Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Guillain Barre; muscle weakness/core/leg/hip weakness; fatigue; difficulty sit/stand/crouch/stand; problems with coordination of hands; Pins and needles hands; This is a spontaneous report from a contactable nurse or other health care professional. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 23Apr2021 11:00 (Batch/Lot Number: ER2731) as dose 2, single for covid-19 immunisation (at the age of 61-year-old). The patient medical history included incomplete spinal cord injury, spinal cord tumor from an unspecified date in 2008 and ongoing, she had an surgery on an unspecified date in 2008, the patient also had kyphosis, and cervical intervertebral disc disease from an unknown date since 2008 ,and she underwent unspecified surgery in Feb2020, the patient also had nerve injury left and nerve block on an unspecified date in 2014. The patient's concomitant medications included gabapentin (GABAPENTIN) taken for neuropathic pain via oral route on an unspecified date in 2008 and ongoing; bupropion (BUPROPION) taken for depression via oral route from an unspecified start date since 20 years and ongoing; tizanidine hydrochloride (ZANAFLEX) taken for muscle spasms via oral route from an unspecified date in 2008 and ongoing; zolpidem (ZOLPIDEM) taken for sleep via oral route from an unspecified start date since 15 years and ongoing; naproxen (NAPROXEN) taken for arthritis via oral route from an unknown date in Apr2020 and ongoing and acetaminophen (ACETAMINOPHEN) taken for arthritis via oral route from an unknown date in Apr2020 and ongoing. The patient did not have any relevant tests. The patient did not received any other vaccines prior to the covid 19 vaccine. Vaccination facility type was hospital. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on an 02Apr2021 11:00 (Batch/Lot Number: EP7533) as dose 1, single for covid-19 immunization. On 24Apr2021, the patient experienced muscle weakness and gullian barre and on an unspecified date, she also experienced fatigue, core/leg/hip weakness difficulty sit/stand, crouch/stand with 1 wk of things knocking, things over and pins and needles hands, problems with coordination of hands. Patient thought she have mild gullian barre and do not want to take a booster of the vaccine. The patient did not received treatment. The seriousness for the events muscle weakness and gullian barre was assessed as persistent/ significant disability/incapacity. The clinical outcome of the events was recovering.  Comments: Fatigue, core/leg/hip weakness difficulty sit/stand, crouch/stand with 1 wk of things, knocking, things over. Pins and needles hands, problems with coordination of hands. I think I have mild gullian barre and do not want to take a booster of the vaccine; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Guillain-Barre syndrome, Muscular weakness and suspect drug BNT162B2 cannot be completely excluded. 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.