Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Gait inability, Headache, Joint stiffness
Clinical narrative: suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional.  A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date.   Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship.  However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms.  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.