Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Meningitis, Pain, Vomiting, Withdrawal syndrome
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of MENINGITIS (Meningitis in her brain/fever brain) and HALLUCINATION (hallucination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (Patient is allergic to synthetic pharmaceutical products). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENINGITIS (Meningitis in her brain/fever brain) (seriousness criterion medically significant), HALLUCINATION (hallucination) (seriousness criterion medically significant), MEMORY IMPAIRMENT (easily forget things), LIMB INJURY (broken arm), CEREBRAL DISORDER (poison in the brain), PAIN (agonizing pain), WITHDRAWAL SYNDROME (withdrawal symptoms), FEEDING DISORDER (cannot eat), INSOMNIA (sleepless nights) and VOMITING (vomiting). At the time of the report, MENINGITIS (Meningitis in her brain/fever brain), HALLUCINATION (hallucination), MEMORY IMPAIRMENT (easily forget things), LIMB INJURY (broken arm), CEREBRAL DISORDER (poison in the brain), PAIN (agonizing pain), WITHDRAWAL SYNDROME (withdrawal symptoms), FEEDING DISORDER (cannot eat), INSOMNIA (sleepless nights) and VOMITING (vomiting) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication Prozac was started few months ago. Mentioned about having an allergy with every synthetic pharmaceutical products. Patient experienced Meningitis in her brain, vaccine almost kill her, easily forget things, broken arm, poison in the brain, hallucination, sleepless nights, agonizing pain, withdrawal symptoms, cannot eat, vomiting, and fever brain. No treatment details were reported. Company comment: This spontaneous case concerns a 67-year-old, female patient with no relevant medical history reported, who experienced serious (Medically significant) unexpected AESI event of Meningitis and serious (Medically significant) unexpected event of Hallucination, unspecified days after receiving second dose of mRNA-1273 Vaccine. The reporter states that the patient reported meningitis in her brain, poison in the brain, fever brain, hallucination, sleepless nights, agonizing pain, vomiting, withdrawal symptoms, broken arm, she cannot eat and easily forgets things and that the vaccine is almost killing her. At the time of the report, outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old, female patient with no relevant medical history reported, who experienced serious (Medically significant) unexpected AESI event of Meningitis and serious (Medically significant) unexpected event of Hallucination, unspecified days after receiving second dose of mRNA-1273 Vaccine. The reporter states that the patient reported meningitis in her brain, poison in the brain, fever brain, hallucination, sleepless nights, agonizing pain, vomiting, withdrawal symptoms, broken arm, she cannot eat and easily forgets things and that the vaccine is almost killing her. At the time of the report, outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.