Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blepharospasm, Body temperature abnormal, Dry eye, Electromyogram
Clinical narrative: Same neuropathy; Heart racing better; Blepharospasm L eye; Worse Fatigue Weakness; Worse Fatigue Weakness; Tachy/bp change; Gastric paresis; Glove stocking pins and temp changes; Dry eyes; EXTENSIVE SFN; SHAKY trembling hands/shakiness/muscle shakiness; More leg weakness and paresthesia constant -Felt heavy; Tingling bilat; Leg weakness/unsteady/leg weakness worse/Legs give out; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via Intramuscularly, in Arm Left, on 12Jan2021 at 14:00 PM (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), DHEA, vit D [VITAMIN D NOS], calcium, estrogen NOS, hydroxyprogesterone caproate (PROGE), and testosterone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 10Feb2021, the patient experienced more leg weakness and paresthesia constant -Felt heavy. On 23Mar2021, the patient had shaky trembling hands/shakiness/muscle shakiness. On 03May2021, the patient had extensive SFN. On 17May2021, the patient experienced gastric paresis, glove stocking pins and temp changes, dry eyes, and tachy/bp change. On 21May2021, the patient had worse fatigue weakness. On 11Jun2021, the patient had blepharospasm L eye. On 20Jun2021, the patient visited to neurologists and think vaccine related and sending her to Infectious disease next week. On 21Jun2021, the patient experienced tingling bilat and neurology (withheld) - complete assessment done with 5 Day steroid taper helped paresthesia and symptoms recurred on day 0. The patient had leg weakness/unsteady/leg weakness worse/Legs give out. On an unspecified date in Jul2021, the patient experienced same neuropathy and heart racing better. The patient underwent lab tests and procedures which included electromyogram: negative on 21Jan2021, electromyogram: normal on 17May2021, magnetic resonance imaging LUMBAR: normal on 03Feb2021 Leg weakness worse, magnetic resonance imaging BRAIN: normal on 24Apr2021, CERVICAL magnetic resonance imaging neck spondylosis: no myelopathy on 29Jan2021, and sars-cov-2 test: negative on 15Mar2021 Nasal Swab. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. Outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of "Neuropathy" "Gastroparesis" due to temporal relationship and current known drug safety profile. 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