ACTHIB administered separately from Pentacel with no reported adverse event; Initial information received on 22-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. The case is linked to US-SA-2025SA023490. This case involves a 4 months old male patient who had HIB (PRP/T) Vaccine [ACT-HIB] administered separately from pentacel 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 and DTAP WITH POLIO for Immunisation. On 22-Jan-2025, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) strength, expiry date, lot number not reported via intramuscular route in the right thigh for Immunization and acthib administered separately from pentacel with no reported adverse event (wrong technique in product usage process) (latency : same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly “ActHIB that was administered today was the lyophilized vaccine component of PENTACEL from yesterday or if it was the actual vaccine. Nurse caregiver wanted to know if there are possible side effects since it was given incorrectly.” 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-2025SA023490:02383817

Menquadfi since it was administered to a patient below 2 years old with no reported adverse event; Initial information received on 22-Jan-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 1 years old female patient (below 2 years old) was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jan-2025, a below2 years old patient was administered (dose 1) (Standard) Meningococcal A-C-Y-W135 (T Conj) Vaccine (frequency-once) (unknown strength, expiry date, batch number and route) in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Caregiver called to inquire of possible side effects with Menquadfi and how long to look out for possible side effects. 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 components being administered separately with no reported adverse event; Initial information received on 22-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to US-SA-2025SA023518 (Cluster case). This case involves a 4 months old male patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] components being administered separately 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 for Immunisation. On 21-Jan-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot 49281-561-01 and 49281-51105, with strength as Standard and unknown expiry) via intramuscular route in the left thigh as Immunization, but on this date only the DTaP-IPV liquid vaccine component was administered and next day on 22-Jan-2025 received an unknown dose of ActHIB vaccine component via intramuscular route in the right thigh leading to pentacel components being administered separately with no reported adverse event (wrong technique in product usage process) (Latency: same day). Reportedly, Caregiver is unsure if the ActHIB that was administered today was the lyophilized vaccine component of PENTACEL from yesterday or if it was the actual vaccine. 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-2025SA023518:02383817

Only the DTaP-IPV component was administered to the patient/The Hib component was not yet administered, with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old male patient to whom only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered to the patient/the hib component was not yet administered, 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 21-Jan-2025, only the dtap-ipv component was administered to the patient at unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK167AA; Expiration date: 20-Oct-2025 strength not reported) via intramuscular route in unknown administration site for Immunization, hib component was not yet administered, with no reported adverse event (single component of a two-component product administered) (latency: on 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.

came down with flu type a. got a positive result on the rapid flu a test/got sick with flu; fever; severe muscle aches; lack of efficacy. got sick with flu a; Initial information received on 23-Jan-2025 regarding an unsolicited valid non-serious case received from patient This case involves a 56 years old female patient who got a positive result on the rapid flu a test/got sick with flu, fever, severe muscle aches and indicating lack of efficacy after receiving influenza USP trival A-B subvirion NO preservative vaccine [Fluzone]. The patient’s past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 06-Dec-2024, the patient received 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength) with lot UT8408LA and expiry date JUN-2026 via intramuscular route in unknown administration site for Flu prevention (Antiviral prophylaxis) On 19-Jan-2025 the patient developed came down with flu type a. got a positive result on the rapid flu a test/got sick with flu (influenza a virus test positive), fever (pyrexia), muscle aches (myalgia) and lack of efficacy. got sick with flu a (vaccination failure) (Latency 1 month 13 days) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. Relevant laboratory test results included: Influenza A virus test – On 19-Jan-2025: Positive Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovering / Resolving for all the events.

Maladministration of the AS01B Adjuvant of Shingrix Alone; Maladministration of the AS01B Adjuvant of Shingrix Alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-DEC-2024, the patient received the 2nd dose of Shingrix. On 30-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 30-DEC-2024 The reporter reported that a patient received Shingrix diluent alone without the powder portion, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter believed this was patient’s Shingrix second dose. There was no patient’s information available, nor lot number or expiration date information either. The vaccine administration facility was the same as primary reporter.

gave them autism; This serious case was reported by a consumer and described the occurrence of autism in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included infliximab for product used for unknown indication. On an unknown date, the patient received Shingrix and infliximab. On an unknown date, an unknown time after receiving Shingrix, the patient experienced autism (Verbatim: gave them autism) (serious criteria GSK medically significant). The action taken with infliximab was unknown. The outcome of the autism was resolved. It was unknown if the reporter considered the autism to be related to Shingrix. The company considered the autism to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that the patient got Shingrix when they started infliximab and it gave them autism. On an unknown date, an unknown time after receiving infliximab, the patient experienced autism. It was unknown if the reporter considered the autism to be related to infliximab. This case has been linked to the US2025AMR010349 case reported by the same reporter.; Sender’s Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR010349:same reporter

Vesicular rash from R pubic/groin down R lateral thigh to knee

Patient inappropriately received a 2nd Prevnar 20 vaccine. No adverse events reported.

Patient reports that the shot was given very high on the arm. Red, painful rash at injection site with swelling. Patient reports openly bleeding for multiple hours after vaccine but is not on blood thinners. Patient states there was a very large amount of pain for ~3 days after shot, that started immediately on injection.