Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
Antiphospholipid antibodies/syndrome; Autonomic dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning patient (pt) of a not reported age or gender. Patient's current conditions, medical history and concomitant therapy was not reported. On 27-MAR-2018 and 27-SEP-2018, the pt was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prophylaxis. On an unknown date, the pt experienced Autonomic dysfunction and Antiphospholipid antibodies/syndrome. At the reporting time, the outcome of the events was not provided. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was stated that the lawyer previously filed a petition, however, the lawsuit would remain unfiled during a period while the legal statute of limitations would remain preserved. Upon internal review, the event of Antiphospholipid antibodies/syndrome was determined to be medically significant.