Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pneumonia, Rash, Swelling
Clinical narrative: Pneumonia; Left side of the body Swollen; Lymph nodes had a reaction to the Vaccine/ Lymph Nodes Swollen on the left side of the breast; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 43-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced RASH (Skin breakout). In August 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes had a reaction to the Vaccine/ Lymph Nodes Swollen on the left side of the breast). In September 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and SWELLING (Left side of the body Swollen). At the time of the report, PNEUMONIA (Pneumonia), LYMPHADENOPATHY (Lymph nodes had a reaction to the Vaccine/ Lymph Nodes Swollen on the left side of the breast) and RASH (Skin breakout) outcome was unknown and SWELLING (Left side of the body Swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient was worried that breakout started in Jul-2021 that was happening now. Patient stated that two weeks after COVID vaccine, her left side of body was swollen. She stated that her lymph nodes had a reaction to the vaccine. Patient's lymph nodes swollen on the left side of the breast. In Sep-2021, patient lost her husband and right after that got pneumonia and still had a lingering cough. Treatment details not reported.  The reporter's causality for the event(s) of left side of body swollen, lymph nodes had a reaction to the vaccine/lymph nodes swollen on the left side of breast, breakout and pneumonia with respect to SKYRIZI(RISANKIZUMAB) was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 43-year-old female patient with plaque psoriasis on treatment with Risankizumab, who experienced the serious (medically significant) unexpected event pneumonia, on the next month after receiving the first dose of mRNA-1273.  It was reported event was resolving and patient still had a lingering cough.  Additional clinical findings, diagnostic tests and treatment details were not provided. Risankizumab 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Live follow up added. Events added.; Sender's Comments: Company comment: This is a spontaneous case concerning a 43-year-old female patient with plaque psoriasis on treatment with Risankizumab, who experienced the serious (medically significant) unexpected event pneumonia, on the next month after receiving the first dose of mRNA-1273.  It was reported event was resolving and patient still had a lingering cough.  Additional clinical findings, diagnostic tests and treatment details were not provided. Risankizumab 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.