Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
POTS/autoimmune, autonomic, and neurological, injuries; Gardasil-induced autoimmune disorder; autoimmune, autonomic, and neurological injuries; Information has been received from a lawyer and refers to a female patient of 14-year-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unspecified date in April 2016, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, lot #, and expiration date were not reported), and received the second dose of vaccine in August 2016. Patient agreed to received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) by being convinced by company marketing that was very safe and prevent cancer. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, on an unspecified date the patient was diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (POTS). Her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to POTS, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Gardasil or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a result of her post-Gardasil symptoms, patient had been unable to engage in activities that a normal young person would enjoy. At the reporting time, the outcome of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). Upon internal review the event autoimmune disorder was considered as medically significant. The event POTS was considering as disabling.