Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | 1957407 | OT / LA |
autoimmune response that generates lichen planus; she noted that her veins looked "darker and blue/One week after noticing the vein discoloration/hyperpigmentation showed up all throughout the body/lichen planus pigmentosus; This spontaneous report was received from a consumer, regarding herself, a 46-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Mar-2024, the patient was vaccinated with the first dose of human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose of 0.5 mL, intramuscularly administrated in the left deltoid (lot #1957407 which has been verified to be a valid number, expiration date reported and validated as 23-Jan-2026) as a prophylaxis. On unspecified date in 2024 (reported as about 7 days later), the patient noted that her veins looked darker and blue. On unspecified date (reported as one week after noticing the vein discoloration) she started itching all over her body for a few days. She thought it was just a rash, but then a month later hyperpigmentation showed up all throughout the body. The patient sought medical attention calling the health care professional (HCP). On 03-Dec-2024, the patient went to see the dermatologist and a biopsy was taken from the left deltoid area, which confirmed that there was an induced autoimmune response (autoimmune disorder) that caused lichen planus pigmentosus. The patient was placed on treatment which had been unsuccessful. At the reporting time, the patient had not recovered from the events. The action taken with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as therapy discontinued. The causal relationship between the events with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Test Date: 20241203; Test Name: biopsy; Result Unstructured Data: confirmed that there was an induced autoimmune response that caused lichen planus pigmentosus