Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
itching; Chronic burning eczema rash all over body; Chronic burning eczema rash all over body; Initial information received on 01-Jun-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves a 43-year-old male patient who had chronic burning eczema rash all over body and itching 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. Concomitant medications included Prednisone; and Tacrolimus for Rash and Pruritus. On 12-Jul-2022, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis Vaccine Suspension for injection (lot number, strength and expiry date-unknown) via subdermal route in unknown administration site for Tetanus. Information on the batch number was requested corresponding to the one at time of event occurrence. On 01-Se-2024 the patient developed chronic burning eczema rash all over body (skin burning sensation), chronic burning eczema rash all over body (eczema) 2 years 1 month 20 days). On an unknown date the patient developed itching (pruritus) (unknown latency). Relevant laboratory test results included: Biopsy skin - On an unknown date: [Lab test (biopsy) on skin condition came back positive for chronic excema] Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness Criteria- Skin burning sensation and eczema was leading to disability.; Sender's Comments: Sanofi company comment dated 04-JUN-2025: This case involves a 43-year-old male patient who had chronic burning eczema rash all over body and itching after receiving Diphtheria-2/Tetanus/5 AC pertussis Vaccine [Adacel]. Further information regarding regarding allergic history, medical history, 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.
PREDNISONE; TACROLIMUS
Test Name: Skin biopsy; Result Unstructured Data: Lab test (biopsy) on skin condition came back positive for chronic excema