Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pelvic discomfort, Perineal disorder, Prostatic specific antigen, Protein total increased
Clinical narrative: diagnosed yesterday with GBS(Guillain-Barre Syndrome) and his doctors believe it is because of the Pfizer Vaccine; noticed urinary retention during the day. He couldn't urinate at all by the evening of the 16Apr2021; increasing weakness in feet, knees, hip flexors.; lumbar puncture showed elevated proteins and lymphocytes.; and lumbar puncture showed elevated proteins and lymphocytes.; severe pain in both thighs and couldn't get comfortable; intermittent perineal and pelvic discomfort; intermittent perineal and pelvic discomfort; He could walk OK at that day/was walking funny; soreness in mid-thigh down to his feet, with tingling in his feet/soreness resolving from mid-thigh down to knee and calves; soreness in mid-thigh down to his feet, with tingling in his feet; mild nausea; muscle ache; severe fatigue; This is a spontaneous report from a contactable physician.   A 54-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported), via intramuscular route of administration, administered in left arm on 28Jan2021, as dose 2, single for COVID-19 immunisation was in hospital. Medical history included mildly elevated cholesterol, seasonal allergies, mild radiculopathy on right arm and glaucoma in left eye all the conditions were ongoing. No family history relevant to adverse event experience. Concomitant medications included atorvastatin (LIPITOR) taking daily for mildly elevated cholesterol; cetirizine hydrochloride (ZYRTEC) taking daily for seasonal allergies; naproxen taken for mild radiculopathy on right arm; latanoprost taken for glaucoma in left eye; dorzolamide hydrochloride, timolol maleate (COSOPT) taken for glaucoma in left eye. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 07Jan2021, as dose 1, single for COVID-19 immunisation and experienced arm discomfort and muscle ache at site of injection. Went away after a day with Tylenol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On the day of second vaccination, the patient had the same muscle ache as the first dose and then severe fatigue the following day, but not to the point could not work. He also had mild nausea on Friday (29Jan2021) but could still eat. By Saturday (30Jan2021), he was back to normal with all of the side effects resolved. The patient started to get soreness on 25Mar2021, mid-thigh down to his feet, with tingling in his feet. He could walk ok at that day. Following day on 26Mar2021, his coworker commented he was walking funny. He noticed his feet were slapping a little bit. However, this improved over next 5 days with soreness resolving from mid-thigh down to knee and calves. His feet felt better with no more tingling by 31Mar2021, and all leg soreness was again resolved. Periodically between 31Mar2021and 15Apr2021, he had intermittent perineal and pelvic discomfort. He walks to work 30 minutes each day and did not have a problem, and no problem stair climbing 11 flights of stairs, so he had a good level of physical fitness. Thursday 15Apr2021, his calves started aching again and felt sore. Friday, 16Apr2021, at 3am he awoke with severe pain in both thighs and could not get comfortable. He was able to only go back to sleep on his stomach. He went to work but still felt off, and noticed urinary retention during the day. He could not urinate at all by the evening of the 16Apr2021. He went immediately to the ER and they discovered 800cc of retained urine. Physical exam was normal for lower extremity muscles. MRI on spine that night and was normal. Ruled out transverse myelitis from C1-sacrum scan. All scans were negative. Admitted to the hospital from the ER on 16Apr2021. On 17Apr2021 was doing ok in the morning but then suddenly had excruciating pain in legs and needed dilauded to tolerate the pain. Did STAT LP, and lumbar puncture showed elevated proteins and lymphocytes. He had minimal weakness in his toes. Started treatment IVIG. Has progressed with increasing weakness in feet, knees, hip flexors. Lost all sensation on S1 through S5, and has no bladder control now. They did a nerve conduction study yesterday, 19Apr2021 and said it was consistent with early Guillain Barre. He was still admitted to the hospital. Prior to these symptoms, he had no viral illness, worked every day, had no fevers, and no diarrhea (to rule out camplobacter). He went hiking. Very supportive of vaccine and recommends people receiving the vaccine, but since the vaccine was the only thing different in his daily routine before these symptoms started, he wanted to make us aware. Even though it is not confirmed to be the direct cause of his adverse events, it stands out to him as the only change in his routine. The patient underwent lab tests and procedures which included CK: 196, comments: normal; TSA: 1.35, comments: normal; lymphocytes: elevated; MRI spine: normal; comprehensive metabolic and CBC: normal; nerve conduction study: unknown; PSA: 1, comments: normal; Protein: elevated; Sed rate: 6; COVID 19: negative; vitamin B12: normal. Therapeutic measures were taken as a result of increasing weakness in feet, knees, hip flexors and treatment with IVIG. Outcome of the events muscle ache, severe fatigue and mild nausea was resolved on 30Jan2021; soreness in mid-thigh down to his feet, with tingling in his feet was resolved on 31Jan2021; intermittent perineal and pelvic discomfort was resolved on 15Apr2021 and rest of the events it was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available clinical data, events Guillain-Barre syndrome, urinary retention and asthenia were most likely intercurrent medical conditions not related to vaccination with BNT162B2.   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.