Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
PAP smear abnormal; positive for type 16; This spontaneous report was received from a nurse via company employee and refers to a 31-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Oct-2006, 28-Dec-2006, and 26-Apr-2007, the patient was vaccinated with doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (dose, strength, route, lot # and expiration date were not reported) for prophylaxis, respectively. In 2026, the patient tested positive for type 16 and PAP (Papanicolaou) smear abnormal (human papilloma virus test positive and smear cervix abnormal). The outcome of both events was unknown. The action taken with suspect vaccine was not applicable. The causal relationship between both events and suspect vaccine was not provided. Lot# is being requested and will be submitted if received.
Test Date: 2026; Test Name: PAP smear; Result Unstructured Data: abnormal; Test Date: 2026; Test Name: tested for type 16; Test Result: Positive