Reporte zur Charge 9LU44A

Symptomtext

fever of 104; pain is okay when not moving arm and when moving pain 6-7 on pain scale; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via medical information (reference number- 00432183) and transmitted to Sanofi on 15-Jan-2021. This case involves a 69 year old female patient who experienced pain in deltoid region which was okay when not moving arm and when moving pain 6-7 on pain scale (pain) and fever of 104 (pyrexia), after she received TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI]. Medical history, medical treatment, vaccination, family history and concomitant medication were not reported. At the time of the event, the patient had ongoing breast cancer. On 12-Jan-2021, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot 9LU44A, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On 12-Jan-2021, the patient developed a non-serious pain in deltoid region which was okay when not moving arm and when moving pain 6-7 on pain scale (pain) and fever of 104 (pyrexia), on the same day following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. Relevant laboratory test results included: Body temperature - On 12-Jan-2021: 104 Pain assessment - On 12-Jan-2021: pain of 6-7 (in a scale of 10 being the worst) It was not reported if the patient received any corrective treatment. At the time of reporting, it was reported that fever was resolved but the arm pain remains the same when the patient was checked on 15-Jan-2021.