Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, Pneumonia, Swelling
Clinical narrative: Lung infection; Swelling; Pain; Lack of effect; COVID-19; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 39-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) for Psoriatic arthritis.    There was no reported medical history.  Concurrent medical conditions included Psoriatic arthritis.   On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received 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. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. In May 2021, the patient experienced COVID-19 (COVID-19), PAIN (Ache) and DRUG INEFFECTIVE (Lack of effect). On an unknown date, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant), SWELLING (Swelling) and PAIN (Pain). In May 2021, DRUG INEFFECTIVE (Lack of effect) had resolved. At the time of the report, PNEUMONIA (Lung infection) outcome was unknown and COVID-19 (COVID-19), PAIN (Ache), SWELLING (Swelling) and PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: This is a spontaneous case concerning a 39-year-old female patient with Psoriatic arthritis on treatment with Adalimumab, who experienced the unexpected  non serios AESI COVID-19 and the serious (medically significant) event Pneumonia. COVID-19 occurred approximately 3 months after the second dose of second dose of mRNA-1273; start date for event pneumonia was not reported.  Clinical course, diagnostic tests and treatment details were not provided. Lack of effect was also captured as an event. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of covid-19, achy and lung infection with humira was not provided and for events swelling and pain was reasonable possibility.  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.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 39-year-old female patient with Psoriatic arthritis on treatment with Adalimumab, who experienced the unexpected  non serios AESI COVID-19 and the serious (medically significant) event Pneumonia. COVID-19 occurred approximately 3 months after the second dose of second dose of mRNA-1273; start date for event pneumonia was not reported.  Clinical course, diagnostic tests and treatment details were not provided. Lack of effect was also captured as an event. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.