Sex: F
Vaccine: COVID19
Symptoms: Blister, COVID-19, Drug ineffective, Headache, Nasopharyngitis
Clinical narrative: had two doses of the COVID-19 vaccine, completed them in APR/2021; States it is covered with single blisters; developed a new rash over her entire anterior trunk./ viral rash; have symptoms of a severe cold/congested nose, severe headache, extreme muscle/body aching; she began to have symptoms of a severe cold on 8/26/2021 and progressively got worse over the next fewdays/ last week that she had gotten sick and tested positive for COVID; bad headache; Pt states that on day 4 after this injection, her "usual pain came back; usual pain came back/still "hurting"; respiratory distress; 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-USASL2021126859), license party for etanercept (ENBREL).  This solicited report (USASL2021126859) was reported to Amgen on 16/AUG/2021 by a consumer from a commercial program and involves a 59 year old female patient who experienced bad headache [PT: headache] 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 11/AUG/2021. Approximately 1 days later, on 12/AUG/2021, the patient had a bad headache. Therefore, the patient took Tylenol (paracetamol) to attempt to relieve. The headache lasted for two days. Treatment for the event included Tylenol (paracetamol). The outcome of the event headache was reported as recovered/resolved. The event headache was resolved on 14/AUG/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event headache. The causal relationship between the event headache and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected.  The reporter's assessment of the causal relationship of the events with the suspect product 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 Assessment:  The event headache was assessed as related to etanercept by Amgen.  The reporter's assessment of headache with the suspect product 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 (23Aug2021): This is a follow-up solicited report form 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-USASL2021126859), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 23/AUG/2021: In this follow up report, the patient's usual pain came back/still hurting [PT: pain], the patient stated that on day four after this injection, her usual pain came back [PT: therapeutic product effect incomplete] while receiving Enbrel with Single Dose Prefilled Autoinjector. On an unknown date in AUG/2021, on day four after this injection, the patient's usual pain came back that she still hurting. Enbrel injection would due in two days. The outcome of the event pain was reported as not recovered/not resolved. The outcome of the event therapeutic product effect incomplete was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the events pain and therapeutic product effect incomplete. The consumer reported that the event therapeutic product effect incomplete was possibly related to Enbrel. The causal relationship between the event pain and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The causal relationship between the event therapeutic product effect incomplete and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected.  Amgen Causality Assessment: The events headache and drug effect incomplete was assessed as related to etanercept by Amgen. The event pain was assessed as unrelated to etanercept by Amgen.   The reporter's assessment of pain and headache with the suspect product 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 (01Sep2021): This is a follow-up solicited report form 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-USASL2021126859), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 01/SEP/2021 AND 08/SEP/2021: The case was upgraded to serious 01/SEP/2021. This serious solicited report was reported to Amgen by a consumer from a commercial program and involves a 59 year old female patient who had respiratory distress [PT: respiratory distress], states it is covered with single blisters [PT: blister], developed a new rash over her entire anterior trunk./ viral rash [PT: viral rash], she began to have symptoms of a severe cold on 8/26/2021 and progressively got worse over the next fewdays/ last week that she had gotten sick and tested positive for COVID [PT: sars-cov-2 test positive], have symptoms of a severe cold/congested nose, severe headache, extreme muscle/body aching [PT: nasopharyngitis] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient's historical vaccination included COVID-19 vaccine (in APR/2021). On 26/AUG/2021, the patient had gotten sick and was tested positive for COVID-19 on 30/AUG/2021. Patient began to have symptoms of a severe cold on 26/AUG/2021 and progressively got worse over the next few days. On an unknown date in 2021, she had a congested nose, severe headache, extreme muscle/body aching, and some respiratory distress. Patient mentioned she was still feels awful but, her breathing improved and the headache was nearly gone. She had two doses of the COVID-19 vaccine, completed them in APR/2021. Patient was exposed to COVID-19 at work. Patient also mentioned she missed Enbrel doses since 25/AUG/2021. On 05/SEP/2021 three days ago, she developed a new rash over her entire anterior trunk. Patient clarified it was covered with single blisters. She did see her physician and was told that it was not "Shingles", but some other viral rash and patient was given an antiviral to take. On 08/SEP/2021, she reported she was doing somewhat better. The outcome of the events respiratory distress, headache, sars-cov-2 test positive, nasopharyngitis were reported as recovering/resolving. The outcome of the events blister, viral rash was reported as unknown. Action taken with Enbrel was reported as unknown for the event headache. Action taken with Enbrel was temporarily withheld for the events sars-cov-2 test positive, nasopharyngitis and respiratory distress. Action taken with Enbrel was continued for the events pain and therapeutic product effect incomplete. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the event headache. Action taken with Single Dose Prefilled Autoinjector was continued for the events pain and therapeutic product effect incomplete. Action taken with Single Dose Prefilled Autoinjector was temporarily withheld for the events sars-cov-2 test positive, nasopharyngitis and respiratory distress. The consumer reported that the event therapeutic product effect incomplete was possibly related to Enbrel. The causal relationship between the events headache, pain, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress and Enbrel was not provided by the consumer. The causal relationship between the events headache, pain, therapeutic product effect incomplete, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress and 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.  Amgen comments: This individual case report does not change the safety profile of the product.    Amgen Causality Assessment  Respiratory distress is serious and unrelated to etanercept.  Blisters, viral rash, drug effect incomplete and headache are non-serious and related to etanercept.  Pain, sars-cov-2 test positive and cold symptoms are non-serious and unrelated to etanercept.   The reporter's assessment of the events headache, pain, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress with the suspect product 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.; Sender's Comments: Based on temporal association, a causal relationship between the events drug effect incomplete headache Blisters, viral rash,  and suspect drug cannot be excluded. Event pain Respiratory distress , and sars-cov-2 test positive and cold symptoms  is considered intercurrent medical condition and is not related to etanercept.The contributory role of the COVID-19 Vaccine to the events of sars-cov-2 test positive,Blisters, viral rash, drug effect incomplete , nasopharyngitis and headache is considered possible. Other events were more likely intercurrent conditions 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 RAs, Ethics Committees, and Investigators, as appropriate..