chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: received an extra dose of pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 15-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (received 1st dose of Pediarix at 2 months), Pediarix (received 2nd dose of Pediarix at 4 months) and Pediarix (received 3rd dose of Pediarix at 6 months).   On an unknown date, the patient received the 4th dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: received an extra dose of pediarix). The outcome of the extra dose administered was 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: 21-AUG-2024 and 22-AUG-2024 The other health professional reported that they had a 15 month old patient that accidentally received an extra dose of Pediarix.  The patient completed a dose at 2 months, 4 months, and 6 months, and then received an extra dose at 15 months which led to extra dose administered. The other health professional asked was there any concern for harm receiving an extra dose of hepatitis b component in this vaccine. No other information was provided.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Menveo administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 3275B, expiry date 30-JUN-2025) for prophylaxis.   Previously administered products included Menveo (1st dose received in 2019) and Menveo (2nd dose received in 2023).   On 21-AUG-2024, the patient received the 3rd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 3rd dose of Menveo administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 The reporter had a patient that received 3 Menveo injections, they had one back in 2019, and then one in 2023, and day before reporting received 3rd dose which led to extra dose administered. The reporter just wanted to know what the recommendations were, or was there any issue with that or harm with the patient.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2nd dose of Arexvy administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L5C22, expiry date 18-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (1st dose received in January 2024).   On 22-AUG-2024, the patient received the 2nd dose of Arexvy. On 22-AUG-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 2nd dose of Arexvy administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 Pharmacist reported that 2 patients (age appropriate, without any contraindications) came into to receive the Arexvy vaccine. After administration, it was determined within the pharmacy database that the patients received Arexvy in January 2024 which led to extra dose administered. This case is linked with US2024105089, same reporter.; Sender's Comments:  US-GSK-US2024105089:SAME REPORTER/ DIFFERENT PATIENT
Sex: U
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who had already received their first 4 doses of DTAP but never got the 5 does before 9 years of age,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 9-year-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTAP (on an unknown date received their first 4 doses ).   On an unknown date, the patient did not receive the 5th dose of DTaP vaccine. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced incomplete course of vaccination (Verbatim: patient who had already received their first 4 doses of DTAP but never got the 5 does before 9 years of age,). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-AUG-2024 A call was transferred for a first line agent where a healthcare professional requested data about the usage of Boostrix in a patient who had already received their first 4 doses of DTAP but never got the 5 does before 9 years of age, which led to incomplete course of vaccination. The requested information about the recommendations and safety and immunogenicity data.  The did not provide anymore data and follow-up was not obtained.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   On 14-AUG-2024, the patient received Engerix B. On 14-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was 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: 22-AUG-2024 A healthcare professional contacted GlaxoSmithKline to inquire about the usage of an expired dose, requesting data to know if it should be repeated which led to expired vaccine used. They provided information about the event, vaccine and patient.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: 47 year old female patient received her third shot for Engerix-B and it was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date) and Engerix B (2nd dose received on an unknown date).   On 22-AUG-2024, the patient received the 3rd dose of Engerix B. On 22-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: 47 year old female patient received her third shot for Engerix-B and it was expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 47 year old female patient received her third shot for Engerix-B and it was expired which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Inflammatory marker increased
Clinical narrative: increased inflammation in her body; This non-serious case was reported by a consumer via call center representative and described the occurrence of inflammation in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inflammation (Verbatim: increased inflammation in her body). The outcome of the inflammation was unknown.   It was unknown if the reporter considered the inflammation to be related to Shingrix.     It was unknown if the company considered the inflammation to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-AUG-2024 The patient self-reported this case. The patient received her 1st dose of Shingrix and she had increased inflammation in her body and that her labs showed raised inflammatory markers. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HIBV, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Hib (Hiberix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Menveo, Havrix, Pediarix, Boostrix, Infanrix, Engerix B, Hiberix and Kinrix. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Pediarix, Boostrix, Infanrix, Engerix B, Hiberix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was 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: 22-AUG-2024 CMA reported that Bexsero, Menveo (1 vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Hiberix stored at 0.1 degree Celsius by 1hr 42 mins on August 15, 2024 administered to patients following the excursion and prior to call which led to incorrect storage of drug.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: an expired dose of adult Engerix-B was given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HBV (Engerix B adult) (batch number 4JG5Y, expiry date 12-AUG-2024) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: an expired dose of adult Engerix-B was given to a patient). The outcome of the expired vaccine used was 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: 22-AUG-2024 The nurse reported that an expired dose of adult Engerix-B was given to a patient which led to expired vaccine used. No further details provided
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got her first dose of Shingrix on 2018; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018, batch number D243K, expiry date 17th May 2025).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got her first dose of Shingrix on 2018). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 The reporter stated that patient who got her first dose of Shingrix on 2018, did she needs to restart the series.  It had been longer than 6 months since patient got first dose do they need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: 4th dose of Shingrix administered; 3rd dose of Shingrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23 February 2018) and Shingrix (2nd dose received on 24th May 2018).   On 18-JUL-2024, the patient received the 4th dose of Shingrix. On 20-NOV-2023, the patient received the 3rd dose of Shingrix. On 20-NOV-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose of Shingrix administered). On 18-JUL-2024, the patient experienced extra dose administered (Verbatim: 4th dose of Shingrix administered). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 Patient came to get her Shingrix vaccine but pharmacist noted that she had previously completed already two series of Shingrix which eld to extra dose administered.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: accidentally administered 2 doses of Hiberix but only the diluent portion of the prefilled syringe; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number 9E3BH, expiry date 09-JUN-2027) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered 2 doses of Hiberix but only the diluent portion of the prefilled syringe) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 22-AUG-2024 Medical Assistant explained they accidentally administered 2 doses of Hiberix but only the diluent portion of the prefilled syringe was administered without reconstituting with the powder from the vial, inappropriate preparation of medication and inappropriate dose of vaccine administered Because they just noticed of the 2 remaining vials of powder, they do not know which patients were administered with the diluent only. Consented to follow up.
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pain at injection site; he was supposed to get the "chicken pox shot" and instead they administered SHINGRIX; Shingrix was administered to 12 year old patient; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 12-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-AUG-2024, the patient received Shingrix (right arm). On 22-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), wrong vaccine administered (Verbatim: he was supposed to get the "chicken pox shot" and instead they administered SHINGRIX) and inappropriate age at vaccine administration (Verbatim: Shingrix was administered to 12 year old patient). The outcome of the injection site pain and wrong vaccine administered were unknown and the outcome of the inappropriate age at vaccine administration was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 22-AUG-2024 The reporter was the father of the patient.  He stated his son received 3 vaccines today (on the day of reporting), 2 in the left arm- (unknown vaccines) and he received Shingrix in the right arm.  He stated he was supposed to get the chicken pox shot and instead they administered Shingrix, which led to wrong vaccine administration.  The patient reported pain at injection sites a few minutes after receiving vaccine.  Medical disclaimer provided and referred to HCP.  12 year old patient received Shingrix, which led to inappropriate age at vaccine administration. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 The pharmacist questioned that patient had received 1st Shingrix 1 year ago, can they complete with 2nd vaccine or do we need to repeat whole series. The patient's age was more than 50 years of age and 1st dose received was 5 years ago in December 2018. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidentally administered a pediatric dose of Engerix-B to an adult; accidentally administered a pediatric dose of Engerix-B to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 32-year-old female patient who received HBV (Engerix B pediatric) (batch number FP9TJ, expiry date 24-MAR-2025) for prophylaxis.   On 14-AUG-2024, the patient received the 1st dose of Engerix B pediatric. On 14-AUG-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult) and adult use of a child product (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2024 Medical Assistant explained that on August 14th 2024 they accidentally administered a pediatric dose of Engerix-B to an adult patient, it was the first dose of a Hepatitis B vaccine which led to accidental underdose and adult use of a child product.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 04-JUL-2026) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was 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: 22-AUG-2024 The medical assistant got a dose of Boostrix for a patient, and she put the needle on it and she put it back on the fridge, and then till the 16 August 2024 lasted in the fridge, and day of reporting another medical assistant gave it to the patient which led to incorrect storage of drug. The caller said that the vaccine that was activate on 16 August 2024 was not administer to the patient, so the vaccine was left on the fridge, and until 22 August 2024 this same vaccine was administer to a patient.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Can I take the 2nd shot this late; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had shingle shot many years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Can I take the 2nd shot this late). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-Aug-2024 The reporter attempted to reach the consumer for more details but had to leave a voice mail.  The reporter asked that how she find out and do have to start over. The reporter asked that she could take the 2nd shot this late. Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Cardiac disorder, Cytokine storm
Clinical narrative: CYTOKINE STORM; AUTOIMMUNE PHENOMENON; HEART ISSUES; This spontaneous report was received from a patient of unspecified age and sex via J&J managed social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, the patient considered injured from Covid vaccine. Four weeks post vaccine, the patient ended up in ER (emergency room) with heart issues. Spike proteins causing cytokine storm and autoimmune phenomenon. On an unspecified date, the patient experienced cytokine storm (Dose in series 1), autoimmune phenomenon (Dose in series 1), and heart issues (Dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cytokine storm, autoimmune phenomenon and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;  Cytokine storm and Autoimmune disorder;  The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: medication error/an inappropriate use due to administering an extra IPV dose with no reported adverse event; Initial information received on 23-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had medication error/an inappropriate use due to administering an extra IPV (VERO) [IMOVAX POLIO] dose 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 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Kinrix) for Immunisation; and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation.  On 23-Aug-2024, the patient received a dose 3 of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot W1A191M, Expiry date:16-Feb-2025, strength was unknown) via intramuscular route in the left thigh for Immunization and medication error/an inappropriate use due to administering an extra ipv dose with no reported adverse event (extra dose administered) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: potential medication error because a patient may have been administered ACT-HIB reconstituted with sterile water instead of the accompanying diluent with no reported adverse event; potential medication error because a patient may have been administered ACT-HIB reconstituted with sterile water instead of the accompanying diluent with no reported adverse event; Initial information received on 23-Aug-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 experienced potential medication error because a may have been administered HIB (PRP/T) Vaccine [ACT-HIB] reconstituted with sterile water instead of the 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 a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK111AA, expiry: 30-Aug-2025 with unknown strength) via unknown route in unknown administration site as immunization, that was reconstituted with sterile water instead of the accompanying diluent with no reported adverse event (product preparation error), (poor quality product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: different diluent was used with ACTHIB other than what is provided with no reported adverse event; Initial information received on 23-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old female patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] with different diluent used with acthib other than what is provided 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 Immunisation; and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad) for Immunisation and PSV 15.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (Frequency: once) (lot UK008AA, Expiry: 31-Dec-24, Strength: standard) via intramuscular route in the right thigh Immunization in which different diluent was used other than what is provided with no reported adverse event (product preparation error) (latency: same day).  It was reported "The lyophilized powder vial was put in sharps".   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: 46.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Injection site pain
Clinical narrative: Ver achy joints, back ache, muscle ache, soreness and swelling at injection sites, slight headache, low grade fever, fatigue
Age: 46.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Ver achy joints, back ache, muscle ache, soreness and swelling at injection sites, slight headache, low grade fever, fatigue
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event, Product dose omission issue
Clinical narrative: missed their second dose; No symptoms reported; This spontaneous report was received from Pharmacist and refers to a patient who at time of their first vaccine was 12 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient had an interruption in their dosing schedule and missed their second dose, the patient never received a second dose. No symptoms reported and no additional details provided.  Additional information is not expected.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; Patient was administered PROQUAD concomitantly with VARIVAX but was supposed to have gotten MMR II; Patient was administered PROQUAD concomitantly with VARIVAX but was supposed to have gotten MMR II; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUL-2024, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, dose, lot #, expiry date, and route of administration were not provided) concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, lot #, expiry date, and route of administration were not provided) (overdose), but was supposed to have gotten measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, lot #, expiry date, and route of administration were not provided) (wrong product administered), all for prophylaxis. No adverse event was reported.  Lot # is being requested and will be submitted if received.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO AE; HCP reported a patient received one dose of GARDASIL9 in 2018 at age 14 but did not get the second dose until 2024 at age 20. No additional information provided. Patient demographic information not provided. No additional AE. No PQC.; This spontaneous report was received from a Medical Assistant and refers to a 20-year-old patient (unknown gender). Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date in 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: female patient who was not pregnant in their mid 20's received GARDASIL 9 about 1 month ago (exact date unknown). When Patient came back 1 month later after receiving GARDASIL 9 patient stated to HCP that she is pregnant.; No additional AE reported.; This spontaneous report was received from a physician via company representative and referred to an adult female patient in her mid 20's (exact age was not provided). This is a prospective report.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown day in July 2024 (reported as 1 month ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The health care professional (HCP) stated that the patient was not pregnant when she received her first dose of this vaccine.  On an unknown day in August 2024, (reported as 1 month later after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9]), the patient stated to the HCP that she was pregnant (Maternal exposure before pregnancy). No other information was known or provided, no additional adverse event (AE) reported (No adverse event). No product quality complaint (PQC) reported.  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: F
Vaccine: HEPA, MEN, MENB
Symptoms: Administration site swelling, Pyrexia
Clinical narrative: fever; swollen upper arm of site of administration; Caller is a medical assistant requesting information on an adult dose of VAQTA administered to a 16 year old patient.; This spontaneous report was received from Other Health Professional and refers to a 16-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included "Tunel Fe".  On 13-AUG-2024, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 ml and not the 0.5 ml ( an adult dose of VAQTA administered to a 16 year old patient), valid lot #X006702, expiration date: 01-OCT-2024, administered for prophylaxis in right lower deltoid (strength, and route of administration were not provided) (overdose); meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), lot #ES49H, expiration date: 31-AUG-2027, administered for prophylaxis in right upper deltoid (dose, strength, formulation, and route of administration were not provided); and meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO), lot #U8124AA, expiration date: 30-SEP-2027, administered for prophylaxis in left upper deltoid (dose, strength, formulation, and route of administration were not provided).  On the same day, the patient experienced fever, and swollen upper arm of site of administration. On the same day, the stop date of the events was reported. The outcome of the events was not reported. The action taken with the suspect therapies regarding the events was not applicable.  The reporter considered the events to be related to hepatitis a vaccine, inactivated (VAQTA).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; 13-year-old who was inadvertently administered GARDASIL 9 outside of recommended interval for two dose series with first dose on 1/24/23 followed by the second dose on 5/25/23; This spontaneous report was received from Physician and refers to a 13-year-old patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JAN-2023, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 25-MAY-2023, the patient was inadvertently vaccinated with the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration). No side effects or symptoms reported.  No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles anyway; Rash was pretty much gone within a week; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles anyway) and rash (Verbatim: Rash was pretty much gone within a week). The outcome of the vaccination failure and shingles were not reported and the outcome of the rash was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-AUG-2024 This case was self-reported by patient. The patient was vaccinated with shingles vaccine and still got shingles anyway.  But it was mild case. The rash was pretty much gone within a week. The patient's physician told that the vaccine did not 100 percent guaranteed to prevent shingles but the lessened the likelihood they would get it and the severity and duration of it was greatly reduced. The patient could had been much worse and asked to get the vaccine. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Herpes zoster oticus, Neuralgia, Post herpetic neuralgia
Clinical narrative: nerve pain; Suspected vaccination failure; got Shingles on my neck, ear (inside as well); got Shingles on my neck, head, shoulder, back shoulder blade and the front upper chest; miserable for almost 3 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included nerve block (have had two nerve blocks and taking two medications).   On an unknown date, the patient received Shingles vaccine. In MAY-2024, an unknown time after receiving Shingles vaccine, the patient experienced feeling miserable (Verbatim: miserable for almost 3 months). On 31-MAY-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: got Shingles on my neck, ear (inside as well)) (serious criteria GSK medically significant) and shingles (Verbatim: got Shingles on my neck, head, shoulder, back shoulder blade and the front upper chest). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: nerve pain). The outcome of the vaccination failure, herpes zoster otitis externa and shingles were not reported and the outcome of the post herpetic neuralgia and feeling miserable were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles, post herpetic neuralgia and feeling miserable to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-AUG-2024 This case was reported by a patient via interactive digital media. The patient had vaccine and got shingles on his/her neck, ear (inside as well), head, shoulder, back shoulder blade and the front upper chest all on the left side. This was on 31st May 2024. The patient was still dealing with severe nerve pain and he/she was seeing a pain management neurology physician.  The patient stated that all that to say that he/she had the vaccine. A lot of good that did. The reporter mentioned that it had been miserable for almost 3 months. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.  Herpes zoster oticus is an unlisted event which is considered unrelated to GSK  Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: nerve pain; Suspected vaccination failure; got Shingles on my neck, ear (inside as well); got Shingles on my neck, head, shoulder, back shoulder blade and the front upper chest; miserable for almost 3 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included nerve block (have had two nerve blocks and taking two medications).   On an unknown date, the patient received Shingles vaccine. In MAY-2024, an unknown time after receiving Shingles vaccine, the patient experienced feeling miserable (Verbatim: miserable for almost 3 months). On 31-MAY-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: got Shingles on my neck, ear (inside as well)) (serious criteria GSK medically significant) and shingles (Verbatim: got Shingles on my neck, head, shoulder, back shoulder blade and the front upper chest). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: nerve pain). The outcome of the vaccination failure, herpes zoster otitis externa and shingles were not reported and the outcome of the post herpetic neuralgia and feeling miserable were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles, post herpetic neuralgia and feeling miserable to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-AUG-2024 This case was reported by a patient via interactive digital media. The patient had vaccine and got shingles on his/her neck, ear (inside as well), head, shoulder, back shoulder blade and the front upper chest all on the left side. This was on 31st May 2024. The patient was still dealing with severe nerve pain and he/she was seeing a pain management neurology physician.  The patient stated that all that to say that he/she had the vaccine. A lot of good that did. The reporter mentioned that it had been miserable for almost 3 months. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.  Herpes zoster oticus is an unlisted event which is considered unrelated to GSK  Shingles vaccine.
Sex: U
Vaccine: RVX
Symptoms: Body temperature increased, Cough, Fatigue, Insomnia, Malaise
Clinical narrative: Suspected Vaccination failure/ I have RSV now; I have RSV now; have been so sick for days.; can't sleep; elevated temperature; my throat is so sore; coughing; so tired; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure/ I have RSV now) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I have RSV now), sickness (Verbatim: have been so sick for days.), sleeplessness (Verbatim: can't sleep), body temperature increased (Verbatim: elevated temperature), sore throat (Verbatim: my throat is so sore), cough (Verbatim: coughing) and tiredness (Verbatim: so tired). The outcome of the vaccination failure, sleeplessness, body temperature increased, sore throat, cough and tiredness were not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the sickness was resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness, sleeplessness, body temperature increased, sore throat, cough and tiredness to be related to RSV vaccine.   The company considered the vaccination failure to be related to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, sickness, sleeplessness, body temperature increased, sore throat, cough and tiredness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-AUG-2024 This case was reported by a patient via interactive digital media. The patient was pretty sure that he/she had RSV at the time of reporting. The patient was so sick for days. The patient could not sleep and his/her throat was so sore from all of the coughing and had an elevated temperature The patient was so tired after receiving the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding RSV were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK RSV vaccine.