chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage patient received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included DTaP (received on an unknown date).   On 15-DEC-2023, the patient received Kinrix. On 15-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage patient received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-FEB-2024 The patient received a dose of Kinrix below than the recommended age limit, which led to inappropriate age at vaccine administration.  The patient already received his 3rd dose of DTaP if Kinrix could be take into account.
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: could cause pericarditis; This serious case was reported by a other health professional via call center representative and described the occurrence of pericarditis in a 43-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   In DEC-2023, the patient received the 1st dose of Shingrix. In JAN-2024, 1 month after receiving Shingrix, the patient experienced pericarditis (Verbatim: could cause pericarditis) (serious criteria GSK medically significant). The outcome of the pericarditis was unknown.   It was unknown if the reporter considered the pericarditis to be related to Shingrix.     It was unknown if the company considered the pericarditis to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 An healthcare professional (HCP) called to ask if Shingrix could cause pericarditis. The healthcare professional mentioned that a immunocompromised patient received the first dose and by the end of January 2024 the patient reported this condition. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix dose 1 about 8 months ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (received 1st dose 8 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received Shingrix dose 1 about 8 months ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-FEB-2024 The reporter asked if he could get shingles again.  The reporter did not give any additional information and abruptly ended the call.  Adverse event filed with limited information. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, COVID-19, Foetal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: COVID-19; FOETAL EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned an infant female. The patient's weight, height, and medical history were not reported. The patient was vaccinated with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, transplacental, batch number: 041A21A,expiry: 29-JAN-2023) dose was not reported, administered on 01-APR-2021 for covid-19 immunization. Concomitant medications included asenapine maleate, cyclobenzaprine hydrochloride, escitalopram oxalate, lamotrigine, and minerals nos/vitamins nos.  On 01-APR-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced foetal exposure during pregnancy. On 30-JUL-2022, the patient experienced covid-19.  On 31-JUL-2022, Laboratory data included: Hearing test done. On 31-JUL-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 09-SEP-2021 and covid-19 on 03-AUG-2022. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and covid-19 as not related.  This report was non-serious. This parent/child case is linked to 20210800697.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Lethargy, Listless
Clinical narrative: Listless; Listless [like he had no energy, lethargic]; Nose started running; Really weird diarrhea; horrible diarrhea; [Listless] like he had no energy, [lethargic]; [Listless like he had no energy,] lethargic; A little confusion; Memory recall (issues); Not been feeling well since the shot; This serious, initial spontaneous safety report from the country was received by Novavax on 24-FEB-2024 from a consumer via the contact center. On 26-FEB-2024, additional information was received from a consumer via the contact center.  An, 75-year-old male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 5 of COVID-19 vaccine) on 30-DEC-2023 at a pharmacy.  Medical history included Bipolar disorder, Hypothyroidism, Blood disorder, Constipation, and SARS-CoV-2 test positive in 2022 or 2023. He was previously vaccinated with 4 doses of Moderna COVID-19 vaccine (elasomeran) on unknown dates, and had no issues with it (No adverse event). The individual had no illnesses up to 1 month prior to vaccination. No allergies were known to the reporter.  The individual was not taking any concomitant medications at the time of vaccination.  On 30-DEC-2023, since vaccination, the individual had not been feeling well since the shot (PT: Malaise) (Serious: Hospitalization). The individual received Novavax COVID-19 vaccine 1 week before a trip. On an unspecified date in 2024, when returning from the trip, the individual was listless (PT: Listless) (Serious: Hospitalization) like he had no energy (PT: Asthenia) (Serious: Hospitalization) and was lethargic (PT: Lethargy) (Serious: Hospitalization). His nose started running (PT: Rhinorrhoea) (Serious: Hospitalization), and then he got really weird and horrible diarrhea (PT: Diarrhoea) (Serious: Hospitalization). The individual also experienced a little confusion (PT: Confusional state) (Serious: Hospitalization) and memory recall issues (PT: Memory impairment) (Serious: Hospitalization). On 25-FEB-2024, the individual went to the emergency room and was admitted to the hospital. As the cause of hospitalization was not specified, the seriousness criterion of Hospitalization was assessed for all events.  At the time of reporting, the event outcomes of Malaise, Listless, Asthenia, Lethargy, Rhinorrhoea, Diarrhoea, Confusional state, and Memory impairment were not recovered/not resolved.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This 75 year-old male experienced: Malaise, Asthenia, Confusional state, Diarrhoea, Lethargy, Listless, Memory impairment and Rhinorrhoea after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The events Malaise, Asthenia, Confusional state, Diarrhoea, Lethargy, Listless, Memory impairment and Rhinorrhoea were reported as serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Memory impairment, Rhinorrhoea
Clinical narrative: Listless; Listless [like he had no energy, lethargic]; Nose started running; Really weird diarrhea; horrible diarrhea; [Listless] like he had no energy, [lethargic]; [Listless like he had no energy,] lethargic; A little confusion; Memory recall (issues); Not been feeling well since the shot; This serious, initial spontaneous safety report from the country was received by Novavax on 24-FEB-2024 from a consumer via the contact center. On 26-FEB-2024, additional information was received from a consumer via the contact center.  An, 75-year-old male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 5 of COVID-19 vaccine) on 30-DEC-2023 at a pharmacy.  Medical history included Bipolar disorder, Hypothyroidism, Blood disorder, Constipation, and SARS-CoV-2 test positive in 2022 or 2023. He was previously vaccinated with 4 doses of Moderna COVID-19 vaccine (elasomeran) on unknown dates, and had no issues with it (No adverse event). The individual had no illnesses up to 1 month prior to vaccination. No allergies were known to the reporter.  The individual was not taking any concomitant medications at the time of vaccination.  On 30-DEC-2023, since vaccination, the individual had not been feeling well since the shot (PT: Malaise) (Serious: Hospitalization). The individual received Novavax COVID-19 vaccine 1 week before a trip. On an unspecified date in 2024, when returning from the trip, the individual was listless (PT: Listless) (Serious: Hospitalization) like he had no energy (PT: Asthenia) (Serious: Hospitalization) and was lethargic (PT: Lethargy) (Serious: Hospitalization). His nose started running (PT: Rhinorrhoea) (Serious: Hospitalization), and then he got really weird and horrible diarrhea (PT: Diarrhoea) (Serious: Hospitalization). The individual also experienced a little confusion (PT: Confusional state) (Serious: Hospitalization) and memory recall issues (PT: Memory impairment) (Serious: Hospitalization). On 25-FEB-2024, the individual went to the emergency room and was admitted to the hospital. As the cause of hospitalization was not specified, the seriousness criterion of Hospitalization was assessed for all events.  At the time of reporting, the event outcomes of Malaise, Listless, Asthenia, Lethargy, Rhinorrhoea, Diarrhoea, Confusional state, and Memory impairment were not recovered/not resolved.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This 75 year-old male experienced: Malaise, Asthenia, Confusional state, Diarrhoea, Lethargy, Listless, Memory impairment and Rhinorrhoea after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The events Malaise, Asthenia, Confusional state, Diarrhoea, Lethargy, Listless, Memory impairment and Rhinorrhoea were reported as serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; Symptoms mild and cold-like; Positive test; Symptoms mild and cold-like; COVID-19; This serious, initial spontaneous safety report was received by Novavax on 26-FEB-2024 from a consumer. On 27-FEB-2024, additional information was received from a company representative.  A 61-year-old male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 5 of COVID-19 vaccine) on 17-OCT-2023 at a pharmacy.  Medical history included previous vaccination with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1 on 23-MAR-2021, dose 2 on the 15th of an unspecified month in 2021, dose 3 (booster) on 04-NOV-2021, and dose 4 (booster) on 04-AUG-2022.  No concomitant medications were reported.  On an unspecified day in FEB-2024, 4 months after vaccination, the individual had mild and cold-like symptoms (PT: Nasopharyngitis). On 26-FEB-2024, the individual tested positive for COVID-19 (PT: Breakthrough COVID-19) via SARS-CoV-2 test, resulting in vaccination failure (PT: Vaccination failure) (Serious: Medically Significant) on 17-OCT-2023.  On 17-OCT-2023, the event outcome of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Nasopharyngitis and Breakthrough COVID-19 were recovering/resolving.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This 61 year-old male experienced: Vaccination failure, Nasopharyngitis and Breakthrough COVID-19 after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Nasopharyngitis and Breakthrough COVID-19 were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; Symptoms mild and cold-like; Positive test; Symptoms mild and cold-like; COVID-19; This serious, initial spontaneous safety report from the country was received by Novavax on 26-FEB-2024 from a consumer. On 27-FEB-2024, additional information was received from a company representative.  A, 60-year-old female was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 5 of COVID-19 vaccine) on 17-OCT-2023 at a pharmacy.  Medical history included previous vaccination with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1 on 23-MAR-2021, dose 2 on the 15th of an unspecified month in 2021, dose 3 (booster) on 04-NOV-2021, and dose 4 (booster) on 04-AUG-2022.  No concomitant medications were reported.  On an unspecified day in FEB-2024, 4 months after vaccination, the individual had mild and cold-like symptoms (PT: Nasopharyngitis). On 26-FEB-2024, the individual tested positive for COVID-19 (PT: Breakthrough COVID-19) via SARS-CoV-2 test, resulting in vaccination failure (PT: Vaccination failure) (Serious: Medically Significant) on 17-OCT-2023.  On 17-OCT-2023, the event outcome of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Nasopharyngitis and Breakthrough COVID-19 were recovering/resolving.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This 60 year-old female experienced: Vaccination failure, Nasopharyngitis and Breakthrough COVID-19 after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Nasopharyngitis and Breakthrough COVID-19 were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She got diagnosed also with COVID despite all the vaccinations; She got diagnosed also with COVID despite all the vaccinations; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She got diagnosed also with COVID despite all the vaccinations". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049947 same reporter/ events, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clot; This is a spontaneous report received from a Physician.   An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood Clot". The physician reported that there were family members who received a COVID Vaccine, they are all smokers and then they all had blood clot at some sort. He had an adult family, and it was a father, a mother and a brother and they are all had COVID Vaccine, they are all smokers, and they all ended up with blood clot. The reporter was wondering if there were any studies about adult smoker and blood clot within the week or two (within the first two weeks) after administering a COVID Vaccine to an adult smoker   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400051457 same reporter/drug/event, different patient;US-PFIZER INC-202400051458 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report received from a Physician.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smokers" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot". The physician reported that there were family members who received a COVID Vaccine, they are all smokers and then they all had blood clot at some sort. He had an adult family, and it was a father, a mother and a brother and they are all had COVID Vaccine, they are all smokers, and they all ended up with blood clot. The reporter was wondering if there were any studies about adult smoker and blood clot within the week or two (within the first two weeks) after administering a COVID Vaccine to an adult smoker.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400051370 same reporter/drug/event, different patient;US-PFIZER INC-202400051458 same reporter/drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report received from a Physician. An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot". The physician reported that there were family members who received a COVID vaccine, they were all smokers and then they all had blood clot at some sort. He had an adult family, and it was a father, a mother and a brother and they all had COVID vaccine, they were all smokers, and they all ended up with blood clot. The reporter was wondering if there were any studies about adult smoker and blood clot within the week or two (within the first two weeks) after administering a COVID vaccine to an adult smoker.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400051457 same reporter/drug/event, different patient;US-PFIZER INC-202400051370 same reporter/drug/event, different patient;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. Vaccination history included: pfizer / biontech (DOSE NUMBER UNKNOWN), administration date: 10Aug2022, when the patient was 47-year-old, for COVID-19 immunization; pfizer / biontech (DOSE NUMBER UNKNOWN), administration date: 16Aug2023, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID-19 treatment from 16Feb2024 to 20Feb2024.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400051928 Same patient, different drug and event;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Latex" (unspecified if ongoing); "Blood Pressure" (ongoing), notes: I Take Medication For Blood Pressure. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative, notes: Took Paxlovid As Prescribed, Had Multiple Negative Covid Tests Over Days. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 18Feb2024 to 23Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number- GJ2524, Vaccine location- Left arm), administration date: 29Sep2022, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE , Vaccine lot number- FM7553, Vaccine location- Left arm), administration date: 19May2022, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine lot number- FF8839, Vaccine location- Left arm), administration date: 10Oct2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Vaccine lot number- ER2613, Vaccine location- Left arm), administration date: 24Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Vaccine lot number- EN6202, Vaccine location- Left arm), administration date: 03Mar2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Feb2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Feb2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: had COVID; had COVID; Had 4 Pfizer Covid vaccines and 1 Moderna Covid vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), on 08Jan2021 as dose 2, single (Lot number: EJ1685), on 21Aug2021 as dose 3 (booster), single (Lot number: EW0185) and on 25Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Sep2022 as dose 5 (booster), single (Lot number: A89140C) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2006 (not ongoing), notes: had surgery in 2006/2007 and has been cancer free since; "chemotherapy", start date: 2007 (unspecified if ongoing); "breast cancer surgery" (unspecified if ongoing); "wheat allergy" (unspecified if ongoing); "allergic to rye" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Sep2022, outcome "unknown", described as "Had 4 Pfizer Covid vaccines and 1 Moderna Covid vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: over weekend so thought would take test this morning to be sure and it was positive so took another and it was positive again; (2024) Negative, notes: took Covid test Saturday morning that was negative; (2024) Positive, notes: over weekend so thought would take test this morning to be sure and it was positive so took another and it was positive again. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective. Clinical course: In Nov2022, she got Covid. Had Covid then and again now. Patient was prescribed with Paxlovid but have a wheat allergy, so caller wanted to make sure before she takes it that there was not any cross-contamination.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2022 as dose 4 (booster), single (Lot number: FM0698), in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in arm, on 14Mar2021 at 09:00 as dose 2, single (Lot number: EN208), in arm and on 16Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FA7485), in arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis", start date: 2009 (ongoing), notes: Tried Ilumya, Now trying Skyrizi; "psoriatic arthritis", start date: 2009 (ongoing), notes: Tried Ilumya, Now trying Skyrizi; "Covid: Positive", start date: 14Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2023, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Tylenol.  Clinical course: Even though the patient had Covid 3 times, the patient is alive with no long term side effects so far. Paxlovid helped greatly, but as a senior on disability the price is terrible. The first time their entire family got Covid. The patient was the last do test positive, no one felt very ill, no side effects. The second time in Jan2023. The patient was very ill for at least a month, went to the doctor, oxygen was at 90, they prescribed nothing, was told they did not believe in Paxlovid, rest Tylenol, fluid no long term effects, no one else in the house got it. In Jan2024, the patient went to see their sister, almost immediately felt like having a cold, went to a clinic for test. Tested positive they asked if wanted Paxlovid and the patient said yes. Felt much better in a few days no rebound. The patient hated the expense but felt like it was worth it. Will keep up vaccines.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "prostate cancer survivor" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Feb2024 to 20Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 infection; COVID 19 infection; This is a spontaneous report received from a Nurse.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 16Feb2024 to 21Feb2024 for the treatment of COVID-19.  No follow-up attempts are possible.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: PNC20
Symptoms: Condition aggravated, Drug ineffective, Pneumonia
Clinical narrative: I had the Pneumonia several times over my life; I had the Pneumonia several times over my life; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "I had the Pneumonia several times over my life". Clinical course: The caller stated she had a PSSV 23 and a PCV 20. Asked if she should get an additional PCV 20 vaccine. Consumer stated she was reading about the pneumonia vaccine, she had had the vaccine several times and she had had the 23 and the 20 and she was told this year (2024), she should not get the 20, she was asked is that correct. Patient had the pneumonia several times over her life.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: A little bit hoarse; This is a spontaneous report received from a consumer or other non HCP.   A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Pfizer covid vaccine (batch/lot number: unknown, administered in arm at a hospital, as dose 1, single), for COVID-19 immunisation; Pfizer covid vaccine (batch/lot number: unknown, administered in arm at a hospital, as dose 2, single), for COVID-19 immunisation; Pfizer covid vaccine (batch/lot number: unknown, administered in arm at a hospital, as dose 3 (booster), single), for COVID-19 immunisation. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "A little bit hoarse".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400053123 same patient and drug, different dose and event;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6198) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms".  Additional information: The patient was calling about the Pfizer COVID-19 vaccine. She had one shot in state and then 3 weeks came back and received a second dose. She had flu like symptoms after the first shot, which she thought was good because she thought it was working.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: her hearing got a little worst; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient in her 70's received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1), administration date: 05Feb2021, for COVID-19 immunisation. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "her hearing got a little worst". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gingival bleeding, Gingival erythema, Gingival pain, Gingival swelling
Clinical narrative: blisters in mouth; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; rash on scalp; blisters on chest; my immune system is confused; Lichen Planus; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 26Feb2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LICHEN PLANUS (non-serious) with onset Jan2022, outcome "unknown"; ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "blisters in mouth"; GINGIVAL SWELLING (non-serious), GINGIVAL ERYTHEMA (non-serious), GINGIVAL PAIN (non-serious), GINGIVAL BLEEDING (non-serious), outcome "unknown" and all described as "swollen, red, sore bleeding gums"; GINGIVAL ULCERATION (non-serious), MOUTH ULCERATION (non-serious), ORAL MUCOSAL ERYTHEMA (non-serious), MOUTH SWELLING (non-serious), outcome "unknown" and all described as "mouth and gums/swollen, red, ulcers"; RASH (non-serious), outcome "unknown", described as "rash on scalp"; BLISTER (non-serious), outcome "unknown", described as "blisters on chest"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "my immune system is confused".  Additional information: It was reported that the events developed months after vaccine but stated that the vaccine triggered these conditions. The patient stated that she had erosive lichen planus in her mouth for over 2 years. She stated it was very painful to eat, brush her teeth or go to the dentist to get teeth cleaned. She also stated that het immune system is confused and it was attacking the cells of her skin and mucous membranes. She believed that the vaccines triggered this condition. Patient also stated that she never had anything like this in her life. She have been very healthy to this point and have lived a very healthy lifestyle.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gingival ulceration, Immune system disorder, Lichen planus, Mouth swelling, Mouth ulceration
Clinical narrative: blisters in mouth; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; rash on scalp; blisters on chest; my immune system is confused; Lichen Planus; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 26Feb2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LICHEN PLANUS (non-serious) with onset Jan2022, outcome "unknown"; ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "blisters in mouth"; GINGIVAL SWELLING (non-serious), GINGIVAL ERYTHEMA (non-serious), GINGIVAL PAIN (non-serious), GINGIVAL BLEEDING (non-serious), outcome "unknown" and all described as "swollen, red, sore bleeding gums"; GINGIVAL ULCERATION (non-serious), MOUTH ULCERATION (non-serious), ORAL MUCOSAL ERYTHEMA (non-serious), MOUTH SWELLING (non-serious), outcome "unknown" and all described as "mouth and gums/swollen, red, ulcers"; RASH (non-serious), outcome "unknown", described as "rash on scalp"; BLISTER (non-serious), outcome "unknown", described as "blisters on chest"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "my immune system is confused".  Additional information: It was reported that the events developed months after vaccine but stated that the vaccine triggered these conditions. The patient stated that she had erosive lichen planus in her mouth for over 2 years. She stated it was very painful to eat, brush her teeth or go to the dentist to get teeth cleaned. She also stated that het immune system is confused and it was attacking the cells of her skin and mucous membranes. She believed that the vaccines triggered this condition. Patient also stated that she never had anything like this in her life. She have been very healthy to this point and have lived a very healthy lifestyle.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oral mucosal erythema, Rash
Clinical narrative: blisters in mouth; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; swollen, red, sore bleeding gums; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; mouth and gums/swollen, red, ulcers; rash on scalp; blisters on chest; my immune system is confused; Lichen Planus; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 26Feb2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LICHEN PLANUS (non-serious) with onset Jan2022, outcome "unknown"; ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "blisters in mouth"; GINGIVAL SWELLING (non-serious), GINGIVAL ERYTHEMA (non-serious), GINGIVAL PAIN (non-serious), GINGIVAL BLEEDING (non-serious), outcome "unknown" and all described as "swollen, red, sore bleeding gums"; GINGIVAL ULCERATION (non-serious), MOUTH ULCERATION (non-serious), ORAL MUCOSAL ERYTHEMA (non-serious), MOUTH SWELLING (non-serious), outcome "unknown" and all described as "mouth and gums/swollen, red, ulcers"; RASH (non-serious), outcome "unknown", described as "rash on scalp"; BLISTER (non-serious), outcome "unknown", described as "blisters on chest"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "my immune system is confused".  Additional information: It was reported that the events developed months after vaccine but stated that the vaccine triggered these conditions. The patient stated that she had erosive lichen planus in her mouth for over 2 years. She stated it was very painful to eat, brush her teeth or go to the dentist to get teeth cleaned. She also stated that het immune system is confused and it was attacking the cells of her skin and mucous membranes. She believed that the vaccines triggered this condition. Patient also stated that she never had anything like this in her life. She have been very healthy to this point and have lived a very healthy lifestyle.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Medical skin condition; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "Medical skin condition". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a Nurse.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 11:00 as dose 3 (booster), 0.3 ml single (Lot number: GJ3277, Expiration Date: 30Jul2023) at the age of 63 years intramuscular, in left deltoid for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia", start date: 31Oct2019 (ongoing); "Hypertension", start date: 17Oct2018 (ongoing); "Anxiety", start date: 08Jan2019 (ongoing); "Chronic back pain", start date: 17Oct2018 (ongoing); "Scoliosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Oct2022, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for COVID in clinic on 13Oct2022, treated with Paxlovid, Ed A-hist and benzonatate (TESSALON). Patient is seen yearly and as needed.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202201191414 same patient, different vaccine dose/event;