Sex: M
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Dermatomyositis, Fatigue, Hypotension
Clinical narrative: necrotizing - dermatomyositis; Necrotizing soft tissue infection; brain fog; Covid; weight loss; low blood pressure; Aches; Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DERMATOMYOSITIS (necrotizing - dermatomyositis) and NECROTISING SOFT TISSUE INFECTION (Necrotizing soft tissue infection) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Not available.  Previously administered products included for COVID-19 prophylaxis: Spikevax. Past adverse reactions to the above products included No adverse event with Spikevax.    In April 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced DERMATOMYOSITIS (necrotizing - dermatomyositis) (seriousness criterion medically significant), NECROTISING SOFT TISSUE INFECTION (Necrotizing soft tissue infection) (seriousness criterion medically significant), BRAIN FOG (brain fog), COVID-19 (Covid), WEIGHT DECREASED (weight loss), HYPOTENSION (low blood pressure), PAIN (Aches) and FATIGUE (Fatigue). At the time of the report, DERMATOMYOSITIS (necrotizing - dermatomyositis), NECROTISING SOFT TISSUE INFECTION (Necrotizing soft tissue infection), BRAIN FOG (brain fog), COVID-19 (Covid), WEIGHT DECREASED (weight loss), HYPOTENSION (low blood pressure), PAIN (Aches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered DERMATOMYOSITIS (necrotizing - dermatomyositis), NECROTISING SOFT TISSUE INFECTION (Necrotizing soft tissue infection), BRAIN FOG (brain fog), COVID-19 (Covid), WEIGHT DECREASED (weight loss), HYPOTENSION (low blood pressure), PAIN (Aches) and FATIGUE (Fatigue) to be related.    No concomitant medication was reported.  The patient received vaccine and booster. And never complaint however, after receiving the booster he kept complaining about brain fog, fatigue, and aches. Then, he tried to give blood like he had been doing for 30 years. He received letter stating they cannot use his blood.   The patient recently been vaccinated about 2.5 months ago. Patient waited three months still feeling the same way he had been feeling went to a different blood donor company and received the same letter.   Then he got COVID, and he got bright red face a couple of weeks later, then a bright red neck, then a bright red head, and shoulder and patches all over his body after several visits to the dermatologist and unsuccessful creams. It was discovered that his muscles felt like marshmallows, and he was losing his weight.   Patient went to the doctor with all symptoms, skin, muscle, fatigue, brain fog, weight loss and low blood pressure. He was sent to neurologist and did a brain scan and lung scan. After the blood work came back, they did an MRI on hist thigh.  After seeing the thigh, they did a biopsy. After several days of waiting, they determined he had necrotizing and or dermatomyositis. This all started with the Moderna vaccine.  Company Comment: This is a Spontaneous case reported by a patient, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Dermatomyositis and Necrotising soft tissue infection, which occurred on an unknown date after SPIKEVAX 2023-2024 vaccine, administered as booster dose within COVID-19 vaccination schedule. As reported, after vaccination the patient had health issues like brain fog, fatigue, aches. He got COVID. He experienced bright red face, neck, head and shoulders, and patches all over the body. Dermatomyositis and Necrotizing soft tissue infection were diagnosed. No information disclosed about diagnostic tests performed, clinical course or treatments received. Causality for Necrotising soft tissue infection was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-770184 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2024: Live significant follow-up received that contains laboratory tests and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-770184:wife case