Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Dizziness, Fatigue
Clinical narrative: Stated her balance was off; She felt dizzy; Joint pain; Sore arm/muscle pain; Chills; Nausea; Fatigue; Headache; Auditory hallucinations sounded like people were whispering around her; visual disturbances/ expected it to be dark after she closed her eyes but it was different colors with white background.; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, AUDITORY (Auditory hallucinations sounded like people were whispering around her), VISUAL IMPAIRMENT (visual disturbances/ expected it to be dark after she closed her eyes but it was different colors with white background.), BALANCE DISORDER (Stated her balance was off), DIZZINESS (She felt dizzy) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 025M20A and 0432219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.  Concomitant products included LEVOTHYROXINE, METFORMIN, METOPROLOL, COENZYME Q10 [UBIDECARENONE] and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced HALLUCINATION, AUDITORY (Auditory hallucinations sounded like people were whispering around her), VISUAL IMPAIRMENT (visual disturbances/ expected it to be dark after she closed her eyes but it was different colors with white background.), ARTHRALGIA (Joint pain), MYALGIA (Sore arm/muscle pain), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). On 28-Oct-2021, the patient experienced BALANCE DISORDER (Stated her balance was off) and DIZZINESS (She felt dizzy). In October 2021, HALLUCINATION, AUDITORY (Auditory hallucinations sounded like people were whispering around her) had resolved. At the time of the report, VISUAL IMPAIRMENT (visual disturbances/ expected it to be dark after she closed her eyes but it was different colors with white background.), BALANCE DISORDER (Stated her balance was off), DIZZINESS (She felt dizzy), ARTHRALGIA (Joint pain), MYALGIA (Sore arm/muscle pain), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. The patient experienced Photopsia  as a symptom of Visual impairment. It was also reported that the patient was Scared her to death. Company Comment : This case concerns a 73 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of Hallucinations, auditory. The event occurred an unknown number of days after the third dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from event of Hallucinations based on medical judgement and review of source document that does not support seriousness criteria.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up appended is significant. Reporter is added, Concomitant medications are added, Events are added.; Sender's Comments: This case concerns a 74 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of Hallucinations, auditory. The event occurred an unknown number of days after the third dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from event of Hallucinations based on medical judgement and review of source document that does not support seriousness criteria.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.