Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Insomnia, Joint swelling, Malaise, Peripheral swelling, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 8ZP2216, expiry date 31st December 2019) for an unknown indication and PNEUMOCOCCAL VACCINE for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included COMBIVENT. On 17th September 2018, the patient received Influenza vaccine Quadrivalent  (intramuscular). On an unknown date, the patient started ADVAIR DISKUS (inhaled) 250/50 ug 1 puff(s) twice daily (2 puff(s) daily). On 17th September 2018, the patient received PNEUMONIA VACCINE. On 17th September 2018, less than a day after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR DISKUS, the patient experienced allergic reaction (serious criteria hospitalization), unwell, facial swelling, unable to walk, chronic obstructive airways disease exacerbated, difficulty breathing, difficulty sleeping, swelling of feet and ankle swelling. The patient was treated with steroids nos. The action taken with ADVAIR DISKUS was unknown. On an unknown date, the outcome of the allergic reaction, unwell, facial swelling, unable to walk, chronic obstructive airways disease exacerbated, difficulty breathing, difficulty sleeping, swelling of feet and ankle swelling were recovered/resolved. It was unknown if the reporter considered the allergic reaction, unwell, facial swelling, unable to walk, chronic obstructive airways disease exacerbated, difficulty breathing, difficulty sleeping, swelling of feet and ankle swelling to be related to Influenza vaccine Quadrivalent. The reporter considered the allergic reaction, unwell, facial swelling, unable to walk, chronic obstructive airways disease exacerbated, difficulty breathing, difficulty sleeping, swelling of feet and ankle swelling to be unrelated to ADVAIR DISKUS. Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine in the left arm and pneumonia vaccine in the right arm. The patient hospitalized for four days for an allergic reaction from the flu and pneumonia vaccine. She was taking the ADVAIR DISKUS medication at the time of her hospital stay but claimed that the ADVAIR was not related to her allergic reaction. Within 8 hours of the vaccination, she could hardly walk and she was put on oxygen for 6 weeks and her face swelled up as well as her feet and ankles swelled over her shoes. They put her on steroids which she just finished recently and she was finally starting to feel back to herself again. She was having an exacerbation with COPD which was also caused by the vaccines. Within 8 hours of receiving the vaccines, she could not breathe and could not sleep for two nights which started. The hospital thought she had a flu bug but she claimed that she got the side effects from the two vaccines which she received at her doctor's office. The doctor's office visit was a well visit and she had no issues prior to the two vaccinations. It was unknown if the reporter considered the allergic reaction, unwell, facial swelling, unable to walk, chronic obstructive airways disease exacerbated, difficulty breathing, difficulty sleeping, swelling of feet and ankle swelling to be related to PNEUMONIA VACCINE.