Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Shoulder arthroplasty, Vaccination site pain
Clinical narrative: Pain at injection site after received two pfizer vaccinations and increased after second vaccination; Shoulder replacement; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer, (manufacturer control number: 21K-163-4170256-00).   A contactable 63-year-old female consumer (patient) reported for herself. This solicited report from the USA by a consumer of a 63-year-old female with events of shoulder replacement surgery and non-serious pain at injection site after received two Pfizer vaccinations and increased after second vaccination and all of the liquid came out of HUMIRA device when patient opened the box with HUMIRA (adalimumab). There was no reported medical history. On unknown dates, the patient experienced pain at injection site after received two Pfizer vaccinations and increased after second vaccination and all of the liquid came out of humira device when patient opened the box. In Aug2021, the patient experienced shoulder replacement surgery. In 2021, the shoulder replacement surgery resolved. On an unknown date, pain at injection site after received two Pfizer vaccinations and increased after second vaccination resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. In Aug2021, the patient had shoulder replacement surgery. She said when she received the two Pfizer vaccinations, had experienced pain at the injection site and pain was increased after second vaccination. She also reported that when she opened the HUMIRA box all of the liquid came out of her HUMIRA device. It was offered her to transfer to a product specialist and she declined to try to get it replaced. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st and 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.  Causality for HUMIRA (adalimumab): The reporter's causality for the event(s) of shoulder replacement surgery and pain at injection site after received two pfizer vaccinations and increased after second vaccination with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of all of the liquid came out of HUMIRA device when patient opened the box with HUMIRA (adalimumab) was a reasonable possibility.   Causality as per reporter (Drug/Vaccine) for Pfizer BioNTech Covid-19 Vaccine for events Shoulder replacement and Device issue was Not; for Vaccination site pain was Not related.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Shoulder arthroplasty and Vaccination site pain. 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.