Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial test, Lumbar puncture abnormal, Meningitis, Viral test
Clinical narrative: Developed meningitis within 1 week of receving COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) (seriousness criterion medically significant). At the time of the report, MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: (Negative) Negative. On an unknown date, Lumbar puncture abnormal: showed active inflammation. On an unknown date, Viral test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment-This spontaneous case concerns a 4-year-old male child with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Meningitis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient developed meningitis within 1 week of receiving COVID vaccine. Lumbar tap done on an unknown date showed active inflammation with negative bacterial culture and viral screening. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 4-year-old male child with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Meningitis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient developed meningitis within 1 week of receiving COVID vaccine. Lumbar tap done on an unknown date showed active inflammation with negative bacterial culture and viral screening. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.