite right since, and the outcome of sharp pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED TO A PATIENT 30 MINUTES PAST THE 6 HOUR MARK OF INITIAL PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported (Dose number in series:1), administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced vaccine administered to a patient 30 minutes past the 6 hour mark of initial puncture.(Dose number in series:1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to a patient 30 minutes past the 6 hour mark of initial puncture was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: THREE HOSPITAL STAYS DIRECTLY AFTER TAKING THE COVID VACCINE; This spontaneous report received from a consumer via social media via a company representative concerned a male patient of unspecified age, race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included: schizophrenia. 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 (dose number in series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the patient had three hospital stays directly after taking the covid vaccine. Number of days hospitalized was unspecified. The reported stated that, "my brother who is schizophrenic has had three hospital stays directly after taking the covid vaccine. It will most likely shut down his organs for good so why vax them anymore. Just another human guinea pig". The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of three hospital stays directly after taking the covid vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211262911-COVID-19 VACCINE AD26.COV2.S-Three hospital stays directly after taking the covid vaccine. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK FOR 10 DAYS AFTER VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 sick for 10 days after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 10 days after vaccination. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID AFTER BEING VACCINATED WITH THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 39 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: 211A21A, and expiry: 14-DEC-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid after being vaccinated with the janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after being vaccinated with the janssen covid 19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: THROWING UP ALL THE TIME FOR TWO MONTHS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced throwing up all the time for two months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of throwing up all the time for two months was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Premature menopause
Clinical narrative: EARLY MENOPAUSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 numbers. No concomitant medications were reported. On an unspecified date, the patient experienced early menopause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of early menopause was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS MOSTLY AT NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient experienced flu like symptoms mostly at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms mostly at night on JUN-2021. This report was non-serious. This report was associated with product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: This spontaneous report received from a patient via social media through company representative concerned a patient of unspecified age, race, ethnicity, 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 (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (dose number in series: 1). 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 reported "I had a myocardial infarction after having the J&J but who knows?" The action taken with covid-19 vaccine was not applicable. The outcome of myocardial infarction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211263270-covid-19 vaccine Myocardial infarction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced received an expired janssen covid-19 vaccine (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired janssen covid-19 vaccine was not reported. This report was non-serious.