Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pruritus, Insomnia, Neuropathy peripheral
Clinical narrative: Neuropathy; Injection site itching; Trouble sleeping last night; felt fatigue and weak; felt fatigue and weak; unspecified rotator cuff tear or rupture of right shoulder,; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from the Regulatory Authority (manufacturer control number: US-AMGEN-USASP2020214057), license party for etanercept (ENBREL).  This serious spontaneous report (USASP2020214057) was reported to Regulatory Authority on 08/DEC/2020 by a consumer and involves a female patient who had a neuropathy [PT: neuropathy peripheral], injection site itching [PT: injection site pruritus], trouble sleeping last night [PT: insomnia] while receiving Enbrel, Reusable Autoinjector. Off label use was reported. No historical medical condition was reported. The patient's current medical condition included unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic, and rheumatoid arthritis. The patient's concomitant medications included Albuterol (salbutamol sulfate), Dicyclomine, diltiazem, Enulose (lactulose), Irbesartan HCT (hydrochlorothiazide, irbesartan), Janumet (metformin hydrochloride, sitagliptin phosphate monohydrate), leflunomide, montelukast, omeprazole, pentoxifylline, prednisone, sertraline HCL, simvastatin, Symbicort (budesonide, formoterol fumarate), Alendronate (alendronate sodium). No co-suspect medications were reported. The patient began Enbrel with Reusable Autoinjector on an unknown date. On an unknown date, the patient had itching at injection sites. Also, the patient had neuropathy and was having trouble sleeping on last night. The patient was taking Enbrel for the indication unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic which was an off label use. No treatment information was received. The outcome of the events neuropathy peripheral, injection site pruritus, and insomnia was reported as not recovered/not resolved. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events injection site pruritus, neuropathy peripheral and insomnia. The consumer reported that the events injection site pruritus, neuropathy peripheral and insomnia was possibly related to Enbrel. The causal relationship between the events injection site pruritus, neuropathy peripheral, insomnia and Reusable Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected.  RA comment: This safety report does not necessarily reflect a conclusion by RA that etanercept, device,caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  Follow-up (20Aug2021): This is a follow-up spontaneous report based on information received by Pfizer from Regulatory Authority (Manufacturer control number US-AMGEN-USASP2020214057) from a contactable consumer, license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 20/AUG/2021: In the additional information it was reported that the patient felt fatigue and weak [PT: fatigue and PT: asthenia] while receiving Enbrel with Reusable Autoinjector. The patient's co-suspect medication included COVID-19 Vaccine. On an unknown date, the patient felt fatigue and weak after first dose of COVID-19 vaccine. The outcome of the events fatigue and asthenia was reported as unknown. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events fatigue and asthenia. The causal relationship between the events fatigue, asthenia and Enbrel with Reusable Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected. Previous version dated 08/DEC/2020, Enbrel indication was incorrectly captured as "rheumatoid arthritis" instead of "unspecified rotator cuff tear or rupture of right shoulder". Enbrel indication has now been updated as unspecified rotator cuff tear or rupture of right shoulder'.  Additional comment: This safety report does not necessarily reflect a conclusion by RA that Denosumab and device, etanercept caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.