Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
anaphylactic reaction to a vaccine" from Sanofi 19 years ago due to their allergic reaction to dairy; Initial information received on 08-Oct-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 5 years old female patient who had anaphylactic reaction to a vaccine from sanofi 19 years ago due to their allergic reaction to dairy after receiving Diphtheria, Tetanus And Nos Pertussis Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Dairy intolerance. On an unknown date, the patient received an unknown dose of suspect Diphtheria, Tetanus And Nos Pertussis Vaccine produced by unknown manufacturer (lot number, expiry date, formulation and strength not reported) via unknown route in unknown administration site for Immunisation. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date, the patient developed anaphylactic reaction to a vaccine from sanofi 19 years ago due to their allergic reaction to dairy (anaphylactic reaction) (latency unknown) following the administration of Diphtheria And Tetanus And Nos Pertussis Vaccine. Reportedly, they stated that their daughter was five years old at time of onset and has an allergic reaction to dairy. They also noted that the adverse reaction has already passed and that their daughter is studying for her masters in genetics at the time of the call. They could no longer recall the brand name, lot number, and expiration date of the product nor any other details surrounding the adverse event. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event. Seriousness criteria- The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 08-Oct-2025: This case involves a 5 years old female patient who had anaphylactic reaction to a vaccine from sanofi 19 years ago due to their allergic reaction to dairy after receiving Diphtheria, Tetanus And Nos Pertussis Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. At the time of the event, the patient had ongoing Dairy intolerance. Lack of information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Dairy intolerance