Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sleep, very tired; Vivid dreams; Extremely weak; Soreness on arm; Sweat beads developed; Sensation on both of her hands; chills; Pins and needles; pain, right hip pain, feet pain, joint pain; joint pain; feet pain; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 12Feb2021 at 12:00 (at the age of 68-years-old) as 1ST DOSE, single dose for covid-19 immunisation. Medical history included neck surgery from 2015 on an unknown date She had degeneration. Had to have C3 4 5 6 all replaced, ongoing osteopenia Diagnosed with bone scan, Heredity Glaucoma and hormone level abnormal from an unknown date and unknown if ongoing. Concomitant medication included latanoprost taken for Heredity Glaucoma from an unspecified start date and ongoing at 1 drop, once a day [one drop in right each night 0.005% othamlamogic solution], estradiol taken for Low hormones and prevent UTIs via virginal route at 0.5 mL, twice a week from an unspecified start date and ongoing. Patient previously took flu shot and experienced tiredness, sore arm and She got sleepy. On an unknown date in Feb2021 the patient experienced pain, right hip pain, feet pain, joint pain, pins and needles, chills and on 12Feb2021 patient experienced Soreness on arm, Sweat beads developed, Sensation on both of her hands. On 17Feb2021 patient experienced Sleep/ very tired, Vivid dreams and Extremely weak. Caller stated on day 12 the symptoms resolved except for chills from the pelvis down. Caller wanted to know if the second dose could cause the same symptoms to be exacerbated. Mentioned she had surgery on left eye it was so bad with glaucoma so no eye drops needed in left. She had minor symptoms initially. She had soreness in her arm where got injection for 2-3 days. This was like she would have if had the Flu Shot. It was very easy. The soreness started the night got the vaccine, but no redness. About 30 minutes after getting the shot she started to develop little sweat beads on the back of her neck, forehead, and inside of her arms. She also then felt a sensation on both of her hands. To her this was very minor. The sweat beads came and went within just a few seconds. It occurred on her way home from getting the vaccine. Initially confirmed the sweat beads only occurred the 12Feb2021, but later mentioned it may have occurred a day later a couple of times. She always took her temperature and she never had a temperature. It was always 97.4. It was reported that she thought it was all over at first. However, on Day fifth she was hanging pictures in her new home. She was just doing normal household things, nothing big, but she became unusually sleep and tired. She laid down on day 5 and thought she needed a nap. She closed her eyes and was out like a light. She never woke up. During this time she had very weird vivid dreams. She even remembers 2-3 of the dreams she had after she woke up. She was sleeping hard. She felt this was gone and had the best nap of her life. However, she had to wake up after 2 hours because her grandson was coming home whom she has adopted. She wanted to go to the store as well. So she got up and went to the store as well. However, after waking, during that time she felt extremely tired. She felt like she was not really fully awake, but then that feeling went away. When this occurred she was wondering why this was happening. It was day 5 from getting the vaccine and she thought the symptoms should have come and gone by then as most people say on the news, and from reading on smart phone it was just 2-3 days. Also, during this time on day 5, that Wednesday, something else was starting to develop that she had not fully connected yet. She mentioned this part was serious. She was starting to get extremely weak. She was weaker than she should be at her age. She was not weak in her arms at all or her upper body. However, she had a great deal of difficulty getting out of chairs and it got to the point it was very noticeable. However, she did not connect it. She did not know she was supposed to connect it. She was not sure exactly what day these following events started, but she knows she did not have it before in the beginning. Her feet were hurting so badly and she could not stand on them. Her right hip started to hurt like it was a knife going through the joint. The right side was her good leg. She already knows her left leg was weaker than her right leg. She knew her right side was the stronger side. However, this was nothing to keep her from walking 2 hours a day. However, her right hip should have been good, but after the vaccine it became very painful. She also had chills up and down her leg. She thought the chills were gone yesterday and had 100% recovered from it all on day 12, which was yesterday, but she realized while waiting on hold she had the chills again. While waiting on hold for the DSU agent she had chills occasionally, especially right leg and would get some in left leg. It was like legs have been inflamed or joints inflamed. She thought she would have to have hip surgery. She also had pain in pelvic area. The bones there had pins and needles at that time. She had the pelvic pain and would be driving in a car, a nice comfortable car. Her right leg had pins and needles for several days along with hip pain. She had foot pain in both feet. It hurt when she stood and walked, her feet hurt. Yesterday morning when she got up she thought a miracle had occurred. She was able to walk across the floor and did not realize she was even walking. It was like normal again. Everything had gone away like it never happened. She knows in her heart of hearts and after talking to her sister who was a retired pharmaceutical scientist these events are all related to the Pfizer COVID 19 Vaccine and she should report these to Pfizer. She was so happy when they went away yesterday. She was still active and likes to walk. She was able to walk for 2 hours and was not sore when she got home. She was fine. She was like she normally was. Today, she feels normal except the chills in her legs again that was a little bit. She has no pain whatsoever. Yesterday morning it was like the pain had disappeared, like she never had it. She confirmed the pain and pins and needles as recovered with lasting effects as she still has the chills. She hopes and prays the pain never comes back. She was willing to take normal aging arthritic pain if she get it because that was life. The flu shot maybe had tiredness and sore arm. Does not have a lot/exp/NDC to provide. The tiredness was 20-25 years ago. She got sleepy.  Outcome of the event chills was not recovered. Outcome of the event Vivid dreams was unknown. Outcome of the events Sensation on both of her hands was recovered on 12Feb2021. Outcome of the event pain, right hip pain, feet pain, joint pain and Pins and needles was Recovered/Resolved with Sequel on 24Feb2021. Outcome of the events was recovered on unspecified date in Feb2021.   Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events pain,Paraesthesia and pain in extremity cannot be totally 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.