Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Cognitive disorder, Computerised tomogram, Confusional state
Clinical narrative: mild headache; moderate fatigue exacerbated with activity; unresolved memory loss; confusion; cognitive delay; modified schedule of 4 hours/day beginning 20Apr2021 and now no longer able to work at all; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 2, single (Lot number: EN6199) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 1 Hypertension" (unspecified if ongoing), notes: Stage 1 Hypertension; "Mild Sleep Apnea" (unspecified if ongoing), notes: Mild Sleep Apnea. Concomitant medication(s) included: COZAAR. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Left), administration date: 12Feb2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "Mild headache and moderate fatigue exacerbated with activity", "Mild headache and moderate fatigue exacerbated with activity". The following information was reported: COGNITIVE DISORDER (disability) with onset 2021, outcome "not recovered", described as "cognitive delay"; CONFUSIONAL STATE (disability) with onset 2021, outcome "not recovered", described as "confusion"; HEADACHE (disability) with onset 2021, outcome "not recovered", described as "mild headache"; FATIGUE (disability) with onset 2021, outcome "not recovered", described as "moderate fatigue exacerbated with activity"; IMPAIRED WORK ABILITY (disability) with onset 2021, outcome "not recovered", described as "modified schedule of 4 hours/day beginning 20Apr2021 and now no longer able to work at all"; AMNESIA (disability) with onset 2021, outcome "not recovered", described as "unresolved memory loss". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2021) Negative, notes: covid test type post vaccination=Nasal Swab;  (22Feb2021) Negative, notes: covid test type post vaccination=Nasal Swab.  Clinical course: It was reported that after second dose patient had in addition to unresolved side effects from the 1st dose, unresolved memory loss, confusion, and cognitive delay. The patient did not receive any other vaccine within four weeks prior to covid-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2 ,a causal relation between the events cognitive disorder, confusional state, headache, fatigue, impaired work  ability, amnesia and the administration of the vaccine 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.