Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypersensitivity, Hypotension, Pulmonary congestion, Vaccination site pain
Clinical narrative: Lung congestion; Low blood pressure; Allergy; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lung congestion) in a male patient of an unknown age 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) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-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 July 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced PULMONARY CONGESTION (Lung congestion) (seriousness criterion medically significant), HYPOTENSION (Low blood pressure) and HYPERSENSITIVITY (Allergy). At the time of the report, PULMONARY CONGESTION (Lung congestion), HYPOTENSION (Low blood pressure) and HYPERSENSITIVITY (Allergy) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Decreased.         No concomitant and treatment medications were 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  CC: This spontaneous case concerns a male patient of unknown age with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Pulmonary congestion in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with an unknown event's onset date. Patient also reported low blood pressure on an unknown date. Outcome of the event was reported as not resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 31 days apart, followed by a booster dose. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Pulmonary congestion in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with an unknown event's onset date. Patient also reported low blood pressure on an unknown date. Outcome of the event was reported as not resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 31 days apart, followed by a booster dose. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.