Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inappropriate schedule of product administration, Incorrect route of product administration, Laboratory test, Osteolysis
Clinical narrative: Significant weight loss; Chronic back pain; terrible pain in the back; Osteolysis; Terrible pain in her extremities; It was her first dose and she was afraid to get the second one now; patient was supposed to get her second one last week and she didn't; Paralyzed from her neck down to her arm, legs, and everything; weakness in extremities; could not move; Received BNT162B2 via subcutaneous route; This is a spontaneous report from a contactable nurse (patient who is a retired nurse who did anesthesia). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), subcutaneous in right deltoid of the upper arm, on 09Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included pain, use of medication to help with sleep, gastroesophageal reflux disease (GERD), and thyroid. The patient's concomitant medications included levothyroxine for thyroid, pantoprazole sodium sesquihydrate (PROTONIX) for GERD, trazodone to help with sleep, zolpidem tartrate (AMBIEN) to help with sleep, morphine (extended relief) for pain, and morphine sulfate (immediate relief) for pain. They also gave the patient diazepam (VALIUM) if she needs to take it but she did plan; she didn't take it. The patient just didn't take diazepam and then pain management doctor put her on morphine extended release. Then, morphine sulphate immediate relief, so she can take up to 4 for day and she was not using now. The COVID-19 vaccine was administered in a pharmacy. The patient would like to report a reaction that she received that she had approximately for an hour and a half, that basically started in an hour after the injection. The patient's first COVID-19 shot was given by Pfizer on 09Mar2021 and what happens in next hour was she became totally paralyzed from her neck down to her arm, legs, and everything. It was approximately about 30 minutes after the shot that she began to notice some weakness in extremities (also reported as eternities) and then they got home an hour later, and her husband left the patient then she got to know she could not move. The patient can breathe, and she was totally conscious, but she could not move, could not pull herself along the floor, could not pull from the sofa, could not move her knee, and could not move her body. So, the patient thought maybe she should report this. On an unspecified date, the patient had significant weight loss. The patient was eating but she was rapidly losing. The patient didn't have COVID-19; she had been tested negative, so she didn't have COVID-19. The patient was tested 4 times for her to be around her grandchildren and make sure everything is okay. The patient had been tested against COVID-19 because of her grandchildren. The patient tried to take them, and she just now received the paper it was negative. So, it was her third one to try to watch her grandchildren because they were infant, and all test results were negative. It was also reported that the patient had no other problem, just the pain clarified as chronic back pain since an unspecified date. The patient checked this as persistent for chronic back pain; it is positive, definitely it's totally osteolysis on an unspecified date. Treatment was received for all events (unspecified medications). The patient went to her primary healthcare doctor as a result of the events and he said it was no big deal and she told him that she disagrees with that. Trazodone was added to zolpidem tartrate to help w with the sleep because she had terrible pain in the back (right here) and her extremities after this incident (unspecified date). It was her first dose and she was afraid to get the second one now. The patient was supposed to get her second one last week and she didn't. So, they told her to come back in 3 weeks or 4 weeks. The patient underwent laboratory test back in December (unspecified year). The patient recovered from "Paralyzed from her neck down to her arm, legs, and everything; weakness in extremities; could not move" on 09Mar2021. The patient had not recovered from "Chronic back pain; terrible pain in the back". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: A contributory role of BNT162B2 to event paralyzed from her neck down to her arm, legs, and everything cannot be excluded based on close 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.