Sex: F
Vaccine: COVID19
Symptoms: Bronchoscopy, Computerised tomogram, Fatigue, Headache, Immune system disorder
Clinical narrative: Rheumatoid arthritis/Both jaws replaced due to RA; Blood pressure and oxygen levels kept dropping; Blood pressure and oxygen levels kept dropping; Sleep apnea; Low potassium; Immune disorder; Arm hurt; Very tired and fatigued; Headache; Sick with a bronchial issue; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASP2021058759), license party for etanercept (ENBREL).  This serious spontaneous report (USASP2021058759) was reported to the company on 15/APR/2021 by a consumer and involves a 48 years old female patient who experienced rheumatoid arthritis/both jaws replaced due to RA [PT: rheumatoid arthritis], blood pressure and oxygen levels kept dropping [PT: oxygen saturation decreased, PT: blood pressure decreased], sleep apnea [PT: sleep apnoea syndrome], low potassium [PT: blood potassium decreased], immune disorder [PT: immune system disorder], sick with a bronchial issue [PT: bronchial disorder], arm hurt [PT: pain in extremity], very tired and fatigued [PT: fatigue], felt a little achy [PT: pain], headache/ bad headache [PT: headache] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included ankylosing spondylitis and rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date (lot number: 1123166, expiration date: 31Aug2023). On an unknown date, the patient stated that she was disabled due to her rheumatoid arthritis (RA) and she had to have both jaws replaced due to rheumatoid arthritis (RA). The patient stated that her jaw was blocking her airway when she slept and she had sleep apnea. On an unknown date in MAY/2018, the patient had surgery which lasted for eight hours and 45 minutes. On an unknown date in early 2020, while she was recovering from the surgery, out of nowhere the patient got sick with a bronchial issue. The patient was placed on oxygen and had several pulmonary function tests and CT's done and during this timeframe she was taking Enbrel intermittently. The patient also mentioned that during this time, she was going for physical therapy but her blood pressure and oxygen levels kept dropping causing her to repeatedly have to go to the emergency room for treatment. On an unknown date, on one of her visits she had low potassium and had to have an infusion and her physical therapy was discontinued. The patient was never admitted as an inpatient. The patient also had a bronchoscopy during this timeframe. The patient had immune disorder. The patient stated that once she took her Enbrel for two months consistently and that was unbelievable the difference in how she feels stating, it works very well for her. The patient stated that she was instructed by one of her physician that she could get the COVID vaccine near the end of her Enbrel cycle. The patient stated that she delayed her first vaccine and fell behind on her Enbrel. On an unknown date, with the first COVID vaccine she stated she was very tired and fatigued, her arm hurt, and she had a headache. The patient stated the second day after the vaccine, she felt even worse. The patient Enbrel was due days ago. The patient was informed by one of her physicians that the COVID vaccine would not be as effective due to her immune disorder. The patient asked if there was any information pertaining to when she should take her next Enbrel dose following her vaccination. The outcome of the events rheumatoid arthritis, oxygen saturation decreased, blood pressure decreased, sleep apnoea syndrome, blood potassium decreased, immune system disorder, bronchial disorder, pain in extremity, fatigue, pain, headache were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events pain, sleep apnoea syndrome, blood potassium decreased, blood pressure decreased, bronchial disorder, oxygen saturation decreased, immune system disorder and rheumatoid arthritis. The causal relationship between the events fatigue, pain in extremity, pain, headache, sleep apnoea syndrome, blood potassium decreased, blood pressure decreased, bronchial disorder, oxygen saturation decreased, immune system disorder, rheumatoid arthritis and Enbrel, Single Dose Prefilled 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, 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.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect products to the reported events cannot be totally excluded. This case will be reassessed once additional information is available.  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.