Sex: F
Vaccine: COVID19
Symptoms: Anorectal disorder, Blood pressure measurement, Condition aggravated, Decreased immune responsiveness, Fall
Clinical narrative: Urinary tract infection (UTI); Had a rash outbreak; Fluid in legs; High blood pressure.; because of the Enbrel it did not go away; Irritable Bowel issues; Irritable Bowel issues and had gotten worse; Problems stomach and rectal; Problems stomach and rectal; Fell; Runny nose; 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 "The company" (manufacturer control number), license party for etanercept (ENBREL).  This solicited report was reported to "The company" on 18Mar2020 by a consumer from a commercial program and involves a 78 years old female patient who fell [PT: fall] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. No current medical condition was reported. 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 18Mar2020, morning, the patient fell. No treatment information was received. The outcome of the event fall was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the event fall. The causal relationship between the event fall and Enbrel with 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.  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.  "The company" Causality Assessment: Event "Fall" was assessed to be non-serious and unrelated to etanercept.  Follow-up (20Oct2020): This is a follow-up 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 "The company" (manufacturer control number), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 20Oct2020: In this follow up, it was reported that the patient experienced fluid in legs [PT: oedema peripheral], runny nose [PT: rhinorrhoea], high blood pressure. [PT: hypertension] while receiving Enbrel, Single Dose Prefilled Autoinjector. On an unknown date, the patient stated that she had fluid in legs, runny nose for about 10 years while on Enbrel. The patient's lab included blood pressure, which revealed that the patient had high blood pressure. The outcome of the events oedema peripheral, rhinorrhoea, hypertension was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events oedema peripheral, rhinorrhoea and hypertension. The causal relationship between the events oedema peripheral, rhinorrhoea, hypertension and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested with the physician.  The reporter's assessment of the causal relationship of the events with the suspect product etanercept 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.  "The company" causality assessment: The event Runny nose was considered as non-serious and related to etanercept. The events Blood pressure high, Leg edema, Fall were considered as non-serious and unrelated to etanercept.  Follow-up (27Jan2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from "The company" (manufacturer control number), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 27Jan2021: It was reported that the patient had a rash outbreak [PT: rash] while receiving Enbrel, Single Dose Prefilled Autoinjector. On an unknown date, the patient stated that she had a rash outbreak. No treatment information was received. The outcome of the event rash was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event rash. The causal relationship between the event rash and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up is not required.  The reporter's assessment of the causal relationship of the events with the suspect product etanercept 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.  "The company" causality assessment: The event Runny nose was considered as non-serious and related to etanercept. The events Blood pressure high, Leg edema, Fall, Rash were considered as non-serious and unrelated to etanercept.  Follow-up (05Apr2021): This is a follow-up 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 "The company" (manufacturer control number), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 05/APR/2021: This follow up information was received from a commercial program. It was reported that the patient had urinary tract infection (UTI) [PT: urinary tract infection] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's current medical condition included rheumatoid arthritis. On an unknown date, the patient had urinary tract infection (UTI) and stated because of the Enbrel it did not go away. The patient had it for three weeks. The patient had been placed on multiple antibiotics and nothing was working. The patient enquired whether she should keep taking it. The outcome of the event urinary tract infection was reported as not recovered/not resolved. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events urinary tract infection. The causal relationship between the event urinary tract infection and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up is not required.  Causality Assessment per company ("The company") for events Fall, Leg edema, Blood pressure high, and Rash was no (unrelated); and for events UTI and Runny nose was yes (related).  Follow-up (22Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer based on information received by Pfizer from "The company" (manufacturer control number) license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 22/APR/2021: In this follow up, the patient experienced irritable bowel issues [PT: irritable bowel syndrome], problems stomach and rectal [PT: anorectal disorder and PT: gastric disorder] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date in 2000 for 21 years prior to this report. On an unknown date for years, the patient reported that she had irritable bowel issues and had gotten worse. Along with an urinary tract infection for a month and on her fourth series of antibiotics. The patient spoke with her Internist provider and he did not know anything and ordered another antibiotic. The patient stated that she has reviewed information on Enbrel and know that it might increase blood pressure, cause urinary tract Infections and runny nose. The patient had a runny nose for 11 years. On an unknown date in MAR/2021, last month after taking COVID-19 Vaccine the patient had problems stomach and rectal, although when probed she had the same issues for years. No treatment information was received. The outcome of the event irritable bowel syndrome was reported as not recovered/not resolved. The outcome of the events anorectal disorder and gastric disorder was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events irritable bowel syndrome, anorectal disorder and gastric disorder. The causal relationship between the events irritable bowel syndrome, anorectal disorder, gastric disorder and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  "The company" Causality Assessment:   The events UTI and runny nose was assessed as related to etanercept by "The company". The events rash, fall, leg edema, blood pressure high, irritable bowel syndrome, rectal disorder and gastric disorder was assessed as unrelated to etanercept by "The company".   The reporter's assessment of UTI, runny nose, rash, fall, leg edema, blood pressure high, irritable bowel syndrome, rectal disorder and gastric disorder  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 event urinary tract infection, rash and runny nose and etanercept cannot be excluded. The events Leg edema, fall, high blood pressure, fall, Gastric disorder, Anorectal disorder, Condition aggravated and Irritable bowel syndrome are considered as  intercurrent conditions and unrelated to etanercept. Events are assessed as unrelated to  BNT162B2.