Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Osteoarthritis, Tongue neoplasm malignant stage unspecified, Vaccination site pain, Weight decreased
Clinical narrative: Carcinoma of tongue; Osteoarthritis; Lost 40 pounds; Bronchitis; Sore arm with Moderna Booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED (Carcinoma of tongue) in a 71-year-old male 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) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced BRONCHITIS (Bronchitis) and VACCINATION SITE PAIN (Sore arm with Moderna Booster vaccine). On an unknown date, the patient experienced TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED (Carcinoma of tongue) (seriousness criterion medically significant), OSTEOARTHRITIS (Osteoarthritis) and WEIGHT DECREASED (Lost 40 pounds). The patient was treated with Surgery (part of his tongue removed) for Tongue neoplasm malignant stage unspecified. In 2021, BRONCHITIS (Bronchitis) and VACCINATION SITE PAIN (Sore arm with Moderna Booster vaccine) had resolved. At the time of the report, TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED (Carcinoma of tongue) had resolved, OSTEOARTHRITIS (Osteoarthritis) had not resolved and WEIGHT DECREASED (Lost 40 pounds) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: lost 40 pounds. No concomitant medication information was provided. The patient had surgery for tongue cancer part of his tongue removed and was off Humira for about three weeks. He had sore arm after Moderna booster vaccine. In 2021, he had bronchitis twice. He was recovering from surgery and had lost 40 pounds. The reporter's causality for the event(s) of tongue cancer, sore arm with Moderna booster vaccine, osteoarthritis, lost 40 pounds, bronchitis onset in 2021 and bronchitis onset in 2021 with Humira(adalimumab)was no reasonable possibility.  No treatment medication was provided. 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 71-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of tongue neoplasm malignant stage unspecified an unknown time after the first and second dose of mRNA-1273. Patient had surgery for tongue neoplasm and part of his tongue was removed. Outcome was reported as not resolved for tongue neoplasm malignant stage unspecified. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Significant Live follow up appended  : Event Information , dosage information and narrative description updated; Sender's Comments: This spontaneous case concerns a 71-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of tongue neoplasm malignant stage unspecified an unknown time after the first and second dose of mRNA-1273. Patient had surgery for tongue neoplasm and part of his tongue was removed. Outcome was reported as not resolved for tongue neoplasm malignant stage unspecified. The benefit-risk relationship of mRNA-1273 is not affected by this report.