Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Renal impairment, Somnolence, Urinary retention
Clinical narrative: This case was reported by a consumer and described the occurrence of passed out in a 63-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included burning (nos). Concomitant medical conditions included high cholesterol and elevated blood pressure. Concurrent medications included Lisinopril, PREVACID, and ZOCOR. In 2008 the subject started Carvedilol (oral) at 6.25 mg twice per day. In 2008, the subject experienced uncontrolled blood pressure and was switched to treatment with COREG CR in 28 July 2009. On the 31 July 2009, she passed out twice. She was hospitalized on an unknown date and discharged on 03 August 2009. She was noted to be dehydrated and stated her "kidneys were elevated" (kidney disorder). Her systolic blood pressure was 56. She was treated with five to six bags of IV (intravenous) fluid which she attributed to diluting her blood and caused anemia. COREG CR treatment continued through August 2009 and "did well". On 21 September 2009 her systolic blood pressure went to 220. She reported since starting the COREG CR on 28 July 2009 she had been cold with freezing hands and feet. She also developed "other problems" (unspecified event). She was fine the month of October except a dry mouth that developed the end of the month. She scheduled to see her physician on November 24th. She was concerned about the breast heaviness, which was later clarified as swelling, causing her bra to be tight. She reported left sided chest pain in the middle of her breast, and felt her heart pounding at times. She felt weak and sleepy. She could not "function in her daily activities" for being so tired. She also noted that she had very cold hands and feet intermittently when the "medication was actually releasing in her body". She developed dry mouth, nasal congestion and a cough. The subject reported that her kidney specialist does not believe that her symptoms are caused by the COREG. The subject reported that she was told by her kidney specialist that she had a high renin. The subject was treated with intravenous fluid(s) (IV fluids). Treatment with COREG was continued. In November 2009 the subject received unspecified dose of Flu vaccine (unknown). On an unspecified date, at an unspecified time after vaccination with flu vaccine, the subject experienced dry mouth, dry nose and cough. At the time of report she inquired to see if a flu shot could cause the dry mouth, dry nose and cough. The subject seemed to recall these occurred at the same time when she received a seasonal flu vaccine in November 2009. She does not know the manufacturer of the vaccine. At the time of reporting the passed out, anemia, breast heaviness, breast swelling, uncontrolled blood pressure, elevated blood pressure, low blood pressure, elevated renal function, chest pain, weakness, heart pounding, nasal congestion, cannot empty bladder completely, unable to function, freezing cold hand, feet were freezing, intermittent coldness, lack of effect, sleepiness, tiredness and dehydration were unresolved. At the time of reporting the dry mouth, cough, and dry nose were unresolved. Caller reports that she had been on COREG for about a year and was placed on COREG CR because her blood pressures continued to be a problem. On July 28th of this year, she was placed on COREG CR. She took it on the 29th and 30th. On the 31st, she passed out twice. Her husband called EMS, she stayed in the hospital til discharge on the 3rd of August. She was noted to be dehydrated and states her kidneys were elevated. Her systolic blood pressure was 56. She was given given 5 to 6 bags of IV fluid. She states that diluted her blood too much, that she became anemic. She took COREG CR the whole month of August and did well. On September 21st her systolic blood pressure went to 220. She reports since starting the COREG CR she has been cold with freezing hands and feet. She has also developed other problems. She was fine the month of October except a dry mouth, that developed the end of the month. She has an MD appointment on November 24th. She is concerned about the breast heaviness, which is later clarified as swelling, causes her bra to be tight. She has left sided chest pain in the middle of her beast, and feel her heart pounding at times. She feels weak and sleepy. Can't function in her daily activities for being so tired. She also notes that she has very cold hands and feet intermittently. She feels this occurs when the medication is actually releasing in her body. She has dry mouth, nasal congestion and a cough that has developed. She did inquire to see if a flu shot could cause the dry mouth, dry nose and cough. She seems to recall these occurring at the same time when she received a seasonal flu vaccine last week. She doesn't know who the manufacturer is. A separate vaccine AE template will be completed for the flu vaccine.