Sex: F
Vaccine: FLUX, FLUX
Symptoms: Gait disturbance, Hypersensitivity, Malaise, Migraine, Muscle spasms
Clinical narrative: A spontaneous report had been received from physician via Pfizer concerning a 69 years old female patient. Medical records also provided. The patient's medical history included flu shot reaction- Guillain Barre, lotensin, ALEVE, FLOVENT aero, latex, SINGULAIR reaction- dizzy/ALEVE caps; reactions: dizziness; category: adverse reaction/ FLOVENT aero; reactions: dizziness; category: adverse reaction, lotensin - lightheaded, doxycycline hyclate, nitrofurantoin monohyd macro caps reaction - hives/doxycycline hyclate tabs; reactions: hives; category: allergy, PHENERGAN reaction - malaise, phenergan reaction- sleepy, codeine reaction - extreme dizziness, ADVAIR, CELEBREX, SINGULAIR, SPIRIVA reaction - headache/CELEBREX caps; reactions:  headache, lactose intolerance; category: adverse reaction, cholesterol meds reaction- muscle weakness, SALAGEN reaction - water retention, antidepressants, PROZAC reaction - get depressed/ PROZAC tabs; reactions: depression; category: allergy, gabapentin reaction- insomnia/ gabapentin tabs; reactions:  insomnia; category: adverse reaction, ADVAIR diskus misc; reactions: migraines; category: migraines, codeine derivatives; reactions: head spings/unable to walk/can't th, influenza virus vaccine whole; reactions: neuropathy; category: other, pantoprazole;  reactions: nausea, PRILOSEC CPDR; reactions:  abdominal pain; category: adverse reaction, PULMICORT FLEXHALER inha; reactions: migraines; category: adverse reaction and pantoprazole;  reactions: stomach cramping. the patient's concurrent diseases included allergic to latex gloves misc, doxycycline hyclate, nitrofurantoin in monohyd macro, allergic to doxycycline, disabled, uses a walker, uses a wheelchair, ADVAIR diskus misc, CELEBREX, gabapentin, influenza virus vaccine whole, SPIRIVA HANDIHALER, TORADOL, VIOXX, latex gloves misc reactions- itching, latex gloves misc reactions- rash, high blood pressure, high cholesterol, fibromyalgia, Sjogren's, CHF, COPD, degenerative disk disease, GERD, osteoporosis, polyneuropathy, TORADOL reaction - lactose intolerance, VIOXX reaction - migraines and head spings/unable to walk. Concomitant medications included A/B otic, acyclovir for Ramsay Hunt syndrome, salbutamol sulfate, allopurinol for gout, amantadine for chronic bronchitis, benzocaine, phenazone for ear pain, Artificial tears, diphenhydramine, phenylalanine, calcium, captopril for type II diabetes with renal manifestations controlled, cinnamomum verum, fluticasone propionate for asthma, glipizide for diabetes mellitus, furosemide and metolazone for edema, hydrocodone, paracetamol for cervicalgia, ipratropium bromide, lidocaine hydrochloride, pregabalin for diabetes with neurological complications, magnesium oxide, ascorbic acid, vitamin B nos, nystatin, fish oil, pantoprazole sodium for esophageal reflux, potassium chloride for hypokalemia, prednisone, vitamins nos, tramadol, trimethobenzamide, salbutamol sulfate, ascorbic acid, tocopherol, salbutamol sulfate, ranitidine hydrochloride, sulfamethoxazole, trimethoprim, ondansetron for nausea, ergocalciferol, diphenhydramine hydrochloride, ergocalciferol, guaifenesin and lactulose. The patient had been receiving respiratory (inhalation) SYMBICORT MDI for asthma, oral PRILOSEC and respiratory (inhalation) PULMICORT FLEXHALER, 0.5 mg/ 2 ml, 1 unit dose via nebulizer two times a day which were started on an unknown date for unknown indications. Patient also received Influenza virus vaccine (intranasal) on an unknown date. (In view of patient's age and the absence of any vaccine lot identifier, manufacturer, brand, or route of administration, the patient almost certainly received an inactivated influenza vaccine). It was reported that the patient was allergic to PRILOSEC (preferred term: drug hypersensitivity) and she had abdominal pain (preferred Term: abdominal pain). Patient also experienced cramps (preferred term: muscle spasms) and malaise (preferred term: malaise) on an unspecified date. She had asthma (preferred term: asthma) and unspecified allergic reaction (Preferred Term: hypersensitivity). She had allergy with Influenza virus vaccine and had neuropathy (Preferred Term: Neuropathy peripheral) on an unknown date. Further reported that patient was also allergic to PULMICORT FLEXHALER and was suffering from migraines (Preferred Term: Migraine). The patient also had walking difficulty (preferred term: gait disturbance). Action taken with SYMBICORT PMDI, PULMICORT FLEXHALER and PRILOSEC were unknown. The outcome of event neuropathy/neuropathy bad in feet was recovering. The outcome of all other reported events was unknown. The company physician assessed the event of cramps, malaise, abdominal pain, unspecified allergic reaction, allergic to PRILOSEC/allergy to PULMICORT FLEXHALER / allergic to Influenza virus vaccine, asthma, neuropathy and migraines to be non serious. The reporter considered the event abdominal pain to be related to the suspect drug of PRILOSEC. Summary of follow up information received by AstraZeneca/Medimmune on 11-Jan-2013 from consumer: Non serious event asthma added. SYMBICORT PMDI was added as suspect drug. Concomitant diseases of uses wheelchair and walker added. Corrected report 16-Jan-2013: Reporter information updated. Summary of follow up information received by AstraZeneca/Medimmune on 21-Jan-2013 from consumer: New events abdominal pain and unspecified allergic reaction added. PULMICORT FLEXHALER added as suspect drug. Concomitant drugs added. Patient demographics updated. Relevant histories added. Corrected report 21-Feb-2013: Case turned to be medically confirmed as medical records provided added as reporter. Order of suspect drugs corrected. Dosing of SYMBICORT added. Concomitant drugs added. Indication for the drug Antipyrine benzocaine added as ear pain. Accu check strip and lancets removed as concomitant drugs as they are test materials. Summary of follow up information received by AstraZeneca/Medimmune on 12-Feb-2016: New non-serious events neuropathy and migraines added. New suspect drug Influenza virus vaccine added. Reporter causality for the event abdominal pain added. Patient's concomitant diseases and concomitant drugs added. Reporter information updated. Case type updated to vaccine from drug. Narrative updated. Summary of follow up information received by AstraZeneca/Medimmune on 23-Dec-2016 from Consumer: New dosing regimen was added for PULMICORT. Non serious event could not walk was added. Event verbatim of neuropathy/neuropathy bad in feet was updated. New reporter was added. Summary of follow up information received by AstraZeneca/Medimmune on 29-Dec-2016 from Physician via Pfizer: Primary reporter Physician added. New Concomitant medication added. Relevant history added. Lab data added. Narrative updated.