Age: 64.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site warmth, Product administered to patient of inappropriate age, Rash, Skin irritation
Clinical narrative: The physician biopsied the area which resulted in a diagnosis of Gianotti Crosti Syndrome; Patient Age 64 years; woke up with an inflamed left arm; She states it was hard and hot at the site of her second injection; She states it was hard and hot at the site of her second injection; The pain lasted 3-4 days; Patient Age 64 years; This spontaneous report was received from a consumer and refers to herself, a 64-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in December 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age).   On an unknown date (after the first dose), she experienced "skin colored bumps" on her elbows and she thought "nothing of it." On 06-FEB-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). On an unspecified date in 2024, after the second dose, she began having irritation in her buttocks and was seen by a physician who "did not see anything." She stated she could not use a washcloth because it causes "red bumps" on her cheeks. She got a second opinion who confirmed her concern. The area in her buttocks was "similar to a diaper rash" and the customer stated it hurts to sit. On an unspecified date in 2024, the physician biopsied the area which resulted in a diagnosis of Gianotti-Crosti syndrome (onset date on an unknown date). The second physician referred her to someone with more experience with this disease process. Customer stated she is a speech pathologist who works with pediatric patients on a regular basis. None of the children she has worked with had experienced these symptoms and she denied the possibility that it could have come from one of her patients. On an unspecified date in 2024 (a few weeks after the second vaccination), she "woke up with an inflamed left arm."; she stated it was hard and hot at the site of her second injection (vaccination site inflammation, vaccination site induration, vaccination site warmth). She stated she did not get hurt, did not fall, had no exercise that particular muscle. The pain lasted 3-4 days (vaccination site pain). Therefore, on an unknown date in 2024, the patient recovered from the event of vaccination site pain. She was treated with topical steroids and cortisone injection since diagnosis. She stated 2 weeks ago she had a "terrible breakout" on her elbow. She followed up with her dermatologist (reported as this morning) and was given additional steroids and advised this would take 2-3 months to resolve on its own. Customer believed it was due to the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations and stated she would not get the third dose. At the time of reporting, the patient had not recovered from the event of Gianotti-Crosti syndrome, the outcome of the events vaccination site inflammation, vaccination site induration, vaccination site warmth was unknown. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all events was not applicable.   The reporter considered all events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   Lot # is being requested and will be submitted if received.