Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain of skin, Pharyngeal oedema, Syncope
Clinical narrative: This case was reported by a consumer via a call center representative and described the occurrence of passed out in a 26-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4M4FS, expiry date 28th June 2016). Concurrent medical conditions included polycystic ovarian syndrome (diagnosed in February 2015. The patient does not have a menstrual cycle without medication.) and infertility (due to Polycystic ovary syndrome). On 14th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 14th October 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced passed out (serious criteria GSK medically significant),  throat swelling (serious criteria other: as per reporter), seizure (serious criteria GSK medically significant), general body pain, joint pain, muscle pain, pain of skin, headache, shivering and body temperature. On 18th October 2015, the patient experienced migraine headache and vomiting. On an unknown date, the patient experienced allergic reaction. On 14th October 2015, the outcome of the passed out, throat swelling and shivering were recovered/resolved. On 18th October 2015, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the seizure, allergic reaction, muscle pain, pain of skin and migraine headache were unknown and the outcome of the general body pain, joint pain and body temperature were recovering/resolving and the outcome of the headache was not recovered/not resolved. The reporter considered the passed out, throat swelling, allergic reaction, general body pain, joint pain, muscle pain, pain of skin, headache, shivering, body temperature and vomiting to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the seizure and migraine headache to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that immediately after receiving the flu vaccine, her throat became really swollen and resolved after about 2 minutes. The throat was not as swollen to the point where she could not breathe or swallow. In about two and a half minutes later after the swollen throat, she began to have mild body aches all over the body. She told the nurse about the side effects and she was asked to sit for a few minutes to make sure her throat would not constrict to the point she could not breathe or swallow. The body aches got worse over the next 30 minutes to the point her skin, joints and muscles hurt more than normal to the point that she was in so much pain that she cried. Her aches were so severe for over 30 minutes after the injection. The severe body aches lasted about 12 hours. The patient was going to go home but went to the doctor's office where her spouse worked. In the office, she passed out and was shivering so bad it looked like she was having a seizure. It was recommended that she should be taken to the hospital. The doctor did not treat the patient in the office. When she reached the emergency room, her temperature was 99 degrees. Within two hours, her temperature rose to 102.5. In the emergency room, she had a chest x-ray, an EKG on her heart, CBC, blood work, a flu swab and a urine analysis. They did the flu swab to make sure she did not have the flu already. The urine analysis was done to see if she may have a urinary tract infection. All test results came back with no problems. Her spike in her temperature could not be explained. She knew that her temperature had to have come from the injection because she checks her temperature every morning due to fertility issues. Wednesday morning before the flu vaccine, her temperature was 97.2. The patient was released after about four hours in the emergency room. At the time of reporting, the patient still had a headache and body aches. The patient had a headache last night almost like a migraine that made her sick to the point of vomiting. At the time of reporting, her temperature was 99.3, which she related to vomiting last night and her body trying to recover. She was required to have the flu shot because she had just been hired to work at the same medical center where she received the vaccine. The doctors and nurses that saw the patient, all agreed that she had an allergic reaction to the vaccine. At present, the patient did not have a primary doctor. The patient was looking for compensation for medical expenses and would be sending a claim to the Legal department.