Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Protracted Psychiatric Complications Including Psychosis; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 28May2025, this case now contains all required information to be considered valid. This is a literature report for the following literature source(s). This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Case report: The patient is a 54-year-old man with no prior psychiatric history, well-functioning with a stable job as supervisor at a large landscaping company. He was married with children and had an excellent relationship with family. He drank alcohol infrequently and did not use any other substances. He has a family history of depression in both his parents. He began to experience symptoms of intense anxiety and paranoia in 2021, 4 days after receiving his second Pfizer BioNTech COVID-19 vaccination. He developed severe insomnia and was fearful that police were pursuing him despite nothing to suggest this was a realistic concern. He did not have COVID-19 when his psychiatric symptoms first started and did not have any medical problems aside from asthma. The patient was first hospitalized 2 weeks after these symptoms began at one of the psychiatric facilities in the area. The documents obtained from that facility indicated his complete blood count, complete PROTRACTED metabolic panel, B12, folate, and thyroid-stimulating hormone were within normal reference ranges except for a mildly elevated total bilirubin. HIV, RPR, and Lyme disease IgG/IgM were negative. Urine toxicology screening did not detect any substances. He was recommended to get a brain magnetic resonance imaging during that hospitalization, but he declined due to fears he would be taken to the police instead. He was discharged from the facility with partial improvement of the symptoms. The discharge diagnoses by the facility were major depressive disorder with psychotic features and generalized anxiety disorder. The discharge medications were risperidone 2 mg nightly, buspirone 15 mg twice a day, and lithium 900 mg nightly (lithium level of 0.86). Upon discharge, he was referred to our facility for outpatient follow-up in our partial hospital program. In the following 2 years, he experienced fluctuations in the symptoms and did not have a sustained return to his premorbid level of functioning. While outpatient, he developed kidney stones, so his lithium was switched to carbamazepine. This was also discontinued once he developed a rash. His risperidone was switched to quetiapine multiple antidepressant trials including fluvoxamine, escitalopram, and venlafaxine, none of which were helpful. Lorazepam was added without any significant benefit. He ended up being psychiatrically hospitalized at our facility 3 additional times. He attempted suicide by overdosing on his medications and another time by trying to hang himself. Given his age, atypical presentation, and presence of symptoms. Neurology involved approximately 7months after the onset of the symptoms. Lumbar puncture was notable for an elevated protein of 147 mg/dL and a corrected white blood cell count of 6 cells/uL. Multiple sclerosis profile, ENC2 panel, and Alzheimer's panel were normal. Repeat lumbar puncture 4 months later was completely normal without any abnormalities. Anti-thyroid peroxidase was elevated at 89 IU/mL and anti-La (SS-B) elevated at 2.3 antibody index. Routine electroencephalogram (EEG) was normal. Brain magnetic resonance imaging with and without contrast only showed minimal scattered subcortical and periventricular white matter T2/ FLAIR hyperintensities, which was likely due to chronic small vessel ischemia. Computed tomography scans of the chest, abdomen, and pelvis and scrotal ultrasound did not show evidence of malignancies. The patient's last psychiatric hospitalization at our facility was approximately 22 months after the initial onset of his symptoms of anxiety and paranoia. Symptoms at the time of this hospitalization included severely depressed mood, decreased concentration, psychomotor retardation, and catatonia evidenced by decreased oral intake, marked ambivalence, selective mutism, mannerisms, and negativism. Laboratory results were only notable for slightly elevated alanine transaminase to 60 units/L, which later resolved. Once on the inpatient unit, he was titrated on lorazepam to 4 mg 3 times daily. His sertraline was increased to 100 mg twice a day. He was continued on quetiapine 100 mg nightly for psychosis. Propranolol 20mg twice a day was added for restlessness but eventually was discontinued due to dizziness and lack of efficacy. Symptoms were refractory to medications, so he was ultimately started on ECT about a month after the admission. He received 11 bifrontal ECT treatments during his hospital stay. His score on the Montgomery-Asberg Depression Rating Scale improved from 39 out of 60 at pre- ECT to 18 out of 60 after 11 ECT treatments. He tolerated the ECT treatments well. He was discharged from the hospital two months after his admission. He received 7 additional bifrontal ECT treatments as an outpatient over the course of 3 months. At the time of his last session, he scored 10 out of 60 on the Montgomery-Asberg Depression Rating Scale. As of 10 months after the last ECT session, he had been tapered off his quetiapine and was undergoing a slow taper of his lorazepam. He remained in full remission without any relapse of symptoms and had returned to premorbid level of function. The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 28May2025, this case now contains all required information to be considered valid. This is a literature report for the following literature source(s). This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Case report: The patient is a 54-year-old man with no prior psychiatric history, well-functioning with a stable job as supervisor at a large landscaping company. He was married with children and had an excellent relationship with family. He drank alcohol infrequently and did not use any other substances. He has a family history of depression in both his parents. He began to experience symptoms of intense anxiety and paranoia in 2021, 4 days after receiving his second Pfizer BioNTech COVID-19 vaccination. He developed severe insomnia and was fearful that police were pursuing him despite nothing to suggest this was a realistic concern. He did not have COVID-19 when his psychiatric symptoms first started and did not have any medical problems aside from asthma. The patient was first hospitalized 2 weeks after these symptoms began at one of the psychiatric facilities in the area. The documents obtained from that facility indicated his complete blood count, complete PROTRACTED metabolic panel, B12, folate, and thyroid-stimulating hormone were within normal reference ranges except for a mildly elevated total bilirubin. HIV, RPR, and Lyme disease IgG/IgM were negative. Urine toxicology screening did not detect any substances. He was recommended to get a brain magnetic resonance imaging during that hospitalization, but he declined due to fears he would be taken to the police instead. He was discharged from the facility with partial improvement of the symptoms. The discharge diagnoses by the facility were major depressive disorder with psychotic features and generalized anxiety disorder. The discharge medications were risperidone 2 mg nightly, buspirone 15 mg twice a day, and lithium 900 mg nightly (lithium level of 0.86). Upon discharge, he was referred to our facility for outpatient follow-up in our partial hospital program. In the following 2 years, he experienced fluctuations in the symptoms and did not have a sustained return to his premorbid level of functioning. While outpatient, he developed kidney stones, so his lithium was switched to carbamazepine. This was also discontinued once he developed a rash. His risperidone was switched to quetiapine multiple antidepressant trials including fluvoxamine, escitalopram, and venlafaxine, none of which were helpful. Lorazepam was added without any significant benefit. He ended up being psychiatrically hospitalized at our facility 3 additional times. He attempted suicide by overdosing on his medications and another time by trying to hang himself. Given his age, atypical presentation, and presence of symptoms. Neurology involved approximately 7months after the onset of the symptoms. Lumbar puncture was notable for an elevated protein of 147 mg/dL and a corrected white blood cell count of 6 cells/uL. Multiple sclerosis profile, ENC2 panel, and Alzheimer's panel were normal. Repeat lumbar puncture 4 months later was completely normal without any abnormalities. Anti-thyroid peroxidase was elevated at 89 IU/mL and anti-La (SS-B) elevated at 2.3 antibody index. Routine electroencephalogram (EEG) was normal. Brain magnetic resonance imaging with and without contrast only showed minimal scattered subcortical and periventricular white matter T2/ FLAIR hyperintensities, which was likely due to chronic small vessel ischemia. Computed tomography scans of the chest, abdomen, and pelvis and scrotal ultrasound did not show evidence of malignancies. The patient's last psychiatric hospitalization at our facility was approximately 22 months after the initial onset of his symptoms of anxiety and paranoia. Symptoms at the time of this hospitalization included severely depressed mood, decreased concentration, psychomotor retardation, and catatonia evidenced by decreased oral intake, marked ambivalence, selective mutism, mannerisms, and negativism. Laboratory results were only notable for slightly elevated alanine transaminase to 60 units/L, which later resolved. Once on the inpatient unit, he was titrated on lorazepam to 4 mg 3 times daily. His sertraline was increased to 100 mg twice a day. He was continued on quetiapine 100 mg nightly for psychosis. Propranolol 20mg twice a day was added for restlessness but eventually was discontinued due to dizziness and lack of efficacy. Symptoms were refractory to medications, so he was ultimately started on ECT about a month after the admission. He received 11 bifrontal ECT treatments during his hospital stay. His score on the Montgomery-Asberg Depression Rating Scale improved from 39 out of 60 at pre- ECT to 18 out of 60 after 11 ECT treatments. He tolerated the ECT treatments well. He was discharged from the hospital two months after his admission. He received 7 additional bifrontal ECT treatments as an outpatient over the course of 3 months. At the time of his last session, he scored 10 out of 60 on the Montgomery-Asberg Depression Rating Scale. As of 10 months after the last ECT session, he had been tapered off his quetiapine and was undergoing a slow taper of his lorazepam. He remained in full remission without any relapse of symptoms and had returned to premorbid level of function.; Sender's Comments: Based on the temporal relationship, the association between the event "Protracted Psychiatric Complications Including Psychosis" with BNT162B2 NOS can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): SG-PFIZER INC-PV202500064750 Master article; Secondary article;
Medical History/Concurrent Conditions: Abstains from recreational drugs; Alcohol use (infrequently); Asthma; Depression (both his parents)
Test Name: total bilirubin; Result Unstructured Data: Test Result: mildly elevated; Test Name: folate; Result Unstructured Data: Test Result: were within normal; Test Name: thyroid-stimulating hormone; Result Unstructured Data: Test Result: were within normal; Test Name: complete blood count; Result Unstructured Data: Test Result: were within normal; Test Name: HIV; Test Result: Negative; Test Name: Lyme disease IgG/IgM; Test Result: Negative; Test Name: complete metabolic panel; Result Unstructured Data: Test Result: were within normal; Test Name: RPR; Test Result: Negative; Test Name: Urine toxicology screening; Result Unstructured Data: Test Result: did not detect any substances; Test Name: B12; Result Unstructured Data: Test Result: were within normal