Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 79-year-old female patient who received Seasonal Influenza vaccine. Co-suspect products included FLOVENT unknown for drug use for unknown indication, VENTOLIN unknown for drug use for unknown indication and Pneumococcal vaccine. Previously administered products included albuterol (received albuterol in the past by another manufacturer). Concomitant products included medication unknown (Nebulizer (Name Unknown)). On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. FLOVENT at an unknown dose and frequency. VENTOLIN at an unknown dose and frequency and Pneumococcal vaccine at an unknown dose. In February 2016, an unknown time after receiving Seasonal Influenza vaccine, FLOVENT and VENTOLIN, the patient experienced influenza (serious criteria hospitalization), pneumonia (serious criteria hospitalization and GSK medical significant), bronchitis (serious criteria hospitalization), sickness, cough and ear pain. In May 2016, the patient experienced feeling abnormal. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), breast cancer (serious criteria GSK medically significant), coughing blood and swelling. The action taken with FLOVENT was unknown. The action taken with VENTOLIN was unknown. On an unknown date, the outcome of the vaccination failure, influenza, pneumonia, bronchitis, breast cancer, sickness, cough, ear pain, coughing blood, swelling and feeling abnormal were unknown. It was unknown if the reporter considered the vaccination failure, influenza, pneumonia, bronchitis, breast cancer, sickness, cough, ear pain, coughing blood, swelling and feeling abnormal to be related to Seasonal Influenza vaccine. The reporter considered the influenza, pneumonia, bronchitis, breast cancer, sickness, cough, ear pain, coughing blood, swelling and feeling abnormal to be unrelated to FLOVENT and VENTOLIN. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she took FLOVENT and at the time of reporting was receiving VENTOLIN. The agent was unable to determine if the patient was taking VENTOLIN at the time of the adverse events. The patient had also received flu and pneumonia vaccine. The patient stated that she had breast cancer a few months before the time of reporting, she was unsure if that occurred in spring or summer. In February 2016, the patient became very sick. She could not stop coughing and had an ear ache and eventually she started coughing blood and experienced swelling. The patient stated that she saw 5 doctors and also went to the emergency room (ER). She was told that she would be ok and that her symptoms would go away. In May 2016, the patient felt as if she was dying and went to a different hospital. Within 10 minutes, she was placed in isolation and was diagnosed with the flu, pneumonia, and bronchitis. This case was considered as suspected vaccination failure, since the time to onset for the event was unknown. The patient did not relate her adverse events to her medication.