chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: explained they accidentally administered only diluent portion of Rotarix; they explained accidentally administered only diluent portion of Rotarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On 24-APR-2024, the patient received Rotarix lyophilized formulation. On 24-APR-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: explained they accidentally administered only diluent portion of Rotarix) and inappropriate dose of vaccine administered (Verbatim: they explained accidentally administered only diluent portion of Rotarix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 3 May 2024: Nurse Practitioner explained they accidentally administered only diluent portion of Rotarix (lyophilized presentation) to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This is 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024056872:Same reporter,Different patient US-GSK-US2024056874:Same reporter,Different patient
Sex: U
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of drug administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of drug administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 3 May 2024: Nurse practitioner explained they accidentally administered only diluent portion of Rotarix (lyophilized presentation) to the patient. The reporter did not have any patient demographics or date of administration for patient. The patient accidentally administered only diluent portion of Rotarix (lyophilized presentation), which led to inappropriate preparation of medication and inappropriate dose of drug administered. The reporter consented to follow up. This is 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024056872:Same reporter,Different patient US-GSK-US2024056871:Same reporter,Different patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: developed shingles after Shingrix/suspected vaccination failure; developed shingles after Shingrix; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a finite number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: developed shingles after Shingrix/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles after Shingrix). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2024 The reporter reported that she knew about a half dozen people who developed shingles after Shingrix but needs to ask their permission before sharing any further information. No additional information provided. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2024059143, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024059143:Same reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 58 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Pennacillian" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Left arm), administration date: 12Apr2021, when the patient was 57-year-old, for COVID-19 immunisation, reaction(s): "Pain", "swelling of injection site", "Lethargy", "Tiredness", "Slight fever"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Right arm), administration date: 04May2021, when the patient was 57-year-old, for COVID-19 immunisation, reaction(s): "Pain", "swelling of injection site", "Lethargy", "Tiredness", "Slight fever". The following information was reported: LETHARGY (non-serious) with onset Dec2021, outcome "unknown"; PAIN (non-serious) with onset Dec2021, outcome "unknown"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tiredness". Additional information: All events onset date was within hours to 1 day from date of each vaccine. Prior vaccinations within 4 weeks was NONE. Relevant test reported as NONE. Specific Relevant Test For Thromboembolic events with Thrombocytopenia reported as None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400103328 same patient, same drug/event, different dose;
Age: 57.0
Sex: F
Vaccine: 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 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm and on 19Jun2023 at 13:00 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Lot number: EL0140), in right arm, on 24Jan2021 as dose 2, single (Lot number: El9262), in right arm, on 21Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 14Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm and on 12Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "asthma" (unspecified if ongoing); "endometrial cancer" (unspecified if ongoing); "transverse myelitis" (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 May2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 01May2024 to 05May2024.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost my sense of taste; lost sense of smell; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY), 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: AGEUSIA (non-serious) with onset 2020, outcome "not recovered", described as "lost my sense of taste"; ANOSMIA (non-serious) with onset 2020, outcome "not recovered", described as "lost sense of smell".  Additional information: The patient had already reported this to Pfizer when it happened, when patient originally took all the stuff, patient lost sense of taste, sense of smell from 2020. Patient still never got anything back. Patient had no sense of smell or taste. So, question was in that time patient had been offer the new updated vaccine. Patient was nervous to take that because if patient got another weird side effect, patient did not know what to do, patient did not know what the, it was stupid because patient was nervous about having another side effect.  The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination Failure; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 50-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 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "To lower triglycerides" (unspecified if ongoing); "shellfish/Soy" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID taken for thyroid disorder, start date: 02Feb2010; EFFEXOR taken for antidepressant therapy, start date: 01Oct2022, stop date: 11May2024; SAM-E taken for arthritis, start date: 01Oct2022; FENOFIBRATE taken for blood triglycerides increased, start date: 01Dec2023. 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; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown", described as "COVID 19"; VACCINATION FAILURE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07May2024 to 11May2024.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Apr2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Left arm, at 12:00:00), administration date: 30Sep2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical location: Left arm, at 12:00:00), administration date: 19Jul2022, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm, at 12:00:00), administration date: 19Dec2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm, at 12:00:00), administration date: 21Aug2023, when the patient was 69-year-old, for Covid-19 Immunization. Patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset 2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. which included paxlovid from 03May2024 to 08May2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
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 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Apr2024 at 12:00 as dose 1, single at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cephalosporin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 5, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Negative; (May2024) Positive, notes: After 3 days of negative tests, symptoms and positive test returned. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 30Apr2024 to 04May2024.
Age: 59.0
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 13May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400105723 Same patient, different drug and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: confirmed caller received the Pfizer COVID vaccine prior to caller having Covid; confirmed caller received the Pfizer COVID vaccine prior to caller having Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "confirmed caller received the Pfizer COVID vaccine prior to caller having Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller is vaccinated and boosted. Have been ultra cautious, but now caller just got it, stating it took 4 years, and now caller has tested positive. Later during the call caller clarified and confirmed caller received the Pfizer COVID vaccine prior to caller having Covid. Patient took Paxlovid as treatment.   Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: starting COVID-19 treatment with Paxlovid; starting COVID-19 treatment with Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. 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; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "starting COVID-19 treatment with Paxlovid". The patient received paxlovid from 02May2024 to 06May2024 as treatment of COVID-19.  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-202400106512 same patient/ different drug and events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, General physical health deterioration, Interchange of vaccine products, Syncope
Clinical narrative: took (3) Pfizer COVID vaccines and (1) Moderna COVID vaccine; died suddenly and unexpectedly of a massive stroke with significant brain bleed; died suddenly and unexpectedly of a massive stroke with significant brain bleed; she was fainting often; her health started to deteriorate; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Moderna covid vaccine, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (death), outcome "fatal", described as "took (3) Pfizer COVID vaccines and (1) Moderna COVID vaccine"; CEREBROVASCULAR ACCIDENT (death), CEREBRAL HAEMORRHAGE (death), outcome "fatal" and all described as "died suddenly and unexpectedly of a massive stroke with significant brain bleed"; SYNCOPE (medically significant), outcome "unknown", described as "she was fainting often"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "her health started to deteriorate". The patient date of death was unknown. Reported cause of death: "died suddenly and unexpectedly of a massive stroke with significant brain bleed". It was not reported if an autopsy was performed.  Clinical course: The 80 year old patient took (3) Pfizer COVID vaccines and (1) Moderna COVID vaccine. She died suddenly and unexpectedly of a massive stroke with significant brain bleed. She was playing tennis and very active up until she took the COVID booster...then her health started to deteriorate and she was fainting often with no explanation from doctors. Reporter was heartbroken and angry that was manipulated by physicians and the media to the take shots!; Reported Cause(s) of Death: died suddenly and unexpectedly of a massive stroke with significant brain bleed; died suddenly and unexpectedly of a massive stroke with significant brain bleed
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: took (3) Pfizer COVID vaccines and (1) Moderna COVID vaccine; died suddenly and unexpectedly of a massive stroke with significant brain bleed; died suddenly and unexpectedly of a massive stroke with significant brain bleed; she was fainting often; her health started to deteriorate; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Moderna covid vaccine, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (death), outcome "fatal", described as "took (3) Pfizer COVID vaccines and (1) Moderna COVID vaccine"; CEREBROVASCULAR ACCIDENT (death), CEREBRAL HAEMORRHAGE (death), outcome "fatal" and all described as "died suddenly and unexpectedly of a massive stroke with significant brain bleed"; SYNCOPE (medically significant), outcome "unknown", described as "she was fainting often"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "her health started to deteriorate". The patient date of death was unknown. Reported cause of death: "died suddenly and unexpectedly of a massive stroke with significant brain bleed". It was not reported if an autopsy was performed.  Clinical course: The 80 year old patient took (3) Pfizer COVID vaccines and (1) Moderna COVID vaccine. She died suddenly and unexpectedly of a massive stroke with significant brain bleed. She was playing tennis and very active up until she took the COVID booster...then her health started to deteriorate and she was fainting often with no explanation from doctors. Reporter was heartbroken and angry that was manipulated by physicians and the media to the take shots!; Reported Cause(s) of Death: died suddenly and unexpectedly of a massive stroke with significant brain bleed; died suddenly and unexpectedly of a massive stroke with significant brain bleed
Sex: M
Vaccine: COVID19
Symptoms: Interleukin level, Multisystem inflammatory syndrome, SARS-CoV-2 test
Clinical narrative: multisystem inflammatory syndrome; This is a literature report, Program ID for the following literature source(s).  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  A 22-year-old man developed multisystem inflammatory syndrome after receiving tozinameran vaccine for immunisation against COVID-19 [route, dosage and time to reaction onset not stated]. The man developed multisystem inflammatory syndrome 9 days after receiving the first dose of tozinameran. He was first exposed to COVID-19 in july 2021. Subsequently, he tested positive 3 days after receiving the first dose of the vaccine. He had several elevated inflammatory markers. Interleukin-6 was elevated at 18.5. He met all five criteria that the centers for disease control and prevention (cdc) as defined by multisystem inflammatory syndrome in adults (MIS-A1). He experienced fever, and he was hospitalised for a week with multiple organ dysfunctions. He had a positive rapid COVID test. He had several inflammatory markers that were positive including IL-6, lactic acid, d-dimer, CRP, ferritin and procalcitonin. After the first day in the hospital, he had an absence of a concomitant severe respiratory illness and did not require any oxygenation. The man was treatment with immune globulin [IVIG] and unspecified steroids. He fully recovered, and he was discharged from hospital after 7 days. Multisystem inflammatory syndrome was considered secondary to tozinameran vaccine.; Sender's Comments: The patient tested COVID 19 positive 3 days after receiving the first dose of the vaccine later developed multisystem inflammatory syndrome 6 days afterwards.  The occurrence of multisystem inflammatory syndrome most likely is triggered by recent COVID 19 infection.  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: Thrombosis
Clinical narrative: blood clots; 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". The patient stated, "Who do I need to contact about my blood clots after receiving the Pfizer Covid 19 vaccine? Should I contact a lawyer instead?"
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: health has been constantly in decline; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "health has been constantly in decline". Additional information: Patient reached out to say the company's COVID vaccine destroyed patient's health. Patient's health has been constantly in decline ever since patient took it.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions were reported; Improperly stored due to late (lost) shipment; Shipment was delayed during transit for an additional 6 days; The patients were notified and scheduled for a repeat dose as per recommendations after contacting the manufacturer. No adverse reactions were reported with first dose or repeat dose; This spontaneous report was received from other health professional concerning to a 4-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 28-FEB-2024, product (measles, mumps, rubella and varicella [Oka-Merck] virus vaccine live [PROQUAD]) was ordered. On (or before) 02-MAR-2024, shipment was to be received in clinic. Shipment was delayed during transit for an additional 6 days and on 08-MAR-2024, was received in clinic (product distribution issue). It was unable to confirm temperature of vaccine for those additional days. The product was mistaken put into clinic stock (also reported as improperly stored due to late [lost] shipment) (product storage error).  On 25-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, administered via subcutaneous on the right thigh, lot number X023876, expiration date 27-MAR-2025 (also reported as 27-MAR-2024, but upon an internal validation, established as 27-MAR-2025) (strength, dose and vaccination scheme were not provided) administered for prophylaxis. On the same date, the patient was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (QUADRACEL) administered via intramuscular on the left thigh, lot number U7838AA (strength, dose, vaccination scheme, expiration date and indication were not provided).  During inventory was discovered that 10 doses were given. The patients were notified and scheduled for a repeat dose as per recommendations after contacting the manufacturer. No adverse reactions were reported (no adverse event) with first dose or repeat dose (extra dose administered).
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: On 4/28/24 Resident c/o cough and congestion. Resident tested positive for covid on 4/28/24 and started on Paxlovid for 5 days and placed on isolation precautions for 10 days.
Age: 36.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Chills, Injection site erythema, Injection site urticaria, Nausea, Pain
Clinical narrative: nausea, fever TMAX 102F, chills, body aches, red wheal on left deltoid approximately 2 cm
Age: 36.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pyrexia
Clinical narrative: nausea, fever TMAX 102F, chills, body aches, red wheal on left deltoid approximately 2 cm
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Rash
Clinical narrative: Donor came the center after 3 days and c/o having a rash on both forearms and had a itching sensation for a day and after 24 hrs, he has no longer an itching sensation.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Dizziness, Dysgeusia, Lethargy
Clinical narrative: extrem body pain and muscle cramps in legs, burning in right thigh, etremely week, nerve pain in thigh, water tasted like medicine, felt faint, lethargic,
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Neuralgia, Pain
Clinical narrative: extrem body pain and muscle cramps in legs, burning in right thigh, etremely week, nerve pain in thigh, water tasted like medicine, felt faint, lethargic,
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: small localized red bumpy rash appeared at injection site about 1.5 days after injection and still present a week later. Patient has not tried anything OTC. Suggested hydrocortisone cream and to follow up with PCP if worsens or doesn't get any better.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine was administered on 4/14/2024. The expiration date on the box states "23SEP24" The pharmacist interpreted this date as September 23, 2024. The actual expiration was September 24, 2023 making the administered product expired at the date of vaccination. The patient reports no ill effects. Sanofi Pasteur drug information representative states the dose is invalid and per CDC guidelines should be re-administered. The patient has been informed of the recommendation.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash erythematous
Clinical narrative: Burning red rash on face down my neck
Age: 65.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Fever, swollen at shot site, redness at shot site, muscular ache, fatigue, loss of apetite, nauseas, weakness
Age: 65.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, swollen at shot site, redness at shot site, muscular ache, fatigue, loss of apetite, nauseas, weakness
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: hard erythematous mass, 3x6 in lesion warm, started 5/14/2024.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Alopecia, Emotional disorder
Clinical narrative: Gradual and complete hair loss . With no regrowth . Resulting in physical and emotional trauma
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Ptt came in.She showed me her left arm which had a bruise about the size of a dime, was red & swollen, about the circumference of an orange.She said had 2 immunizations this weekend. I asked her if the area hurt or itched. She said both. I asked if she'd taken anything for it. She said no. She asked what she can take.  I asked if she had any medical conditions.  She said only Cancer. She said she is not on any Chemo or Radiation.She has just been on a pill for 5 yrs now. She was rubbing her arm. I told her this could make it worse & recommended against rubbing it. I suggested she ice it down to help the swelling & take Benadryl. I asked if it was getting gradually better or worse.  She said it is much better than it was on Saturday & is continuing to get better. I also recommended she follow up with a Physician if it did not continue to get better.  She said she'd had a bad reaction to a Tetanus shot before where her arm & armpit were badly swollen. I pulled her form & she'd only listed Pcn  as an allergy. She said it didn't say anything about Vaccines. I read it to her showing that it did. She didn't say anything  to the RPh about the previous Rxn.  She said the RPh gave both shots in the same arm, Tetanus & TwinRx.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: ongoing 3 years now.. 1 surgery so far ...still impinged
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Aug2023 at 13:15 as dose 6 (booster), single (Lot number: GK0928) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pennacillian allergy" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Left arm), administration date: 12Apr2021, when the patient was 57-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Right arm), administration date: 04May2021, when the patient was 57-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 3203080, Intramuscular, Anatomical site of injection: Right arm), administration date: 03Dec2021, when the patient was 58-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FM0173, Intramuscular, Anatomical site of injection: Right arm), administration date: 18Jun2022, when the patient was 59-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot number: Oj5346, Anatomical site of injection: left arm), administration date: 14Nov2022, when the patient was 59-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever". The following information was reported: LETHARGY (non-serious) with onset 24Aug2023, outcome "unknown"; PAIN (non-serious) with onset 24Aug2023, outcome "unknown"; PYREXIA (non-serious) with onset 24Aug2023, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset 24Aug2023, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset 24Aug2023, outcome "unknown", described as "tiredness". Additional information: Onset date of all events-within hours to 1 day from date of vaccination. Prior vaccinations within 4 weeks was NONE. Relevant test reported as NONE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400103328 same patient, same drug/event, different dose;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Aug2023 at 13:15 as dose 6 (booster), single (Lot number: GK0928) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pennacillian allergy" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Left arm), administration date: 12Apr2021, when the patient was 57-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Right arm), administration date: 04May2021, when the patient was 57-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 3203080, Intramuscular, Anatomical site of injection: Right arm), administration date: 03Dec2021, when the patient was 58-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FM0173, Intramuscular, Anatomical site of injection: Right arm), administration date: 18Jun2022, when the patient was 59-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot number: Oj5346, Anatomical site of injection: left arm), administration date: 14Nov2022, when the patient was 59-year-old, for covid-19 immunisation, reaction(s): "Pain", "Swelling at injection site", "tiredness", "lethargy", "slight fever". The following information was reported: LETHARGY (non-serious) with onset 24Aug2023, outcome "unknown"; PAIN (non-serious) with onset 24Aug2023, outcome "unknown"; PYREXIA (non-serious) with onset 24Aug2023, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset 24Aug2023, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset 24Aug2023, outcome "unknown", described as "tiredness". Additional information: Onset date of all events-within hours to 1 day from date of vaccination. Prior vaccinations within 4 weeks was NONE. Relevant test reported as NONE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400103328 same patient, same drug/event, different dose;
Sex: M
Vaccine: RSV, RSV
Symptoms: Abdominal discomfort, Malaise, Nausea, Pain
Clinical narrative: Muscle ache; Nausea and churning stomach issues; This is a spontaneous report received from a pharmacist from a sales representative.  A 64-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 08May2024, outcome "recovering", described as "Muscle ache"; NAUSEA (non-serious) with onset 08May2024, outcome "recovering", described as "Nausea and churning stomach issues". It was unknown if therapeutic measures were taken as a result of myalgia, nausea.  Additional Information: The patient was experiencing the events for 5 days.
Sex: M
Vaccine: RSV, RSV
Symptoms: Myalgia, Nausea
Clinical narrative: Muscle ache; Nausea and churning stomach issues; This is a spontaneous report received from a pharmacist from a sales representative.  A 64-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 08May2024, outcome "recovering", described as "Muscle ache"; NAUSEA (non-serious) with onset 08May2024, outcome "recovering", described as "Nausea and churning stomach issues". It was unknown if therapeutic measures were taken as a result of myalgia, nausea.  Additional Information: The patient was experiencing the events for 5 days.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No reported signs/symptoms of adverse effects.; Caller stated that product was administered after a not supported excursion. No reported signs/symptoms of adverse effects.; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 29-APR-2024, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025342, expiration date: 12-MAY-2025, administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided) after a not supported excursion, but they reported no signs or symptoms as well as adverse effects (improper storage of product in use), as limited information was available.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; doses have been administered after a supported temperature/Vaccine excursion on 14-MAR-2024/date of vaccination 20-MAR-2024; This spontaneous report was received from a nurse and referred to a 4-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-MAR-2024, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. Afterwards, on 20-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), administered intramuscularly in the right deltoid for prophylaxis (strength and dose was not provided) (Product storage error). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). Patient's response was reported as none. No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA001624: US-009507513-2405USA001625: US-009507513-2405USA001626: US-009507513-2405USA001627: US-009507513-2405USA001628: US-009507513-2405USA001629:
Sex: F
Vaccine: HPV4
Symptoms: Affective disorder, Type 3 diabetes mellitus
Clinical narrative: type 3 diabetes; mood disorders; Information has been received from a physician via social media regarding a case in litigation, concerning a female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 2 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  The patient was diagnosed with type 3 diabetes along with mood disorders after her second shot with vaccine. The outcome was not reported. The causality was related.  Upon internal review, the type 3 diabetes was considered to be medically significant.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2405USA002823: US-009507513-2405USA002786:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report TE (case 02599702). Caller reported one lot number of VARIVAX was administered to one patient on an unspecified date; No additional AE; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT).  On unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot X020149 is a valid lot number, expiration date was reported as 01-AUG-2025), 1 dose administered as prophylaxis (strength, vaccination scheme, anatomical location, and route of administration were not provided) (product storage error). The temperature excursion last 0 hours, 27 minutes and 0 seconds at a temperature of -11.7 degree Celsius. The vaccine also had previous temperature excursions of 0 hours, 20 minutes and 0 seconds with a temperature of -14 degree Celsius to -10 degree Celsius and other of 2 hours, 50 minutes and 0 seconds with a temperature of -10 degree Celsius to 8 degrees Celsius. No additional adverse event.