received two doses of Shingrix on the same day back on January 8th 2025 by accident; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 08-JAN-2025, the patient received the 3rd dose of Shingrix. On 08-JAN-2025, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced accidental overdose (Verbatim: received two doses of Shingrix on the same day back on January 8th 2025 by accident). The outcome of the accidental overdose was unknown. Additional Information: GSK receipt date: 09-JAN-2025 The pharmacist reported that the patient received two doses of Shingrix on the same day which led to, accidental overdose.

Expired dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 06-JAN-2025, the patient received the 1st dose of Havrix. On 06-JAN-2025, an unknown time after receiving Havrix, 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: 06-JAN-2025 The patient received his first dose of Havrix that was expired on 13th December 2024 which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.

A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two serotypes tested (types 3 and 18C). However, her last pneumococcal vaccine was 12 years prior.; Literature Report. This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, she was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. It was reported that her last pneumococcal vaccination was 12 years ago. On an unknown date, reported as 12 years later, A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two serotypes tested (types 3 and 18C). The outcome of the event was not provided. The authors of the article considered low levels of antibodies as related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown). A copy of the published article is attached as further documentation of the patient’s experience. Lot # is being requested and will be submitted if received.

ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and this was considered an extra dose with no adverse event; ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and this was considered an extra dose with no adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves HIB (PRP/T) VACCINE [ACT-HIB] was administered to a 11 year old female patient and child was not intended to receive ACT-HIB and this was considered an extra dose with no adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine and HPV vaccine VLP rL1 2v (baculovirus) (Human papillomavirus (types 16, 18) vaccine, adsorbed) for Immunisation. On 27-Jan-2025, the 11 year old patient received 0.5 ml (dose 3) of HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK092AB; Expiration Date: 31-May-2025) via intramuscular route in the left deltoid for Immunization and child was not intended to receive ACT-HIB and this was considered an extra dose with no adverse event (product administered to patient of inappropriate age) (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.

inappropriate use due to only the diluent of ACT-HIB was given to a patient with no reported adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, the inappropriate use due to only the diluent of HIB (PRP/T) Vaccine [ACT-HIB] was given to a patient 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 inappropriate use due to only the diluent of HIB (PRP/T) Vaccine Powder and solvent for solution for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination was given to a patient with no reported adverse event (single component of a two-component product administered) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Supervisor did not have the patient’s information at the time of the call. 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.

PENTACEL being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] being inadvertently administered to a patient after being exposed to a shipping 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 Pneumococcal Vaccine Conj 20V (CRM197) (Prevnar 20) for Immunisation. On 27-Jan-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK114AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the left vastus lateralis for Immunization and pentacel being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event (poor quality product administered) (latency : same day). Reportedly “This situation is pre-assessed as a medication error/an inappropriate use due to administration of PENTACEL after a shipping excursion.” This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of the diluent supplied with the yf-vax with no reported ae; administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of the diluent supplied with the yf-vax with no reported ae; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age female patient who received yellow fever vaccine – US [YF-VAX] reconstituted using a sterile diluent for an MMR vaccine instead of the diluent supplied with the YF-VAX with no reported adverse event. The patient’s past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect yellow fever vaccine – US Solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization, reconstituted using a sterile diluent for an MMR vaccine instead of the diluent supplied with the YF-VAX with no reported adverse event (product preparation error) (poor quality product administered) (Latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, the patient was a singer on a cruise ship. She was mandated to take a yellow fever vaccine, and since the dose was invalid, she needs to be re-vaccinated as soon as possible. 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.

received menquadfi 26 months apart, she didn’t receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, the child female patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 26 months apart, she didn’t receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 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 Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination 26 months apart, she didn’t receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event (product administered to patient of inappropriate age) (unknown latency). Reportedly, The problem is she didn’t receive the 2nd Menquadfi after the age of sixteen. Both were done before the patient turned 16 but were 26 months apart. They want to know if the patient is still immunized or do they need the booster after age of sixteen even though the patient had the 2 Menquadfi. 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.

expired Havrix vaccine was administered; 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 11-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis. On 14-JAN-2025, the patient received Havrix. On 14-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix vaccine was administered). 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: 14-JAN-2025 The office manager reported that an expired Havrix vaccine was administered to a patient which led to, expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2025004473, reported by the same reporter.; Sender’s Comments: US-GSK-US2025004473:Same reporter/Different patient

Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis. On 04-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that who received Shingrix adjuvant alone without the powder as a Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025001095, reported by the same reporter, for a different patient.; Sender’s Comments: US-GSK-US2025001095:Same reporter/Different aptient