Age: 61.0
Sex: F
Vaccine: PNC
Symptoms: Functional gastrointestinal disorder, Hypoaesthesia, Nausea, Neurological symptom, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer, based on information received by Pfizer from agency (manufacturer control number: US-AMGEN-USASP2018022929), license party for etanercept (ENBREL). Initial Receipt Date = 16/FEB/2018. This serious spontaneous report (USASP2018022929) was reported to agency on 16/FEB/2018 by a consumer and involves a 61 years old female patient whose Enbrel greatly intensified her lupus, diarrhea, felt badly, neurological symptoms including numbness and tingling felt extremely weak, and had nausea  while receiving Enbrel. Off label use was reported. No historical medical condition was reported. The patient's current medical condition included mixed connected tissue disease. No concomitant medications were provided. The patient's co-suspect medication included PREVNAR 13. The patient began Enbrel on 05/JUN/2017. The patient took Enbrel for mixed connected tissue disease which was reported as an off label use. On the same day, after the first dose the patient felt badly and as per her Enbrel greatly intensified her lupus due to which she discontinued the therapy with Enbrel. The patient was received PREVNAR 13 during the same time. On an unknown date in JUN/2017, two weeks after the injection the patient had delayed reaction which included neurological symptoms included numbness and tingling, nausea, bowel disruption and diarrhea. Also she felt extremely weak. As per the patient's physician both medications caused a synergistic effect on the lupus. No treatment information was received. The outcome of the events systemic lupus erythematosus, diarrhoea, feeling abnormal, hypoaesthesia, asthenia, nausea and paraesthesia was reported as recovered/resolved. The event feeling abnormal was resolved on 05/JUN/2017. The events systemic lupus erythematosus, diarrhoea, hypoaesthesia, asthenia, nausea, and paraesthesia were resolved on an unknown date in JUL/2017. Action taken with Enbrel was temporarily withheld on 05/JUN/2017 for the events feeling abnormal and systemic lupus erythematosus. The consumer reported that the event systemic lupus erythematosus was possibly related to Enbrel. The causal relationship between the events diarrhoea, feeling abnormal, hypoaesthesia, paraesthesia, asthenia, nausea and Enbrel was not provided by the consumer. The reporter declined consent for follow up. Agency 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 case report does not change the safety profile of the product. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: There is no plausible mechanism to implicate PREVENAR 13 to the occurrence of the serious event "intensified lupus " due to the information currently available. More information such as medical history and concomitant medications are needed for fully medical assessment. 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.