Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8264A | OT / LA |
patient looked like they were punched on their left arm because there was bruising and under it; tight spot that seems like a lump; Patient initially felt heat and the bruising got more pronounced; swelling; tight spot that seems like a lump; This situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65; Initial information received on 20-Feb-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who looked like they were punched on their left arm because there was bruising and under it, tight spot that seems like a lump, patient initially felt heat and the bruising got more pronounced, this situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65 and swelling 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. At the time of the event, the patient had ongoing Autoimmune disorder. Concomitant medications included Acetylsalicylic acid (Baby aspirin). On 14-Feb-2025, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine 1x(once) dose 0.5 ml Suspension for injection (strength-standard) lot U8264A expiry-31-Aug-2026 via intramuscular route in the left deltoid for Immunization, this situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65 (off label use) (latency same day). On 15-FEB-2025 the patient looked like they were punched on their left arm because there was bruising and under it (contusion), tight spot that seems like a lump (rash) (mass), patient initially felt heat and the bruising got more pronounced (feeling hot) and swelling (latency 1 day). Reportedly, the patient told them about getting ADACEL every 10 years. Pharmacist asked the patient if they were on blood thinners and patient declined but said that they were taking baby aspirin. 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 Not Recovered / Not Resolved for all the events except off label use.
Autoimmune disorder
Baby aspirin