Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation, Muscle rigidity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: vestibular neuritis; Severe vertigo; had shooting pins and needles in all extremities; rigidness; Felt like I was on a boat swaying and unable to walk in a straight line; booster; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 (Lot number: 30130BA) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 29Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: E51685), administration date: 07Jan2021, when the patient was 36 years old, for COVID-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730), administration date: 17Dec2020, when the patient was 36 years old, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 08Oct2021, outcome "unknown", described as "booster"; VESTIBULAR NEURONITIS (hospitalization, medically significant) with onset 17Oct2021, outcome "recovered" (2021), described as "vestibular neuritis"; VERTIGO (hospitalization) with onset 17Oct2021, outcome "recovered" (2021), described as "Severe vertigo"; PARAESTHESIA (hospitalization) with onset 17Oct2021, outcome "recovered" (2021), described as "had shooting pins and needles in all extremities"; MUSCLE RIGIDITY (hospitalization) with onset 17Oct2021, outcome "recovered" (2021), described as "rigidness"; GAIT DISTURBANCE (hospitalization) with onset 17Oct2021, outcome "recovered" (2021), described as "Felt like I was on a boat swaying and unable to walk in a straight line". The patient was hospitalized for immunisation, vestibular neuronitis, vertigo, paraesthesia, muscle rigidity, gait disturbance (hospitalization duration: 3 day(s)). Patient was hospitalized for 3 days with what was diagnosed as vestibular neuritis. Patient had severe vertigo that lasted 1 hour per episode; at least 6-7 episodes in 24h period. Patient also had shooting pins and needles in all extremities and rigidness at periods of an episode. When not having vertigo episode, patient felt like he was on a boat swaying and was unable to walk in a straight line. The events "vestibular neuritis", "severe vertigo", "had shooting pins and needles in all extremities", "rigidness" and "felt like i was on a boat swaying and unable to walk in a straight line" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Oct2021) negative. Therapeutic measures were taken as a result of vestibular neuronitis, vertigo, paraesthesia, muscle rigidity, gait disturbance. Treatment included methylprednisolone (MEDROL DOSE-PAK).; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious hospitalized events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.