Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Fatigue, Pneumonia, SARS-CoV-2 test
Clinical narrative: Cellulitis of arm; Blood was real low; Skin scaly; Affected right leg / Leg was messed up red; Tired; Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and CELLULITIS (Cellulitis of arm) in a 57-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.    The patient's past medical history included COVID-19 in December 2020 and Psoriatic arthritis. Concomitant products included METHOTREXATE for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced CELLULITIS (Cellulitis of arm) (seriousness criterion medically significant), VOLUME BLOOD DECREASED (Blood was real low), SKIN EXFOLIATION (Skin scaly), ERYTHEMA (Affected right leg / Leg was messed up red) and FATIGUE (Tired). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia) was resolving, CELLULITIS (Cellulitis of arm), VOLUME BLOOD DECREASED (Blood was real low), SKIN EXFOLIATION (Skin scaly) and FATIGUE (Tired) had not resolved and ERYTHEMA (Affected right leg / Leg was messed up red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Volume blood: Blood was real low.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  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 57-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) events of Pneumonia and Cellulitis. The events occurred on unknown date. It should be noted that the patient received two doses of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of the report, the event Pneumonia was resolving and the event Cellulitis had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 57-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) events of Pneumonia and Cellulitis. The events occurred on unknown date. It should be noted that the patient received two doses of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of the report, the event Pneumonia was resolving and the event Cellulitis had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.