Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sensitivity to weather change, Vaccination site pain
Clinical narrative: Knee effusion/blood and fluid 200cc out of knee; Vaccination site pain; sore arm after second covid vaccination; Sore arm; Headache; Knee arthritis increased with weather change; Knee arthritis increased with weather change; Knee arthritis increased with weather change; This is a solicited report from the marketing program received by Pfizer from Abbvie (manufacturer control number: 21K-163-3920504-00). A non-contactable consumer (patient) reported that a 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH-COVID 19 VACCINE, Solution for injection) via intramuscular on May2021 (at the age of 69-year-old) as dose 1, single, also received bnt162b2 (PFIZER-BIONTECH-COVID 19 VACCINE, Solution for injection) via intramuscular on an unspecified date as dose 2, single for COVID-19 immunization and adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous on an unspecified date at unknown dose and frequency for moderate to severe chronic plaque psoriasis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date the patient experienced Knee effusion/blood and fluid 200cc out of knee (Medically significant)and on an unknown date in 2021 knee arthritis increased with weather change. The patient experienced sore arm and headache on an unknown date in May2021. The patient received treatment for the events. Upon Follow-up information it was reported that, an adult female with events on an unknown date blood and fluid 200cc out of knee and sore arm after second Covid vaccination with Humira. She received first and second dose covid-19 vaccine manufactured by Pfizer/Biontech. The outcome of the events was unknown and the other events outcome for Knee effusion/blood and fluid 200cc out of knee was recovering and for vaccination site pain was recovered. Sore arm after second Covid vaccination outcome was recovered.  Causality for adalimumab and bnt162b2: The reporter causality for the events knee arthritis increased with weather change, sore arm, headache and knee arthritis increased with weather change was not provided.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of knee arthritis increased with weather change onset in 2021, sore arm, headache and knee arthritis increased with weather change onset in 2021 was not provided. The reporter's causality for the event(s) of blood and fluid 200cc out of knee and sore arm after second Covid vaccination with Humira (adalimumab) was no reasonable possibility.  Causality for bnt162b2: The reporter causality for the event(s) Knee effusion (Joint effusion) and Vaccination site pain (Vaccination site pain) with bnt162b2 was possible.  Follow-up (19Jan2022): This is a solicited follow-up report based on the information received by Pfizer from AbbVie (Mfr Control No.: 21K-163- 4233786-00). A contactable consumer reported for herself included: Updated information: Reporter contact updated, New events added with outcome, Clinical information added.  Follow-up (19Jan2022): This Follow-up report contains no new safety information.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events of arthritis, condition aggravated, sensitivity to weather change, pain in extremity, headache and the suspect drug BNT162B2. Based on the follow up received the causal association between the events knee hemarthrosis and vaccination site pain cannot be excluded.