Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis, Illness, Meningeal disorder, SARS-CoV-2 test, Weight
Clinical narrative: Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning; Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning; Caller states that she had the vaccine last Friday, 15Dec2023 at 4:00PM. The next day, 16Dec2023, she was so sick, she felt she had no memory; This spontaneous case was reported by a patient and describes the occurrence of ENCEPHALITIS (Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung disorder NOS (lung condition diagnosed in 2000.) in 2000. Previously administered products included for Product used for unknown indication: Pfizer vaccine (lot number: - EL9269, Dose 1.) on 24-Feb-2021, Pfizer vaccine (lot number: - ER6204, Dose 2.) on 19-Mar-2021, Pfizer vaccine (lot number: - 33030BD, Dose 3.) on 28-Dec-2021, Pfizer vaccine (lot number: - GJ or C 6738, Dose 3.) on 18-Nov-2022, Flu vaccine (3 months before the Moderna vaccine.) and RSV vaccine (2 months before the Moderna vaccine.). Past adverse reactions to the above products included No adverse event with Flu vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and RSV vaccine; and Sickness with Pfizer vaccine.    On 15-Dec-2023 at 4:00 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Nov-2023, the patient experienced ILLNESS (Caller states that she had the vaccine last Friday, 15Dec2023 at 4:00PM. The next day, 16Dec2023, she was so sick, she felt she had no memory). On 16-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ENCEPHALITIS (Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning) (seriousness criterion medically significant) and MENINGEAL DISORDER (Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning). At the time of the report, ENCEPHALITIS (Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning), MENINGEAL DISORDER (Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning) and ILLNESS (Caller states that she had the vaccine last Friday, 15Dec2023 at 4:00PM. The next day, 16Dec2023, she was so sick, she felt she had no memory) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative. On an unknown date, Weight: She lost 3 lbs.         Patient receives other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  On 16-Dec-2023 she was so sick, she felt she had no memory. She had severe headache and it felt like someone was blowing up a dynamite in her head. She could not walk, could not stay awake and slept most of the time all day and all night on Sunday and Monday. She was hurting all over, she was nauseated and could not eat. She lost 3 lbs. and have been sick. Her headache is better at the time of the call and she was able to walk. Her head feels like she had encephalitis as inside her skull, it was burning like the meninges are burning. She was able to eat breakfast today, 20-Dec-2023 but could not taste anything. She tested negative for Covid.  Treatment information was not provided. Company comment: This spontaneous case concerns an 86-year-old female patient, with no relevant medical history reported, who experienced the expected and serious (medically significant) AESI of ENCEPHALITIS (among other non-serious events) on the following day of the dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, considered as the fifth dose of the vaccine schedule. The day after the vaccination, she felt sick, with headache, nausea, and no memory. She could not walk, slept most of the time and could not eat. She felt like she had encephalitis. She tested negative for COVID- 19. No treatment was reported. No further clinical information was available for medical review. Patient´s age could be a risk factor for encephalitis. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.