Received Jul 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y019459 | — |
No other AE; underwent a temperature excursion and was administered; This Spontaneous report was received from Other health professional and referred to a/an 16-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 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: Y019459) (Expiration date: 16-Feb-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, On 05-Jun-2026, the patient experienced underwent a temperature excursion and was administered (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 Other 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 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 Other health professional considered the event No adverse event to be non-serious and the event Product storage issue to be non-serious