Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Giulian-Barre syndrome with fever; Giulian-Barre syndrome with fever; severe muscle weakness; somnolence; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 15:45 as dose 2, single (Lot number: EN6198) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine headache" (unspecified if ongoing); "Hypertension intermittent" (unspecified if ongoing), notes: Hypertension intermittent. There were no concomitant medications. Patient did not receive any other vaccine on same day and not receive other vaccine in four weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 04Feb2021, for COVID-19 immunization, reaction(s): "difficulties focusing and completing tasks", "Guillain Barre syndrome", "fever", "severe muscle weakness", "somnolence". The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), PYREXIA (non-serious), outcome "recovered with sequelae" and all described as "Giulian-Barre syndrome with fever"; MUSCULAR WEAKNESS (non-serious), outcome "recovered with sequelae", described as "severe muscle weakness"; SOMNOLENCE (non-serious), outcome "recovered with sequelae"; DISTURBANCE IN ATTENTION (non-serious), outcome "recovered with sequelae", described as "difficulties focusing". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (13Dec2020) Negative, notes: Nasal Swab; (13Jan2022) Negative, notes: Nasal Swab; (07Mar2022) Negative, notes: Nasal Swab; (27Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of guillain-barre syndrome, pyrexia, muscular weakness, somnolence, disturbance in attention with bed rest, valacyclovir 1000 mg PO QID and ibuprofen 400 mg PO TID. Patient received BNT162b2 (BNT162B2), on 06Feb2022 at 15:45 as dose 3, single (Lot number: unknown) intramuscular, in left arm for covid-19 immunisation.   Clinical course: It was reported that patient experienced giulian-barre syndrome with fever, severe muscle weakness, somnolence, difficulties focusing and completing tasks for 2 and 3 weeks after 2nd vaccination.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event guillain-barre syndrome and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further 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.