Received Jul 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Z005469 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Z008509 | — |
Head and neck cancer; he patient received their first dose on 12/17/2026 and second dose on 2/24/2026.; This Spontaneous report was received from Physician and referred to a/an 51-year-old ( Race Unknown ) ( Ethnicity No Information) Male Adult 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 17-Dec-2025, 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: Z005469) (Expiration date: 27-Feb-2026). On 24-May-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: Z008509) (Expiration date: 23-Jul-2027). 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, 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 17-Dec-2025, the patient experienced he patient received their first dose on 12/17/2026 and second dose on 2/24/2026. (Product administered to patient of inappropriate age). On 17-Jun-2026, the patient experienced Head and neck cancer (Head and neck cancer). The Outcome of Head and neck cancer was not provided. The Outcome of Product administered to patient of inappropriate age 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 Head and neck cancer was Not applicable with Not Applicable dechallenge and rechallenge results. 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 Head and neck cancer 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 Product administered to patient of inappropriate age 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 Product administered to patient of inappropriate age with Not Applicable dechallenge and rechallenge results. The Physician considered the event Head and neck cancer (,) 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 Product administered to patient of inappropriate age (,) 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 Head and neck cancer (,) 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 administered to patient of inappropriate age (,) 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 Physician considered the event Product administered to patient of inappropriate age to be non-serious Upon internal review, the event Head and neck cancer was determined to be Medically Significant.