Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Illness, Pain in extremity, Sinusitis
Clinical narrative: Smell loss; Taste loss; Sinus infection; Pain in arm; Illness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Illness), ANOSMIA (Smell loss), AGEUSIA (Taste loss), SINUSITIS (Sinus infection) and PAIN IN EXTREMITY (Pain in arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second 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) Solution for injection in pre-filled pen. On 20-May-2020, the patient experienced ILLNESS (Illness). On an unknown date, the patient experienced ANOSMIA (Smell loss), AGEUSIA (Taste loss), SINUSITIS (Sinus infection) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, ILLNESS (Illness) had resolved and ANOSMIA (Smell loss), AGEUSIA (Taste loss), SINUSITIS (Sinus infection) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Lost 20 lbs.         Concomitant and treatment drugs were not reported.  On unknown dates, the patient experienced weight loss, lost smell, lost taste, sinus infection and sore arm due to second Moderna vaccine. On 20 May 2020, the patient experienced illness. On an unknown date, illness resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of illness, weight loss and sore arm due to second Moderna vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of lost smell, lost taste and sinus infection was not 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 is a spontaneous case concerning a 59-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse events of special interest of Anosmia and Ageusia, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 59-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse events of special interest of Anosmia and Ageusia, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.