Symptomtext
Squamous Cell Skin Carcinoma (Keratoacanthoma); white scab; Initial information regarding an unsolicited non-valid non-serious case was received on 02-Jul-2021 from a Consumer via Medical Information (Reference number- 00667476) and transmitted to Sanofi on 02-Jul-2021. This case involves a 60-year-old female patient who experienced white scab (scab) and diagnosed with non-serious squamous cell skin carcinoma (keratoacanthoma) (keratoacanthoma) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination. On 20-Sep-2020, the patient received 0.7 ml dose (total) (once) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ484AA via and expiry date 30-Jun-2021] via intramuscular route in the right arm for prophylactic vaccination. On 20-Sep-2020 the patient developed non-serious white scab (scab) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 11-Mar-2021 the patient diagnosed with non-serious squamous cell skin carcinoma (keratoacanthoma) 5 months 22 days following the following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported that, "Caller from Pharmacy Claims Services reports that a patient received a Fluzone Quadrivalent High Dose vaccine on 20Sep2020 and then developed a white scab. On 21Feb2021, the patient went to the Dermatologist and was tested and returned on 11Mar2021 and was diagnosed with Squamous Cell Skin Carcinoma (Keratoacanthoma). The patient believes that it is due to the Fluzone Quadrivalent High Dose vaccine potentially leaking down her arm and causing the skin cancer. The skin cancer and the vaccine anre in the same location. This was treated by excising and removing the lesion. There is no further information regarding this. Product used: Used. Still using product: No. Was Device Used: Yes". It was unknown if the patient experienced any additional symptoms/events. Details of laboratory data were not reported. The patient was treated by excising and removing the lesion. At the time of report, the outcome of events was unknown.