Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
the son developed a big lump under the armpit; received the first dose of either GARDASIL or GARDASIL 9 as a teenager approximately 10-12 years ago; received the second dose of the vaccine series, never received the third dose in the series.; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On an unknown date (reported as approximately 10-12 years ago), the patient was vaccinated either with the first dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); or with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On an unknown date, the patient was vaccinated either with the second dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); or with the second dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) injection, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On an unspecified date (reported as after received the second dose of the vaccine either human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) or quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL), the patient experienced big lump under the armpit (axillary mass). It was stated that the patient never received the third dose of the previous mention vaccine either human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) or quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) (inappropriate schedule of product administration) At the time of the reporting, the outcome of the event of axillary mass was not reported. The causal relationship between the event of axillary mass with the suspect vaccines either human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) or quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine suspension for injection (GARDASIL) was not provided.