Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z004474 | — |
No symptoms reported.; Nurse reports GARDASIL 9 stored in refrigerator that experienced an excursion beginning 5/1/2026 and was administered to a patient on 5/29/26. No symptoms reported. See additional AE cases filed #03018060 and #03018041. Caller gave permission to cont; This Spontaneous report was received from Nurse and referred to a/an 16-years-old ( Race Unknown ) ( Ethnicity Unknown) Female Adolescent 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 29-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 (0.50 mL) (total) (Batch/Lot Number: Z004474) (Expiration date: 16-Aug-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 29-May-2026, the patient experienced Nurse reports GARDASIL 9 stored in refrigerator that experienced an excursion beginning 5/1/2026 and was administered to a patient on 5/29/26. No symptoms reported. See additional AE cases filed #03018060 and #03018041. Caller gave permission to cont (Product storage issue). On an unknown date, the patient experienced No symptoms reported. (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 Nurse considered 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 and 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 The Nurse considered the event No adverse event to be non-serious and the event Product storage issue to be non-serious