Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Condition aggravated, Polymyalgia rheumatica, Red blood cell sedimentation rate
Clinical narrative: Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber ad expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine. The patient previously took morphine, and had allergies; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization, and had polymyalgia rheumatica, RS3PE, elevated ESR and elevated CRP. On an unspecified date in 2021, after the second dose of vaccination, the patient's developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened. The reported events have resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized on an unspecified date in 2021 for two days due to the reported events. The patient had received methylprednisolone (MEDROL) and prednisone as treatment for the reported events. The outcome of the events, 'developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had a nasal swab test in Mar2021 that was negative post-vaccination.  Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible temporal association, a causal association between the reported 'polymyalgia rheumatica and RS3PE including elevated ESR and CRP ' (aggravated, already reported after the first dose of vaccine) and 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.