Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | — | — |
inappropriate schedule of vaccine; Product administered to patient of inappropriate age; This spontaneous report was received from a lawyer and refers to a 1-month-old female patient who was involved in a litigation process regarding quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (case). All details regarding the patient's medical history, concurrent conditions and concomitant therapies were captured in case. On 15-MAR-2005, at the age of 1 month, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (product administered to patient of inappropriate age). On 16-AUG-2005, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (inappropriate schedule of product administration). On 17-Nov-2005, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis. This was one of several reports regarding the same patient.