Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Jaw disorder, Lymphadenopathy, Pain in extremity, Pain in jaw, Peripheral swelling
Clinical narrative: leg pain, left side of his body; swelling to his left arm; swollen lymph nodes, swollen neck lyphnodes to the left side of his neck; inabilitly to move his jaw accompanied by severe pain; inabilitly to move his jaw accompanied by severe pain; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from another company (manufacturer control number: US-AMGEN-USASL2021043173), license party for etanercept (ENBREL).  This non-serious solicited report (USASL2021043173) was reported to a company on 18/MAR/2021 by a consumer from a commercial program (PSP00086) and involves a 63 year old male patient who experienced leg pain, left side of his body [PT: pain in extremity], swelling to his left arm [PT: peripheral swelling], swollen lymph nodes, swollen neck lyphnodes to the left side of his neck [PT: lymphadenopathy], inabilitly to move his jaw accompanied by severe pain [PT: jaw disorder], inabilitly to move his jaw accompanied by severe pain [PT: pain in jaw] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Reusable Autoinjector on an unknown date. On 22/FEB/2021, the patient took his previous injection to recent last dose. At that point patient's Enbrel was put on hold for getting first Covid (coronavirus disease) vaccine. On 02/MAR/2021, the patient was administered first Covid (coronavirus disease) vaccine. On 12/MAR/2021, the patient restarted Enbrel. On 13/MAR/2021, the patient woke with swollen lymph nodes, leg pain which was right below the knee and had inability to move his jaw which was accompanied by severe pain. The patient reported all the pain was located on the left side of his body. The patient also had swelling to his left arm. The patient reported that he was seen and treated in the emergency room and all reported symptoms resolved post unspecified treatment. On 18/MAR/2021, the patient developed swollen on neck lymph nodes to the left side of his neck. The outcome of the event lymphadenopathy was reported as not recovered/not resolved. The outcome of the events pain in extremity, peripheral swelling, jaw disorder, pain in jaw were reported as recovered/resolved. The events pain in extremity, peripheral swelling, jaw disorder, pain in jaw were resolved on an unknown date in MAR/2021. Action taken with Enbrel was reported as unknown for the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder and pain in jaw. Action taken with Reusable Autoinjector was reported as unknown for the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder and pain in jaw. The causal relationship between the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder, pain in jaw and Enbrel was not provided by the consumer. The causal relationship between the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder, pain in jaw and Reusable Autoinjector was not provided by the consumer. Follow up has been requested.  The reporter's assessment of the causal relationship of the events with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  Company's Causality Assessment: The events Leg pain, Swelling arm, Lymph nodes enlarged, Jaw disorder, Pain in jaw were considered as non-serious and related to etanercept.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drugs to the reported events "leg pain, left side of his body", "swelling to his left arm", "swollen lymph nodes, swollen neck lyphnodes to the left side of his neck" and "inabilitly to move his jaw accompanied by severe pain" cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.