Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | 3 | Y005248 | OT |
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | 2 | — | — |
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | 1 | — | — |
the patient received a third dose of PEDVAXHIB at 6 months of age; a lump on the left thigh (2cm)/slightly irregular shaped; with redness; This spontaneous report was received from a nurse and refers to a 6-month-old female patient. The patient had no medical history, concomitant therapies and no known drug reactions or allergies. On unknown dates, the patient was vaccinated with 1st and 2nd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. On 27-FEB-2025, the patient was vaccinated with 3rd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection at a dose of 0.5 mL, administered intramuscularly, lot #Y005248, expiration date 17-SEP-2026, for prophylaxis (anatomical location was not reported) (Inappropriate schedule of vaccine administered). Three other unknown vaccines were given that day. On an unspecified date in 2025, the patient experienced a 2-centimeter, slightly irregular shaped lump on the left thigh with redness. On 01-MAR-2025, the patient went to urgent care with aforementioned symptoms. The patient was not hospitalized and no treatment was rendered. The patient's current status and the outcome of the events was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information is not expected.