Received Jun 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U7838AA | OT / LA |
patients had injection site reaction that was red; injection site reaction that was swollen; injection site reaction that was hot to touch; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who had injection site reaction that was red, swollen and was hot to touch after receiving Diphtheria-15/Tetanus/5 HYBRID AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine live (ENDERS-EDMONSTON), Mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 HYBRID AC pertussis/IPV (VERO) vaccine Suspension for injection (lot U7838AA and expiry date- 25-Jul-2027) strength-unknown via intramuscular route in the left deltoid for Immunization. On an unknown date the patient developed injection site reaction that was red, swollen, and hot to touch (vaccination site erythema), (vaccination site swelling) and (vaccination site warmth) (latency: unknown). Reportedly- 3 separate patients that had reaction with specific lot number. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events.
PROQUAD