Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Neck pain; arm was sore with covid vaccine; Arthritis; Arthralgia; Back pain; Stiffness; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (Mfr. Control no #: 21K-163-3861485-00).  Solicited report  by a consumer of a 60-year-old adult male patient with events of neck sore (other medically important condition) and non-serious arm was sore with covid vaccine, stiffness associated with arthritis, arthritis pain and back got sore if bent a certain way or worked in the garden with humira (adalimumab). The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported) intramuscularly, first dose on an unspecified date, then second dose on an unspecified date, at single dose for COVID-19 vaccination; adalimumab (HUMIRA) subcutaneously from an unspecified date at unknown dose for Ankylosing spondylitis. There was no reported medical history. Concomitant drugs not reported. On unknown dates, the patient experienced neck sore, arm was sore with covid vaccine, stiffness associated with arthritis, arthritis pain and back got sore if bent a certain way or worked in the garden. On unknown dates, neck sore and arm was sore with covid vaccine resolved. Covid-19 vaccine was also considered suspect. The patient stated if he was bending a certain way or working in the garden his back was getting sore, but just normal soreness. He was using topicals. His neck got sore. He had spinal fusion. His arthritis was not bad as of 14Apr2021. He had some pain and stiffness but humira helped tremendously. it was unknown if patient was enrolled in a covid-19 vaccine trial. The patient received 1st dose covid-19 vaccine manufactured by Pfizer. The patient also received 2nd dose covid-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of the events Neck pain and Vaccination site pain was recovered on unspecified dates; outcome of events Arthritis and Arthritic pains was recovering; outcome of event Sore back was not recovered; outcome of the other event was unknown.  Causality for HUMIRA (ADALIMUMAB): the reporter's causality for the events of neck sore, arm was sore with covid vaccine and back got sore if bent a certain way or worked in the garden with humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of stiffness associated with arthritis and arthritis pain with humira (adalimumab) was a reasonable possibility. Causality for Covid-19 vaccine: the reporter's causality for the event of Vaccination site pain was probable. The reporter's causality for the other events was not reported.  The reporter's assessment of the causal relationship of the other events (except event Vaccination site pain) with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a compatible temporal association and known product safety profile there was a reasonable possibility that events vaccination site pain and arthralgia were related to BNT162B2 Pfizer vaccine. The other reported events are attributed to intercurrent medical conditions and assessed unrelated to BNT162B2 vaccine. 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  Committees and Investigators, as appropriate.