Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeding disorder, Injection site discolouration, Injection site pain, Insomnia
Clinical narrative: This is a solicited report from a non-Pfizer sponsored program from a contactable consumer, based on information received by Pfizer from (manufacturer control number: PR-AMGEN-PRISL2021131589), license party for etanercept (ENBREL). This non-serious solicited report (PRISL2021131589) was reported to Health Authority on 23/AUG/2021 by a consumer from a commercial program (PSP00086) and involves a 37 year old female patient who experienced black and blue, at the injection site [PT: injection site discolouration] and while she got the injection it burned a little [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector.No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported.The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On Saturday, 21/AUG/2021, the patient injected the injection and stated while she got the injection it burned a little. On an unknown date in AUG/2021, the patient developed black and blue, at the injection site.No treatment information was received. The outcome of the events injection site discolouration and injection site pain was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site discolouration and injection site pain.The causal relationship between the events injection site discolouration, injection site pain and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer.The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. The reporter's assessment of the causal relationship of the events Injection site discoloration and Injection site burning with the suspect product, Enbrel, 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. Health Authority's Causality Assessment: The events Injection site discoloration and Injection site burning were assessed as non-serious and related to etanercept (ENBREL). Follow-up (25Aug2021): 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 Health Authority (manufacturer control number: PR-AMGEN-PRISL2021131589), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 25/AUG/2021 AND 30/AUG/2021: In this follow up, the patient reported she got itching all over her body with some rash on her body [PT: rash pruritic], unable to sleep/insomnia [PT: insomnia], was nauseous/not able to eat [PT: nausea], and experienced anxiety/felt uneasy [PT: anxiety], while receiving Enbrel with Single Dose Prefilled Autoinjector. on an unknown date in AUG/2021, the patient experienced itching all over her body with some rash on her body. She also reported anxiety and insomnia. The patient felt uneasy, was unable to sleep, nauseous, and not able to eat. The patient did not inject Enbrel on Saturday 28/AUG/2021, due to these side effects she experienced after her previous dose. The outcome of the event rash pruritic, insomnia, nausea, and anxiety was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as temporarily withheld for the events rash pruritic, insomnia, nausea and anxiety. The causal relationship between the events rash pruritic, insomnia, nausea, anxiety and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. No further information is expected. No follow up required. Case PRISL2021132676 was identified as duplicate of PRISL2021131589. Source document from PRISL2021132676 has been copied over to case PRISL2021131589 which will be the case of record. PRISL2021132676 will be deleted. The reporter's assessment of the causal relationship of the events Injection site discoloration, Injection site burning, Itchy rash, Insomnia, Nausea, and Anxiety with the suspect product, Enbrel, 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. Health Authority's Causality Assessment: The events Injection site discoloration and Injection site burning were assessed as non-serious and related to etanercept (ENBREL). The events Itchy rash, Insomnia, Nausea, and Anxiety were assessed as non-serious and unrelated to etanercept (ENBREL). Follow-up (25Aug2021): 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 Health Authority (manufacturer control number: PR-AMGEN-PRISL2021132676), license party for etanercept (ENBREL). This non-serious solicited report (PRISL2021132676) was reported to Health Authority on 25/AUG/2021 by a consumer from a commercial program (PSP00086) and involves a 37 year old, female patient who got itching all over her body with some rash on her body [PT: rash pruritic], unable to sleep/insomnia [PT: insomnia], nausea/not able to eat [PT: nausea], anxiety/feels uneasy [PT: anxiety] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient experienced itching all over her body with some rash on her body. She also reported anxiety and insomnia. The patient felt uneasy, unable to sleep, nausea, and not able to eat. No treatment information was received. The outcome of the events rash pruritic, anxiety, insomnia and nausea was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events rash pruritic, anxiety, insomnia and nausea. The causal relationship between the events rash pruritic, anxiety, insomnia, nausea and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  The reporter's assessment of the causal relationship of the events Itchy rash, Anxiety, Insomnia, and Nausea with the suspect product, Enbrel, 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.  Amgen's Causality Assessment: The events Itchy rash, Anxiety, Insomnia, and Nausea were assessed as non-serious and related to etanercept (ENBREL). Follow-up (25Aug2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available), based on information received by Pfizer from Health Authority (Manufacturer control number PR-AMGEN-PRISL2021132676), license party for etanercept (ENBREL). CORRECTION DATED 25/AUG/2021: Case PRISL2021132676 was identified as duplicate of PRISL2021131589. Source document from PRISL2021132676 has been copied over to case PRISL2021131589 which will be the case of record. PRISL2021132676 will be deleted after one last submission. The reporter's assessment of the causal relationship of the events Anxiety, Insomnia, Nausea, and Itchy rash with the suspect product, Enbrel, 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. Health Authority's Causality Assessment: The events Anxiety, Insomnia, Nausea, and Itchy rash were assessed as non-serious and related to etanercept (ENBREL). Follow-up (10Sep2021): New information received from Health Authority in response to query mail sent regarding clarification with action taken of unknown in XML and temporarily withheld in narrative for both drug and device of the retained case PRISL2021131589, while in duplicate case PRISL2021132676, action taken was provided as unknown in both XML and narrative includes: It was noted that action taken has been explained in the narrative for drug and device - "Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as temporarily withheld for the events rash pruritic, insomnia, nausea and anxiety." Follow-up (02Sep2021): 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 Health Authority (manufacturer control number: PR-AMGEN-PRISL2021131589), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 02/SEP/2021: This case was upgraded to serious case. In this follow up, the patient had Steven johnson syndrome [PT: stevens-johnson syndrome] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient's co-suspect medication included Covid-19 Vaccine. On an unknown date, the patient went to her rheumatologist and was taken off Enbrel. The patient had developed Steven Johnson syndrome, rheumatologist believed it was from COVID vaccine, but since she had one dose of Enbrel as well, he decided to take her off Enbrel as well. The patient would start Orencia (abatacept). The outcome of the event stevens-johnson syndrome was reported as unknown. Action taken of Enbrel with Single Dose Prefilled Autoinjector was withdrawn for the event stevens-johnson syndrome. The causal relationship between the event Stevens-Johnson syndrome and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested. Health Authority Comment: This individual case report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events Injection site discoloration, Injection site burning, Itchy rash, Insomnia, Nausea, Anxiety, and Stevens Johnson syndrome with the suspect products, Enbrel and COVID vaccine, 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. Health Authority's Causality Assessment: The event Stevens Johnson syndrome was assessed as serious and unrelated to etanercept (ENBREL). The events Injection site discoloration and Injection site burning were assessed as non-serious and related to etanercept (ENBREL). The events Itchy rash, Insomnia, Nausea, and Anxiety were assessed as non-serious and unrelated to etanercept (ENBREL). Sender's Comments: Based on the limited information currently available, the event Stevens Johnson syndrome is assessed as unrelated to Covid-19 Vaccine and etanercept (ENBREL). The events Injection site discoloration and Injection site burning are assessed as related to etanercept and unrelated to Covid-19 Vaccine. The events Itchy rash, Insomnia, Nausea, and Anxiety are assessed as unrelated to COVID-19 Vaccine and etanercept. This case will be reassessed when additional information becomes available.