chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait disturbance, Seizure
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait inability, Nervous system disorder, Seizure
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Fatigue, Gait inability, Magnetic resonance imaging
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Malaise, Pain, Paraesthesia, Scan brain, Seizure
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Biopsy brain abnormal, Death, Demyelination, Laboratory test, Neurological symptom
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Acute kidney injury, Altered state of consciousness, Asthenia, Atrial fibrillation, Biopsy brain abnormal
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Blood immunoglobulin G increased, CSF protein increased, Cerebral disorder, Depressed level of consciousness, Electroencephalogram normal
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Endotracheal intubation, Fatigue, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Partial seizures
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis, Pneumonia staphylococcal, Positron emission tomogram, Rash erythematous, Respiratory failure
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Spinal cord disorder, Splenomegaly, Unresponsive to stimuli
Clinical narrative: Coma from neurological complications; Had 4 strokes; Seizure; Lost his ability to walk; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMA (medically significant), outcome "not recovered", described as "Coma from neurological complications"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had 4 strokes"; SEIZURE (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Lost his ability to walk". The events "coma from neurological complications", "had 4 strokes", "seizure" and "lost his ability to walk" required physician office visit.  Clinical course: The reporter stated that his father was in a coma from neurological complications after getting the RSV and COVID vaccines the day after Holiday. He first lost his ability to walk, then had 4 strokes and a seizure. He was 69 (no unit) and was perfectly healthy. All of the doctors were puzzled.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received four Pfizer vaccinations within the last 2 years and still got/contracted COVID; received four Pfizer vaccinations within the last 2 years and still got/contracted COVID; This is a spontaneous report received from a Consumer or other non HCP.   A 59-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 "received four Pfizer vaccinations within the last 2 years and still got/contracted COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid. Clinical course: While enrolling the patient into financial assistance program, the patient stated that they received four Pfizer vaccinations within the last 2 years and still got sick. Patient was also curious if they had potentially missed a dose, since she had now contracted COVID.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient 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: URTICARIA (non-serious), outcome "unknown", described as "hives".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Device leakage, Syringe issue
Clinical narrative: the little syringe that goes into the adaptor broke and it leaked out and malfunction occurred during preparation; the little syringe that goes into the adaptor broke and it leaked out and malfunction occurred during preparation; the little syringe that goes into the adaptor broke and it leaked out and malfunction occurred during preparation; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), DEVICE BREAKAGE (non-serious), DEVICE MALFUNCTION (non-serious), outcome "unknown" and all described as "the little syringe that goes into the adaptor broke and it leaked out and malfunction occurred during preparation". Additional information: The reporter could not remember exactly what the issue was.  Causality for "the little syringe that goes into the adaptor broke and it leaked out and malfunction occurred during preparation" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she had Pfizer Vaccine before but still had Covid; she had Pfizer Vaccine before but still had Covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she had Pfizer Vaccine before but still had Covid".  Clinical course: The caller called in as she was trying to get Paxlovid and she had Pfizer Vaccine before but still had Covid and Paxlovid cost like a lot of money now.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 2.0
Sex: U
Vaccine: FLUX, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the vaccine was accidentally administered to a 2 year and 17-month-old instead of flu vaccine with no reported adverse event; the vaccine was accidentally administered to a 2 year and 17-month-old instead of flu vaccine with no reported adverse event; Initial information received on 19-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA025179(CLUSTER).  This case involves a 2 years old patient of an unknown gender who was accidentally administered Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Influenza Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2024, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown expiry date, lot number) (Strength: Standard) (Frequency: Once) via intramuscular route in the left deltoid for immunization.  On 19-Jan-2024, the patient was accidentally administered Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Influenza Vaccine with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  It was reported, HCP calling regarding ADACEL. Caller stated that the vaccine was accidentally administered to a 2 year and 17-month-old instead of flu vaccine. Caller would like to know the potential adverse effects and what to monitor in the children. Follow-up possible. Caller provided Physician contact information for follow-up.This situation is pre-assessed as a medication error/an inappropriate use due to administration of product instead of a flu vaccine, more so to patient younger than 10.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: FLUZONE HD QIV was accidentally administered to the patient due to wrongly grabbing the product from the refrigerator with no reported adverse event; 16 year old patient receiving the FLUZONE HD by accident with no reported adverse event; Initial information received on 23-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 16 years old female patient who was accidentally administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] due to wrongly grabbing the product from the refrigerator with no reported adverse event and patient received the vaccine by accident at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine B RFHBP/NADA/NHBA OMV (Bexsero); and Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Prophylactic vaccination (Immunization).  On 11-Jan-2024, the patient was accidentally administered a dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8233AA, expiry date-  01-JUN-2024) via intramuscular route in the left deltoid for Immunization due to wrongly grabbing the product from the refrigerator with no reported adverse event (wrong product administered) patient received the vaccine by accident with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Reason: Outside workers unplugged refrigerator after building flooded Max/low temperature reached: 72.9F Duration out of labelled range: 11 hours and 19 minutes with no reported adverse event; One dose of IPOL was administered post temperature excursion with no reported adverse event; Initial information received on 23-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old male patient where reporter reported reason: outside workers unplugged refrigerator after building flooded max/low temperature reached: 72.9f duration out of labelled range: 11 hours and 19 minutes with no reported adverse event and one dose of ipol was administered post temperature excursion with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Jan-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot W1C751M/ V1B901M and expiration date- 02-Jun-2024/ 11-Nov-2025) via intramuscular route in the right arm (strength: not provided) for Immunisation (product storage error) and (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dose omission issue
Clinical narrative: patient missed her second dose of imovax rabies with no adverse event; Initial information received on 24-Jan-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 36 years old female patient who experienced missed her second dose of Rabies (Hdc) Vaccine [Imovax Rabies] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Nov-2023, the patient missed her second dose of imovax rabies Powder and solvent for suspension for injection with no adverse event (product dose omission issue) (Latency: same day) (lot number, expiry date: unknown) (Strength: standard) (Indication: for pre-exposure prophylaxis).  It was reported, Pharmacist called to ask that if a patient missed her second dose of IMOVAX RABIES, should the patient restart the vaccination series or finish her 2nd shot even if it's months later. IMOVAX RABIES is used as pre-exposure vaccination as the patient is going to a travel for a couple of months. It is unknown to the pharmacist as to why she missed her second dose and it may be the patient forgot about it. The patient was scheduled on 24NOV2023 to take her second dose and it's exactly 2 months delay from now. This situation is pre-assessed as a medication error/an inappropriate use due to missed dose of IMOVAX RABIES.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Heart rate irregular
Clinical narrative: INITIAL ONSET OF ATRIAL FIBRILLATION WHICH LASTED ALMOST 2 HOURS. I FELT MY IRREGUALR HEARTBEAT IN MY CHEST AND BY PULSE. SMARTDEVICE WITH ECG FUNCTION ALSO IDENTIFIED ATRIAL FIBRILLATION. I HAD NO ASSOCIATED SYMPTOMS. MY CARDIOLOGIST HUSBAND GAVE ME METOPROLOL. HE ALSO DID A LITERATURE SEARCH AND FOUND THAT STUDIES ARE DEMONSTRATING NEW ONSET OF ATRIAL FIBRILLATION WITHIN ONE MONTH OF RSV VACCINE WHICH IS WHY I AM REPORTING THIS.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive the 2nd dose in Shingrix series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20-APR-2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Did not receive the 2nd dose in Shingrix series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2024 It was reported that reporter called on behalf of her husband. He received first vaccine of Shingrix 20-APR-2018 and did not receive the 2nd dose in Shingrix  series. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 69.0
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 from product quality group.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 15:45 as dose 5 (bdoster), single (Lot number: GH9703), in left arm and on 26May2023 at 10:00 as dose 6 (booster), single (Lot number: 6J3270) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in left arm, on 05Apr2021 at 08:45 as dose 2, single (Lot number: ER8737), in left arm and on 27Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Jan2024 to 20Jan2024.; Sender's Comments: fqe
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer. A 70-year-old female patient (not pregnant) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), on 03Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD/alpha-1" (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 Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid started on 13Jan2024 to 19Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: BREAST CANCER; This solicited report received from a consumer via Regulatory Authority: Social Media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced breast cancer (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and breast cancer was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Breast cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Hib Conjugate (Hiberix) was given to patient instead of Hep B vaccination. Therefore patient received double dose of HIB vaccination at one time since she also received Pentacel that same day.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: About a week after receiving the vaccine I started  feeling pain in my left shoulder around the vaccine site. This continued for a month, gradually worsening until it felt like I had torn a rotavator cuff  with very limited mobility. At this time I self medicated with a Lidocaine patch and heat for up to 6 hrs./day. I take the patch off at night, as prescribed, and then wear it daytime for about 12 hrs. This continues through today when I still have the initial discomfort.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE DATE OF VIABILITY.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: I am currently pregnant, I got the vaccine for the baby's immune system. Symptoms include: red, raised welt at injection site. The welt is itchy, tender, and hot to the touch.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Urticaria
Clinical narrative: I am currently pregnant, I got the vaccine for the baby's immune system. Symptoms include: red, raised welt at injection site. The welt is itchy, tender, and hot to the touch.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: RN administered incorrect dose. 12 year old + dose was given to a 10 year old patient. No immediate adverse reaction noted.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Muscle spasms, Pruritus, Rash, Rash erythematous
Clinical narrative: 6:30pm the day of the vaccination: Bumpy rash on arm, itchy hands.  Administered a Benadryl pill and this helped.  The following morning she had severe cramping in her calf muscle to the point that she was limping and could barely walk.  Administered ice and ibuprofen.  Calf has not improved nearly 72 hours later.  5:30pm on 1/30 during dinner she starting experiencing itchy, closing throat sensations (as she does with strawberries) while eating foods she has never been allergic to.   6:30am on 1/31 she woke up with a red rash on her upper back.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Throat irritation, Throat tightness
Clinical narrative: 6:30pm the day of the vaccination: Bumpy rash on arm, itchy hands.  Administered a Benadryl pill and this helped.  The following morning she had severe cramping in her calf muscle to the point that she was limping and could barely walk.  Administered ice and ibuprofen.  Calf has not improved nearly 72 hours later.  5:30pm on 1/30 during dinner she starting experiencing itchy, closing throat sensations (as she does with strawberries) while eating foods she has never been allergic to.   6:30am on 1/31 she woke up with a red rash on her upper back.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Death, General physical health deterioration, Pyrexia
Clinical narrative: Rapidly progressive symptoms on 1/26/24, worsening cough development of fever. On the morning of 1/27/24 status rapidly changed, and pt died on 1/26/24 at 10:25am. Pt was comfort directed care, and DNR/DNI, so hospitalization was not initiated given pts goals of care.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE DATE OF VIABILITY
Age: 30.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash
Clinical narrative: generalized rash
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE ROZEN INSTEAD OF REFRIGERATED
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEEAD OF REFRIGERATED
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was not an adverse event. Pt received an accidental 3rd dose of MMR. First given 12/9/2020, the second 11/30/2023 and the 3rd 01/29/2024
Age: 16.0
Sex: F
Vaccine: COVID19, FLU4, HEPA
Symptoms: Asthenia, Decreased appetite, Joint swelling, Peripheral swelling, Pyrexia
Clinical narrative: Student experienced fever, poor appetite, low energy and swelling of ankles and feet  on day 2 after vaccination until half of day 3 (total 1.5 days).  Symptoms resolved with no treatment. Could still walk and fit regular shoes.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arexy administered to pregnant woman instead of Abrysvo. No symptoms.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: felt tired and sick to my stomach. Started to get lightheaded and had a hard time catching my breath. Went to the doctor.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Discomfort, Pain
Clinical narrative: felt tired and sick to my stomach. Started to get lightheaded and had a hard time catching my breath. Went to the doctor.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram, Fatigue, Pain
Clinical narrative: felt tired and sick to my stomach. Started to get lightheaded and had a hard time catching my breath. Went to the doctor.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: afib (atrial fibrillation); felt pain; discomfort; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 22Dec2023, outcome "unknown"; PAIN (non-serious) with onset 22Dec2023, outcome "unknown", described as "felt pain"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "afib (atrial fibrillation)". The events "afib (atrial fibrillation)", "felt pain" and "discomfort" required physician office visit. Clinical course: The caller refers that he and his wife (both 81-year-old) got the Pfizer COVID-19 vaccine. They both felt pain and discomfort right after getting shot and he also felt dizziness and shortness of breath within two or three weeks after having the vaccine, he went to the doctor and was diagnosed with afib (atrial fibrillation).   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.