Sex: M
Vaccine: COVID19, UNK
Symptoms: Flatulence, Heart rate, Hyperhidrosis, Insomnia, Pain in extremity
Clinical narrative: Sore arm; up half the night/couldn't sleep; Diarrhea /his current symptoms include loose bowels; tired/feeling "real run down"; don't feel like eating," "gassy," feeling warm but afebrile; don't feel like eating," "gassy," feeling warm but afebrile; don't feel like eating," "gassy," feeling warm but afebrile; Sweating/diaphoretic; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number:US-AMGEN-USASP2021135667), license party for etanercept (ENBREL).   This non-serious spontaneous report (USASP2021135667) was reported to Amgen on 31Aug2021 by a consumer and involves a male patient who experienced sore arm [pain in extremity], was up half the night and couldn't sleep [insomnia], "gassy" [flatulence], felt warm but was afebrile [feeling hot], was sweating/diaphoretic [hyperhidrosis], had diarrhea/loose bowels [diarrhoea], was tired and feeling "real run down" [fatigue], and didn't feel like eating [decreased appetite] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 (corona virus disease 2019) Vaccine. The patient began Enbrel on an unknown date. The patient stated after his first two COVID-19 vaccinations, he did not experience any symptoms except for a sore arm. On 27Aug2021 Friday, the patient's blood pressure reading right before receiving the booster was 122/80 (unit not provided).The patient received a booster for the COVID-19 vaccine from his primary care provider (also Enbrel prescriber) and began to experience adverse effects. In the evening of 27Aug2021, the patient did not feel so bad and just tired. On 28Aug2021, Saturday, the patient experienced diarrhea and felt run down. The patient denied any vomiting and was up half the night on Saturday and Monday and could not sleep. On 29Aug2021, Sunday, the patient administered his dose of Enbrel and felt that his symptoms were progressively worsening and felt like he may have made an error by administering his Enbrel dose. On an unknown date in Aug2021, the patient's symptoms included loose bowels, did not feel like eating, gassy, felt warm but afebrile, sweating even with light activity. The patient mentioned that he just walked a short distance to put his clothes in the laundry and this normal activity caused him to become extremely diaphoretic. The patient's heart rate was normal and thought his blood pressure was normal. No treatment information was received. The outcome of the events pain in extremity, fatigue, diarrhoea, insomnia, flatulence, feeling hot, hyperhidrosis, decreased appetite was reported as unknown. Action taken with Enbrel was reported as unknown for the events pain in extremity, flatulence, feeling hot, hyperhidrosis and decreased appetite. Action taken with Enbrel was continued for the events fatigue, diarrhoea, and insomnia. The causal relationship between the events pain in extremity, fatigue, diarrhoea, insomnia, flatulence, feeling hot, hyperhidrosis, decreased appetite and Enbrel was not provided by the consumer. Follow up has been requested for the lot number only.   Follow-up (10Sep2021): This is a follow-up spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (Manufacturer control number: US-AMGEN-USASP2021135667), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 10/SEP/2021: In this followup report, the patient clarified that already discarded the old packaging and would not have access to lot number. No further information is expected. No follow up required.