Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | RA |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | RA |
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Nodule/ They developed a nodule in the arm; administered a double dose (2 separate administrations) of Engerix B; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of nodule on extremity in a adult female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included hiv infection. On an unknown date, the patient received Engerix B (right arm), Engerix B (right arm) and HPV vaccine. On an unknown date, an unknown time after receiving Engerix B, Engerix B and HPV vaccine, the patient experienced nodule on extremity (Verbatim: Nodule/ They developed a nodule in the arm) and overdose (Verbatim: administered a double dose (2 separate administrations) of Engerix B). The outcome of the nodule on extremity was resolved and the outcome of the overdose was not applicable. The reporter considered the nodule on extremity to be related to Engerix B, Engerix B and HPV vaccine. The company considered the nodule on extremity to be related to Engerix B, Engerix B and HPV vaccine. Additional Information: GSK receipt date: 10-JUN-2025 The patient was administered a double dose (2 separate administrations) of Engerix B to an HIV patient in the same arm, which led to overdose. The patient developed a nodule in the arm at next visit, but it resolved spontaneously without any additional intervention. A HPV vaccine was also given on the same day as the Engerix vaccines.
HIV infection