Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Skin test
Clinical narrative: areflexia throughout/decreased sensation to pinprick; B/L CN 7 weakness; areflexia throughout/decreased sensation to pinprick; Bilateral lower extremity weakness and pain/patchy weakness in RLE > LLE; Bilateral lower extremity weakness and pain; paresthesia in bilateral hands and legs; acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre syndrome); lumbar puncture showed no WBC and significantly increased protein to 107; lumbar puncture showed no WBC and significantly increased protein to 107; This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261), intramuscular on 24Jan2021 at single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.  Medical history included 'Cryptogenic cirrhosis s/p liver tx 20Jun2020, T2DM on insulin, Factor V Leiden, CAD s/p stent x3 (2008), hyperlipidemia', NSAIDS allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, acetylsalicylic acid (ASPIRIN), bupropion hydrochloride (WELLBUTRIN), carvedilol, citalopram, ergocalciferol, insulin glargine (LANTUS), melatonin, metformin, omeprazole, senna alexandrina (SENNA).  The patient previously took atorvastatin and experienced Allergies to Atorvastatin, promethazine and experienced Allergies to promethazine, tolmetin and experienced Allergies to tolmetin, INSULIN for T2DM (Type 2 diabetes mellitus). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Bilateral lower extremity weakness and pain and paresthesia in bilateral hands and legs on 26Jan2021. Symptoms began two days after first dose of the Pfizer vaccine (received on 24Jan2021) and have continued to progress over the last 2.5 weeks. His neurological exam now (10Feb2021) includes areflexia throughout, patchy weakness in RLE > LLE, decreased sensation to pinprick and B/L CN 7 weakness. His lumbar puncture showed no WBC and significantly increased protein to 107 in 2021. This is all consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association in 2021. The patient underwent lab tests and procedures which included lumbar puncture: no WBC and significantly increased protein to 107 in 2021, neurological examination: areflexia throughout, patchy weakness in RLE > LLE and B/L CN 7 weakness on 10Feb2021, Rapid SARS-CoV-2 (COVID-19) by PCR Nasopharyngeal swab on M4 (NASO): negative on 06Feb2021, skin test: decreased sensation on 10Feb2021. The adverse events result in Emergency room/department or urgent care. Hospitalization for all the events. Therapeutic measures were taken as a result of events (IVIg). The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, patient developed signs and symptoms which were consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association. In addition, a contributory role of patients co-morbidities 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.