Reporte zur Charge UI232AA

Symptomtext

shortness of breath; tongue swelling; Initial information regarding an unsolicited valid non-serious case was received from a physician via agency (Reference number- 00457437) and transmitted to Sanofi on 02-Feb-2021. This case involves a 33 year old male patient who experienced shortness of breath (dyspnoea) and tongue swelling (swollen tongue), while he received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 13-Jan-2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UI232AA, expiry: 30-Jun-2015) via intramuscular route in the right arm for prophylactic vaccination. On 13-Jan-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination. On 13-Jan-2015, the patient developed a non-serious shortness of breath (dyspnoea) and tongue swelling (swollen tongue) 2 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Physician stated the patient is scheduled to have the Coronavirus disease (COVID-19) vaccine tomorrow and she was hoping to get an answer to her question before then. The caller was asking for ingredients of Fluzone Quadrivalent (she is not sure which one) and Adacel from 2015 No laboratory data was provided It was not reported if the patient received a corrective treatment. At the time of report, the outcome of events was unknown.