Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADVAIR DISKUS inhalation powder for chronic obstructive pulmonary disease and asthma. The patient's past medical history included Crohn's disease (performed a procedure (colonoscopy and upper GI) and diagnosed with Crohn's disease), internal hemorrhage (on 25th June 2007, was hospitalized for internal bleeding (received 2 units of blood)), obstruction (blockage (gastrointestinal) of which had to have intestines removed), hospitalization (hospitalized in March 2018 as there was growth in her intestine), syncope and epilepsy. Concurrent medical conditions included epilepsy (diagnosed prior to taking the vaccine), chronic obstructive pulmonary disease (diagnosed prior to taking the vaccine), asthma (diagnosed prior to taking the vaccine), allergy (diagnosed prior to taking the vaccine) and gastroesophageal reflux disease (diagnosed prior to taking the vaccine). Concomitant products included ADVAIR, famotidine, FLONASE, folic acid, KLOR-CON, Levothyroxine, omeprazole, ONFI, BANZEL, ALLEGRA and felbamate. On 15th June 2018 07:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient started ADVAIR DISKUS (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In June 2018, less than a week after receiving SHINGRIX and less than a year after starting ADVAIR DISKUS, the patient experienced burning sensation. On 16th June 2018, the patient experienced unconscious (serious criteria GSK medically significant) and fall. On an unknown date, the patient experienced headache, generalized aching and candidiasis. ADVAIR DISKUS was continued with no change. In June 2018, the outcome of the burning sensation was recovered/resolved. On an unknown date, the outcome of the unconscious was recovered/resolved and the outcome of the headache, generalized aching and candidiasis were not recovered/not resolved and the outcome of the fall was unknown. It was unknown if the reporter considered the unconscious, burning sensation, headache, generalized aching and fall to be related to SHINGRIX and ADVAIR DISKUS. The reporter considered the candidiasis to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the candidiasis to be related to ADVAIR DISKUS. Additional details were provided as follows: The patient concomitant product included 6 different Allergy medicines, CONTESSA and Vitamins. The patient had a long medical history, and it was hard to get a full understanding of all of the events as she seemed to go off topic quite a lot. While listing her concomitant medications, she listed ADVAIR as one of them that she has been taking for years. She states that she has candidiasis infections while taking the product. It was unclear whether she was hospitalized for the infections. At the time of reporting, the patient was talking about ADVAIR during these times but does not think that it had anything to do with any of her symptoms. The patient's knows that she did not have a seizure that night. The patient stated that she was fine for an hour and then collapsed and became unconscious for about 2 and a half minute, after she became conscious stated that she had pain all over her body including her arms, hands, legs, neck, shoulders, and back, she stated that the pain had lessened in her legs but she has burning that continues in the other aforementioned areas. The patient had a constant headache. The patient had not any other unconscious episodes since the first time, the was informed that with the appropriate PI (product information) information and suggested that she follow up with her doctor regarding her symptoms. The patient did not report to the emergency room or have to be hospitalized for the events.