Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Back pain, Fatigue, Nausea, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Low back and abdominal pain.; Low back and abdominal pain; nausea; fatigue; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021068568), license party for etanercept (ENBREL).  This non-serious solicited report (USASL2021068568) was reported to Amgen on 03/MAY/2021 by a consumer from a commercial program (PSP00086) and involves a 57 year old female patient who had nausea [PT: nausea] and fatigue [PT: fatigue] while receiving Enbrel, Single Dose Prefilled Autoinjector, lot number 1125682, Expiration Date 30Sep2023. No historical medical condition was reported. The patient's current medical condition included psoriatic 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. On an unknown date in 2021, the patient received the first dose covid-19 vaccine. On an unknown date in 2021, the patient received the second dose covid-19 vaccine. On an unknown date in 2021, the patient had nausea and fatigue for several days after. On 29/APR/2021, the patient held Enbrel therapy. On 03/MAY/2021, the symptoms had resolved and resumed Enbrel. No treatment information was received. The outcome of the events nausea, fatigue was reported as recovered/resolved. The events nausea, fatigue were resolved on 03/MAY/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as temporarily withheld for the events nausea and fatigue. The causal relationship between the events nausea, fatigue and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number.  Causality Assessment: Nausea, Fatigue. Per Company (Amgen) was No.  The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up (14Jun2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021068568), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 14/JUN/2021: This case was upgraded to serious. This serious solicited report was reported by a consumer and involves a patient who experienced rectal bleeding [PT: rectal haemorrhage], low back and abdominal pain. [PT: back pain, PT: abdominal pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient stated that she was experiencing improvement in symptoms related to psoriatic arthritis since beginning Enbrel. On 13/JUN/2021, yesterday of this report, the patient began experiencing rectal bleeding, low back and abdominal pain. The patient would be contacting her primary care physician to discuss. The outcome of the events rectal haemorrhage, back pain, abdominal pain were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events rectal haemorrhage, back pain and abdominal pain.The causal relationship between the events rectal haemorrhage, back pain, abdominal pain and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has not been requested.  Amgen comment: This individual case report does not change the safety profile of the product.    The causality Assessment for the events Nausea, Fatigue, Rectal bleeding Per Company (Amgen) was unrelated. The causality Assessment for the events Low back pain, Abdominal pain Per Company (Amgen) was related.; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine, cannot be excluded for the reported events of rectal bleeding, abdominal pain, back pain, nausea and fatigue, based on temporal relationship and the known product safety profile. The events rectal bleeding, nausea and fatigue are related to etanercept. Abdominal pain and back pain are not related to etanercept. There is limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.  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.