Received May 29, 2026
Reports are unverified and do not show that a vaccine caused an event. Full disclaimer
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8618AA | IM / RA |
fairly large injection site reaction/ knot is still swollen; Initial information received on 20-May-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54-year-old female patient who experienced fairly large injection site reaction/ knot is still swollen after receiving diphtheria, tetanus and acellular pertussis vaccine [ADACEL] The patient's past medical history, past drugs, vaccination(s), and family history were not provided. Concomitant medication(s) included diclofenac (Diclofenac). On 02-Apr-2026, the patient received 0.5ml of diphtheria, tetanus and acellular pertussis vaccine [ADACEL] (Suspension for injection) (batch number: U8618AA, expiration date: 31-Aug-2027) (strength: standard, frequwncy: once) via intramuscular route in an unknown administration site for immunization (Immunisation). The pharmacist reported that the patient had a fairly large injection site reaction (Vaccination site swelling, onset: 02-Apr-2026, latency: same day). At the time of reporting, approximately 50 days had elapsed since the injection, and the swelling was still present. Action taken: Not applicable. Corrective treatment: Diclofenac 75 mg twice a day was administered for treatment of the injection site reaction. Event outcome: Vaccination site swelling was not recovered, not resolved, and ongoing.
Comments: NONE
Diclofenac