Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue, Joint swelling, Pneumothorax, Vaccination site reaction
Clinical narrative: swelling, tiredness; Vaccination site reaction; Collapse of lung; The patient experienced left wrist swelling; The patient experienced left wrist swelling and left wrist pain; This is a solicited report based on the information by Pfizer from Manufacturer control number: 21K-131-4120055-00. A contactable 74-year-old female consumer (patient) reported that:  Solicited report from State by a consumer of a 74 year old female with events of Right lung collapsed and non-serious Left wrist swelling, tiredness, reaction to Covid-19 vaccine and left wrist pain with Humira 40mg/0.4ml (Adalimumab) and Humira 40mg/0.8ml (Adalimumab). The patient had a relevant medical history of Rheumatoid arthritis. In 2021, the patient experienced Left wrist swelling and Left wrist pain. In May2021, the patient experienced Right lung collapsed. In Oct2021, the patient experienced Reaction to covid-19 vaccine. On 12Oct2021, the patient experienced Tiredness. BNT162B2 (TOZINAMERAN) was also considered suspect. The alternative etiology for the event of tiredness was reported as the third dose of covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 16Feb2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On 09Mar2021, she received second dose COVID-19 Vaccine manufactured by Pfizer. On 12Oct2021, she received third dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the packaging was discarded. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of Right lung collapsed, left wrist swelling, tiredness and left wrist pain with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of reaction to covid-19 vaccine was not provided. AbbVie's opinion is that the event of Right lung collapsed is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of Left wrist swelling, tiredness, reaction to covid-19 vaccine and left wrist pain are related to Humira 40mg/0.4ml(adalimumab).  causality for Humira 40mg/0.8ml(adalimumab): The reporter's causality for the event(s) of Right lung collapsed, left wrist swelling, tiredness and left wrist pain with Humira 40mg/0.8ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of reaction to covid-19 vaccine was not provided. AbbVie's opinion is that the event of right lung collapsed is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of left wrist swelling, tiredness, reaction to covid-19 vaccine and left wrist pain are related to Humira 40mg/0.8ml(adalimumab). Causality as per reporter between bnt162b2 (TOZINAMERAN) with event Tiredness was possible, with event vaccination site reaction was possible, with other events was not reported.  The reporter's assessment of the causal relationship of the events with the suspect product 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 needed. information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Right lung collapsed ,Left wrist swelling, tiredness, reaction to Covid-19 vaccine and left wrist pain cannot be 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