Received Jul 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 2 | — | OT |
leg was burning hot; right thigh was red, leg turned really red, from the middle of thigh, where the vaccine was administered all the way to the toe. like it was burned with boiling water., only red dots were observed all over the leg; started to swell; screamed crying; stools smell way different from before, like chemical smell.; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves a 4 months old male patient whose leg was burning hot, stools smell way different from before, like chemical smell., right thigh was red, leg turned really red, from the middle of thigh, where the vaccine (Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel]) was administered all the way to the toe. like it was burned with boiling water., only red dots were observed all over the leg, started to swell and screamed crying. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jun-2025, the patient received a dose 2 of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Strength = standard) Suspension for injection 1X(Once) (batch number and expiry date unknown) via intramuscular route in unknown administration site for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 26-JUN-2025 the patient screamed crying (crying) (latency 2 to 3 hours) and leg was burning hot (burning sensation), right thigh was red, leg turned really red, from the middle of thigh, where the vaccine was administered all the way to the toe. like it was burned with boiling water., only red dots were observed all over the leg (erythema), started to swell (peripheral swelling) (latency same day). On an unknown date in Jun 2025 the patient's stools smell way different from before, like chemical smell. (abnormal faeces), (latency few days approximately). Reportedly, Within 2 minutes of picking the patient up, the leg turned really red, from the middle of thigh, Within 5 minutes, parents got to a pediatrician. Within 10 minutes, the leg turned to its normal color. The patient seemed ok till present day. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Unknown for the event abnormal faeces and Recovering / Resolving for all other events.