Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Polymerase chain reaction, Somnolence, Visual impairment
Clinical narrative: about every 3-4 weeks bulous lesion (1-2) with sharp pain on L.; about every 3-4 weeks bulous lesion (1-2) with sharp pain on L.; migratory paresthesias on bilateral extremities; When I received first Pfizer vaccine 23Dec2020, after 24hrs sudden onset of extreme weakness; confusion (inability read and comprehend patient chart); heavy head; vision issue; inability to type and fell asleep while typing; when stood up felt legs giving out or very weak; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 23Dec2020 08:30 (Lot number: Ej1685) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Addisons on low dose prednisone 2.5mg" (unspecified if ongoing); "SVT" (unspecified if ongoing); "asthma" (unspecified if ongoing); "dysautonomia" (unspecified if ongoing); "menopause" (unspecified if ongoing); "migraine" (unspecified if ongoing); "h/o low Vit d" (unspecified if ongoing); "Vit b12" (unspecified if ongoing); "lymphocytic vasculitis from skin biopsy of blister rash" (unspecified if ongoing); "and microfibril neuropathy mild" (unspecified if ongoing); "suspect vzv" (unspecified if ongoing); "&UMN inflammation" (unspecified if ongoing); "Allergy: PCn" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Propafenone, reaction(s): "Allergy". The following information was reported: ASTHENIA (hospitalization, disability) with onset 24Dec2020 09:30, outcome "not recovered", described as "When I received first Pfizer vaccine 23Dec2020, after 24hrs sudden onset of extreme weakness"; CONFUSIONAL STATE (hospitalization, disability) with onset 24Dec2020 09:30, outcome "not recovered", described as "confusion (inability read and comprehend patient chart)"; HEAD DISCOMFORT (hospitalization, disability) with onset 24Dec2020 09:30, outcome "not recovered", described as "heavy head"; VISUAL IMPAIRMENT (hospitalization, disability) with onset 24Dec2020 09:30, outcome "not recovered", described as "vision issue"; SOMNOLENCE (hospitalization, disability) with onset 24Dec2020 09:30, outcome "not recovered", described as "inability to type and fell asleep while typing"; LIMB DISCOMFORT (hospitalization, disability) with onset 24Dec2020 09:30, outcome "not recovered", described as "when stood up felt legs giving out or very weak"; PARAESTHESIA (hospitalization, disability) with onset 27Dec2020, outcome "not recovered", described as "migratory paresthesias on bilateral extremities"; DERMATITIS BULLOUS (hospitalization, disability), outcome "not recovered", PAIN (hospitalization, disability) with onset 24Nov2020 09:30, outcome "not recovered" and all described as "about every 3-4 weeks bulous lesion (1-2) with sharp pain on L.". The patient was hospitalized for asthenia, confusional state, head discomfort, visual impairment, somnolence, limb discomfort, paraesthesia, dermatitis bullous, pain (hospitalization duration: 7 day(s)). The events "when i received first pfizer vaccine 23dec2020, after 24hrs sudden onset of extreme weakness", "confusion (inability read and comprehend patient chart)", "heavy head", "vision issue", "inability to type and fell asleep while typing", "when stood up felt legs giving out or very weak", "migratory paresthesias on bilateral extremities", "about every 3-4 weeks bulous lesion (1-2) with sharp pain on l." and "about every 3-4 weeks bulous lesion (1-2) with sharp pain on l." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (10Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of asthenia, confusional state, head discomfort, visual impairment, somnolence, limb discomfort, paraesthesia, dermatitis bullous, pain. Clinical course: The facility where the COVID-19 vaccine was administered is Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was treated with Acyclovir and steriods for adverse events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events confusional state, head discomfort, visual impairment, somnolence, limb discomfort, paraesthesia, dermatitis, bullous, pain, asthenia cannot be totally 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.