Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
Miller Fisher variants of Guillain-Barre Syndrome (GBS); Information was received from a lawyer, via social media regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-FEB-2007, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) suspension for injection as Prophylaxis (dose, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On an unknown day in April 2007, the patient experienced Miller Fisher variants of Guillain-Barre Syndrome (GBS). Moreover, the patient was entitled to compensation. At the reporting time, the outcome of Guillain-Barre Syndrome was not reported. The reporter considered Guillain-Barre Syndrome as a result of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (related). Upon internal review, Guillain-Barre Syndrome was determined to be medically significant.