Age: 33.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Atypical pneumonia, Body temperature, Hypersensitivity, Intentional product misuse, Pain
Clinical narrative: ATYPICAL PNEUMONIA; ALLERYGY SYMPTOMS WORSE; WHEN SHE FEEL LIKE SHE "STARTS HURTING; SHE DOES ENBREL INJECTION EVERY 7-10 DAYS; fever of 103; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021091359), license party for etanercept (ENBREL).     This serious solicited report (USASL2021091359) was reported to Amgen on 11/JUN/2021 by a consumer from a commercial program and involves a 33 year old, female patient who atypical pneumonia [PT: atypical pneumonia], allergy symptoms worse [PT: hypersensitivity], she does Enbrel injection every 7-10 days [PT: intentional product misuse], when she feel like she starts hurting [PT: pain], fever of 103 [PT: pyrexia], bad side effects [PT: adverse reaction] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included ibuprofen. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel on an unknown date in 2012. On an unknown date, the patient started using Reusable Autoinjector. The patient stated that she did her Enbrel injection every 7 to 10 days and that her HCP was aware, she takes it when she felt like she starts hurting. Additionally, the patient had atypical pneumonia. Subsequently, the patient had to stop Enbrel once before for about four to five weeks. On an unknown date, Enbrel therapy was resumed. The patient also stated that she felt like the injections made her allergy symptoms worse. On an unknown date in 2021, the patient stated that she skipped a week between each dose of covid-19 vaccine. On 02/MAY/2021, the patient just took second covid-19 vaccine. On an unknown date in 2021, the patient had really bad side effects after vaccine, she had a fever of 103 (unit was not provided) for about three days even after taking ibuprofen. No treatment information was received. The outcome of the events atypical pneumonia, hypersensitivity, intentional product misuse, pain, pyrexia, adverse reaction were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was temporarily withheld for the event atypical pneumonia. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events pain, hypersensitivity. The consumer reported that the event hypersensitivity was possibly related to Enbrel. The causal relationship between the events atypical pneumonia, intentional product misuse, pain, pyrexia, adverse reaction and Enbrel was not provided by the consumer. The causal relationship between the events atypical pneumonia, intentional product misuse, pain, hypersensitivity, pyrexia, adverse reaction and Reusable Autoinjector was not provided by the consumer. Follow up has been requested  Amgen comment:  This safety report does not necessarily reflect a conclusion by Amgen that etanercept caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual report does not change the safety profile of the product.  Amgen Causality Assessment: event Atypical pneumonia; Allergy aggravated was related to etanercept; events Fever; Adverse reaction; Intentional misuse in dosing frequency; Pain were unrelated to etanercept.  The reporter's assessment of the causal relationship of the events (except hypersensitivity) 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.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data and known drug safety profile, a causal relation between events hypersensitivity, pain, pyrexia and vaccination with BNT162B2 cannot be excluded. The event atypical pneumonia was most likely an intercurrent medical condition not related to BNT162B2 vaccine. Based on the available clinical data and pharmacological properties of etanercept, a contributory role of etanercept to events atypical pneumonia, hypersensitivity, pyrexia 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.