Age: 39.0
Sex: F
Vaccine: HPV4, HPV9, HPV9, HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: GARDASIL adverse reaction.; lump at injection site/sore, tender to touch; Product Lot number issue; lump at injection site that showed up in 1 week post injection was administered, happened all three injections; lump at injection site that showed up in 1 week post injection was administered, happened all three injections; lump at injection site that showed up in 1 week post injection was administered, happened all three injections; This spontaneous report was received from a other health professional, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strengths, vaccination schemes, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported), both therapies as prophylaxis.  On an unknown date, the reporter mentioned she wanted to report a quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (also reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), conflicting information) adverse reaction (adverse drug reaction) of an unknown patient. It was reported as mild reaction but an interesting one, the information was very vague. The outcome of adverse drug reaction was not reported.   The causal relationship between the event and the suspect therapies was related.  This is an amended report: the LLT Adverse drug reaction should be changed to LLT Vaccination adverse reaction as the suspect product is a vaccine.  Follow-up information has been received from the medical assistant on 01-FEB-2024.  It was reported that the patient was a 39-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 28-MAY-2023, 10-JUL-2023 and 17-NOV-2023, the patient received the 3 doses of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), administered intramuscularly, 2 doses in the left deltoid and 1 dose in the right deltoid (lot number U039259 is an invalid lot number for human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Lot number U039259 is a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date reported and validated as 09-AUG-2024; lot number U037064 is an invalid lot number for human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Lot number U037064 is a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date reported and validated as 10-AUG-2024; and lot number W026152 is an invalid lot number for human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Lot number W026152 is a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); strength was not reported).  On 04-JUN-2023, 17-OCT-2023 and 24-NOV-2023 (also reported as 1 week post injection), the patient presented lump at injection site, it happened after all three injections (vaccination site mass). It was reported that the lump lasted for about a week (recovered), and it was sore and tender to touch (vaccination site pain).  The outcome of vaccination site pain was reported as recovered. The causal relationship between the events and the suspect therapies was related.  An Identifiable Patient was missing in the initial report.