Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Pyrexia
Clinical narrative: hallucinations; extremely high blood pressure; Fever; other vaccine same date product=Influenza; Patient received Moderna as dose 1 and dose 2; BNT162B2 as dose 3 for booster./Other vaccine same date product=Influenza; Patient received Moderna as dose 1 and dose 2; BNT162B2 as dose 3 for booster.; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:00 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 23Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna (Dose Number: 2; Location of injection: Arm Right; Vaccine Administration Time: 12:00 PM), administration date: 17Feb2021, when the patient was 61 years old, for COVID-19 immunization; Moderna (Dose Number: 1; Location of injection: Arm Right; Vaccine Administration Time: 09:30 AM), administration date: 15Jan2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 23Nov2021, outcome "unknown", described as "Patient received Moderna as dose 1 and dose 2; BNT162B2 as dose 3 for booster./Other vaccine same date product=Influenza"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Patient received Moderna as dose 1 and dose 2; BNT162B2 as dose 3 for booster."; PRODUCT USE ISSUE (non-serious) with onset 23Nov2021, outcome "unknown", described as "other vaccine same date product=Influenza"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE"; HALLUCINATION (medically significant) with onset 24Nov2021 18:00, outcome "recovering", described as "hallucinations"; HYPERTENSION (non-serious) with onset 24Nov2021 18:00, outcome "recovering", described as "extremely high blood pressure"; PYREXIA (non-serious) with onset 24Nov2021 18:00, outcome "recovering", described as "Fever". The events "hallucinations", "extremely high blood pressure" and "fever" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (24Nov2021) extremely high. Therapeutic measures were taken as a result of hallucination, hypertension, pyrexia. Patient had no Covid prior vaccination and no Covid tested post vaccination.  The lot number for the vaccine, [bnt162b2 ], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be 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