Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac monitoring, Cardiac stress test normal, Cough, Echocardiogram normal, Haematoma
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Influenza vaccine. Co-suspect products included pneumococcal vaccine. The patient's past medical history included pneumonia, bronchitis (A history of pneumonia and bronchitis throughout her life), lung injury (cut skin on her lung), cough, wheezing (cough and wheezing began 4 to 5 years ago, related to her asthma), mitral valve prolapse (in 1990), venous insufficiency (3 yrs ago) and cardiac ablation (heart ablation 2 to 3 years before reporting date). Previously experienced adverse reactions included peripheral swelling (Began 3 to 4 years ago, swelling of the legs). Concurrent medical conditions included allergenic desensitization procedure (allergy shots which she currently takes once monthly from 2015), asthma (Her allergies to cats, pecans and oak trees led to a diagnosis of asthma), skin fragility, congenital skin disorder (her fragile skin was inherited from her mother and has crepey skin due to her genetics), palpitation (started in 1997, her heart rate has raced up to 200 beats per minute), psychomotor hyperactivity (The patient claimed she has always been hyper and talked fast), allergic to cats, allergy to nuts (Pecans) and allergy to plants (oak trees). Concomitant products included ZYRTEC, VENTOLIN HFA, Fluticasone Nasal Spray, SYMBICORT, TYLENOL and XANAX. In October 2017, the patient received Influenza vaccine. On an unknown date, the patient received pneumococcal vaccine at an unknown dose. On 1st January 2018, less than a year after receiving Influenza vaccine and unknown after receiving pneumococcal vaccine, the patient experienced mitral insufficiency (serious criteria hospitalization and GSK medically significant) and premature atrial contraction. On 12th February 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria hospitalization and GSK medically significant) and influenza A virus infection (serious criteria hospitalization). On an unknown date, the patient experienced cough, wheezing and sleepiness. On an unknown date, the outcome of the vaccination failure and sleepiness were unknown and the outcome of the pneumonia and influenza A virus infection were recovered/resolved and the outcome of the mitral insufficiency and premature atrial contraction were not recovered/not resolved and the outcome of the cough and wheezing were recovering/resolving. It was unknown if the reporter considered the vaccination failure, pneumonia, influenza A virus infection, mitral insufficiency, premature atrial contraction, cough, wheezing and sleepiness to be related to Influenza vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she had a history of a racing heart for years and it would race 200 beats per minute which started in 1997. The patient had an ablation on the top of her legs 2 to 3 years ago because her blood wasn't flowing well so she wore stockings on both legs with Velcro to cover the bottom of her legs to prevent swelling. The patient had been going to a wound doctor the past summer for a Hematoma and the wound didn't heal until last month. She went to a vein doctor 3 to 4 years ago and they noticed that her veins were bad. The patient was diagnosed with venous insufficiency about 3 years ago. She also reported that she cut her skin on the lower left side on the outer side of her left leg on a lounge chair and it took from 15th May 2016 to February to heal. The patient reported that she used the VENTOLIN product for emergency and typically would take the VENTOLIN product 4-6 hours per day but she tried not to take the product at night because it hacked her up at night when she slept. The reporter described it as it made her heart race at night and gave her a high so she did take the VENTOLIN at night often. The patient was told that she had a leaky mitral valve. She also reported that she went to the hospital and was diagnosed with pneumonia and flu type A. They gave her breathing treatments and she had been on a steroid. The patient was hospitalized overnight for 3 to 4 days because they thought she had heart failure. The patient passed her echocardiogram and stress test. An ablation on her heart was performed 2 to 3 years ago. The patient was diagnosed with premature atrial contraction (PACS) and had to wear a monitor for 30 days. Patient claimed that she got sleepy after taking XANAX and it relaxed her. This case has been considered as suspected vaccination failure since the time to onset and laboratory test for influenza was unknown. No additional detail was provided. This case has been linked with case US2018044064 (same patient) for pharma drug.