Received Jun 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012864 | — |
no other AE; Pharmacist calling with report of a product being administered after a temperature excursion. Date of excursion: 4/1/2026-4/9/2026 Administration: 4/9/2026 Name of vaccine(s): GARDASIL 9 Lot/Expiration: y012864 5/29/2026 Temperature/Time: (14.8c); Information has been received from Business Partner. This Spontaneous report was received from Pharmacist and referred to a/an 34-years-old ( Race Unknown ) ( Ethnicity Unknown) 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 09-Apr-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) (total) (Batch/Lot Number: Y012864) (Expiration date: 29-May-2026) dose form was Suspension for injection (Dose Text: 0.5mL once). 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 09-Apr-2026, the patient experienced Pharmacist calling with report of a product being administered after a temperature excursion. Date of excursion: 4/1/2026-4/9/2026 Administration: 4/9/2026 Name of vaccine(s): GARDASIL 9 Lot/Expiration: y012864 5/29/2026 Temperature/Time: (14.8c) (Product storage issue). On an unknown date, the patient experienced no other AE (No adverse event). The Outcome of Product storage issue 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 Product storage issue 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 Pharmacist 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 Product storage issue (,) 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 Pharmacist considered the event No adverse event to be non-serious and the event Product storage issue to be non-serious