Sex: F
Vaccine: COVID19
Symptoms: Intracranial hypotension, Magnetic resonance imaging head, Meningitis
Clinical narrative: post vaccine meningitis; intra cranial hypotension/spontaneous intracranial hypotension/intracranial hypotension with headaches; This spontaneous case was reported by a patient and describes the occurrence of MENINGITIS (post vaccine meningitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced MENINGITIS (post vaccine meningitis) (seriousness criterion medically significant) and INTRACRANIAL HYPOTENSION (intra cranial hypotension/spontaneous intracranial hypotension/intracranial hypotension with headaches). At the time of the report, MENINGITIS (post vaccine meningitis) and INTRACRANIAL HYPOTENSION (intra cranial hypotension/spontaneous intracranial hypotension/intracranial hypotension with headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: normal.         No concomitant medications were reported.  The patient got the second booster in April. Previous vaccines and first booster did not cause the patient any problems. But 48 hours after second booster, the patient developed headaches when the patient stand up from sitting. After 30 seconds or so it subsides. At first, it was bad and stopped the patient in tracks. It was slightly less at the time of report but still occurring. The patient seen primary and a neurologist and had a brain MRI with contrast, which was normal. The consensus/guess was that this was spontaneous intra cranial hypotension post vaccine meningitis. The neurologist patient saw in August only knew about migraines but did say that this hypotension if there was a small leak did not always show up on an MRI. His only suggestion was to repeat an MRI in 6 months.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Meningitis and the unexpected event of Intracranial hypotension. The events occurred 48 hours after receiving the fourth dose of mRNA-1273 Vaccine. The patient developed headaches when the patient stands up from sitting which would later subside. Consult with neurologist was done and MRI of the head was done and showed normal results. Patient was advised repeat MRI after 6 months. Treatment information was not provided. The outcome of the events was reported as not resolved. Event seriousness assessed as per Regulatory Authority report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2022: Live Significant information received on 27-SEP-2022,  reporter details (contact number) and patient details (gender) was updated.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Meningitis and the unexpected event of Intracranial hypotension. The events occurred 48 hours after receiving the fourth dose of mRNA-1273 Vaccine. The patient developed headaches when the patient stands up from sitting which would later subside. Consult with neurologist was done and MRI of the head was done and showed normal results. Patient was advised repeat MRI after 6 months. Treatment information was not provided. The outcome of the events was reported as not resolved. Event seriousness assessed as per Regulatory Authority report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.