Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
had an anaphylactic reaction to the tetanus vaccine, ADACEL; Initial information received on 31-Jan-2025 regarding an unsolicited valid serious case received from a Nurse. This case involves an unknown age and unknown gender patient had an anaphylactic reaction to the tetanus vaccine, 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 an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number, expiry date and strength: not reported) via unknown 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 an unknown date the patient had an anaphylactic reaction to the tetanus vaccine, ADACEL (anaphylactic reaction) (latency unknown) Reportedly, the reporter do not know what component of ADACEL the patient reacted to. She asked if there were any components in TYHPHIM VI that are the same as ADACEL Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (anaphylactic reaction). At time of reporting, the outcome was Unknown for the event anaphylactic reaction. Seriousness Criteria: Medically significant for the event anaphylactic reaction; Sender's Comments: Sanofi Company Comment dated on 04-Feb-2025: Based on the information available, the role of the vaccine cannot be established. Further information regarding concurrent condition during vaccination, previous reaction to the vaccination or similar vaccine, tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.