Age: 82.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Biopsy skin abnormal, Injection site erythema, Injection site oedema, Injection site pain, Skin cancer
Clinical narrative: Malignant fast-growing skin cancer at the vaccination site; Injection site edema; Injection site erythema; Injection site pain; The vaccination site of surgical removal of skin cancer, looked like a burn; This is a spontaneous case, reported by pharmacist to VAERS (VAERS ID: 867572-1) and initially retrieved on 25-May-2020, concerning an 82-year-old, male patient.  The patient's medical history included glaucoma, high blood pressure, thyroid disorder, diabetes, cardiac disorder, pain, allergy to sulfonamide and allergy to morphine.  The patient's concomitant medications included potassium and digoxin, both for an unknown indication. It was reported that the patient's concomitant medications included also medications for glaucoma, blood pressure, thyroid, diabetes, bowel and pain.  On 01-Feb-2018, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: arm, dose, batch number and expiry date: not reported] as vaccine.  On the same day, as reported in the same arm as influenza vaccine, the patient was administered non-company co-suspect Pneumovax vaccine [pneumococcal vaccine polysacch 23v, route of administration: intramuscular, anatomical location: arm, dose, batch number and expiry date: not reported] as vaccine.  On unspecified date, an unknown amount of time after vaccination, the patient experienced injection site pain, injection site erythema and injection site edema. The patient was seen by specialist and had a skin biopsy on the vaccination site. The patient was informed it was cancer and subsequently had surgical removal of the skin cancer. The patient was diagnosed with malignant fast-growing skin cancer at the vaccination site.  On 25-Feb-2020, the patient sought medical attention and was seen by a physician during an office visit. It was reported that the vaccination site which was also site of the surgical removal of skin cancer looked like a burn, so the patient was prescribed Silvadene (silver sulfadiazine) creme as a treatment.  At the time of this report, the outcome of all events was not resolved.  Per company, the event cancer of skin' was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to INN Flu Vaccine Seasonal.  The case is linked to case 202003967 (the same reporter).  Follow up information reported by other non-health professional on 21-Jul-2020 to Med Communications (reference number: SEQ20-00535) via Merck Global Pharmacovigillance: Information regarding primary reporter (pharmacist) provided and two new reporters added. Patient's date of birth and initials were provided. New reference number added. No changes in the narrative.   Company comment: An 82-year-old male patient was administered INN Flu Vaccine Seasonal vaccine. On the same day, as reported in the same arm as influenza vaccine, the patient was administered non-company co-suspect Pneumovax. An unknown amount of time after vaccination, the patient experienced vaccination site oedema, vaccination site erythema, vaccination site pain. The patient had a skin biopsy on the vaccination site and was informed it was cancer, subsequently had surgical removal of the skin cancer. Reportedly, the patient was diagnosed with malignant fast-growing skin cancer at the vaccination site. Causality is assessed as possibly related for vaccination site oedema, vaccination site erythema and vaccination site pain. More information of patient's medical history of skin changes before vaccination. Regarding the event of skin cancer, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)'. It was reported that the vaccination site which was also site of the surgical removal of skin cancer looked like a burn, causality for the event of scar is assessed as not related.; Sender's Comments: An 82-year-old male patient was administered INN Flu Vaccine Seasonal vaccine. On the same day, as reported in the same arm as influenza vaccine, the patient was administered non-company co-suspect Pneumovax. An unknown amount of time after vaccination, the patient experienced vaccination site oedema, vaccination site erythema, vaccination site pain. The patient had a skin biopsy on the vaccination site and was informed it was cancer, subsequently had surgical removal of the skin cancer. Reportedly, the patient was diagnosed with malignant fast-growing skin cancer at the vaccination site. Causality is assessed as possibly related for vaccination site oedema, vaccination site erythema and vaccination site pain. More information of patient's medical history of skin changes before vaccination. Regarding the event of skin cancer, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)'. It was reported that the vaccination site which was also site of the surgical removal of skin cancer looked like a burn, causality for the event of scar is assessed as not related.