Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Central nervous system vasculitis, Dizziness, Fatigue, Headache
Clinical narrative: Vasculitis on her head, at the back of the brain; Horrible pain in the neck; Pain on the back; Feeling dizzy; Motion sickness; Vertigo; Horrible headaches; raging headache; Nausea; awful nausea; feeling tired, fatigue; Sore arm; Body aches; A spontaneous report was received from a 53-year-old, female, patient who was also a physician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasculitis on her head, at the back on the brain, sore arm, feeling tired; fatigue, body aches, awful nausea; nausea all day long, horrible headaches, motion sickness, feeling dizzy, horrible pain in the neck, vertigo, and pain on the back.   There was no medical history provided. There were no concomitant medications reported.  On 24 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm, for prophylaxis of COVID-19 infection.   On 25 Dec 2020, the patient experienced sore arm, feeling tired, body aches, and fatigue, which continued through Sunday, 26 Dec 2021.   On 27 Dec 2020, she began experiencing awful nausea, horrible headaches, vertigo, and motion sickness in addition to the ones she suffered before.   On 28 Dec 2020, the patient experienced nausea all day long.   On 29 Dec 2020, she went to the emergency room (ER) as she was feeling dizzy, had nausea, and had a raging headache. In the ER, she was given IV fluids, diphenhydramine hydrochloride, and other non-specified medications that helped with her symptoms. The patient went home with prescriptions and the next day she had results from lab work done, which included sedimentation rate was 44 (doubled) and her plaquette count was above normal. Treatment form her primary care physician included steroids, acetylsalicylic acid, meclizine hydrochloride, and prednisone. The patient reported an MRI was done and her physician told her she had vasculitis on her head, at the back on the brain. She was referred to a neurologist and was asked to do more bloodwork.   On 12 Jan 2021, the patient reported she was still experiencing horrible pain in the neck, nausea, vertigo, dizziness, and pain on the back, with symptoms beginning on an undisclosed date.   Action taken with mRNA-1273 to the events was not provided.  The outcome for the events, vasculitis on her head, at the back on the brain, sore arm, feeling tired, fatigue, body aches, horrible headaches, and motion sickness, was unknown. The events, pain in the neck, nausea, vertigo, dizziness, and pain on the back, were considered not resolved.; Reporter's Comments: This case concerns a 53 year old female patient experienced a serious unexpected event of Central nervous system vasculitis and NS events of sore arm, feeling tired; fatigue, body aches, awful nausea; nausea all day long, horrible headaches, motion sickness, feeling dizzy, horrible pain in the neck, vertigo, and pain on the back. The events occurred few days after first dose of the study medication administration. Treatment included IV fluids, diphenhydramine hydrochloride, steroids, acetylsalicylic acid, meclizine hydrochloride and prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.