Age: 54.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Blister, Blister rupture, Hypersensitivity, Laboratory test, Pruritus
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of painful blisters in a 54-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hepatitis C and post traumatic stress syndrome (described as "PTSD"). Concurrent medications included Antidepressant, Multivitamins and Unknown (Unspecified medications). On 28 August 2013 at 15:00 to 16:00 the subject received a dose of FLUARIX (intramuscular, right arm). On the morning of 29 August 2013, 1 day after vaccination with FLUARIX, the subject experienced painful blisters and allergic reaction. Less than a month after vaccination with FLUARIX, the subject experienced yellow colored drainage from wound (described as "blisters had yellowish color liquid"). The subject described the "painful, nasty" blisters as "huge blisters on her left side of her body: left arm, left side of her back and base of the neck." The subject described the size of the blisters as "huge (about the size of half a dollar)." The subject sought medical attention at the emergency room. The subject was treated with pain medication (Painkiller (unknown "pain pills")), antibiotics, antibiotics. The emergency room referred the subject to a dermatologist. The dermatologist "noticed that not all blisters were broken open, so the dermatologist drained the blisters during her visit." The blisters contained a "yellowish color liquid" (yellow colored drainage from wound) and the blisters were "sticky to touch." The subject also sought medical attention from her nurse practitioner who told the subject she was "experiencing a severe allergic reaction to the flu vaccine." The subject expressed concern that "the blisters are leaving a scar." At the time of reporting the events were unresolved. The subject reported that she "is contacting her attorney to initiate a lawsuit." Information on how to contact the GlaxoSmithKline legal department was provided to the subject per her request at the time of reporting. Follow up was received from Merck on 16 September 2013. A healthcare professional confirmed this case. The healthcare professional provided the following statement from the subject: "I have experienced what I believe a serious side effect. I have developed huge blisters on my back, neck, and arm. The injection site was on my right side and the majority of the blisters are on my left side." Follow up was received from Merck on 23 September 2013. The subject sought medical attention from the emergency room on 31 August 2013 "due to the pain." Per the report, at the emergency room "her blisters were lanced." The subject was treated with "unspecified pain pills, antibiotics, and creams." No further details were provided. Follow up was received from pharmacist on 18 October 2013. The pharmacist reported that this case had been reported to a Regulatory Authority; however, no reference number was provided. The pharmacist considered this case to be serious. The onset date of all symptoms was reported as 29 August 2013 (previously the yellow colored drainage from wound was reported as an onset in 2013). The events are unresolved at the time of this reporting, The pharmacist documented that per the wound clinic, the events are probably related to the suspect product. The pharmacist documented that the events were not life threatening or involve severe or permanent disability. The pharmacist noted that the subject "says will scars, back, neck and arm." The pharmacist documented that the events jeopardized the subject or required intervention. The pharmacist did not know if other factors were associated with the events. The pharmacist documented that the dose administered was 0.5ml and was a primary dose. The pharmacist reported the lot number of the FLUARIX was 27NA; however, GSK sales data confirmed that the lot number was 27NA2. The pharmacist reported that she "sent request to [company] corporate privacy office" when asked about concomitant medications for the subject.