chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Post-acute COVID-19 syndrome, Protein total
Clinical narrative: Patient has had COVID 3 times; Patient has had COVID 3 times; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "transplant recipient" (unspecified if ongoing), notes: was a transplant recipient 17 years ago. There were no concomitant medications. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2019, outcome "not recovered", described as "Long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2019, outcome "not recovered" and all described as "Patient has had COVID 3 times". The patient underwent the following laboratory tests and procedures: test: Unknown results; Protein total: continued to be high, notes: protein levels have continued to be high.  Clinical course: Caller was positive with COVID in 2019, she brought it home from a student and then patient got it. She doesn't know where patient got COVID the next two times. Also clarified that she thinks one of patient's vaccines were by Pfizer. Clarified patient took the Johnson and Johnson COVID-19 Vaccine. Patient tried to do another one as a follow-up booster, but had such an adverse effect she didn't proceed with further vaccination. Patient has had COVID 3 times and she's been vaccinated. Patient is now experiencing long COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pleuritic pain, Pyrexia, Tachycardia
Clinical narrative: Worst persistent headache of my lifeHeadache felt like vasculitis (vascular origin); high fever; shaking chills; tachycardia; pleuritic chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization. The following information was reported: VASCULAR HEADACHE (non-serious), outcome "recovered with sequelae", described as "Worst persistent headache of my lifeHeadache felt like vasculitis (vascular origin)"; PYREXIA (non-serious), outcome "recovered with sequelae", described as "high fever"; CHILLS (non-serious), outcome "recovered with sequelae", described as "shaking chills"; TACHYCARDIA (non-serious), outcome "recovered with sequelae"; PLEURITIC PAIN (non-serious), outcome "recovered with sequelae", described as "pleuritic chest pain". The events "worst persistent headache of my lifeheadache felt like vasculitis (vascular origin)", "high fever", "shaking chills", "tachycardia" and "pleuritic chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vascular headache, pyrexia, chills, tachycardia, pleuritic pain.  Additional information: Worst persistent headache of her life that started within several hours of the vaccination, proceeded by high fever and shaking chills. Headache felt like vasculitis (vascular origin), unremitting and unresponsive to usual abortive medical management (acetaminophen, NSAIDs, migraine meds, etc.) with persistent tachycardia and pleuritic chest pain. Patient did not receive  other vaccine in four weeks or other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280974 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Vascular headache
Clinical narrative: Worst persistent headache of my lifeHeadache felt like vasculitis (vascular origin); high fever; shaking chills; tachycardia; pleuritic chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization. The following information was reported: VASCULAR HEADACHE (non-serious), outcome "recovered with sequelae", described as "Worst persistent headache of my lifeHeadache felt like vasculitis (vascular origin)"; PYREXIA (non-serious), outcome "recovered with sequelae", described as "high fever"; CHILLS (non-serious), outcome "recovered with sequelae", described as "shaking chills"; TACHYCARDIA (non-serious), outcome "recovered with sequelae"; PLEURITIC PAIN (non-serious), outcome "recovered with sequelae", described as "pleuritic chest pain". The events "worst persistent headache of my lifeheadache felt like vasculitis (vascular origin)", "high fever", "shaking chills", "tachycardia" and "pleuritic chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vascular headache, pyrexia, chills, tachycardia, pleuritic pain.  Additional information: Worst persistent headache of her life that started within several hours of the vaccination, proceeded by high fever and shaking chills. Headache felt like vasculitis (vascular origin), unremitting and unresponsive to usual abortive medical management (acetaminophen, NSAIDs, migraine meds, etc.) with persistent tachycardia and pleuritic chest pain. Patient did not receive  other vaccine in four weeks or other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280974 same patient, different vaccine dose/event;
Sex: F
Vaccine: RSV
Symptoms: Throat lesion
Clinical narrative: blister in her mouth; lesions into to her throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A female patient received PF-06928316 (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: ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "blister in her mouth"; THROAT LESION (non-serious), outcome "unknown", described as "lesions into to her throat". Additional information: The caller was a pharmacist asking if the mouth blisters was part of the effects of Abrysvo. The caller stated a patient has reported blister in her mouth and lesions into to her throat.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Known allergies: penicillin" (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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Aug2023 to 16Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300281623 same patient, different drug/event.;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "DDD" (unspecified if ongoing); "periodic depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: got at hospital because she was sick with Covid; got at hospital because she was sick with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Lot number: GH9697) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), on 08Apr2021 as dose 2, single (Lot number: EW0151) and on 03May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Had Lyme a few years ago" (unspecified if ongoing); "ehrlichiosis, a tick disease" (unspecified if ongoing), notes: Had 2 tick disease 3 years ago, she is negative now, but she wonders; "Did affect her memory a little bit" (unspecified if ongoing), notes: Did affect her memory a little bit; "shingles" (unspecified if ongoing); "chicken pox" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; HYDROXYCHLOROQUINE. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "not recovered" and all described as "got at hospital because she was sick with Covid". The event "got at hospital because she was sick with covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (20Aug2023) 101.5, notes: Last night fever 101.5; (21Aug2023) 100, notes: Today fever is about 100; SARS-CoV-2 test: (unspecified date) Positive, notes: She tested the next morning and tested positive; (20Aug2023) Positive, notes: Unit: Not Provided; Weight: (unspecified date) 92 and a half pounds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient's height was reported to be about 5 foot. The lot number for the 3rd Pfizer Covid vaccine looked like FM or FN 992Z. It's handwritten and the patient can't tell.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 ". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "tobacco user" (unspecified if ongoing), notes: He is considered for life insurance as tobacco user. The patient took concomitant medications. He takes a lot of vitamins (unspecified). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On 3rd day he tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Patient got vaccine probably in Apr2021 got 1st dose and 3weeks later 2nd. Then it was all over the news get booster. He got in Nov2021 but not same day. Then got another the next May2022 which was 6 months. Then Nov2022 got next booster. He started Paxlovid with unknown start date. He doesn't go to doctor until at deaths door. On 3rd day he tested positive and had telehealth and they sent order to (name-withheld).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment, Paxlovid from 10Aug2023 to 14Aug2023.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulphur drug" (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 Aug2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid from 13Aug2023 to 17Aug2023 as treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose: 3, 4 Moderna, Dose: 1, 2, 5 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6205), in left arm and on 03Apr2021 as dose 2, single (Lot number: EP7533) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Lot number: 939906), in left arm and on 14May2022 as dose 4 (booster), single (Lot number: 049L2IA), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown", described as "Dose: 3, 4 Moderna, Dose: 1, 2, 5 Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after test negative; (21Aug2023) Positive, notes: Positive Test with Symptoms on 21Aug2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: patient was down for 3 days after taking pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "patient was down for 3 days after taking pfizer vaccine".  Additional information: patient age was reported as 35-49, age group adult.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion with no reported adverse event; 1 dose of IPOL vaccine was already given after the excursion, with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 9 years old male patient who was administered vaccine IPV (vero) [IPOL] post temperature excursion 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 diphtheria vaccine toxoid, tetanus vaccine toxoid (TD) for; and HIB Vaccine (HIB) for Immunisation.  On 25-Jul-2023, the patient received 0.5 mL dose 3 of suspect IPV (vero), Suspension for injection (batch number: V1B891M) via intramuscular route in the right deltoid for Immunization post temperature excursion (poor quality product administered) (same day latency) (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion with no reported adverse event and was Unknown for the event 1 dose of ipol vaccine was already given after the excursion, with no reported adverse event.  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 guidelines. 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: IPOL vaccine was given to a patient after the expiration date with no reported adverse event; Initial information received on 11-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who reported IPV (VERO) [IPOL] vaccine was given to a patient after the expiration date 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 Hepatitis B Vaccine for Prophylactic vaccination (immunization).  On 11-Aug-2023, the patient received a dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot U1C571M expiry date: 17-JUN-2023 via intramuscular route in unknown administration site for immunization.  On 11-Aug-2023  ipol vaccine was given to a patient after the expiration date with no reported adverse event (expired product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event ipol vaccine was given to a patient after the expiration date with no reported adverse event.  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 guidelines. 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: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ADACEL was administered with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old female patient to whom expired dose of adacel was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Aug-2023, the patient received 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection lot C5921BA, expiry date: 29-Jul-2023 via intramuscular route in the left deltoid for immunization (strength unknown), expired dose of adacel was administered with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse reports that they administered an expired ACT-HIB today with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] today 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for prophylactic vaccination (Immunisation).  On 14-Aug-2023, the patient received a dose of 0.5 ml (dose 4) once total of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (strength: standard) (lot: UJ803AA; expiry adte : unknown) via intramuscular route in left leg for Immunisation.  On 14-Aug-2023 the patient was administered an expired act-hib today with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Nurse declined to provide email. Nurse asks for information regarding the expired dose; asks if there are any recommendations about how to document the expired dose on the patient's vaccine record."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: inappropriate administration of PENTACEL to a patient that was no longer suitable for use post excursion with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who had inappropriate administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that was no longer suitable for use 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 10-Jun-2023, the patient had inappropriate administration of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ806AA, expiry date- 18-FEB-2024) via unknown route in unknown administration site for Immunization that was no longer suitable for use post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller reported a temperature excursion due to an unknown cause. The excursion occurred on 06JUN2023. The lowest temperature reached negative 0.92 C and the total excursion lasted 1 hour and 15 minutes. Pentacel was administered on 10JUN2023 after being exposed to NEGATIVE 0.92 C.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient administered daptacel that expired on Jun 21, 2023 with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2-year-old female patient administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] that expired on jun 21, 2023 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 HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 03-Aug-2023, the patient received 0.5 ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown) (lot: C5893AA, expiry date: 21-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 03-Aug-2023 the patient had an event of patient administered daptacel that expired on jun 21, 2023 with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  it was unknown if any lab data/test results available.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  Outcome: unknown  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: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Gait inability, Opisthotonus, Peripheral swelling, Seizure
Clinical narrative: leg swelling; the patient could not walk after one of her shots; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 3 years old female patient who had leg swelling and could not walk after one of her shots after receiving diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and HIB (PRP/T) vaccine [ACT-HIB].  The patient's past vaccination(s) included Rotavirus vaccine and Pentacel for immunization. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection and HIB (PRP/T) vaccine, powder and solvent for solution for injection via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had leg swelling (peripheral swelling) and could not walk after one of her shots (gait disturbance) (unknown latency).  Reportedly, rotavirus vaccine, PENTACEL, and possibly Prevnar-13 (the patient's mother knew she received 3 vaccines, but as unsure if Prevnar-13 was the name of the 3rd vaccine); after these shots, the patient developed seizures. When the patient developed seizures. at night the patient would arch her back, her eyes would open, and her body would lock up. The patient was hooked up to electrodes, and they confirmed that they saw seizure activity. The seizure activity was off and on, and at one point it occurred every day for a couple of months. The patient's mother reports that since these events occurred after the patient received PENTACEL.The patient's mother reported that even with the individual vaccines (DAPTACEL, ACT-HIB), the patient still had some reactions like leg swelling; states that the patient could not walk after one of her shots  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (peripheral swelling, gait disturbance).  At time of reporting, the outcome was Unknown for the events peripheral swelling, gait disturbance
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a consumer got an expired dose of ACTHIB with no reported adverse event; Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 15 months old male patient who got an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Aug-2023, the patient received an expired dose of 0.5 ml dose 4 of suspect of standard strength HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (lot: UJ803AA, Expiry date: 13-Aug-2023) via intramuscular route in the right vastus lateralis for Immunisation with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 guidelines. 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: 5.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was given IPOL that was exposed to temperature excursion with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 5 years old female patient who was given IPV (VERO) [IPOL]that was exposed to temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Aug-2023, the patient received a standard total dose 1 of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot W1A191M, expiry date- 18-AUG-2023) via subcutaneous route in the right arm for Immunization that was exposed to temperature excursion with no reported adverse event (poor quality product administered) (latency- same day). Caller asks if they should re-vaccinate the patients after being given IPOL that was exposed to temperature excursion and is no longer suitable for use.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.; Sender's Comments:  US-SA-2023SA256760:01733160
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired vaccine was administered with no adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient to whom administered expired Hib (PRP/T) Vaccine [Act-Hib] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr); Varicella Zoster Vaccine (Varicella Vaccine); Hepatitis A Vaccine (Hepatitis A); And Pneumococcal Vaccine (Pneumococcal Vaccine) for Prophylactic vaccination.  On 18-Aug-2023, the patient received expired dose of 0.5 ml of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 12-Aug-2023 and lot UJ796AA) via intramuscular route in left vastus lateralis for immunization (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 68.0
Sex: M
Vaccine: RAB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: shots that was given three days after his initial shot, was given in the buttocks with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient).  This case involves a 68 years old male patient who got shots that was given three days after his initial shot, was given in the buttocks with no reported adverse event while receiving vaccine Rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, about 2 and a half months ago, the patient received day 0, 7, and 14 in the arm and 3rd dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection with unknown strength, batch number & expiry date via unknown route in the buttock nos with no reported adverse event (incorrect route of product administration) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old male patient who was inadvertently administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] 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 hepatitis A vaccine (Hepatitis A) for Prophylactic vaccination.  On 21-Aug-2023, the patient was inadvertently administered a standard expired total dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 mL (lot UJ796AA, expiry date- 12-AUG-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller with question on whether dose needs repeating.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Blood test, Cardiac ablation, Cardiac amyloidosis, Dizziness
Clinical narrative: Bilateral Pulmonary Embolsion  on 8/11/21.    Shortness of Breath, then Head rush and passed out.   Ambulance called, spent 8 days in the hospital Cardiac Arrhythmia Cardiac Amyloidosis
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Imaging procedure abnormal, Loss of consciousness, Pulmonary embolism, Sudden death
Clinical narrative: Bilateral Pulmonary Embolsion  on 8/11/21.    Shortness of Breath, then Head rush and passed out.   Ambulance called, spent 8 days in the hospital Cardiac Arrhythmia Cardiac Amyloidosis
Age: 96.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Neuralgia from right breast to the back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 96-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had Shingles around 15 years ago.).   In MAY-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria medically significant) and post herpetic neuralgia (Verbatim: Neuralgia from right breast to the back). The outcome of the vaccination failure was unknown and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure and post herpetic neuralgia to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: Receipt date: 15-AUG-2023 The reporter was the daughter of the patient who reported that patient received first dose of Shingrix in January 2023 and second dose in May 2023.  The patient had Shingles around 15 years ago.  Now the patient had neuralgia from right breast to the back.  This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles was unknown.  The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: who diagnosed shingles; rash in the arm, which was painful; rash in the arm, which was painful and itchy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 97LJ7) for prophylaxis.   On 04-AUG-2023, the patient received the 1st dose of Shingrix (unknown arm). On 08-AUG-2023, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: who diagnosed shingles), painful rash (Verbatim: rash in the arm, which was painful) and itchy rash (Verbatim: rash in the arm, which was painful and itchy).  The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the shingles was unknown and the outcome of the painful rash and itchy rash were not reported.   It was unknown if the reporter considered the shingles, painful rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the shingles, painful rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt date: 16-AUG-2023 A pharmacist reported that a patient got the 1st dose of Shingrix on 04 August 2023.  On 08 August 2023, the patient noticed a rash in the arm, which was painful and itchy.  On the 14th, the patient went to the doctor, who diagnosed shingles, and prescribed antivirals to the patient.  The reporter consented to follow up.