Symptomtext
Vaccination site lump; Vaccination site redness; Vaccination site warmth; Vaccination site swelling; mild soreness at the injection site; mild soreness at the injection site; mild soreness at the injection site; This spontaneous report was received from a registered nurse, concerning a 36-year-old female patient. The patient's pertinent medical history included skin cancer diagnosed in 2012. The patient did not have any concomitant medications and drug reactions or allergies. On 10-DEC-2021, 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) pre-filled syringe, in the left deltoid, at a dose of 0.5 milliliter (ml) by intramuscular route (lot number U008315, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-AUG-2023), indication reported as "human papillomavirus (HPV) vaccine". Subsequently, she experienced mild soreness at the injection site that lasted a few days and then went away (vaccination site pain). On 25-FEB-2022 and 16-JUN-2022, she was vaccinated with the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, in the left deltoid, at a dose of 0.5 milliliter (ml) by intramuscular route (lot numbers U032636 and U029623, which were verified to be valid lot numbers, expiration dates not reported but upon internal validation established as 26-OCT-2023). The reporter further stated, the patient developed new onset of mild soreness at the injection site that lasted a few days and then went away (vaccination site pain) on unspecified dates in 2022 reported as "after the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)". On 03-JUL-2022 reported as "approximately 2 weeks after the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)", the patient experienced redness, warmth and swelling with a lump at the injection site (vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site mass). The patient was advised to use cold compress. However, she contacted physician on 05-JUL-2022, as there was no improvement, she was still experiencing redness and swelling. At the time of the report, the outcome of the events vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site mass was reported as not resolved. Causality assessment was not provided by the reporter.