Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal tenderness, Anaemia, Aphagia, Asthenia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unable to eat in a 33-year-old female patient who received FLULAVAL (batch number 5N5MM, expiry date unknown). Concurrent medical conditions included gastrointestinal disorder (lower left abdominal pain) and drug allergy (allergy to Sulfa drug and PARAFON FORTE). Concomitant products included COLACE. On 21st October 2014 11:30, the patient received FLULAVAL. On 21st October 2014 11:30, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. In October 2014, less than a month after receiving FLULAVAL, the patient experienced lost on weight and feel warm all over body. On 21st October 2014, the patient experienced unable to eat (serious criteria GSK medically significant). On 22nd October 2014, the patient experienced sweating, rapid heartbeat, anemia, burning in stomach, stomach inflammation, dizziness, stomach tenderness and weakness. On 25th October 2014, the patient experienced bloating and fullness. The patient was treated with omeprazole. On an unknown date, the outcome of the unable to eat, anemia, burning in stomach, stomach inflammation, bloating and fullness and stomach tenderness were not recovered/not resolved and the outcome of the sweating, rapid heartbeat, dizziness and feel warm all over body were recovered/resolved and the outcome of the weakness and lost on weight were unknown. The reporter considered the unable to eat, sweating, rapid heartbeat and dizziness to be related to FLULAVAL. It was unknown if the reporter considered the anemia, bloating and fullness, weakness, lost on weight and feel warm all over body to be related to FLULAVAL. The reporter considered the burning in stomach, stomach inflammation and stomach tenderness to be unrelated to FLULAVAL. Additional information: Prior to receiving the flu shot, the patient reports that she had seen the doctor for lower left abdominal pain, which was checked out. The doctor told her that she was fine and that it was a gastrointestinal problem, and he advised her to change her diet and drink more fluids. The patient was not able to eat very well from the time that she received the flu vaccine. On 22 October 2014, 1 day after vaccination, she experienced lightheadedness, dizziness, some sweating, weakness, rapid heartbeat, stomach tenderness, and burning in her stomach. All symptoms resolved except for the burning in her stomach and stomach tenderness, which has been persistent. She experienced the same group of symptoms 2 days later. Each time she had this group of symptoms, they lasted about 30 minutes, and it has happened about twice per week since she got the flu shot. The first time she had to sleep off her symptoms. The second time on 23 October 2014, she had to call the ambulance and went to the ER. They took her vitals, and she was diagnosed with stomach inflammation and sent home. She went back to the ER on October 25, 2014 with bloating and fullness, and she suspected that she had an ulcer. She was sent home, and on 28 October 2014, she had a double endoscopy that determined that she did not have an ulcer, but mild inflammation. On the night of 28 October 2014, in addition to the burning sensation in her stomach, she felt warm all over her body, had rapid heartbeat, and weakness that lasted a couple of minutes. On 28 October 2014, she was prescribed Omeprazole for the burning in her stomach to block the acid in her stomach. She was taking Omeprazole 20mg one capsule twice daily, and she was feeling extremely full and not able to eat very well. In the past two weeks she has lost about 5 lbs as a result of being unable to eat. She has stopped taking the Omeprazole.