Received Jul 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8232AA | OT |
5 Localized raised large red bumps on right side of neck under jawline in lymph node area; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves 21 years old female patient who had 5 localized raised large red bumps on right side of neck under jawline in lymph node area after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jul-2025, the patient received a dose of 1 DF (total) (dosage form) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot U8232AA) (strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation). On 10-Jul-2025, the patient developed 5 localized raised large red bumps on right side of neck under jawline in lymph node area (rash erythematous) (Ltency: 2 days). Action taken was not applicable. The patient was treated with Diphenhydramine hydrochloride (Benadryl) for Rash erythematous. At time of reporting, the outcome was Not Recovered / Not Resolved for the event.