Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Gait disturbance, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: excruciating low lumbar pain from L5 and S; Was unable to walk and sit; This is a spontaneous report from a contactable nurse(patient). The 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 13Mar2021 16:15 (Lot Number: EN6204) as single dose for precautionary for getting covid 19. Medical history included severe asthma, she had lumbar fusion T9-L5. Her lumbar back area was the worst area on her body even before she got the Covid vaccine. She had been in pain all the time 24 hours a day, 7 days a week. There were no concomitant medications. On 14Mar2021 morning, she was unable to walk and sit, experiencing excruciating low lumbar pain from L5 and S. It continued all day, pain excruciated was screaming and crying until yesterday afternoon went to the hospital. She had not experienced pain ever like this. If she got up to use the bathroom, it was pain, excruciating pain the whole time she's up. The hospital didn't admit her because she did an MRI with contrast and without contrast and it showed no changes from her last MRI in Nov2020. She was still in severe pain. Doctor in the emergency room gave her 2 IV push of hydromorphone hydrochloride (DILAUDID) and did nothing. There was no pain as long as she's not moving but when she got up or move or go to the washroom to urinate has excruciating pain. She was supposed to get on the plane tomorrow not able to get out of bed. Pain was localized in one area like stabbing burning and excruciating pain if moving. It's not like a muscle or joint pain you get from a flu vaccine. She was prescribed Oxycodone 5/325 from the emergency room. She didn't take any oxycodone last night, she was hesitant to take pain meds. She was laying prone in bed except to get up to restroom, her husband gave her one of the oxycodone before he left for work this morning. It was unknown if the oxycodone was working, since she hadn't moved yet, she's laying prone and had not moved to the right or to the left and she just took it about 45 minutes ago. Lab data also included blood work, MRI with and without contrast, Covid test, with unknown results. Seriousness criteria for events was disability. Outcome of events was not recovered. She asked the emergency room doctor could this be related to the Covid vaccine and the doctor would not state whether he thought it was or was not. She's thinking it was related because it is so new and it's the only thing new that's been introduced into her body. Relatedness of drug to reactions by reporter was related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported excruciating low lumbar pain from L5, which resulted unable to walk and sit,  and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association.    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 RA, IEC, as appropriate.