New-onset paranoia; This literature-non-study case was reported in a literature article and describes the occurrence of PSYCHOTIC DISORDER (New-onset paranoia) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Concurrent medical conditions included Type II diabetes mellitus (was well controlled), Hypothyroidism (was well controlled) and Hypertension (was well controlled).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSYCHOTIC DISORDER (New-onset paranoia) (seriousness criterion medically significant). The patient was treated with QUETIAPINE for Psychosis paranoid, at a dose of 150 milligram, extended release; SERTRALINE for Psychosis paranoid, at a dose of 50 milligram; SERTRALINE for Psychosis paranoid, at a dose of 100 milligram; RISPERIDONE for Psychosis paranoid, at a dose of 2 milligram, (at night) and RISPERIDONE for Psychosis paranoid, at a dose of 4 milligram. At the time of the report, PSYCHOTIC DISORDER (New-onset paranoia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alpha 1 globulin: normal. On an unknown date, Alpha 2 globulin: normal. On an unknown date, Anti-NMDA antibody: within normal limits. On an unknown date, Antimitochondrial antibody: normal. On an unknown date, Antinuclear antibody: Negative. On an unknown date, Audiogram: unremarkable. On an unknown date, Beta globulin: normal. On an unknown date, Blood albumin: normal. On an unknown date, Blood thyroid stimulating hormone (0.36-3.74): 1.37 milli -international unit per millilitre. On an unknown date, C-reactive protein: within normal limits, normal range was less than 0.29. On an unknown date, Computerised tomogram head: without contrast was unremarkable and provided no evidence for dementia. On an unknown date, Depression rating scale score: (Negative) Patient Health Questionnaire-2 scores- Negative. On an unknown date, Double stranded DNA antibody: normal. On an unknown date, Drug screen: within normal limits. On an unknown date, Full blood count: within normal limits. On an unknown date, Immunoglobulins: normal. On an unknown date, Metabolic function test: within normal limits. On an unknown date, Monoclonal immunoglobulin: normal. On an unknown date, Psychiatric evaluation: unremarkable. On an unknown date, Red blood cell sedimentation rate (1-20): 14 mm/hr. On an unknown date, Smooth muscle antibody: normal. On an unknown date, Thyroxine free (0.076-1.46): 1.34 ng/dL. On an unknown date, Urine analysis: within normal limits. On an unknown date, Vitamin D (30-100): Low 18.2 ng/mL.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered PSYCHOTIC DISORDER (New-onset paranoia) to be possibly related.    The case refers to a 45-year-old woman who presented to the outpatient psychiatry department after having psychosis for 3 months. The new-onset paranoia and auditory hallucinations began 1 month after receiving her second mRNA-1273 (Moderna) COVID-19 vaccine. The patient had abruptly quit her job of 18 years and stopped eating, losing 56 pounds in 4 months. The patient would only get dressed in the dark, believing people could see her in her closet or bathroom behind a closed door. She would pace all day and stopped doing the household chores she had done for years. She would wake her husband in the middle of the night trying to convince him that the neighbors were going to hurt her and were breaking into their home. She became angry when he tried to convince her these things were not real. Due to this irrational fear, she would sleep only 2 to 3 hours per night and no longer slept in the bedroom, preferring to lock herself in the bathroom to sleep. She heard whispers of people talking about her and would carry on full conversations with them. She would only do this in a room alone with the door closed. Past psychiatric history was negative for any mood or thought disorder. Family history was negative for psychiatric and neurologic conditions. Patient had no previous legal issues or substance abuse history. Her vitamin D level was low and replacement was provided 2 months after initial presentation. No concomitant medications were reported. Patient's reaction after the first injection was not identified if there was any. Patient had stopped the quetiapine due to sedation. Dose of Risperidone was increased to 4 mg within 2 weeks. The patient was uninsured and did not have access to electroconvulsive therapy due to cost and availability. She was referred to the neurology department for further imaging, autoimmune encephalitis panel, and possible lumbar puncture.  Company comment: This literature non-study case concerns a 45-year-old female patient, with negative medical history for any mood or thought disorders, no previous legal issues or substance abuse history, and negative depression screening performed by her primary care physician. Family history was negative for psychiatric and neurologic conditions. She presented to the outpatient psychiatry department after having psychosis for 3 months with paranoia and auditory hallucinations that began 1 month after receiving her second dose of mRNA-1273 vaccine. Her urinalysis, drug screen, complete blood count, and complete metabolic panel were within normal limits. Results for thyroid-stimulating hormone (1.37 mIU/mL), free T4 (1.34 ng/dL), erythrocyte sedimentation rate (14 mm/h), antiN-methyld-aspartate (NMDA) receptor antibodies, and C-reactive protein (< 0.29) were all within normal limits. Workup for systemic autoimmune or inflammatory conditions was negative with negative anti-nuclear antibodies and normal smooth muscle antibody titer, mitochondrial antibody immunoglobulin G (IgG), a-1 fraction, a-2 fraction, ß fraction, ? fraction, albumin fraction, M spike, and double-stranded DNA. Her vitamin D level was low at 18.2 ng/mL, and replacement was provided 2 months after initial presentation. Computed tomography of the head without contrast was unremarkable and provided no evidence for dementia. She had not taken steroids in the months prior to presentation, and delirium was ruled out, as she consistently remained oriented x4 with no temporal alterations in sensorium. The patient had some improvement on quetiapine extended release 150 mg and sertraline 50 mg but had stopped the quetiapine a few days before her visit due to sedation. Sertraline was increased to 100 mg, but paranoia returned quickly after her visit. Risperidone 2 mg at night was added, which was minimally effective and thus was increased to 4 mg within 2 weeks. The patient was uninsured and did not have access to electroconvulsive therapy due to cost and availability. She was referred to the neurology department for further imaging, autoimmune encephalitis panel, and possible lumbar puncture. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2022: Live follow up received by safety on 24-Nov-2022 has email with full text article and contains significant information. Reporter information and literature information was updated, lab data and medical history was added, product information was added, event outcome was updated.; Sender's Comments: This literature non-study case concerns a 45-year-old female patient, with negative medical history for any mood or thought disorders, no previous legal issues or substance abuse history, and negative depression screening performed by her primary care physician. Family history was negative for psychiatric and neurologic conditions. She presented to the outpatient psychiatry department after having psychosis for 3 months with paranoia and auditory hallucinations that began 1 month after receiving her second dose of mRNA-1273 vaccine. Her urinalysis, drug screen, complete blood count, and complete metabolic panel were within normal limits. Results for thyroid-stimulating hormone (1.37 mIU/mL), free T4 (1.34 ng/dL), erythrocyte sedimentation rate (14 mm/h), antiN-methyld-aspartate (NMDA) receptor antibodies, and C-reactive protein (< 0.29) were all within normal limits. Workup for systemic autoimmune or inflammatory conditions was negative with negative anti-nuclear antibodies and normal smooth muscle antibody titer, mitochondrial antibody immunoglobulin G (IgG), a-1 fraction, a-2 fraction, ß fraction, ? fraction, albumin fraction, M spike, and double-stranded DNA. Her vitamin D level was low at 18.2 ng/mL, and replacement was provided 2 months after initial presentation. Computed tomography of the head without contrast was unremarkable and provided no evidence for dementia. She had not taken steroids in the months prior to presentation, and delirium was ruled out, as she consistently remained oriented x4 with no temporal alterations in sensorium. The patient had some improvement on quetiapine extended release 150 mg and sertraline 50 mg but had stopped the quetiapine a few days before her visit due to sedation. Sertraline was increased to 100 mg, but paranoia returned quickly after her visit. Risperidone 2 mg at night was added, which was minimally effective and thus was increased to 4 mg within 2 weeks. The patient was uninsured and did not have access to electroconvulsive therapy due to cost and availability. She was referred to the neurology department for further imaging, autoimmune encephalitis panel, and possible lumbar puncture. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.