Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: No additional AEs or PQC; HCP calling to report an AE/PQC regarding the GARDASIL 9 vaccine. HCP reported that there was a leakage around the needle hub of the GARDASIL 9 vaccine. HCP stated that the patient was administered the GARDASIL 9 vaccine affected by the PQC. HCP repo; HCP calling to report an AE/PQC regarding the GARDASIL 9 vaccine. HCP reported that there was a leakage around the needle hub of the GARDASIL 9 vaccine. HCP stated that the patient was administered the GARDASIL 9 vaccine affected by the PQC. HCP repo; the patient received less than the recommended dose of the GARDASIL 9 vaccine.; crack in hub very small, it was not seen during preparation for administration; This spontaneous report was received from a pharmacist, concerning a patient of unknown gender and age.  The patient's medical, concurrent conditions and concomitant therapies were not reported.   On 01-AUG-2024, healthcare professional (HCP) reported that there was a leakage around the needle hub of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine (Syringe issue). HCP stated that the patient was administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) affected by the PQC (Poor quality device used). HCP reported that the patient received less than the recommended dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine (Accidental underdose). HCP provided limited pertinent information and demographic data since she was not the one who administered the vaccine or experienced the PQC regarding the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine. HCP stated that it was another healthcare worker who experienced and administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine affected by the PQC. HCP could not provide the lot number, expiration date or NDC of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). HCP would callback with the required information at a later time. HCP stated that she would send photos to the email address regarding the PQC. HCP stated that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine was available for retrieval. No additional adverse event reported.    This is a non-valid case due lack of patient identifiers.  Follow-up information has been received from a pharmacist on 08-AUG-2024.  Lot# of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was provided as 1967338 and expiry date: 26-JAN-2026. Product was successfully retrieved.  Follow-up information has been received from a pharmacist on 01-OCT-2024.  On 01-AUG-2024, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine leakage during administration due to cracked hub. The vaccine was administered via intramuscular route. Medication error occurred during preparation for administration, since there was a crack in hub but was very small and was not seen during preparation (Product preparation error). Administration was stopped when leaking was noticed. No revaccination reported. Outcome of the event was reported as recovered. No illness at vaccination time. Routine well child visit. On the same date, the patient received meningococcal vaccine a/c/y/w conj (TET TOX) (MENQUADFI), lot# U8113BA, expiry date: 31-JUL-2024 and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX), lot# TD2FD, expiry date: 31-MAY-2024. No temperature excursion occurred. Vaccine was returned to manufacturer on 08-AUG-2024 (also reported as 09-AUG-2024, conflicting information).