Received Jun 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z006890 | — |
HCP reports a Hepatitis B tray was mistakenly placed into the GARDASIL 9 carton and a GARDASIL 9 tray was mistakenly placed into the Hepatitis B carton. As a result, the GARDASIL 9 was pulled instead of the Hep B.; patient was inadvertently administered a GARDASIL 9 dose instead of a Hepatitis B vaccine; the patient experienced irritability for 2 or 3 days following vaccination; This Spontaneous report was received from Physician and referred to a/an 3-years-old ( Race Unknown ) ( Ethnicity Unknown) Male Child patient. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 05-Jun-2026, the patient started therapy with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 (0.50 mL) (Batch/Lot Number: Z006890) (Expiration date: 03-Sep-2027) dose form was Injection (Dose Text: 0.5ml/na). At the time of the Event´s occurrence, the patient was not started on hepatitis b vaccine (recombinant) suspension for injection. The patient started therapy with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 for the treatment of prevention, In Jun-2026, the patient experienced the patient experienced irritability for 2 or 3 days following vaccination (Irritability postvaccinal). On 05-Jun-2026, the patient experienced patient was inadvertently administered a GARDASIL 9 dose instead of a Hepatitis B vaccine (Wrong product administered). On an unknown date, the patient experienced HCP reports a Hepatitis B tray was mistakenly placed into the GARDASIL 9 carton and a GARDASIL 9 tray was mistakenly placed into the Hepatitis B carton. As a result, the GARDASIL 9 was pulled instead of the Hep B. (Product storage error). The Outcome of Irritability postvaccinal was not provided. The Outcome of Wrong product administered was not provided. The Outcome of Product storage error was not provided. The action taken with hepatitis b vaccine (recombinant) suspension for injection regarding Irritability postvaccinal was Not applicable. The action taken with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 regarding Irritability postvaccinal was Not applicable. The Physician considered the event Product storage error (,) to be not assessed to Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121, the event Wrong product administered (,) to be not assessed to hepatitis b vaccine (recombinant) suspension for injection, the event Wrong product administered (,) to be not assessed to Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121, and the event Product storage error (,) to be not assessed to hepatitis b vaccine (recombinant) suspension for injection the causality for the event Irritability postvaccinal to hepatitis b vaccine (recombinant) suspension for injection was not reported, and the causality for the event Irritability postvaccinal to Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 was not reported, The Physician considered the event Product storage error to be non-serious, the event Irritability postvaccinal to be non-serious, and the event Wrong product administered to be non-serious