Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dysphagia, Dyspnoea, Headache, Nausea, Swollen tongue
Clinical narrative: Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; 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(manufacturer control number: US-AMGEN-USASL2021053617), license party for etanercept (ENBREL).  This non-serious solicited report (USASL2021053617) was reported on 07/APR/2021 by a consumer from a commercial program (PSP00046b) and involves a 61 year old male patient who had headache [PT: headache], nausea [PT: nausea], tongue swelling [PT: swollen tongue], could not process his breath [PT: dyspnoea] and could not swallow his saliva [PT: dysphagia] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included methotrexate. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. It was reported that the patient was using Enbrel for about five to six years. On an unknown date in MAR/2021, the patient received a recent injection of Enbrel. On 27/MAR/2021 at 10:00 AM, the patient received covid-19 vaccine. On the same day, the patient had nausea and headache but then it went away. On the same day at 05:30 PM, the patient had tongue swelling. The patient could not swallow his saliva and could not process his breath. Subsequently, the patient went to ER (Emergency room) and was started on Benadryl (diphenhydramine hydrochloride), prednisone and ranitidine. The patient was instructed by the physician not to receive a second dose of covid vaccine. The outcome of the events headache and nausea was reported as recovered/resolved. The outcome of the events swollen tongue, dyspnoea and dysphagia was reported as unknown. The events headache, nausea were resolved on 27/MAR/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events headache, nausea, swollen tongue, dyspnoea and dysphagia. The causal relationship between the events headache, nausea, swollen tongue, dyspnoea, dysphagia and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number.  Causality Assessment: Events Swallowing difficult, Breathing difficult, Swelling of tongue and Nausea were assessed to be not related to etanercept.; Sender's Comments: Based on a temporal association and the known safety profile, the reported events are considered possibly related to BNT162B2. The events were unrelated to etanercept.  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.