Received Jun 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z010824 | — |
No additional AE reported; a fourth dose of GARDASIL9 was administered to a patient; This Spontaneous report was received from Consumer or other non health professional and referred to a/an 12-year-old ( Race Unknown ) ( Ethnicity Unknown) Adolescent patient of unknown gender. 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 24-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 (Batch/Lot Number: Z010824) (Expiration date: 20-Aug-2027) dose form was 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 Prophylaxis, On 24-Jun-2026, the patient experienced a fourth dose of GARDASIL9 was administered to a patient (Extra dose administered). On an unknown date, the patient experienced No additional AE reported (No adverse event). The Outcome of Extra dose administered was not provided. The Outcome of No adverse event was not provided. 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 Extra dose administered was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 regarding No adverse event with Not Applicable dechallenge and rechallenge results. The Consumer or other non health professional considered the event No adverse event (,) 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 Extra dose 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 The Consumer or other non health professional considered the event No adverse event to be non-serious and the event Extra dose administered to be non-serious