Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of syncope in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4LX29, expiry date 30th June 2016). Concomitant products included PAXIL and low dose ASPIRIN. On 8th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 9th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced syncope, fall and bruise of head. On an unknown date, the patient experienced leg cramps. On an unknown date, the outcome of the syncope and leg cramps were recovered/resolved and the outcome of the fall and bruise of head were recovering/resolving. The reporter considered the syncope, fall and bruise of head to be possibly related to FLUARIX QUADRIVALENT. The reporter considered the leg cramps to be unrelated to FLUARIX QUADRIVALENT. Additional details provided were as follows: This care was reported by a nurse who herself was the patient. On 8th October 2015, at 16:30, the patient received a dose of FLUARIX QUADRIVALENT. On 9th October 2015, at around 4am (approximately 12 hours after vaccination), the patient woke up with leg cramps. She began walking around and experienced syncope. Due to syncope, the patient experienced a fall and hit her head, which resulted in head contusion. The patient went to emergency room, no overnight hospitalization was required.  Follow up information was received from nurse on 3rd August 2016: This was upgraded to serious due to the events passed out and unresponsive to stimuli. The patient's demographic details were updated. The patient had been a nurse since 1983 and had always been adamant about educating her patients, family, and friends about the importance of getting a flu shot every season. The patient had received a flu vaccine every year for the past 15 years or so and have never had a reaction like syncopal episode before receiving the vaccine and have never had one since so she truly believe it to be directly related to the vaccine. On 8th October 2015, around 3.00 or 4.00 pm, the patient received the FLUARIX QUADRIVALENT. She received the vaccine about 12 hours earlier at her place of employment. On 9th August 2015, the patient has a syncopal episode. Her boyfriend found her after she passed out, fallen against the door frame, had a head contusion, and was responsive. In October 2015, less than a month after vaccination, the patient experienced chronic fatigue and headaches. Her chronic fatigue resulted in her inability to work from the end of October to the end of April. The chronic fatigue that followed was devastating since it had affected not only the patient's ability to work but many aspects of her home and personal life also. The patient had lab work done to see if it would reveal any causes for the chronic fatigue and the laboratory tests did not show any abnormalities that would explain the fatigue. The patient had lost wages for 6 months and this had greatly affected her life. She had losses of 21,840.00 dollars during the time that she was not able to work full time bases on her most recent job salary and continue to lose approximately the same amount over the next year if she was unable to return to work full time. The patient had recently been able to return to work part time. She was unable to pay the ambulance bill, hospital bill and imaging bill from the night she went to emergency room. The patient provided the letter from the attorney regarding the bills that her health insurance did not cover along with enclosed copies of the medical bills associated with this reaction. The patient had submitted the letter to make GlaxoSmithKline aware of the adverse effects that this vaccine had caused. She also requested financial compensation for her financial losses caused by the vaccine. The patient gave consent to contact her healthcare professional and provided contact details for the same. The VAERS details were updated.