chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer 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, 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 12-DEC-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: DIARRHEA; FEVER; CHEST PAIN; HEADACHE; VOMITING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: sometimes general headaches, and other pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JAN-2022, the patient experienced chest pain, headache, and vomiting. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 19-JAN-2022, the patient experienced diarrhea, and fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, diarrhea, and fever, and the outcome of vomiting was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as the reporter indicates they were exposed to someone with Covid and they later felt ill but tested negative for Covid. There is no product quality issue described in the information reported. Approval to void this record due to no PQC identified) based on the PQC evaluation/investigation performed. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIARRHEA; FEVER; CHEST PAIN; HEADACHE; VOMITING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: sometimes general headaches, and other pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JAN-2022, the patient experienced chest pain, headache, and vomiting. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 19-JAN-2022, the patient experienced diarrhea, and fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, diarrhea, and fever, and the outcome of vomiting was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as the reporter indicates they were exposed to someone with Covid and they later felt ill but tested negative for Covid. There is no product quality issue described in the information reported. Approval to void this record due to no PQC identified) based on the PQC evaluation/investigation performed. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Aphonia, Inappropriate schedule of product administration, Off label use, Pneumonia, SARS-CoV-2 test
Clinical narrative: LOSS OF VOICE; SINUS INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; PNEUMONIA; This spontaneous report received from a patient concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included doxycycline. On an unspecified date, the patient received the second dose of covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose, 1 total, administered for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (dose number in series: 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date in 2021, the patient experienced sinus infection and had been sick for a month (dose number in series 1). On an unspecified date in DEC-2021, the patient experienced pneumonia (dose number in series 1). On an unspecified date, the patient experienced loss of voice (dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, had not recovered from loss of voice, and the outcome of sinus infection, off label use and inappropriate schedule of vaccine administered was not reported. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. On an unspecified date, the patient received Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2), (intramuscular, form of admin, and batch number were not reported), dose was not reported, administered for prophylactic vaccination.  The action taken with risankizumab, and Pfizer biontech covid-19 vaccine (tozinameran) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220138480--. 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: 30.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Sinusitis
Clinical narrative: LOSS OF VOICE; SINUS INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; PNEUMONIA; This spontaneous report received from a patient concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included doxycycline. On an unspecified date, the patient received the second dose of covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose, 1 total, administered for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (dose number in series: 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date in 2021, the patient experienced sinus infection and had been sick for a month (dose number in series 1). On an unspecified date in DEC-2021, the patient experienced pneumonia (dose number in series 1). On an unspecified date, the patient experienced loss of voice (dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, had not recovered from loss of voice, and the outcome of sinus infection, off label use and inappropriate schedule of vaccine administered was not reported. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. On an unspecified date, the patient received Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2), (intramuscular, form of admin, and batch number were not reported), dose was not reported, administered for prophylactic vaccination.  The action taken with risankizumab, and Pfizer biontech covid-19 vaccine (tozinameran) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220138480--. 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: Oxygen saturation, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information received on 21-JAN-2022. 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: 1855191 expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered 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 omicron (coded as suspected covid-19 infection and suspected clinical vaccination failure), and  and was hospitalized (date unspecified) for 3 days. (Dose number in series 1) Laboratory data (dates unspecified) included: Oxygen (NR: not provided) low. It was reported as "I take your vaccine and booster 4 days after I got my booster I was sick, I was in the hospital with omicron for 3 days"  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This case was associated with product quality complaint number 90000213232. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220145043 (dose number in series 2). This case, from the same reporter is linked to 20220139924.; Sender's Comments: V0: 20220139342-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20220139342-COVID-19 VACCINE AD26.COV2.S- Suspected covid-19 infection. 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: Adverse drug reaction
Clinical narrative: SIDE EFFECTS TURNED OFF SOME PEOPLE; This solicited report received from a pharmacist via an agency: COVID 19 Booster Exploration concerned multiple patients. No past medical histories or concurrent conditions were reported. The patients initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin Unknown, batch number: Unknown, expiry: Unknown) doses, start therapy dates 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. During qualitative research interview, on an unspecified date, multiple patient experienced side effects (unspecified) that turned off some people. The reporter described general perceptions of the JnJ COVID-19 vaccine and said that "side effects "turned off" some people and immunizers from JnJ COVID-19 vaccine. Also mentioned general perception that immunity does not last as long." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects turned off some people was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and side effects "turned off" some people and immunizers from j&j covid-19 vaccine as related. Company causality between covid-19 vaccine ad26.cov2.s, and side effects "turned off" some people and immunizers from J&J covid-19 vaccine was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220139723-COVID-19 VACCINE AD26.COV2.S- Side effects "turned off" some people and immunizers from J&J covid-19 vaccine. This event(s) is considered not related. 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).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: WERE ZOMBIES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced were zombies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of were zombies was not reported. This report was non-serious. This case, from the same reporter is linked to 20220141741 and 20220141910.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Movement disorder
Clinical narrative: BONE PAIN; COULD NOT GET UP FROM TOILET; This spontaneous report received from a patient concerned a female of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: herpes. The patient previously received covid-19 vaccine ad26. cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 1, 01 in total was administered on 25-JUN-2021 prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2. s, the patient experienced going to bathroom fine since vaccination, no need of taking laxative that were prescribed, edema in legs, pain in the left arm where she had the injection tired (dose number in series was 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 2, 01 in total was administered middle of buttock on 07-DEC-2021 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, following vaccination with covid-19 vaccine ad26. cov2. s, the patient told that she had bone pain bone pain and she could not get up from toilet (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bone pain and could not get up from toilet was not reported. This report was non-serious. This case, involving the same patient is linked to 20210708323.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer from social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, administered for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after taking the vaccine patient died due to unknown cause of death (dose number in series 2). It was unknown if an autopsy was performed. Reporter stated that, "it hurts to see friend died after taking vaccines". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220144897-COVID-19 VACCINE AD26.COV2.S- Died. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder, Impaired work ability
Clinical narrative: PROBLEM WITH MY BLOOD; 3 WEEKS I CAN'T WORK; This spontaneous report received from a patient via a company representative (social media) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 01 in total administered, dose and start therapy date were not reported for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sick for two weeks, oxygen was very low resulted into suspected covid-19 infection (omicron infection) (suspected clinical vaccination failure) (dose number in series was 1). On an unspecified date, patient was hospitalized for 3 days. Hospital discharge information was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, dose number in series was 2, 01 in 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, patient was hospitalized and experienced problem with blood (dose number in series was 2). The patient thought that the medicine was bad medicine for the blood also stated that the hospital gave lots of shots to thin patient's blood. The patient told that received lot off shot to thin their blood. The patient couldn't work 3 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problem with my blood and 3 weeks I can't work was not reported(dose number in series was 2). This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20220139342.; Sender's Comments: V0: 20220145043-COVID-19 VACCINE AD26.COV2.S-Problem with my blood. 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: Taste disorder
Clinical narrative: WEIRD TASTE IN MOUTH, ON TONGUE AND LIPS; This spontaneous report received from a patient 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination.  On an unspecified date, the patient experienced weird taste in mouth, on tongue and lips when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, within a few hours of booster vaccination, the patient experienced weird taste in mouth, on tongue and lips (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth, on tongue and lips on an unspecified date in JAN-2022 (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220162550.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Confirmed clinical vaccination failure; Confirmed COVID-19 Infection; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: grass allergy, alcoholic, smoker, and gout. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total, administered on 10-APR-2021 at 14:00 for prophylactic vaccination. Concomitant medications included allopurinol for gout.  On 11-APR-2021, the patient experienced body aches, fatigue, headache, joint aches and low grade fever (dose number in series 1). On 2021, treatment medications included: ibuprofen, and paracetamol for joint aches. The patient recovered from body aches, joint aches, low grade fever, headache, and fatigue on 11-APR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: unknown) dose was not reported, 1 total, administered on OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects which includes headache, sore throat, fatigue, post nasal drip, nasal congestion and cough (confirmed clinical vaccination failure, and confirmed covid-19 infection) (dose number in series 2). Patient did not experienced fever, shortness of breath and loss of taste/or smell. On 22-JAN-2022, the patient underwent Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213856. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed. This case, involving the same patient is linked to 20210832866.; Sender's Comments: V0- 20220145974 -Covid-19 vaccine ad26.CoV-2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TESTED POSITIVE; This spontaneous report received from a patient concerned a White Hispanic or Latino 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 administration not reported, batch number: 1805029, expiry: 23-AUG-2021) dose was not reported, dose number in series was 1, 01 in total was administered on 14-MAR-2021 to left arm for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s. The patient additionally received non-company suspect vaccine included: BNT 162 (Pfizer) (form of administration, route of administration, and batch number were not reported) dose was not reported, dose number in series was 2, administered on 03-DEC-2021 for prophylactic vaccination.  Patient received unspecified concomitant medications. On 23-JAN-2022, following vaccination with BNT 162, the patient tested positive with Bi Nax Now antigen take home test (coronavirus disease-19 test positive). Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 tested positive was not reported (dose number in series was 2). This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Influenza like illness, Magnetic resonance imaging, SARS-CoV-2 test, Tremor
Clinical narrative: SHAKING WHICH STARTS IN HIS STOMACH AND MOVES TO HIS CHEST AND THEN EVENTUALLY AFFECTS HIS WHOLE BODY/WHOLE BODY SHAKING SIMILAR TO PARKINSONS; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included: rectal cancer, and stroke, and concurrent conditions included: sulfur and codeine allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel bisulfate, docusate, famotidine, losartan, metoprolol succinate, and tamsulosin. On 01-APR-2021, the patient experienced flu like symptoms. On 06-APR-2021, the patient experienced shaking which starts in his stomach and moves to his chest and then eventually affects his whole body/whole body shaking similar to parkinsons. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Negative, CT scan (NR: not provided) not reported, not reported, and MRI (NR: not provided) not reported, not reported, not reported. Treatment medications (dates unspecified) included: cannabidiol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 07-APR-2021, and had not recovered from shaking which starts in his stomach and moves to his chest and then eventually affects his whole body/whole body shaking similar to parkinsons. This report was non-serious. This case, from the same reporter is linked to 20220147012 and 20220147068.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Injection site swelling, Lupus-like syndrome
Clinical narrative: INJECTION SITE SWELLING; DRUG INDUCED LUPUS; This spontaneous report received from a patient concerned a 58 year old female The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: Unknown and expiry: Unknown) dose was not reported, (dose number in series 1) 01 total, administered on 04-AUG-2021 for prophylactic vaccination. The patient developed lumps/tumors (diagnosed as marginal B-cell lymphoma) she had injection site pain which she was not sure whether due to the original or the booster and had injection site lump (dose number in series 1). The patient had not recovered from injection site pain, injection site lump and marginal B-cell lymphoma (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: Unknown) dose was not reported, (dose number in series 2) 01 total administered in left deltoid on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that she during that first dose that she received the booster and was not sure if it worsened her symptoms. On an unspecified date patient had injection site swelling which was rated as a 1/10 but it was noticeable and was still there. The patient did the blood work on 26-JAN-2022 with the diagnosis of drug induced lupus. She stated she spoke to health care professional (HCP) and she was stunned with the report, she stated she was going for additional testing in several days (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, and the outcome of drug induced lupus was not reported (dose number in series 2). This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220145846.; Sender's Comments: 20220146890-COVID-19 VACCINE AD26.COV2.S-Drug induced lupus. 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: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Expired MMR II vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients pertinent medical history and drug reactions or allergies were not reported. The concomitant therapies included sterile diluent.  On 28-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T001213 and expiration date reported as 12-JAN-2022), 0.5 milliliter for prophylaxis (expired product administered). The vaccine did not have any temperature excursions. No additional AE reported. No PQC.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Miliaria
Clinical narrative: got a large hot rash on arm where vaccine was given, below the injection site; This case was reported by a nurse via sales rep and described the occurrence of heat rash in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In November 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced heat rash. In December 2021, the outcome of the heat rash was recovered/resolved.   It was unknown if the reporter considered the heat rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: The patient received a dose of Bexsero in unknown arm and within 24 hours on 24th November 2021, the patient got a large hot rash on arm below injection site and lasted for about two weeks. The reporter consented to follow-up.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number FS734, expiry date 21st January 2022) for prophylaxis.   On 26th January 2022, the patient received the 2nd dose of Boostrix. On 26th January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter reported a patient was administered an expired dose of the Boostrix vaccine inadvertently in the left deltoid, which led to expired vaccine used. The reporter consented to follow up. The case has been linked to US2022014888, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022014888:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/complete series Shingrix, now experiencing shingles; outbreaks of shingles on feet; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (had received Zostavax in 2015).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient completed series of Shingrix and now experiencing outbreaks of shingles on his feet. The patient was asking if a booster dose or third dose was required with Shingrix. The reporter provided medical informer phone number for health care professional reference. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation were unknown at the time of reporting. The reporter consented to follow-up.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 12/19/2021, second on 27-Jan-2022.; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 1-month-old male patient who received HBV (Engerix B) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 27th January 2022, the patient received the 2nd dose of Engerix B. On 27th January 2022, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received a 2nd dose of Engerix B later than the recommended interval, which led to drug dose administration interval too long. Consent to follow up was granted.
Sex: M
Vaccine: COVID19
Symptoms: Acne, Alopecia, Feeling abnormal, Palpitations, Skin disorder
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE (VACCINE INEFFECTIVE); SUSPECTED COVID-19 INFECTION; MARKS/PIMPLED ON HAND AND THIGHS; EXPERIENCING HEART PALPITATIONS; FEELING WEIRD; HAIR FALLING OFF ARMS/ LOST HAIR ON LEGS AND ARMS; SKIN LOOKING WEIRD; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with the additional information received on 25-JAN-2022 and 29-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced feeling weird and not the same, his hair falling off arms or lost hair on his legs and arms, his skin looking weird, all had happened since he had received vaccine. He had marks or pimpled on his hand and thighs, and he had trouble in breathing, experienced heart palpitations and he reported that vaccine was ineffective as he caught the COVID (coronavirus disease) and had suspected clinical vaccination failure. He stated that he were live in a homeless shelter and could not got a job. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling weird, hair falling off arms/ lost hair on legs and arms, skin looking weird, marks/pimpled on hand and thighs, experiencing heart palpitations, suspected clinical vaccination failure (vaccine ineffective) and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214414.; Sender's Comments: V0:20220146969-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 CLINICAL VACCINATION FAILURE (VACCINE INEFFECTIVE); SUSPECTED COVID-19 INFECTION; MARKS/PIMPLED ON HAND AND THIGHS; EXPERIENCING HEART PALPITATIONS; FEELING WEIRD; HAIR FALLING OFF ARMS/ LOST HAIR ON LEGS AND ARMS; SKIN LOOKING WEIRD; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with the additional information received on 25-JAN-2022 and 29-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced feeling weird and not the same, his hair falling off arms or lost hair on his legs and arms, his skin looking weird, all had happened since he had received vaccine. He had marks or pimpled on his hand and thighs, and he had trouble in breathing, experienced heart palpitations and he reported that vaccine was ineffective as he caught the COVID (coronavirus disease) and had suspected clinical vaccination failure. He stated that he were live in a homeless shelter and could not got a job. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling weird, hair falling off arms/ lost hair on legs and arms, skin looking weird, marks/pimpled on hand and thighs, experiencing heart palpitations, suspected clinical vaccination failure (vaccine ineffective) and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214414.; Sender's Comments: V0:20220146969-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: Tremor
Clinical narrative: WHOLE BODY SHAKING; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced whole body shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole body shaking was not reported. This report was non-serious. This case, from the same reporter is linked to 20220147012 and 20220146346.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Sinus tachycardia, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS TACHYCARDIA; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: antibiotic allergies (erythromycin and amoxicillin), topical reactions (unspecified), grapes and chocolate allergy, penicillin allergy, and gluten allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, patient's heart rate was going up and down. Patient visited urgent care a few times. On 22-APR-2021, urgent care recommended to visit hospital, where the patient was diagnosed with palpitations and sinus tachycardia. Laboratory data included: Heart rate (NR: not provided) heart rate up and down. On 27-DEC-2021, the patient was diagnosed with covid-19 (suspected covid-19 infection) and thus had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, sinus tachycardia and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220147539-Covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure-This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned an 71 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, 1 total administered on 31-MAR-2021 to left arm for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total administered on 01-JAN-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2022, the patient tested positive for Covid with the Binax Now test when treated 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 tested positive for Covid was not reported (dose number in series 2). This report was non-serious. This case was associated with a product quality complaint: 90000214055. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.