Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: autoimmune disorder; odd pain in her hips, lower back, lower abdomen, anterior groin; odd pain in her hips, lower back, lower abdomen, anterior groin; odd pain in her hips, lower back, lower abdomen, anterior groin; odd pain in her hips, lower back, lower abdomen, anterior groin; she had a significant reaction from the second shot, on her arm, she had a decent sized red indurated area; she had a significant reaction from the second shot, on her arm, she had a decent sized red indurated area; Chills/rigors; high fever; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231), dose 2 via an unspecified route of administration, administered in deltoid left on 05Jan2021 (at the age of 53-year-old) as single dose for COVID-19 immunisation. Th patient's medical history included basal cell skin cancer on her leg, diagnosed many year ago. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No family medical history. There were no concomitant medications. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730) in right deltoid on 17Dec2020 (at the age of 53-year-old) for COVID-19 immunisation. Patient received both, the first on 17Dec2020, and second 05Jan2021, and starting the beginning of Jun2021, she was having odd pain in her hips, lower back, lower abdomen, anterior groin, and she went to the doctor, this may be completely unrelated, but she was a nurse, and thought to see what if it's related, so thought to call. She did see her doctor, who ordered a ton of bloodwork, thinking this was an autoimmune disorder, so she was referred to rheumatologist, and she wanted to let Pfizer know, prior to Jun2021, she was 52, on no meds, was healthy, she had a basal cell skin cancer on her leg, but otherwise no medical issues, and this was probably unrelated, but what if it was. She didn't know a specific day when this pain started, she noticed it, at the beginning of Jun2021, she got up in the morning, and was achy, she thought it was odd, but as the day went on it improved, and then each day she started up in the morning achy, now it was to the point, she saw her doctor on 23Jun2021, and had started to become, this was interfering with her work, when she got up from seated, it was debilitating pain, almost like her legs couldn't hold her up, and she walked and it lessens, but it was horrible discomfort, she saw the doctor on 23Jun2021, who ordered autoimmune lab work, which she had done and they called her back, said it was suspicious of autoimmune disorder, some things were positive or high, and they want her to see a specialist, and she had an appointment on 27Aug2021. She didn't take meds, just with being a nurse, she worked through it, but it was to the point, she was a leukaemia nurse, inpatient, and did lifting and pulling, and when she first got up and people ask if she was ok, she was slow to walk, and she went from totally normal, had all the energy, was able to walk fast to debilitated, but it was probably a coincidence. Seriousness: She felt disabled when she first got up, it was worse, but she said to her husband, she felt disabled, but she did not think really, it was only when she was first up, then she started walking and it's better through the day, but if she sit or laid for a period of time, it was horrible; so she clarified seriousness as medically significant. Patient stated she had a significant reaction from the second shot, on her arm, she had a decent sized red indurated area, and for exactly 8 hours, had chills, rigors, high fever, which lasted 8 hours and that was it. First dose was nothing, no sore arm, no achy arm. Red indurated area happened on 07Jan2021 at 15:29PM and it went away, it was there for maybe a couple days and faded away. Stated she expected these reactions. Investigations: Stated she had to have the blood work repeated, the first time she went to the lab, they wanted her to go to a certain one, but she didn't and they didn't did run the tests properly. Labs were collected 23Jun2021, that same day, caller had labs after that, but they didn't send those, she had no additional copy. ANA titer: caller stated it said low antibody level but it's listed as high. The patient underwent lab tests and procedures which included Sjogren's Antibody: positive at 2.2, ANA screen: positive, ANA titer: critical high of 1;40 (h), SSA: negative at less than 1.0, SSB: positive at 2.2, all on 23Jun2021. The outcome of the events "odd pain in her hips, lower back, lower abdomen, anterior groin" and "autoimmune disorder" was not recovered, of the other events was recovered on an unspecified date.; Sender's Comments: Based on the available information in the case,a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events autoimmune disorder,arthralgia,backpain,groin pain and abdominal pain lower.  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