Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Hyporeflexia, Immunoglobulin therapy, Laboratory test normal, Magnetic resonance imaging spinal normal
Clinical narrative: Guillain barre syndrome; developed acute onset of urinary retention; generalized burning pain both feet hands back and face; weakness of my legs R>L; difficulty walking; constipation; dry mouth; hypertension; GD1a and ASIALO GM1 ganglioside titers reported as high; Sensory, decreased to LT/PP in stocking glove distribution, Vib decreased in toes; Vib decreased in toes; Reflexes 1+throughout except absent.; Sx' worsened over 2 weeks but then concentrated distally in arms and legs; dose received: 3; This is a spontaneous report from a contactable physician (patient). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Lot Number: FC3181) dose 3 intramuscular, administered in Arm Left on 20Sep2021 11:00 as dose 3 (booster), single for covid-19 immunization. Patient medical history included hypertension. Concomitant medications included atorvastatin calcium (LIPITOR); losartan potassium (COZAAR); acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: em9809), via intramuscular in the arm left on 11Feb2021 and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EL8982), via intramuscular in the arm left on 21Jan2021 as a single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had been tested for COVID-19 since the vaccination. On 30Sep2021, patient experienced developed acute onset of urinary retention, generalized burning pain both feet hands back and face, weakness of my legs r>l, difficulty walking, constipation, dry mouth, hypertension, gd1a and asialo gm1 ganglioside titers reported as high, sensory, decreased to lt/pp in stocking glove distribution, vib decreased in toes, vib decreased in toes, reflexes 1+throughout except absent, sx' worsened over 2 weeks but then concentrated distally in arms and legs hoover on 20Sep2021, dose received: 3. The patient was hospitalized for all events from 14Oct2021 to 19Oct2021. Patient visited Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to adverse events. The patient underwent lab tests and procedures which included anti-ganglioside antibody: high on Oct2021, electromyogram: non specific findings on Oct2021, lumbar puncture: csf protein 42, csf WBC 0 on 14Oct2021, magnetic resonance imaging head: wnl on 03Oct2021, magnetic resonance imaging spinal: no high grade canal on 03Oct2021, neurological examination: sensory decreased to lt/pp/vib decreased in toes on 14Oct2021 Sensory, decreased to LT/PP in stocking glove distribution, Vib decreased in toes. Reflexes 1+throughout except absent , sars-cov-2 test: negative on 03Oct2021 Nasal swab, sars-cov-2 test: negative on 14Oct2021. Therapeutic measures were taken as a result of all events. The outcome for events was recovering.; Sender's Comments: Considering a plausible temporal relationship, a causal relation between reported events and BNT162B2 cannot be totally excluded. Case will be reassessed if follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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