Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm was sore for days after the injection; This is a 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-USASL2021032735). This case was split from master case 2021233644 for an 52-year-old female patient taking COVID-19 (Coronavirus disease of 2019) vaccine and experienced arm sore for days after the injection. An 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 years as unknown, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (ongoing).Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her arm was sore for days after the injection".  Additional information: This non-serious solicited report (USASL2021032735) was reported to Amgen on 26/FEB/2021 by a consumer from a commercial program (PSP00086) and involves a 52 year old female patient who stated that the medication goes in that it hurts extremely bad [PT: injection site pain] 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 stated that all was going well with her injections expect for when the needle pierces her skin and the medication goes in that it hurts extremely bad. No treatment information was received. The outcome of the event injection site pain was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event injection site pain.The causal relationship between the event injection site pain and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer.The reporter declined to provide lot number. Follow-up has been requested with physician. The reporter's assessment of the causal relationship of the event 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. Company (Amgen) Assessment: There was no causality for event Pain during injection. ADDITIONAL INFORMATION RECEIVED ON 13/APR/2021: It was reported that the patient continues to have a large amount of pain during injection [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's concomitant medications included COVID-19 (Coronavirus disease of 2019) vaccine. On an unknown date, the patient stated that continues to have a large amount of pain during injection and it is not getting any better. The patient stated that she had her COVID-19 (Coronavirus disease of 2019) vaccine and her arm was sore for days after the injection. The patient stated that she had an injection site reaction that was just redness at site but did not go away for three weeks after the injection.No treatment information was received. The outcome of the event injection site pain was reported as not recovered/not resolved. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event injection site pain. The causal relationship between the event injection site pain and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number only. Causality assessment: For ENBREL and the events Pain during injection Per company (Amgen) was Yes.   No follow-up attempts possible. No further information expected.