Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | W033612 | LA |
vaccine administered past expiration date; soreness at vaccine site; This spontaneous report was received from a Physician Assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Jun-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #W033612, expiration date: 03-Mar-2025, dose not reported), dose number 1, for prophylaxis (expired product administered). No adverse event was reported. Follow up information has been received from the reporter on 02-Jul-2025 referring to an 18 year-old male patient. The patient's concurrent conditions included attention deficit hyperactivity disorder (ADHD). Historical drugs included Meningococcal vaccine (Meningococcal vaccine). Concomitant medications included Adderall (Amfetamine aspartate;Amfetamine sulfate;Dexamfetamine saccharate;Dexamfetamine sulfate) . On 04-Jun-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) past expiration date in Left Arm, by a trained healthcare professional at private doctor's office. The vaccine was purchased with private funds. The vaccine had been properly stored loading up to administration. Error discovered shortly after, patient was notified. Followed up via phone, no unexpected adverse outcomes. On an unspecified date in 2025, the patient experienced soreness at vaccine site (Vaccination site pain), consistent with expected response to vaccine. At the reporting time, the outcome of Vaccination site pain was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was not applicable. The causal relationship between the event of Vaccination site pain and Human Papillomavirus 9-valent Vaccine, Recombinant was not reported.
ADHD
Adderall