Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
in the 13 years she received Sanofi's Tdap vaccine, she has developed celiac disease; develop a rash; Initial information received on 04-Aug-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp 9healthcare professional). This case involves an unknown age female patient who had celiac disease and rash 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 an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Immunization. Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed celiac disease (coeliac disease) and develop a rash (rash) (unknown latency). Reportedly, A female patient reported a 13-year rash from Sanofi's Tdap vaccine, which she reported as an adverse event. Now, her doctor is considering another Tdap vaccine, but she is concerned about the vaccine's gluten content, as she has developed celiac disease. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness Criteria: This event was assessed as medically significant (coeliac disease).; Sender's Comments: Sanofi Company Comment dated 06-Aug-2025,This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding tolerance, allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.