chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HG2649) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Osteoporosis" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Aug2020, stop date: 03Jun2024; ALENDRONATE, start date: Jan2022, stop date: 05Jun2024; ACYCLOVIR [ACICLOVIR], start date: 22May2024, stop date: 27May2024. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: Unknown. Not recorded, Location of injection: Arm Left), administration date: 03Oct2022, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: FK9893, Location of injection: Arm Left), administration date: 22Apr2022, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: EW0196, Location of injection: Arm Right), administration date: 07Oct2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 13Jan2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2024) Negative; (13Jun2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID 19; Treatment of COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Lot number: GJ6739) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2023 at 10:00 as dose 6 (booster), single (Lot number: 3030335), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 08Feb2010, stop date: 13Jun2024; SERTRALINE, start date: 14Jul2008, stop date: 13Jun2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID 19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; SARS-CoV-2 test: negative, notes: I tested negative for Covid the next day; positive, notes: Two days later I am testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: After Paxlovid was finished, the patient tested negative for Covid the next day. Two days later, he was testing positive again.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. 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 includes paxlovid from 03Jun2024 to 08Jun2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 07Jun2024 to an unknown date.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Jun2024 to 09Jun2024.  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: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded
Age: 64.0
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 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HH7595) at the age of 64 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 05Jun2024 to 09Jun2024.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Nurse.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Pentagram" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Jun2024 to 10Jun2024.; Sender's Comments: Based on the current available limited information in the case provided, temporal association of events,  Known drug safety profile the causal association between the events Drug ineffective , COVID-19 and the use of suspect product cannot be fully excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: It was reported that the patient received other vaccination in 2 weeks and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 04Jun2024 to 09Jun2024  Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "ITP & Hashimoto's" (unspecified if ongoing); "ITP & Hashimoto's" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Manufacturer unknown, vaccine location: Left arm), administration date: 23Oct2022, when the patient was 37-year-old, for COVID-19 immunization. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 04Jun2024 to 09Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Scleral haemorrhage
Clinical narrative: subconjunctival hemorrhage so basically like flare up eye; broken blood vessel on sclera; This is a spontaneous report received from a Nurse.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jun2024 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation.The following information was reported: SCLERAL HAEMORRHAGE (non-serious) with onset Jun2024, outcome "unknown", described as "broken blood vessel on sclera"; CONJUNCTIVAL HAEMORRHAGE (non-serious) with onset Jun2024, outcome "unknown", described as "subconjunctival hemorrhage so basically like flare up eye". Additional information:Patient just got the Pfizer COVID booster shot, it may be three days or two days before 14Jun2024. And shortly after patient got the vaccine there is a subconjunctival hemorrhage so basically like flare up eye.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02May2024 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that after completing the five-day course of Paxlovid as prescribed (25May2024-29May2024), the patient felt better for about a day and a half. Then on 04Jun2024, the Covid symptoms returned, and took another Covid home test, with result "Positive". This is what she believes is called a Boomerang or rebound infection.    Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Patient had very sore arm; This is a spontaneous report received from a Nurse from a sales representative.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Patient had very sore arm". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: The event did not result in Hospitalization Prolonged.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: FD0809) at the age of 56 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergy:bactrim, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination in 2 weeks and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 11Jun2024 to 16Jun2024  No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Mar2024 as dose 1, single (Lot number: HN0477) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Known allergies was none. 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; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 7; 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 "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included COVID 19 Treatment (Brand- Pfizer) received from 05Jun2024 to 09Jun2024.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported vaccination failure  & COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Only illness I've had since was covid about 5-6 weeks ago; Only illness I've had since was covid about 5-6 weeks ago; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US097791.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Mar2022 (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 2024, outcome "unknown" and all described as "Only illness I've had since was covid about 5-6 weeks ago". Additional information: Only illness I've had since was covid about 5-6 weeks ago. was pretty ill, but symptoms only about half as bad & lasted half as long as when i had covid in Mar2022. I slept through most of it. last Covid booster was around June last year, and I'm overdue this years flu shot, which I should organise this week.
Sex: U
Vaccine: COVID19
Symptoms: Coagulopathy, Myocardial infarction
Clinical narrative: heart attack; blood clotting; 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; COAGULOPATHY (medically significant), outcome "unknown", described as "blood clotting".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he have been diagnosed with covid after taking all shots and booster over the years; he have been diagnosed with covid after taking all shots and booster over the years; 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)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blind" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "he have been diagnosed with covid after taking all shots and booster over the years". The events "he have been diagnosed with covid after taking all shots and booster over the years" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from an unknown date to unknown date. Clinical course: Upon report, it was said that he had been diagnosed with covid after taking all shots and booster over the years. Wednesday he was diagnosed with Covid. Said that he had a bad symptoms of chest pain. His ribs in his back and in the morning, he had to go to the Emergency Room where he was diagnosed. He went to the pharmacy and was given. The reported product was Paxlovid. Mentioned that he had (withheld) and couldn't go online because he was blind.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 25-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. The following information was reported: SEIZURE (medically significant), outcome "unknown". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol reached 34.3F for 21 mins, was administered to patient with no reported adverse event; This case is submitted following an incorrect Worldwide ID in case ID (2024SA161078) which will be deleted. This report contains no new information.  Initial information received on 24-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient to whom IPV (VERO) [Ipol] that reached 34.3f for 21 was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Mar-2024,  the suspect patient received of IPV (VERO) (Suspension for injection) (lot IPV (VERO) (Suspension for injection), (dose, expiry date and strength: unknown) via intramuscular route in the left deltoid for prophylactic vaccination (Immunization) (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 and Regulatory Authority 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: 11.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: max/low temperature reached: 1.0 c or 34.3 f duration out of labelled range: less than an hour with no reported adverse event; menquadfi was administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who had administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after it was exposed to max/low temperature reached: 1.0 Celsius or 34.3 Fahrenheit for less than an hour due to human error 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 HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination On 03-Jun-2024, the patient received a 0.5 ml (millimeter), 1X-total dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, expiry date: 30-Mar-2026 and lot U7945BB) via intramuscular route in the right arm as immunization and was administered post excursion with no reported adverse event (poor quality product administered) (same day latency).  On an unknown date the max/low temperature reached: 1.0 ccelsus or 34.3 f for less than an hour due to human error with no reported adverse event (product storage error).   Human Error: Yes, the extended stability data does not cover the excursion.   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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered either only the DTap-IPV portion or the HIB portion of the vaccine without constituting both vaccines with no reported adverse event; Initial information received on 10-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered either only the dtap-ipv portion or the hib portion of the vaccine without constituting both vaccines with no reported adverse event with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Powder and suspension for suspension for injection lot UK026AA, expiry- 30-JUN-2025 via unknown route in unknown administration site for immunization (strength, dose unknown)either only the dtap-ipv portion or the hib portion of the vaccine without constituting both vaccines with no reported adverse event (single component of a two-component product administered) (same day latency).   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 and Regulatory Authority 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.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: administration of ACTHIB that has been diluted with sterile water instead of its accompanying diluent with no reported adverse event; Initial information received on 10-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and demographics who was administered of HIB (PRP/T) vaccine [ACT-HIB] that has been diluted with sterile water instead of its accompanying diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site for immunization; that has been diluted with sterile water instead of its accompanying diluent with no reported adverse event (product preparation error) (latency: same day). Information on batch number was requested.  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: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given PENTACEL that has expired last 02Jun2024 with no reported adverse event; Initial information received on 10-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that has expired last 02jun2024 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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 10-Jun-2024, the patient received total, 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UJ958AB and expiry 02-Jun-24) (strength: standard) (expired vaccine administered) (latency same day) via intramuscular route in the right thigh for immunization.  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: medication error due to inappropriate administration of ACTHIB that had been reconstituted with an alternate diluent with no reported adverse event; Initial information received on 10-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced medication error due to inappropriate administration of hib (prp/t) vaccine [Act-hib] that had been reconstituted with an alternate diluent 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 pneumococcal vaccine conj 20V (crm197) (Prevnar 20) for prophylactic vaccination; and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination.  On 03-Jun-2024, the patient received dose 3 of 0.5 ml dose of suspect Powder and solvent for solution for injection of hib (prp/t) vaccine Lot UJ965AA, expiry date: 08-Nov-2024, Strength: standard, frequency: once via intramuscular route in the left vastus lateralis as immunization and had medication error due to inappropriate administration of acthib that had been reconstituted with an alternate diluent with no reported adverse event (product preparation error) (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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered YF-Vax with sterile water diluent with no adverse event; Initial information received on 13-Jun-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age/gender patient who was administered YELLOW FEVER VACCINE [YF-VAX] with sterile water diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect YELLOW FEVER VACCINE - US, Solution for injection with sterile water diluent (product preparation error) (latency same day) (lot U7883AA and expiry 30-Nov-24 and 31-Oct-2025) (dose, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: At 2:30pm on the day of vaccination the mother called to ask what the side effects of the vaccine were. Patient was said to be having some difficulty breathing. I spoke with her on the phone and she said she was having a lot of mucus or something come up in her throat. She was advised to contact her primary care physician and also, if conditions persisted, to go to the emergency room or an urgent care clinic. We called back to check on Pt after another 30 or so minutes and they were in the waiting room at the ER as her symptoms had gotten worse. I spoke with the mother, again today and she said they had had to administer an EPI and a Benadryl IV. Caydence was still having to take Benadryl to counteract the reaction even today.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Skin indentation
Clinical narrative: indetation size of dime
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated she got really warm while shopping after her immunization yesterday. also has heat/swelling/redness/pain on upper arm where vaccine was given.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: PATIENT CONTACTED US REPORTING OF TINGLING SENSATION ALL OVER BODY ABOUT POST 1  WEEK VACCINATION. IT HAS BEEN OCCURING CONTINOUSLY EVERY DAY UNTIL CURRENT. SHE HAS 2-5 EPISODES PER DAY. SHE MENTIONED SHE HASN'T HAD ANY INJURIES OR ILLNESSES PRIOR OR AFTER VACCINATION.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Administered the pediatric dose 0.5mL of Hep B to the adult.
Age: 1.0
Sex: F
Vaccine: HEP, HEP, MMR, MMR, VARCEL, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra dose of pediatric hepatitis B instead of 1st dose of hep A. no events noted
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electromyogram, Immune system disorder, Lumbar puncture
Clinical narrative: Ménière?s disease,, sudden immune system overload.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Meniere's disease
Clinical narrative: Ménière?s disease,, sudden immune system overload.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, UNK
Symptoms: Syncope
Clinical narrative: Syncope Vasovagal
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death, Syncope
Clinical narrative: Online Report of sudden death of softball coach while on campus. Victim collapsed and died. DOSE#1 date 02/01/21 LOT#043L20A DOSE#2 date 03/02/21 LOT#013A21A Site location for DOSE#1 on VAX CARD and for DOSE#2, unable to ascertain location info for either site.
Age: 0.75
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: not experiencing any side effects; administered the Gardasil 9 vaccine at 9 Months old; intravenous in right leg; not suppose to get any vaccines today; This spontaneous report was received from consumer (patient's mother) referring to a 9-month-old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 28-MAY-2024, the patient was taken to health care professional (HCP)'s office, she was not supposed to get any vaccines that day. However, the nurse came in and administered her the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intravenously (strength, dose, lot #, and expiry date were not provided) for prophylaxis (Product administered to patient of inappropriate age, Incorrect route of product administration, Accidental exposure to product). The reporter was made aware while she was still at the HCP office. The patient was not experiencing any side effects in an hour (No adverse event).
Age: 0.42
Sex: U
Vaccine: PNC15
Symptoms: No adverse event
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of VAXNEUVANCE; A HCP called to report that his data logger in his vaccine refrigerator quit working on 03/08/2024 but was not realized and reset until 05/31/2024, which resulted in unknown temperature condition exposure to the vaccines.  A dose of VAXNEUVANCE affec; This spontaneous report was received from a Registered Nurse concerning a 5 month old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies were not reported.       On 29-APR-2024 the patient was vaccinated with an improper stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # X019624, expiration date: 07-NOV-2025, at a dose of 0.5 milliliters, administered as prophylaxis (dose schedule, route and site of administration were not reported) (product storage error). It was reported that the data logger stopped functioning on 08-MAR-2024. No adverse events were reported. ; Sender's Comments:  US-009507513-2406USA001816: US-009507513-2406USA001983: US-009507513-2406USA001829: US-009507513-2406USA001859:
Age: 0.67
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of VAXNEUVANCE; A dose of VAXNEUVANCE affected by the unknown temperature conditions was then inadvertently administered to a patient on 04/16/2024; This spontaneous report was received from a nurse and refers to an 8-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  It was reported that the data logger in the vaccine refrigerator quit working on 08-MAR-2024 but was not realized and reset until 31-MAY-2024, which resulted in unknown temperature condition exposure to the vaccines.  On 14-APR-2024, a dose of improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5ml / once, lot #X019624, expiration date: 07-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) affected by the unknown temperature conditions was then inadvertently administered to a patient on that date. The patient did not experience any adverse issues or side effects from the administered dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). The operator of device was reported as health professional. No other information was able to be provided during the call. No Product quality complaint. No prior excursions reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2406USA001859: US-009507513-2406USA001816: US-009507513-2406USA001829: US-009507513-2406USA001684: US-009507513-2406USA001795: US-009507513-2406USA001818: US-009507513-2406USA001844: US-009507513-2406USA001849: US-009507513-2406USA001893: US-009507513-2406USA001974: US-009507513-2406USA001983: US-009507513-2406USA001987: US-009507513-2406USA002012: US-009507513-2406USA002143: US-009507513-2406USA001983:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC; Caller reported vaccines were administered after temperature excursions.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #X023403, expiration date: 03-APR-2025 underwent a temperature excursion (TE) at a temperature of 48-4 F for time frame of 58 minutes.  On 23-MAY-2024, after TE the patient was vaccinated with improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X023403, expiration date: 03-APR-2025, administered orally for prophylaxis (strength and exact dose were not provided) (product storage error). There was not previous TE. Operator of device was reported as health professional. No other information provided. No additional adverse events or product quality complaint reported.  This is one of several reports received from the same reporter.; Sender's Comments:  UM-009507513-2406UMI004508: US-009507513-2406USA004757: US-009507513-2406USA004803: US-009507513-2406USA004898: US-009507513-2406USA004987:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A second dose of Spikevax (2023-2024) Moderna COVID vaccine was administered to a patient under the age of 65 years old without documented immunocompromising conditions. Current vaccine recommendations are for only 1 dose for this age group.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a patient who received a dose of PROQUAD a couple of weeks before they turned 1 year old (date unknown); a patient received a 3rd dose of PROQUAD a couple of weeks before the patient turned 4 year old (date unknown); the doctor prescribed an additional dose of PROQUAD after the patient turned 1 year old (date unknown); the doctor prescribed an additional dose of PROQUAD after the patient turned 1 year old (date unknown); The caller did not report any other adverse event/no other AE; This spontaneous report has been received from a nurse practitioner referring to a infant patient of gender (exact age unknown). The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On an unknown date (reported as a couple of weeks before turning 1-year-old), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status, strength, dose, lot number, expiration date and route of administration were not reported) for prophylaxis (Product administered to patient of inappropriate age). Because this dose was given early, on an unknown date (reported as after the patient turned 1-year-old), the doctor prescribed an additional dose (second dose) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status, strength, dose, lot number, expiration date and route of administration were not reported) (Product prescribing issue, Extra dose administered). On an unknown date (reported as a couple of weeks before the patient turned 4-year-old), the patient received a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status, strength, dose, lot number, expiration date and route of administration were not reported) for prophylaxis (Product administered to patient of inappropriate age). The reporter did not report any other adverse event (AE) and did not have any further information. No product quality complaint (PQC) was reported.  Lot # is being requested and will be submitted if received.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: patient was given a full adult Havrix dose inadvertently; 30 month old patient was given a full adult Havrix dose inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 30-month-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   On 07-JUN-2024, the patient received Havrix 1440 adult. On 07-JUN-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: patient was given a full adult Havrix dose inadvertently) and adult product administered to child (Verbatim: 30 month old patient was given a full adult Havrix dose inadvertently). The outcome of the accidental overdose and adult product administered to child 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: 11-JUN-2024 Reporter reported that the child patient was given a full adult Havrix dose inadvertently, which led to accidental overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: starting on Day 10 post-vaccine administration: 101-102 fever, lethargy (up and active  for 1-2 hrs a day max), loss of appetite.  Ongoing 2 days later now. At the same intensity.