Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Swelling, X-ray
Clinical narrative: and really horrible radiating pain down both of her legs, front and back.; She also said there was numbness in her leg; swelling in her sacrum; headache; nausea; She said she had severe joint pain; severe muscle weakness, and pain; she did not have any appetite; and had troubles staying awake.; HCP said that she also had neurological problems; had a fever of 102 for 5 days; diarrhea; dizzy; severe muscle weakness, and pain/  weakness in legs; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; This is a spontaneous report from a contactable other HCP (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Borderline multiple myeloma (Borderline Multiple myeloma for 10-15 years), ongoing Monoclonal gammopathy, covid-19 from Mar2020, Severe allergies, ongoing having a lot of immunology problems going on/ immunocompromised, sarcoidosis from 1970, Russian flu, 5 episodes of anaphylaxis, had 9-10 episodes of total body hives, has been resuscitated twice, B cell blood malignancy, allergic to over 30 drugs and lingering COVID symptoms: dry cough, muscle and joint pain, headache, dizziness, and diarrhea. The patient's concomitant medications were not reported. Patient previous received hepatitis vaccines and TB for immunization and experienced did not respond/ nonresponsive, received Swine Flu for immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173, expiry: 31Aug2021), on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation and experienced high fever, joint pain, some weakness in her legs/severe muscle weakness, headache, nausea, she was very ill / She said she was pretty sick for 10 days, diarrhea and muscle pain. The patient experienced dizzy, and severe muscle weakness, and pain/ weakness in legs, both on 10Jun2021 with serious criteria of disability, diarrhea, and had a fever of 102 for 5 days on 10Jun2021. Her immunologist cleared her for the vaccine because she has an unsettling allergy history. He did an immunology review of her allergies and prior vaccination problems before determining if she could get the COVID vaccine. He wrote her a letter that said she had to get the vaccine in a room with an IV ready and the defibrillator ready as well. Her immunologist thought it was prudent she try the first dose. She did have COVID already in 2020. She ended up in the emergency room from the vaccine. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. The second dose reaction was different. The day she got the second dose 09Jul2021, she got home okay without problem and went to bed. When she got up in the morning she had trouble getting out of bed. She had difficulty walking. She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking (10Jun2021). She also said there was numbness in her leg, swelling in her "sacrum," and really horrible radiating pain down both of her legs, front and back. She was fine the day she received the shot, but had great difficulty getting out of bed the next day. She said she still could not drive because she was still dizzy and nauseated. She added that she had headache, nausea, and diarrhea. She said she had on and off diarrhea for 6 or 7 days, and couldn't keep anything down without having it. She said she had severe joint pain, severe muscle weakness, and pain, and had a fever of 102 for 5 days (from 10Jun2021 to 15Jun2021). On the 5th day of her having fever, she said she was struggling to put one foot in front of the other in terms of walking. She said she was also starting to feel as if she was paralyzed. She was having troubles trying to walk normally since there was weakness in her legs. She also said she did not have any appetite. She spent a lot of time in bed, sleeping, and had troubles staying awake. She said she had a bad headache. She said she called 911, and went to the hospital. She stayed there for 2 days. She said it was very unpleasant. She also had neurological problems as well such as extreme difficulty in walking, standing up, and profound leg weakness. However, she said that her neurologist assured her that it would go away within 4 to 5 weeks. She said it has already been 5 weeks since her 2nd dose, but she was still not feeling well. She was improving, but not well. She said she was physically not much better. She was having severe bilateral leg and sacral pain. Her sacrum was hot and swollen so she called the ambulance. She went to the ER because she had difficulty walking. She went to the ER. After five days of the second dose she still had a fever and trouble walking. The ER did multiple scans including a CAT scan of her abdomen and pelvis, an x-ray of her pelvis, and MRI of her upper and lower spine. She also had blood cultures and multiple lab work done. They were trying to rule out Guillain-Barre. She was in the ER for 2 days. She was very sick. The second day she was in the ER they told her she could go home. She thought it was because they were busy. No one explained to her the results of her tests or what was going on. Once her fever was done they didn't have to deal with her anymore. They sent her home when she was still sick with leg pain, trouble walking, and still had diarrhea. She was still nauseated, and was just eating jello. It is week 5 and she is really physically not much better. She can't drive because she was still dizzy and nauseated. She has leg pain, trouble sleeping, and muscle weakness in her legs. She is not recovered from the second dose. She thought she was going to die from it. It took a lot to call 911 especially as a nurse, but the numbness and pain in her legs was really severe. She had such weakness that she had trouble standing up and navigating through her apartment without falling down. She had made slight improvement. She mentioned that she had the flu back in 1988, so she felt very ill, and was in the hospital for 2 weeks. She was a long haul COVID patient who is enrolled in a long haul COVID program. She has been sick for a year and a half now since having COVID. She got COVID in Mar2020, and did not recover well. that is one of the reasons why they delayed her vaccination. She had to do prednisone during that time, and had to wait 6 weeks after completing the Prednisone to get the vaccine. Her baseline was a subnormal temperature of 96.1 because of her immunology issue. So 102 is really high for her. She had lingering COVID symptoms, and was a long haul patient. She had a cyclic problem with dry cough, muscle and joint pain, headache, dizziness, and diarrhea. She would have it bad for 7 days, and then recover a couple of days, and then it repeats itself. She couldn't drive because she was too dizzy and weak to drive. It was not safe to drive. She didn't have enough strength in legs to stop the car. She was seen by a neurologist several days after her emergency room visit. He examined her, and asked her reaction to the Pfizer vaccine. He said he had other patients with similar outcomes. She was immunocompromised . She has had borderline Multiple myeloma for 10-15 years. She has Monoclonal gammopathy, MGUS, she had it for a while. There are periods of time where her protein is elevated making her borderline for myeloma. She has had a couple rounds of prednisone to suppress the protein. She has a positive ANC. She has a multitude of issues. She was diagnosed with sarcoidosis in 1970 bust is in remission. She is tested regularly for sarcoidosis. She thinks she might be having a gallbladder attack now. In the past, she has been a non responder to vaccines. She got out of healthcare for that reason. She did not respond to hepatitis vaccines. She doesn't have NDC/lot/expiration for those vaccines. The infectious disease doctor at the time told her she shouldn't be a nurse for that reason because it put her at risk for hepatitis. She was also nonresponsive to TB. She doesn't have NDC/lot/expiration to any of the ones she has been non responsive to. Last time she was vaccinated she had Swine Flu. She was having a lot of immunology problems going on. The doctor recommended her not get a flu vaccine. It was later discovered that she was a non responder to hepatitis and TB. She has had no flu vaccine since swine flu in the 70s. In 1988 she had the flu, and was in hospital for two weeks and almost died from that. One of the doctors she worked with died from flu. He was a surgeon. He died so she thought she was going to. She barely squeezed by. She was allergic to over 30 drugs'. No information on those drugs provided. She has had 5 episodes of anaphylaxis. She had been resuscitated twice. She has had 9-10 episodes of total body hives. The COVID vaccine knocked her down to 0. She has had to cancel her last 5 weeks of life. She was homebound. She couldn't get out of bed and get dressed. When she had COVID in Mar2020, she had an antibody tested 3 months later and 6 months later that both showed no antibodies. She has a B cell blood malignancy, and the b cells pump up the immune system. So she wasn't surprised she didn't have antibodies. Events caused emergency room visit and physician office visit. The outcomes of events dizzy, severe muscle weakness, and pain/ weakness in legs, She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking, nausea, diarrhea, had a fever of 102 for 5 days were recovering while other events were unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "dizziness and muscular pain" and suspect drug BNT162B2 cannot be 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.