Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Headache, Loss of personal independence in daily activities, Pruritus
Clinical narrative: Patient reported following side effects: brain swelling, itching on her head, and pain in her head; The patient reported that she was unable to work; Patient reported following side effects: brain swelling, itching on her head, and pain in her head; Patient reported following side effects: brain swelling, itching on her head, and pain in her head; This spontaneous case was reported by a patient and describes the occurrence of BRAIN OEDEMA (Patient reported following side effects: brain swelling, itching on her head, and pain in her head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 024M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRAIN OEDEMA (Patient reported following side effects: brain swelling, itching on her head, and pain in her head) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The patient reported that she was unable to work), PRURITUS (Patient reported following side effects: brain swelling, itching on her head, and pain in her head) and HEADACHE (Patient reported following side effects: brain swelling, itching on her head, and pain in her head). At the time of the report, BRAIN OEDEMA (Patient reported following side effects: brain swelling, itching on her head, and pain in her head), PRURITUS (Patient reported following side effects: brain swelling, itching on her head, and pain in her head) and HEADACHE (Patient reported following side effects: brain swelling, itching on her head, and pain in her head) had resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The patient reported that she was unable to work) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The suspect product dosage was reported as unknown. Patient had received 8 Moderna vaccinations but was only able to provide 2 lot numbers. Patient was unable to pay her bills and had lost her apartment as a result of brain swelling. The patient reported that she was unable to work as a licensed massage therapist or become a doctor due to the Moderna vaccine's negative effect. The patient was treated as unspecified treatment.  Company Comment: This is a Spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the serious (per medically significant) unexpected event of Brain Oedema which occurred on an unknown date and onset latency with a dose of mRNA-1273 for COVID-19 Vaccination. No further clinical information or diagnostic tests results were disclosed for analysis. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact