Sex: F
Vaccine: COVID19, UNK
Symptoms: Knee arthroplasty, Pain, Swelling
Clinical narrative: Knee replacement; Pain; Swelling; Reaction Information Country: USA Reaction Onset: 2021  DESCRIBE REACTION(S) (include relevant test/lab data):  Knee replacement (Knee arthroplasty Recovering/resolving Pain (Pain  - Unknown Swelling (Swelling - Unknown  Solicited report from the USA by a consumer of a 65 year old female with events of knee replacement and non-serious pain and swelling with Humira 40mg/0.4ml (Adalimumab). The patient had a relevant medical history of Non tobacco, Abstains from alcohol, no Illicit drug use and penicillin allergy manifested by hard to breath, rash and swelling.   In 2021, the patient experienced pain  and swelling. On 18Oct2021, the patient experienced Knee replacement. pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect.   On 18Oct2021, patient had knee replacement. Patient kept Humira off Suspect Drug(S) Information .It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Unknown Date, patient received 1st dose .COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number Unknown, expiration date Unknown.  Causality for HUMIRA 40MG/0.4ML(Adalimumab) The reporter's causality for the event(s) of knee replacement, pain and swelling was not provided. (name withheld) opinion is that there is no reasonable possibility that the events of knee replacement, pain and swelling are related to humira 40mg/0.4ml(adalimumab).  Change History On 22Dec2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "pain" and "swelling" were added  check all appropriate to adverse reaction: other medically important  condition  Suspect Drug(S) (include generic name) Treatment Un-blinded Humira 40MG/0.4ML(40 Milligram, solution for injection in pre-filled pen) (adalimumab) unknown Daily dose: citrate free Route of administration: subcutaneous Indications for use:  moderate to severe rheumatoid arthritis. Therapy dates (from/to): 05mar2021 Therapy duration: 96 Days  Seq.No.: 1 Knee replacement (Knee arthroplasty) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  UNK Pain (Pain) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine):  No reasonable possibility Dechallenge: UNK Swelling (Swelling) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge :  UNK  Pfizer biotech covid-19 vaccine (tozinameran) (tozinameran) Seq.No. 2 Drug: Pfizer biotech covid-19 vaccine (tozinameran) (tozinameran) Route of Admin: Intra-muscular Therapy Dates/Duration:  Indications for use: COVID-19 Vaccination Therapy Dates (From/To):  Causality: Knee replacement (Knee arthroplasty) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Possible Dechallenge:  N/A Pain (Pain) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge :  N/A Swelling (Swelling) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge : N/A  concomitant drugs and dates of administration (Exclude those used to treat event:  Concomitant Drugs Not Reported  Did event abate after stopping drug? NA Other Relevant History:  Patient Medical History: non tobacco  abstains from alcohol no illicit drug use  penicillin allergy manifested by hard to breath, rash and swelling  Study no : facilitated collect Report source: study Report type: follow-up  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a causal association between the reported events knee arthroplasty, pain, swelling and the suspect BNT162b2 cannot be totally 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.