Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Inflammation, Malaise, Rash
Clinical narrative: Inflammation; Unwell; Skin breakout; Pian in elbow; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INFLAMMATION (Inflammation), MALAISE (Unwell), RASH (Skin breakout) and ARTHRALGIA (Pian in elbow) in a 57-year-old female 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-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) Citrate free. In 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INFLAMMATION (Inflammation), MALAISE (Unwell), RASH (Skin breakout) and ARTHRALGIA (Pian in elbow). In 2022, COVID-19 (COVID-19) had resolved. At the time of the report, INFLAMMATION (Inflammation) had not resolved, MALAISE (Unwell) and ARTHRALGIA (Pian in elbow) outcome was unknown and RASH (Skin breakout) was resolving.            Concomitant medication was not reported.  On unknown dates, the patient experienced not doing well, inflammation and breakouts on knuckles and scalp and elbow hurt. In 2022, the patient experienced COVID. In 2022, the COVID resolved. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment medication was not reported.  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 57 year old female patient with concurrent condition of plaque psoriasis, who experienced the unexpected non serious AESI of COVID 19 , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, investigation and treatment was available in the report. The event resolved. Co suspect Adalimumab and the COVID 19 pandemic could be confounders for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live Significant Follow up was added which considered new event added and for event covid-19 event outcome was updated to resolved.; Sender's Comments: This spontaneous case concerns a 57 year old female patient with concurrent condition of plaque psoriasis, who experienced the unexpected non serious AESI of COVID 19 , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, investigation and treatment was available in the report. The event resolved. Co suspect Adalimumab and the COVID 19 pandemic could be confounders for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.