Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U8492AA | OT / RA |
patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA109153 and US-SA-2025SA109105. This case involves a 10 years old female patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine after receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine and measles vaccine, mumps vaccine, rubella vaccine (MMR) both for Immunisation. On 14-Apr-2025, the patient received an unknown dose (0.5ml) of suspect receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult; Suspension for injection with unknown strength (lot U8492AA with expiry date 28-FEB-2027) via intramuscular route in the right arm for Immunization. On 14-APR-2025 the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency: same day). Reportedly: she noticed the change in the color of the TENIVAC box from green to blue. It was the first time they had a complaint from all patients given TENIVAC describing that it was like a painful burning sensation while injecting the vaccine. 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 Unknown for the event.; Sender's Comments: US-SA-2025SA109105: US-SA-2025SA109153:
Polio vaccine; MMR