Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary; This spontaneous case was reported by a consumer and describes the occurrence of SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) (seriousness criteria disability and medically significant). At the time of the report, SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) outcome was unknown. No concomitant medication was reported. Patient took 2 shots and felt sick. He was permanently disabled. He had mental health problems because the shots cross the blood-brain barrier. He was schizophrenic at the time of reporting. Before taking the shot, he had never had any signs of mental health issues. Then he was like hearing voices in his head, like scary. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, Updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:For nephew