Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) received by Pfizer (manufacturer control number: RA-RASL2021034564). This case was split from master case #2021247454 to capture a 61-year-old female patient taking 2nd dose of COVID-19 vaccine and experienced headache..  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (First dose), administration date: 07Apr2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "fever". The following information was reported: HEADACHE (non-serious) with onset 29Apr2021, outcome "unknown", described as "Headache".  Additional information: This non-serious solicited report (RASL2021034564) was reported on 03/MAR/2021 by a consumer from a commercial program (PSP00086) and involves a 60 year old female patient who developed shortness of breath, weakness, and cough/diagnosed with pleural effusion [PT: pleural effusion] 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. Approximately two weeks ago, on an unknown date in FEB/2021, the patient developed shortness of breath, weakness, and cough. Then, she was seen by a physician and diagnosed with pleural effusion. The patient has been seen by a cardiologist and EKG (Electrocardiogram) was performed, which was normal. The patient was prescribed Lasix (furosemide sodium). The patient was instructed to withheld Enbrel until further evaluation. The patient currently has missed two Enbrel injections. Treatment for the event pleural effusion included Lasix (furosemide sodium). The outcome of the event pleural effusion was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was temporarily withheld for the event pleural effusion. The causal relationship between the event pleural effusion and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up not required. ADDITIONAL INFORMATION RECEIVED ON 29/APR/2021: In this follow up report patient experienced fever [PT: pyrexia], headache [PT: headache] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 Vaccine. On an unknown date in 2021, patient restarted on Enbrel. On 07/APR/2021, the patient received a COVID-19 vaccine developed a fever after receiving the vaccine. Subsequently, patient was instructed to withhold Enbrel until after receiving the second COVID-19 vaccine injection. The patient received second COVID-19 vaccine on 28/APR/2021 and have a headache today on 29/APR/2021. The patient has missed three doses of Enbrel during this time. The patient reports ongoing periods of shortness of breath with increased activity. The outcome of the events pyrexia and headache were reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was temporarily withheld for the events pyrexia and headache. The causal relationship between the events pyrexia, headache and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247454 same patient/vaccine, different dose/event