chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inappropriate age at vaccine administration; Infanrix was given to an adult patient instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old female patient who received DTPa (Infanrix) (batch number 7ec55, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical Assistant reported that a dose of Infanrix was given to an adult patient instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: receiving a third (extra) dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was recovered/resolved.  Additional details were provided as follows: The pharmacist called on behalf of the patient. The reporter stated that, patient forgot they had received second dose, resulting in them receiving a third dose, which led to extra dose administered. No demographics collected. The reporter did not consent to follow up.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: today dose is the third (3 dose); This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 94-year-old female patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 23rd August 2021, the patient received the 3rd dose of Shingrix. On 23rd August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter called to report that, a female patient who did not record getting 2 dose of Shingrix, went to get the supposed 2 dose but got home and realized she had had the second dose, so today dose was the third (3 dose). The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in early 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The case was reported by the patient for herself. The age at vaccination was not applicable for this report. The patient never received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose greater than 6 months./Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 13th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that 2nd dose of Shingrix greater than 6 months and 2nd dose not yet given till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up. The case had been linked with US2019129052 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019129052:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patients information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Psychotic disorder, Wheezing, X-ray
Clinical narrative: Looked like double pneumonia.; Started wheezing; Psychotic episode/psychotic episode; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Looked like double pneumonia.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PSYCHOTIC DISORDER (Psychotic episode/psychotic episode). On an unknown date, the patient experienced PNEUMONIA (Looked like double pneumonia.) (seriousness criterion medically significant) and WHEEZING (Started wheezing). The patient was treated with PREDNISONE for Adverse reaction, at an unspecified dose and frequency and SALBUTAMOL (ALBUTEROL HFA) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Looked like double pneumonia.) and WHEEZING (Started wheezing) outcome was unknown and PSYCHOTIC DISORDER (Psychotic episode/psychotic episode) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication also included antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293194 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Myocardial infarction, Pericarditis
Clinical narrative: Heart attack; Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and PERICARDITIS (Pericarditis) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant) and PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE for Pericarditis, at a dose of .6 mg once a day; IBUPROFEN for Pericarditis, at an unspecified dose and frequency and GLYCERYL TRINITRATE (NITRO [GLYCERYL TRINITRATE]) for Heart attack, at a dose of 3 shots. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PERICARDITIS (Pericarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: unknown Results were unknown.         Concomitant product was not provided by the reporter.  Patient reported that within 20 hours of receiving second dose of moderna vaccine he experienced pericarditis. Patient went to the emergency room (ER) because he thought he was having a heart attack, doctor thought so too hence he was given 3 shots of Nitro.  He was not admitted.  They ran lots of other tests. He was otherwise healthy, took no other medications. The patient went for a follow-up appointment three weeks back and still had it, and had not gone away yet. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Laboratory test, Medication error, Platelet count
Clinical narrative: HEMORRHAGIC STROKE; MEDICATION ERROR (RECEIVED A FULL SERIES OF PFIZER FOLLOWED BY JNJ VACCINE); This spontaneous report received from a consumer via a company representative concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hemorrhagic stroke, and concurrent conditions included: controlled hypertension, hyperlipidemia, and overweight. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination.  The patient received a full series of Pfizer sometime between MAR-2021 and MAY-2021.  On JUL-2021, Laboratory data included: Lab tests were normal. On 01-AUG-2021, Laboratory data included: Platelet count (NR: not provided) 4800 and the patient had 3 brain bleeds. On 11-AUG-2021, the patient had medication error (received a full series of pfizer followed by JNJ vaccine). On 16-AUG-2021, the patient experienced hemorrhagic stroke and was hospitalized for one day. On 17-AUG-2021, the patient died from hemorrhagic stroke. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error (received a full series of Pfizer followed by JNJ vaccine) was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837606 -covid-19 vaccine ad26.cov2.s- Hemorrhagic 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).; Reported Cause(s) of Death: Hemorrhagic stroke
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Fatigue, Feeling hot, Neck pain
Clinical narrative: MESSED UP / SLURRED SPEECH; HAND PAIN LIKE HITTING A NERVE; FELT TIRED; STROKE; FEELING REALLY HOT; NECK PAIN FOR 4 HOURS; This spontaneous report received from a patient concerned a 60 year old female of unspecified race and origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Non-smoker, and other pre-existing medical conditions included: The patient was healthy.  The patient work and exercise. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total administered, start therapy date were not reported (3 to 4 months ago) for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included covid-19 vaccine for prophylactic vaccination which the patient mentioned taking after JANSSEN Vaccine. On JUN-2021, the patient experienced stroke, feeling really hot, neck pain for 4 hours, hand pain like hitting a nerve and felt tired. The patient took medical attention for it but only they treated her hand pain and referred her to a hospital which she refused to do. On AUG-2021, the patient experienced messed up / slurred speech. The patient  refused and said ,she did not want to go to a doctor or hospital because she might get more sick (she mentioned Covid in her area was bad).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really hot, neck pain for 4 hours, and felt tired, and the outcome of messed up / slurred speech, hand pain like hitting a nerve and stroke was not reported This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210841218-covid-19 vaccine ad26.cov2.s -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: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MESSED UP / SLURRED SPEECH; HAND PAIN LIKE HITTING A NERVE; FELT TIRED; STROKE; FEELING REALLY HOT; NECK PAIN FOR 4 HOURS; This spontaneous report received from a patient concerned a 60 year old female of unspecified race and origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Non-smoker, and other pre-existing medical conditions included: The patient was healthy.  The patient work and exercise. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total administered, start therapy date were not reported (3 to 4 months ago) for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included covid-19 vaccine for prophylactic vaccination which the patient mentioned taking after JANSSEN Vaccine. On JUN-2021, the patient experienced stroke, feeling really hot, neck pain for 4 hours, hand pain like hitting a nerve and felt tired. The patient took medical attention for it but only they treated her hand pain and referred her to a hospital which she refused to do. On AUG-2021, the patient experienced messed up / slurred speech. The patient  refused and said ,she did not want to go to a doctor or hospital because she might get more sick (she mentioned Covid in her area was bad).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really hot, neck pain for 4 hours, and felt tired, and the outcome of messed up / slurred speech, hand pain like hitting a nerve and stroke was not reported This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210841218-covid-19 vaccine ad26.cov2.s -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).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular insufficiency, Disturbance in attention, Influenza like illness, Magnetic resonance imaging, Malaise
Clinical narrative: SHE CAN'T CONCENTRATE NOR THINK CLEARLY; VISUAL IMPAIRMENT; BLOOD CLOTS IN SPLEEN; CUT OFF BLOOD SUPPLY TO HER BRAIN; MUSCLES DETERIORATING; NOT FEELING WELL/NOT NORMAL/FEELING SICK; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63-year-old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and stroke. Concurrent conditions included: blood clots, cigarette smoker, marijuana use, and non-alcoholic. The patient experienced swollen throat and tongue when treated with olmesartan medoxomil (Benicar). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 15-MAY-2021 in the afternoon at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021, the patient experienced flu-like symptoms, achiness not feeling well and not normal. On 01-JUN-2021, the patient experienced deteriorating muscles. On 12-JUL-2021, the patient was diagnosed with blood clots in spleen which cut off blood supply to her brain and was hospitalized. On 16-JUL-2021, the patient experienced visual impairment (was not able to read questions on the questionnaire on the paper). For 5 days she was hospitalized for the same and discharged on 17-JUL-2021. On 20-AUG-2021, MRI was done, and result was not reported, on an unspecified date, the patient had another MRI scan result was not reported. On an unspecified date the patient was not able to concentrate nor think clearly. Patient has no one to take care of her and felt helpless and sick all the time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, blood clots in spleen, muscles deteriorating, visual impairment, not feeling well/not normal/feeling sick, cut off blood supply to her brain, and she can't concentrate nor think clearly. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210846635-COVID-19 VACCINE AD26.COV2.S - Blood Clots In Spleen, Cut Off Blood Supply To Her Brain,  Visual Impairment, Flu-Like Symptoms, muscles Deteriorating,  She Can't Concentrate Nor Think Clearly. 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).  20210846635-COVID-19 VACCINE AD26.COV2.S -Not Feeling Well/Not Normal/Feeling Sick. This event is labeled  and is therefore considered potentially related.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy, Thrombosis, Visual impairment
Clinical narrative: SHE CAN'T CONCENTRATE NOR THINK CLEARLY; VISUAL IMPAIRMENT; BLOOD CLOTS IN SPLEEN; CUT OFF BLOOD SUPPLY TO HER BRAIN; MUSCLES DETERIORATING; NOT FEELING WELL/NOT NORMAL/FEELING SICK; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63-year-old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and stroke. Concurrent conditions included: blood clots, cigarette smoker, marijuana use, and non-alcoholic. The patient experienced swollen throat and tongue when treated with olmesartan medoxomil (Benicar). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 15-MAY-2021 in the afternoon at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021, the patient experienced flu-like symptoms, achiness not feeling well and not normal. On 01-JUN-2021, the patient experienced deteriorating muscles. On 12-JUL-2021, the patient was diagnosed with blood clots in spleen which cut off blood supply to her brain and was hospitalized. On 16-JUL-2021, the patient experienced visual impairment (was not able to read questions on the questionnaire on the paper). For 5 days she was hospitalized for the same and discharged on 17-JUL-2021. On 20-AUG-2021, MRI was done, and result was not reported, on an unspecified date, the patient had another MRI scan result was not reported. On an unspecified date the patient was not able to concentrate nor think clearly. Patient has no one to take care of her and felt helpless and sick all the time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, blood clots in spleen, muscles deteriorating, visual impairment, not feeling well/not normal/feeling sick, cut off blood supply to her brain, and she can't concentrate nor think clearly. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210846635-COVID-19 VACCINE AD26.COV2.S - Blood Clots In Spleen, Cut Off Blood Supply To Her Brain,  Visual Impairment, Flu-Like Symptoms, muscles Deteriorating,  She Can't Concentrate Nor Think Clearly. 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).  20210846635-COVID-19 VACCINE AD26.COV2.S -Not Feeling Well/Not Normal/Feeling Sick. This event is labeled  and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Death, Hospitalisation
Clinical narrative: ENDED UP IN THE HOSPITAL; DEATH; This spontaneous report received from a consumer via a company representative from social media concerned 'multiple patients'. The patient's height, and weight were not reported.  No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.   On an unspecified date, the many patients got vaccinated and ended up in the hospital, and were hospitalized (date unspecified). The number of days of hospitalization were not reported. On an unspecified date, the patients died from an unknown cause of death. It was unspecified if an autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine was not applicable. The patients died of death and ended up in the hospital on an unspecified date. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210844140, 20210844317 and 20210844359.; Sender's Comments: V0-20210846858-COVID-19 VACCINE AD26.COV2.S-Death and Ended up in the Hospital(Fatal); These events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with amoxicillin, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry date was not reported) dose was not reported, frequency 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 21-AUG-2021, the patient experienced suspected covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. The patient experienced symptoms cough, sore throat, and runny nose on 21-Aug-2021. 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 20210846436. This report was associated with product quality complaint:90000191006; Sender's Comments: V0: 20210847490-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: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient undergone laboratory test SARS-CoV-2 IgG (Immunoglobulin G) antibody (ARF COV-2 AB IGG SPIKE), semi quantitative which came negative (less than 1.00) (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000190792.; Sender's Comments: V0: 20210849914-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Thrombosis, Ultrasound scan
Clinical narrative: NOT FEELING WELL; HEADACHE; BLOOD CLOT IN LEFT THIGH; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 170 pounds, and height was 71 inches. 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: 093A2112, and expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced flu-like symptoms, chills, the night of the vaccination for about 3 days. The patient was not feeling well after the vaccination. On 04-AUG-2021, the patient noticed a lump on his left thigh. On 05-AUG-2021, patient experienced headache which still present. On 17-AUG-2021, the patient went to the emergency room, did an ultrasound, waited there for 6 hours and was told that he had a blood clot in left thigh. He was seen by his primary health care professional on reporting date and instructed to report his symptoms. The patient was started on Eliquis (apixaban) for 3 months till further assessed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 09-APR-2021, and had not recovered from blood clot in left thigh, headache, and not feeling well. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210851502-COVID-19 VACCINE AD26.COV2.S-Blood clot in left thigh. 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: Multiple sclerosis, Suspected COVID-19, Vaccination failure
Clinical narrative: UPTICK IN MULTIPLE SCLEROSIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 42 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: knee surgery, back surgery, gall bladder surgery, lumbar (l5) discectomy, post traumatic stress disorder, fallopian tube removal, and bladder urgency, and concurrent conditions included: depression, anxiety, muscle spasms, tremors, restless leg syndrome, low vitamin D levels, pain, sleep issues, and tactile sensation. 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. 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 AUG-2021, the patient was fully vaccinated but contracted covid and experienced suspected clinical vaccination failure and on an unspecified date, the patient experienced uptick in multiple sclerosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uptick in multiple sclerosis, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191183.; Sender's Comments: V0: 20210851690-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   20210851690-Covid-19 vaccine ad26.cov2.s-Uptick in multiple sclerosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Feeling abnormal, Productive cough, SARS-CoV-2 test
Clinical narrative: WET COUGH; FELT A LITTLE OFF; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 205 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol use (once weekly), and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. No drug abuse or illicit drug usage. Patient had no past medical history and medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency one total, administered on 08-JUN-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient was symptom free from the 11-AUG-2021 until the 14-AUG-2021 and Laboratory data included: COVID-19 virus test (NR: not provided) Positive coded as (confirmed clinical vaccination failure and confirmed covid-19 infection). Then patient experienced fatigue, cough, headache and became symptoms free on 16-AUG-2021. On 25-AUG-2021, he got home from work and he felt a little off and developed a headache a wet cough. Laboratory data included: Body temperature (NR: not provided) 106.1 F. Patient had not mentioned to his health care professional about testing positive for COVID-19. He might be able to access his test results, and would be willing to provide. He did not have access to his vaccination card at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and wet cough, and the outcome of confirmed clinical vaccination failure and felt a little off was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191022.; Sender's Comments: V0-20210851723-COVID-19 VACCINE AD26.COV2.S-Confirmed Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: WET COUGH; FELT A LITTLE OFF; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 205 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol use (once weekly), and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. No drug abuse or illicit drug usage. Patient had no past medical history and medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency one total, administered on 08-JUN-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient was symptom free from the 11-AUG-2021 until the 14-AUG-2021 and Laboratory data included: COVID-19 virus test (NR: not provided) Positive coded as (confirmed clinical vaccination failure and confirmed covid-19 infection). Then patient experienced fatigue, cough, headache and became symptoms free on 16-AUG-2021. On 25-AUG-2021, he got home from work and he felt a little off and developed a headache a wet cough. Laboratory data included: Body temperature (NR: not provided) 106.1 F. Patient had not mentioned to his health care professional about testing positive for COVID-19. He might be able to access his test results, and would be willing to provide. He did not have access to his vaccination card at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and wet cough, and the outcome of confirmed clinical vaccination failure and felt a little off was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191022.; Sender's Comments: V0-20210851723-COVID-19 VACCINE AD26.COV2.S-Confirmed Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: SUDDEN HEARING LOSS ON LEFT EAR ABOUT THREE WEEKS AFTER JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient via company representative concerned a patient of 32 year old. The patient's height, and weight were not reported. Prior to vaccination patient had not visited doctor or other healthcare professional office/clinic visit and patient was not diagnosed with COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 1 total dose was administered to the left arm on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included lisdexamfetamine mesilate. On 27-JUL-2021 13:00, the patient experienced sudden hearing loss on left ear about three weeks after Johnson and Johnson vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered with sequelae from sudden hearing loss on left ear about three weeks after Johnson and Johnson vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851751- Covid-19 vaccine ad26.cov2.s- Sudden hearing loss on left ear. 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: 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 consumer concerned multiple patients. Initial information was processed along with the additional information received from central complaint vigilance Organization on 26-AUG-2021. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown)1 total dose was administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer stated that at his work place, 25 people had tested positive for Covid-19. He stated that he was unsure who they all were due to privacy, and that he did not know if and what vaccine each of them got. However, he stated that some of those 25 individuals received the Janssen Covid-19 Vaccine and still got sick with covid- 19 (suspected covid-19 infection, suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000191131.; Sender's Comments: V0: 20210851777-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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative from social media (twitter) 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, expiry: Unknown) 1 total administered, 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 was diagnosed with the covid-19 infection (suspected clinical vaccination failure) and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210852374. This report was associated with product quality complaint.; Sender's Comments: V0:20210851820-COVID-19 VACCINE AD26.COV2.S-Suspected COVID-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210851820-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 62 year old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered in left arm on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in AUG-2021, 2 Weeks ago, patient did a rapid antibody test at his local pharmacy and the results showed zero antibodies. Laboratory data included: SARS-CoV-2 rapid antibody test (NR: not provided) Negative. Patient heard that these tests that you get at a local pharmacy was not always accurate so he decided to get another test done at his doctor's office. On 20-AUG-2021 he got blood drawn and today on 25-AUG-2021 the antibody test results came back as negative. Laboratory data included: Antibody test (NR: not provided) Negative and the patient experienced confirmed immunological vaccine failure. He does not know the name of the test but it's similar to the Test. His doctor was aware of his test results and told him that these tests were not recommended. He wanted to know if he was still protected in this case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was associated with a product quality complaint: 90000191002. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852120-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative from social media  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 not reported, batch number: Unknown, expiry: Unknown) 1 total administered, 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 was diagnosed with the covid-19 infection (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210851820. This report was associated with product quality complaint.; Sender's Comments: V0: 20210852374-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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