Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Vaccination failure, Vaccination site pain
Clinical narrative: Basal cell carcinoma on nose and forehead; Stress; On 07 Feb 2021 received first dose and 07-Mar-2021 received second dose/Jul-2022 tested covid-19 positive; COVID-19 virus test positive; Congestion; Sore throat; Cough; Diarrhea; Site soreness with each covid vaccination; Nausea; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BASAL CELL CARCINOMA (Basal cell carcinoma on nose and forehead) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Pregnancy in 1973, Pregnancy in 1981, Crohn's disease and Small bowel resection (Two). Family history included Congestive heart failure (father had a congestive heart failure) and Lung cancer (Mother had lung cancer). Concurrent medical conditions included Drug allergy (Remicade allergy), Alcohol use, Non-tobacco user, Hypothyroidism, Vitamin D decreased and Basal cell carcinoma face. Concomitant products included LEVOTHYROXINE for Hypothyroidism, VITAMIN D3 for Vitamin D decreased, METHOTREXATE, FOLIC ACID and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA for an unknown indication.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. In 2021, the patient experienced COUGH (Cough), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Site soreness with each covid vaccination), NAUSEA (Nausea), PYREXIA (Slight fever) and HEADACHE (Headache). In January 2022, the patient experienced RESPIRATORY TRACT CONGESTION (Congestion) and OROPHARYNGEAL PAIN (Sore throat). In July 2022, the patient experienced COVID-19 (COVID-19 virus test positive) and VACCINATION FAILURE (On 07 Feb 2021 received first dose and 07-Mar-2021 received second dose/Jul-2022 tested covid-19 positive). On an unknown date, the patient experienced BASAL CELL CARCINOMA (Basal cell carcinoma on nose and forehead) (seriousness criterion medically significant) and STRESS (Stress). At the time of the report, BASAL CELL CARCINOMA (Basal cell carcinoma on nose and forehead), COVID-19 (COVID-19 virus test positive), COUGH (Cough), RESPIRATORY TRACT CONGESTION (Congestion), OROPHARYNGEAL PAIN (Sore throat), STRESS (Stress), VACCINATION FAILURE (On 07 Feb 2021 received first dose and 07-Mar-2021 received second dose/Jul-2022 tested covid-19 positive), DIARRHOEA (Diarrhea), NAUSEA (Nausea), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE PAIN (Site soreness with each covid vaccination) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: (Positive) Positive.         Patient had No Illicit drug use.  The indication for concomitant drug Centrum silver used for maintenance.  The patient had basal cell carcinoma on her nose and forehead that was in the past and she was not sure if it was before being on HUMIRA. Patient said that it popped up about ten years later and patient thought she might be on HUMIRA at that time. Patient had injection site soreness with each. In Jan-2022, patient had sore throat and congestion. Patient was experiencing stress at the thought of having a virtual visit. In Jul-2021, patient was tested positive for COVID-19. Patient had headache, cough, slight fever, nausea and diarrhea if she tried were patients symptoms.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 72 year old female patient with relevant medical history of Basal cell carcinoma face and family history of lung carcinoma (mother), who experienced the unexpected serious (medically significant) event of Basal cell carcinoma (reported as Basal cell carcinoma on nose and forehead), unknown days after, and the non serious , unexpected AESI of COVID 19, more than 3 months after receiving the second dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Vaccination failure was noted. The patient received the primary doses (first and second) with the same vaccine according to the recommended schedule. No further information on detailed clinical course, investigations, treatment and outcome of the events was available in the report. Elderly age of the patient could be a risk factor for the events. COVID 19 pandemic could be a confounder for the event COVID-19. Medical history of Basal cell carcinoma could be confounding and family history of lung cancer could be risk factor for the event Basal cell carcinoma. Concomitant methotrexate and co suspect adalimumab could be risk factors for Basal cell carcinoma. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2021-620978 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Suspect drug information, event information, laboratory/diagnostic procedures and narrative description updated. On 19-Jan-2022: Patient demographics, medical history, suspect drug information, concomitant drug information and narrative description updated.; Sender's Comments: This spontaneous case concerns a 72 year old female patient with relevant medical history of Basal cell carcinoma face and family history of lung carcinoma (mother), who experienced the unexpected serious (medically significant) event of Basal cell carcinoma (reported as Basal cell carcinoma on nose and forehead), unknown days after, and the non serious , unexpected AESI of COVID 19, more than 3 months after receiving the second dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Vaccination failure was noted. The patient received the primary doses (first and second) with the same vaccine according to the recommended schedule. No further information on detailed clinical course, investigations, treatment and outcome of the events was available in the report. Elderly age of the patient could be a risk factor for the events. COVID 19 pandemic could be a confounder for the event COVID-19. Medical history of Basal cell carcinoma could be confounding and family history of lung cancer could be risk factor for the event Basal cell carcinoma. Concomitant methotrexate and co suspect adalimumab could be risk factors for Basal cell carcinoma. The benefit-risk relationship of mRNA-1273 is not affected by this report.