Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Nervousness, Pain in extremity, Pharyngitis, Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of apparent life threatening event in a female patient who received ADVAIR 250/50 mcg and 500/50 mcg multi dose powder inhaler for asthma and chronic obstructive pulmonary disease and the occurrence of could not work (nos) after being vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The patient's past medical history included back pain, chest pain, irregular heartbeat, palpitation, hospitalization and pneumonia. Concurrent medical conditions included acid reflux, allergies, asthma, generalized anxiety disorder, high blood pressure, hyperlipidemia, nervousness (which is worse now), seasonal allergic rhinitis, shortness of breath and uterine disorder. The patient also stated that dust and perfumes irritate her. The patient clarified that the bad anxiety and worsened nervousness seemed to start after she moved to a different state 13 years ago. Past medications included SEREVENT, FLOVENT and "different things" throughout her life. Concurrent medications included Albuterol/ipratropium, Lisinopril, hydrochlorothiazide (HCTZ), Tramadol, Tizanidine, BUSPAR and Letrozole. On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff (s) twice per day. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced apparent life threatening event, nervousness (described as very nervous, nervous a lot, "worse nervousness ever"), headache and feels like head is going to explode, muscle spasm, leg pain, shortness of breath walking, decreased potassium, low immune system, could not work (nos) ("flu shot stayed out of work 2 days"), bilateral ear infection, throat irritation, dysphonia (described as irritation in my voice and hoarseness), worsened mood (described as little aggravated), pneumonia, more asthma attack, asthma attacks more severe, and asthma worse on ADVAIR, cough, bad bough, waking up coughing, constantly coughing, pharyngitis, adverse event (described as severe things happen when using ADVAIR), exhausted and feels like she is tired, decreased energy level, near death experience ("almost lost my life"), upper respiratory infection, real bad anxiety, a lot of snoring, chronic obstructive pulmonary disease and spells (unspecified attack). The patient was hospitalised. On an unknown date, the patient received Influenza vaccine (details unknown). Less than a year after vaccination with Influenza vaccine, the subject experienced could not work (nos). The dose of Fluticasone propionate+salmeterol xinafoate was increased. At the time of reporting, the events were unresolved. The caller stated her age at onset is unknown because she has been in and out of hospital. The patient states she has been on ADVAIR for 10-13 years. The exact start date is unknown. She stated she was on ADVAIR 250/50 mcg and then was changed to ADVAIR 500/50 mcg for both asthma and COPD. When asked if both strengths caused these side effects, her response was yes. She specifically stated the upper respiratory infections, throat irritation, and hoarseness occurred on both. But she did not experience weakness on ADVAIR 250/50 mcg. She stated that currently she uses the ADVAIR 500/50 mcg and takes 1 puff in the morning and 1 puff around 3-4pm. The recent hospitalization occurred while the patient was on the ADVAIR 500/50 mcg. The patient states she was hospitalized for a week. She states she had an attack but it wasn't an asthma attack. This is when she was diagnosed with COPD. She reported someone had to drive her to the hospital because if she went via ambulance she doesn't think "she would have made it." The patient stated while in the hospital she was treated with a drug mixed with magnesium to open her lungs. The drug name was not clear. She specifically stated she received this medication three times a day. She stated it took a long time for the hospital to open her lungs. She was placed on oxygen and a heart monitor, and her potassium level dropped. She currently can't walk to far without being out of breath and she doesn't go outside. She stated she is on medical leave from her job now. The patient describes her immune system being low by stating "anytime someone gets something I would be the first person to get it", such as a stomach virus or cold. She stated she was told her immune system was low at the hospital. She stated that after she received a flu shot she had to stay out of work for 2 days indicating that her immune system was low. The patient did not know the name of the flu shot. The patient stated she tried to quit taking ADVAIR because she doesn't want to be on it forever but when she tried to quit she couldn't breathe or walk. The patient stated she will have a sudden attack if someone cuts the grass. She stated when she had pharyngitis she had to wear a mask over her face to prevent getting sick. The patient stated she had pneumonia both before starting ADVAIR and while on ADVAIR. The patient states her asthma attacks are more severe while on ADVAIR. When asked how soon side effects started after using ADVAIR the called responded this is unknown.