Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging pelvic, Physical examination, Polymyalgia rheumatica, SARS-CoV-2 test
Clinical narrative: PMR; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 56 years for covid-19 immunisation; influenza vaccine (INFLUENZA), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Ulcerative colitis (full remission)" (unspecified if ongoing); "eosinophilic esophagitis (remission)" (unspecified if ongoing); "paroxysmal supra-ventricular tachycardia" (unspecified if ongoing). Patient had no covid prior vaccination. There were no concomitant medications. Past drug history included: Codeine, reaction: "Drug allergy: Codeine"; Oxycodone, reaction: "Drug allergy: oxycodone"; Hydrocodone, reaction: "Drug allergy: hydrocodone". Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FM9992), administration date: 27Apr2022, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FH8027), administration date: 16Nov2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3302), administration date: 13Jan2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL0140), administration date: 22Dec2020, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 01Oct2022, outcome "not recovered", described as "PMR". Approximately seven days following injection of 22Sep2022, she noted a pulling like sensation in her pelvis. Initially, this sensation was not painful, just very unusual. Over the next 10 weeks, symptoms persisted, yet evolved and became more painful. She was no longer able to bend over, or roll over in bed without significant tautness and pain. On 14Dec2022, she was seen by MD, for evaluation of worsening pelvic/bilateral leg pain. Physical examination of bilateral hips was found to be normal. Physician decided to move forward with pelvic magnetic resonance imaging (MRI) due to subjective complaints. Findings identified diffuse enlargement of tendons in pelvic bowl, and hamstrings. She was subsequently seen by rheumatologist, who had diagnosed her with polymyalgia rheumatica (PMR). She had been treated consistently with steroids since diagnosis and will likely require at least one year of steroid treatment. After diagnosis, she did research the diagnosis, and saw that there was a possible connection between Covid injection and PMR. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging abdominal: (unspecified date) diffuse enlargement of tendons in pelvic bowl, notes: and hamstrings; Physical examination of bilateral hips: (unspecified date) normal; SARS-CoV-2 test: (11Jan2023) Negative, notes: Nasal Swab; (08Mar2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of polymyalgia rheumatica and included treatment with longterm steroid treatment.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event polymyalgia rheumatica is related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available. 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.