Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, auditory, Paranoia
Clinical narrative: audible hallucination; Paranoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:00 as dose 3 (booster), single (Lot number: gh9694) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing), notes: htn; "sleep apnea" (unspecified if ongoing); "depression" (unspecified if ongoing); "kidney disease" (unspecified if ongoing), notes: kidney disease. Concomitant medication(s) included: MECLIZINE HCL; CITRACAL [CALCIUM CITRATE]; MAGNESIUM; AMLODIPINE; MICARDIS; MYRBETRIQ; ZETIA; BUPROPION; LASIX [FUROSEMIDE]; POTASSIUM; SOLIFENACIN; GABAPENTIN; ATORVASTATIN; VENLAFAXINE; COQ10 [UBIDECARENONE]; BABY ASPIRIN. Past drug history included: Codeine, reaction(s): "known allergies: codeine"; Lidocaine, reaction(s): "known allergies: lidocaine"; Quinapril, reaction(s): "known allergies:quinapril"; Beta blockers, reaction(s): "known allergies: beta blockers", notes: beta blockers. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: PARANOIA (non-serious) with onset 24Sep2022 at 11:00, outcome "not recovered", described as "Paranoid"; HALLUCINATION, AUDITORY (medically significant) with onset 24Sep2022 at 11:00, outcome "not recovered", described as "audible hallucination". Therapeutic measures were not taken as a result of hallucination, auditory, paranoia.  Clinical Course: Patient had injection on Friday afternoon. By Saturday around 11am patient had been having audible hallucination. Hearing storys told about her hearing her family's voices in the hallway talking about her family was not present. Paranoid people are listening to her, monitoring her phone and ipad, recording her conversations by having recorders in ceiling vents.afraid she was being drugged by her food. Extremely emotional about the events she was hearing. Confrontational about what she was hearing. Afraid her money was being taken afraid items were being taken from her house.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Hallucination, auditory cannot be excluded for the suspect drug BNT162B2. the case will be reassessed once new information is available.  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 RAs, Ethics Committees, and Investigators, as appropriate.