chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: An adult patient reported that her physician has recommended her to get PEDVAX HIB after her spleen surgery; No additional AEs were reported; This spontaneous report was received from a consumer referring to herself, an adult female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient's physician recommended her to get haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, for prophylaxis (strength, dose, frequency, route of administration, anatomical vaccination site, lot number, and expiration date were not provided) after her spleen surgery. The patient did not get the vaccine yet but she would get the vaccine after her surgery and other unspecified adult patients from the physician's office might have received haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) after surgeries (product prescribing issue).  No additional adverse events (AEs) were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; report inadvertent administration of expired GARDASIL 9 to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-DEC-2023, the patient was inadvertent vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (lot #1775811 was verified to be a valid number, expiration date reported and established as 07-DEC-2023) (dose, vaccination scheme, strength, injection site and route of administration were not provided) (expired product administered).  No additional adverse event was reported.
Age: 33.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mobility decreased, Myalgia
Clinical narrative: difficulty lifting her arm; received GARDASIL 9 and received her first dose in February of 2023. Reported patient tolerated her first dose well, however had muscular/upper arm pain following her second dose administration for three weeks; This spontaneous report has been received from a physician and refers to an adult female patient (by the first event occurrence between 26 to 27-year-old; currently by the reporting time 34-year-old).  The patient's pertinent medical history, previous reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in February 2018, she received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (IM), which patient tolerated well. Then on an unspecified date in April 2023, she received the second dose (lot numbers W013388 and W021492 have been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for syringe formulation, expiration dates were not provided, but upon internal validation, they were established as 16-DEC-2024 and 20-OCT-2024, respectively) both doses with indications reported as "vaccinations" (prophylaxis) (for both doses strength, vaccination scheme frequency, and anatomical site of application were not provided). On an unspecified date in 2023 (reported as following her second dose for three weeks), she had muscular/upper arm pain (myalgia); also she experienced difficulty lifting her arm (movement disorder). By the reporting time, the patient was also reported as recovered from this events.  On 20-DEC-2023 (also reported as today), patient was due for her third dose, however declined it due to her experienced adverse events; therefore action taken after second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was withdrawn.  The causal relationship between myalgia and movement disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two reports for the same patient (split case from 2312USA008380).  This is an amended report. This safety report ID MARRS# 2401USA001036 was previously submitted with the incorrect WWUID : US-009507513-2312USA008380, and this new follow-up submission is to provide the correct identification number WWUID: US-009507513-2401USA001036. WWUID: US-009507513-2312USA008380 refers to an existing case (MARRS# 2312USA008380), therefore this safety report is not being nullified, just updated to reflect US-009507513-2312USA008380 is now correctly referenced as an E2B Report Duplicate in case MARRS# 2401USA001036.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervicitis human papilloma virus, Loop electrosurgical excision procedure
Clinical narrative: patient received GARDASIL 4 when she was a kid in 2007 and 2008. She then had a "bad HPV infection of her cervix" in 2016; This spontaneous report has been received from a physician and refers to an adult female patient (by the first event occurrence between 26 to 27-year-old; currently by the reporting time 34-year-old).  The patient's pertinent medical history, previous reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2007 (when patient was approximately 18-year-old; conflicting information as she was also reported as a kid), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection administered intramuscularly (IM) (also reported as "1 dose"). The second dose was administered also IM on an unspecified date in 2008 (lot numbers, 658282/0929U and 659657/1487U have been determined to be valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), expiration dates were not provided but upon internal validation, they were established as 25-MAR-2010 and 05-AUG-2023, respectively), both doses administered with an indication reported as "vaccination" (prophylaxis) (for both doses strength, vaccination scheme, frequency, and anatomical site of application were not provided). On an unknown date in 2016, the patient experienced a bad (severe) human papilloma virus (HVP) infection of her cervix (papilloma viral infection) for which she had a loop electrosurgical excision procedure (LEEP) (reported as "leap procedure"). By an unknown date, the patient got recovered for this event.  The causal relationship between papilloma viral infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  This is one of two reports for the same patient.  This is an amended report. Product tab and events tab have been updated.  This is an emended report. This safety report ID MARRS# 2401USA004592 was previously submitted with the incorrect WWUID : US-009507513-2312USA008380, and this new follow-up submission is to provide the correct identification number WWUID: US-009507513- 2401USA004592. WWUID: US-009507513-2312USA008380 refers to an existing case (MARRS# 2312USA008380), therefore this safety report is not being nullified, just updated to reflect US-009507513-2312USA008380 is now correctly referenced as an E2B Report Duplicate in case MARRS# 2401USA004592
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient is asymptomatic; HCP called to report a dose of MMRII was administered to a patient one day after the expiration date. Date of administration was 01/08/2024. Expiration date on the product was 01/07/2024.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). The patient's concurrent conditions and pertinent medical history was not provided.  On 08-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 1 dose, lot #W017557, expiration date: 07-JAN-2024, administered for prophylaxis (strength, route of administration and anatomical location were not provided) (expired vaccine used).  No adverse events reported.
Age: 0.42
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered to a patient since the excursion.; No additional AE; This spontaneous report was received from a nurse concerning to a 5-month-old patient of unspecified gender. The patient's medical history, previous drug reactions, drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 19-DEC-2023, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947621, expiration date: 02-MAY-2024 (strength, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X020316, expiration date: 18-OCT-2025 (strength, and route of administration were not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 1 dose, lot #U7536AA, expiration date: 30-SEP-2025, all administered for prophylaxis (strength, and route of administration were not provided) (Product storage error), as the went through a temperature excursion of 59.45 Fahrenheit degrees (F) for a time frame of 18 hours 30 minutes. Moreover, there were previous temperature excursions of 53.29 F for 1 Hour 45 Minutes; and 49.73 F for 1 Hour. There was no report of adverse effect or product quality complaint involved.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA005823:02533422 US-009507513-2401USA005734:02533433 US-009507513-2401USA005828:02533384 US-009507513-2401USA005851:02533391 US-009507513-2401USA006334:02533396 US-009507513-2401USA006342:02533398 US-009507513-2401USA005923:02533409 US-009507513-2401USA006004:02533416 US-009507513-2401USA006082:02533429 US-009507513-2401USA006339:02533381 US-009507513-2401USA006039:02533304
Age: 0.5
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 26-DEC-2023, the patient was vaccinated with improperly stored doses of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947621, expiration date: 02-MAY-2024 (strength, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X020316, expiration date: 18-OCT-2025 (strength, and route of administration were not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 1 dose, lot #U7536AA, expiration date: 30-SEP-2025, all administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion was 59.45 Fahrenheit degrees (F) and time frame 18 hours 30 minutes. There were previous temperature excursions of 53.29 F for 1 Hour 45 Minutes; and 49.73 F for 1 Hour. There was no report of adverse effect or product quality complaint involved.   This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2401USA005734: US-009507513-2401USA005789: US-009507513-2401USA005828: US-009507513-2401USA005851:
Age: 0.42
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC reported; ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered; This spontaneous report has been received from a nurse, concerning a 5-months-old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On 11-DEC-2023 (since the excursion), the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947621, expiration date: 02-MAY-2024, administered orally; pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X020316, expiration date: 18-OCT-2025, (strength, and route of administration were not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 1 dose, lot #U7536AA, expiration date: 30-SEP-2025 (strength, and route of Administration were not provided). All of them administered as prophylaxis.  All vaccines were involved in a temperature excursion of 59.45F, during a time frame of 18 hours 30 minutes 0 seconds (Product storage error). There was a previous temperature excursión of 53.29F for 1 hour 45 minutes 0 seconds; 49.73F for 1 hour 0 minutes 0 seconds. No patient symptoms, nor additional adverse event (AE)/nor product quality complaint (PQC)  were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA005823: US-009507513-2401USA005789:02533384 US-009507513-2401USA005734: US-009507513-2401USA005851: US-009507513-2401USA006039: US-009507513-2401USA006339: US-009507513-2401USA006334: US-009507513-2401USA006342: US-009507513-2401USA005923: US-009507513-2401USA006004: US-009507513-2401USA006082:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand=Pfizer / BioNTech; 08Sep2022/ vaccine brand other= COVID-19 (MODERNA) Vaccine, 12YRS+, 50mcg/0.5mL (2023-2024); 22Sep2023; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 6, single (Lot number: GH9694) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06May2022 as dose 5, single (Lot number: FM9992) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Sep2023 as dose 7, single) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4(booster), single) for covid-19 immunisation. The patient's relevant medical history included: "obese, 300 lbs at 6'3"" (unspecified if ongoing), notes: obese, 300 lbs at 6'3''. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2023, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; 08Sep2022/ vaccine brand other= COVID-19 (MODERNA) Vaccine, 12YRS+, 50mcg/0.5mL (2023-2024); 22Sep2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.Treatment included Paxlovid.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), 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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Negative; (05Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose numer unknown, single (Batch/Lot number: unknown), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Positive Covid test after testing negative Multiple days; Positive, notes: Positive Covid test after testing negative Multiple days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair is failing out in bunches; This is a spontaneous report received from a Consumer or other non HCP.  A 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 and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: ALOPECIA (medically significant), outcome "unknown", described as "hair is failing out in bunches". The patient reported she saw on social media that other people's hair is falling out. She inquired about what should she do and how to stop it.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Laboratory test, Pulmonary embolism
Clinical narrative: deep vein thrombosis; pulmonary embolism; This is a spontaneous report received from a consumer. A 54-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (lot number unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure high" (unspecified if ongoing); "underactive thyroid" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE taken for hypothyroidism; ZYRTEC taken for hypersensitivity; METOPROLOL taken for hypertension; MONTELUKAST taken for hypersensitivity. Vaccination history included: Covid-19 vaccine (primary immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "unknown"; PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown". The patient was hospitalized for deep vein thrombosis, pulmonary embolism (start date: 03Jan2024, discharge date: 04Jan2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Iab test: unknown results. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism. Clinical course: The patient got the vaccine because she was going to be travelling outside of the country. The patient did not have other covid and non-covid vaccines in 4 weeks prior this vaccination. The patient stated, "In early Oct2023, I did get the vaccine. I am healthy and I just got a deep vein thrombosis and a pulmonary embolism. I have no history of any kind of issue, but I did get the booster (clarified as Pfizer COVID-19 Vaccine)." The patient was hospitalized from 03Jan2024 to 04Jan2024 (overnight) due to the events with treatment. The patient had tons and lots of lab test.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a Physician from a sales representative.  A 66-year-old 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 and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), 7 days after the suspect product(s) administration, outcome "unknown", described as "stroke".  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: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMI XBB.1.5 cannot be totally excluded for the reported event. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes 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.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Soon after COVID shot that the sister of the reporter died after having a sudden cardiac issue or event one week before Christmas; This is a spontaneous report received from a Nurse from a sales representative.  A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 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: CARDIAC DISORDER (death) with onset Dec2023, outcome "fatal", described as "Soon after COVID shot that the sister of the reporter died after having a sudden cardiac issue or event one week before Christmas". It was unknown if therapeutic measures were taken as a result of cardiac disorder. The patient date of death was Dec2023. Reported cause of death: "Soon after COVID shot that the sister of the reporter died after having a sudden cardiac issue or event one week before Christmas". It was not reported if an autopsy was performed. Clinical course: It was reported that COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the temporal relationship, the association between the fatal event "sudden cardiac issue" with COMIRNATY can not be fully excluded.  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.; Reported Cause(s) of Death: Soon after COVID shot that the sister of the reporter died after having a sudden cardiac issue or event one week before Christmas
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid now (last week); tested positive for Covid now (last week); This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 83-year-old male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "tested positive for Covid now (last week)".  The patient received 2 doses of the Pfizer Covid vaccine a couple years ago back when the pandemic first began and did not get anymore. He had good luck with them, no reactions or anything. He tested positive for Covid now (last week) and wondering if he can take Paxlovid because he does not feel good now. He stated in his case he got vaccinated 2-3 years before Jan2024 and none of the new variants were out so that is probably why it was ineffective and he undoubtedly got one of these new varieties (variants) in the meantime.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing), notes: Kidney disease; "Known allergies: Statins" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 30.0
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 30-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 21Jan2021 as dose 1, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Thyroid disease" (unspecified if ongoing), notes: Thyroid disease; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive; (08Jan2024) turned red, notes: Took COVID test today 08Jan2024. It turned red within 5 minutes, although I waited the 15 minutes. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Incorrect route of product administration
Clinical narrative: ill; COVID Vaccine given intravenously; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 (BNT162B2 NOS), in Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years intravenous, in left arm for covid-19 immunisation. The patient's relevant medical history included: "dialysis" (ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccine 4 weeks prior to vaccination. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Aug2023, outcome "unknown", described as "COVID Vaccine given intravenously"; ILLNESS (hospitalization), outcome "unknown", described as "ill".The patient was put in the hospital for a whole week. The patient stated that she got the COVID Vaccine in Aug2023, and she had been in the hospital three times since she got it.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She has also had all the Pfizer COVID vaccines except the last one./ they have a patient who's positive again; She has also had all the Pfizer COVID vaccines except the last one./ they have a patient who's positive again; This is a spontaneous report received from a Physician from medical information team, Program ID:  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma Was diagnosed 20 plus yeas ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "She has also had all the Pfizer COVID vaccines except the last one./ they have a patient who's positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive, notes: Patient who had 3 previous episodes of COVID- 2 years ago, 1 year ago, Sep2023 and has tested positive again; (2022) Positive, notes: Patient who had 3 previous episodes of COVID- 2 years ago, 1 year ago, Sep2023 and has tested positive again; (Sep2023) Positive, notes: Patient who had 3 previous episodes of COVID- 2 years ago, 1 year ago, Sep2023 and has tested positive again; (08Jan2024) Negative; (10Jan2024) Positive, notes: Patient who had 3 previous episodes of COVID- 2 years ago, 1 year ago, Sep2023 and has tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Physician reported that he has a patient who had 3 previous episodes of COVID - 2 years ago, 1 year ago, Sept2023 and has tested positive again. Each time the patient has received Paxlovid. She has also had all the Pfizer COVID vaccines except the last one. Wanted to know if  there any information on treating a patient 4 times with Paxlovid. Paxlovid was taken as treatment for COVID-19 .Standard paxlovid dose by mouth for 5 days.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine products BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Near death experience, Pneumonia
Clinical narrative: Cardiac arrest; he almost died; pneumonia; This is a spontaneous report received from a Physician, Program ID:.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 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: CARDIAC ARREST (medically significant, life threatening) with onset Dec2023, 30 min after the suspect product(s) administration, outcome "unknown"; NEAR DEATH EXPERIENCE (medically significant, life threatening) with onset Dec2023, 30 min after the suspect product(s) administration, outcome "unknown", described as "he almost died"; PNEUMONIA (medically significant) with onset Dec2023, outcome "unknown".  Clinical course details: A Doctor, called in to inquire if it is normal for a patient to have severe symptoms following a COVID-19 Vaccination. Doctor stated he had a patient to whom suffered pneumonia and almost went into cardiac arrest (verbatim he almost died) and symptoms started 30 minutes after receiving the COVID-19 Vaccine in Dec and wanted to know if this was normal.  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: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMI XBB.1.5 cannot be totally excluded for the reported events. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes 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.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: Sjogren's SS-A antibody plus lupus; Sjogren's SS-A antibody plus lupus; 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 1, 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: SJOGREN'S SYNDROME (medically significant), SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown" and all described as "Sjogren's SS-A antibody plus lupus". The patient underwent the following laboratory tests and procedures: Antibody test: Sjogren's SS-A. The patient had no symptoms until they got the COVID vaccines from Pfizer. The patient described that the pain and suffering experience was unreal.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Delirium, Feeling abnormal, Illness, Pyrexia
Clinical narrative: being semi-delirious; dehydrated; having a high fever; really sick; really feels bad; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.   A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "emphysema" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE (unknown manufacturer), The caller has had a total of six vaccines since 2020), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE (unknown manufacturer)), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE (unknown manufacturer)), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (unknown manufacturer)), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE (unknown manufacturer)), for COVID-19 immunization. The following information was reported: DELIRIUM (medically significant), outcome "unknown", described as "being semi-delirious"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated"; PYREXIA (non-serious), outcome "unknown", described as "having a high fever"; ILLNESS (non-serious), outcome "unknown", described as "really sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "really feels bad". Clinical course: The caller mentioned that she is at high risk because she has emphysema and got the vaccine last Oct, and she got her flu shot this year. She had other stuff going on. Caller got really sick after Christmas Day and realized that she thinks it is not the flu. There are times that she really feels bad, like getting dehydrated, having a high fever, and being semi-delirious. She is thinking that if she hadn't gotten the vaccine, maybe she wouldn't be calling and would be disappointed because of what happened to her. The caller has had a total of six vaccines since 2020. The caller would like Pfizer to know that they need to improve the effectiveness of the vaccines for people to avoid getting the virus.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Product storage error
Clinical narrative: Just enter Patient was administered Covid vaccine 5 days beyond use date on product
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Expired product administered
Clinical narrative: Just enter Patient was administered Covid vaccine 5 days beyond use date on product
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: Just enter Patient was administered Covid vaccine 5days beyond use date on product
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: Just enter Patient was administered Covid vaccine 5days beyond use date on product
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid normal, Blood magnesium, Blood potassium decreased, Blood sodium decreased, Brain natriuretic peptide normal
Clinical narrative: Patient complained of shortness of breath for 2 weeks. Presented here to the ED on 1/9/24.Patient and family got upper respiratory illness and his family got over it except the patient. O2sat on RA is 87% - hooked patient to 2LNC. O2sat increased to 92%. GCS 15, ambulatory. 01-09-2024 20:56 42-year-old male with history of leukemia on CAR-T therapy last infusion April 2023 presents to the ED for evaluation of shortness of breath.  Patient had a cold 2 weeks ago as well as his whole family.  Everyone else is better but the patient has gotten worse over the last 2 or 3 days.  Feeling feverish send having shortness of breath, especially when he tries to exert himself.  No nausea or vomiting.  Does have a cough that is productive of green sputum.  No abnormal rash.  No difficulty urinating.  He has a card saying he is under the care of Dr. search says he is with medical facility.   Review of systems negative except as documented in the HPI.  Nursing notes and vital signs reviewed.   GENERAL: Ill-appearing but awake and alert HEAD: normocephalic, atraumatic  EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric, mild posterior pharynx cobblestoning NECK: Supple, non-tender; no meningismus, anterior cervical lympadenopathy present LUNGS: L tachypnea, Rales throughout, moderate air movement HEART: Tachycardic rate with regular rhythm, no murmur  CHEST: No deformity; non-tender  ABDOMEN: The abdomen is soft, non tender in all quardrants, bowel sounds present, no rebound or gaurding EXTREM: Normal ROM; no deformity, no calf asymmetry. There is no pedal edema.  SKIN: No rash; no diaphoresis  BACK: No CVA TTP, No spinal tenderness NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Coma scale, Dyspnoea, Dyspnoea exertional
Clinical narrative: Patient complained of shortness of breath for 2 weeks. Presented here to the ED on 1/9/24.Patient and family got upper respiratory illness and his family got over it except the patient. O2sat on RA is 87% - hooked patient to 2LNC. O2sat increased to 92%. GCS 15, ambulatory. 01-09-2024 20:56 42-year-old male with history of leukemia on CAR-T therapy last infusion April 2023 presents to the ED for evaluation of shortness of breath.  Patient had a cold 2 weeks ago as well as his whole family.  Everyone else is better but the patient has gotten worse over the last 2 or 3 days.  Feeling feverish send having shortness of breath, especially when he tries to exert himself.  No nausea or vomiting.  Does have a cough that is productive of green sputum.  No abnormal rash.  No difficulty urinating.  He has a card saying he is under the care of Dr. search says he is with medical facility.   Review of systems negative except as documented in the HPI.  Nursing notes and vital signs reviewed.   GENERAL: Ill-appearing but awake and alert HEAD: normocephalic, atraumatic  EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric, mild posterior pharynx cobblestoning NECK: Supple, non-tender; no meningismus, anterior cervical lympadenopathy present LUNGS: L tachypnea, Rales throughout, moderate air movement HEART: Tachycardic rate with regular rhythm, no murmur  CHEST: No deformity; non-tender  ABDOMEN: The abdomen is soft, non tender in all quardrants, bowel sounds present, no rebound or gaurding EXTREM: Normal ROM; no deformity, no calf asymmetry. There is no pedal edema.  SKIN: No rash; no diaphoresis  BACK: No CVA TTP, No spinal tenderness NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit