Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vaccination site mass, Vaccination site pain
Clinical narrative: confusion that progressed to hallucinations; BP now runs from 145-150/195-98 mmHg, elevated blood pressure; confusion; a new lesion of progression; knot and pain in arm at injection site; knot and pain in arm at injection site; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017453 (BioNTech SE), 2018SA137109 (Sanofi).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; teriflunomide (AUBAGIO), since 12Apr2018) at 14 mg daily (14 mg, daily (once a day)), oral for multiple sclerosis; ofatumumab (KESIMPTA), first regimen) at first injection and second regimen) at second injection for multiple sclerosis; ozanimod hydrochloride (ZEPOSIA) for 26 days. The patient's relevant medical history included: "total hysterectomy", start date: 25Apr2017 (unspecified if ongoing), notes: without any hot flashes or mood swings; "lumbar puncture" (unspecified if ongoing), notes: spinal tap. Concomitant medication(s) included: VITAMIN D NOS taken for vitamin supplementation. The following information was reported: HALLUCINATION (medically significant), outcome "unknown", described as "confusion that progressed to hallucinations"; BLOOD PRESSURE INCREASED (medically significant), outcome "recovered", described as "BP now runs from 145-150/195-98 mmHg, elevated blood pressure"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confusion"; CENTRAL NERVOUS SYSTEM LESION (non-serious), outcome "unknown", described as "a new lesion of progression"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "knot and pain in arm at injection site". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 145-150 mmHg; (unspecified date) 195-98 mmHg; (07Jan2025) 150/90 mmHg, notes: yesterday afternoon; (08Jan2025) 160/95 mmHg, notes: this morning; Magnetic resonance imaging: (unspecified date) a new lesion of progression, notes: Central nervous system lesion. The action taken for teriflunomide was dosage not changed; for ofatumumab and ozanimod hydrochloride was unknown. Therapeutic measures were taken as a result of blood pressure increased. The patient blood pressure (BP) being high, her pre-teriflunomide baseline BP now runs from 145-150/195-98 mmHg, elevated blood pressure. The consumer's blood pressure was 150/90 yesterday afternoon and was 160/95 this morning. Treatment for elevated blood pressure included Losartan. Treatment for hot flashes included Estradiol. On an unknown date the patient received Pfizer covid vaccine. On an unknown date after unknown latency patient experienced knot and pain in at injection site (injection site mass and injection site pain). The patient sated her most recent MRI (magnetic resonance imaging) showed a new lesion of progression (Central nervous system lesion). Patient stated MRI done after she took second injection on Kesimpta. The action taken was not applicable for confusion, hallucination and central nervous system lesion; and no action taken and the therapy was continued for rest of the events for teriflunomide; unknown for all events for other suspects.  Corrective treatment was losartan for blood pressure increased, not reported for rest. The event outcome was recovered/resolved blood pressure increased, unknown for injection site mass and injection site pain, confusion, hallucination and central nervous system lesion. The reporter causality was unassessable for confusion, hallucination and central nervous system lesion and not reported for other events.  The company causality was not reportable for all events. The seriousness criteria was medically significant for hallucination.  The reporter's assessment of the causal relationship of "confusion that progressed to hallucinations", "bp now runs from 145-150/195-98 mmhg, elevated blood pressure", "confusion", "a new lesion of progression" and "knot and pain in arm at injection site" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Company Comment: Withheld company comment dated 27Nov2024: This case involves a 43-year-old female patient who experienced confusion that progressed to hallucinations, while she was treated with terifiunomide (Aubagio) and Pfizer Covid vaccine, Ofatumumab (Kesimptal and Ozanimod hydrochloride [Zeposia]. The causal role of drug cannot be excluded for event. However, lack of information regarding event details, patient's compliance, treatment received, Jab data, medical and concomitant medications precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow up information. Case serious was yes, company agent causal was no, case outcome was unknown.  Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 is under agreement with BIONTECH SE.; Sender's Comments: There is not a reasonable possibility that the reported events hallucination, blood pressure increased, confusion state, CNS lesion was related to the suspect product event most likely due to patient underlying contributory factors. Causality to the events vaccination site mass and vaccination site pain are most likely due to the vaccination.