Sex: F
Vaccine: COVID19
Symptoms: Sensitivity to weather change, Sinusitis
Clinical narrative: Flare up throughout the body due to covid vaccination; Flare up throughout the body due to winter; Allergic to Enbrel; Asthma flare-up; Sinus infection; Bronchitis; Covid 19 vaccine route of administration: Endocervical; This is a spontaneous report from a contactable healthcare professional, based on the information received by Pfizer from agency (manufacturer control number: US-AMGEN-USASP2020193179), license party for etanercept (ENBREL).  This spontaneous report (USASP2020193179) was reported to agency on 25/NOV/2020 by an other health professional and involves a 41-year-old female patient who was allergic to Enbrel [PT: drug hypersensitivity], asthma flare-up [PT: asthma], sinus infection [PT: sinusitis], and bronchitis [PT: bronchitis] while receiving Otezla and Enbrel. No historical medical condition was reported. The patient's current medical condition included psoriatic arthropathy, cough, disease of upper respiratory tract, herpesviral (herpes simplex), irritable bowel syndrome, lupus erythematosus, infection of the skin, migraine, oligomenorrhea, personal history of other diseases of psoriasis, unspecified skin changes and asthma. The patient had allergic to Arava (Leflunomide), cimzia prefl kit (certolizumab pegol), Depo-Medrol (Methylprednisolone Acetate), Humira (Adalimumab), lidocaine, methotrexate, stelara (Ustekinumab), tetracycline, and allergic to Latex gloves and secure glove. The patient's concomitant medications included albuterol [salbutamol], benzonatate, Cymbalta (duloxetine hydrochloride), fexofenadine, multivitamin [vitamins nos], thyroid, and prednisone, Wal Zyr (cetirizine hydrochloride) and amoxicillin and potassium clavulanate. No co-suspect medications were reported. The patient began Otezla on 15/JUN/2016 and Enbrel on an unknown date. On an unknown date, the patient had bronchitis and asthma flare-up that later resulted in a sinus infection. The patient confirmed that she was established on Otezla therapy. On an unknown date, the patient had been allergic to Enbrel. No treatment information was received. The outcome of the events sinusitis, bronchitis, asthma were reported as not recovered. The outcome of the event drug hypersensitivity was reported as unknown. Action taken with Otezla was continued for the events sinusitis, bronchitis and asthma. Action taken with Enbrel was reported as unknown for the event drug hypersensitivity. The other health professional reported that the event drug hypersensitivity was possibly related to Enbrel. The causal relationship between the events sinusitis, bronchitis, asthma, drug hypersensitivity and Otezla was not provided by the other health professional. The causal relationship between the events sinusitis, bronchitis, asthma and Enbrel was not provided by the other health professional. Follow-up has been requested for lot number only.  Agency's assessment: the events Drug allergy, Sinus infection, Bronchitis, and Asthma aggravated were assessed as non-serious.  Follow-up (22Feb2021):This is a follow up spontaneous report from a contactable consumer, based on information received by Pfizer from agency (manufacturer control number: US-AMGEN-USASP2020193179), license party for etanercept (ENBREL).   ADDITIONAL INFORMATION RECEIVED ON 22/FEB/2021: In this follow-up information, This serious spontaneous report involves an adult female patient who had flare up throughout the body due to covid vaccination [PT: psoriatic arthropathy], due to winter [PT: sensitivity to weather change] while receiving Otezla, Enbrel. The patient's concomitant medications included azelastine, famotidine, ferrous gluceptate, folic acid, montelukast, and progesterone. The patient's co-suspect medications included Covid 19 vaccine. The patient began Otezla on 15/JUN/2016 and Enbrel on an unknown date. On an unknown date, the patient had flare up throughout the body due to covid vaccination (two round) and also due to winter. The outcome of the events psoriatic arthropathy, sensitivity to weather change was reported as not recovered/not resolved. Action taken with Otezla was continued for the events sensitivity to weather change and psoriatic arthropathy. Action taken with Enbrel was reported as unknown for the events sensitivity to weather change and psoriatic arthropathy. The causal relationship between the events sensitivity to weather change, psoriatic arthropathy and Otezla was not provided by the other health professional. The causal relationship between the events sensitivity to weather change, psoriatic arthropathy and Enbrel was not provided by the other health professional.  Agency Comment: This safety report does not necessarily reflect a conclusion by agency that apremilast, 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