Age: 72.0
Sex: F
Vaccine: FLUX, UNK, UNK
Symptoms: Pollakiuria, Product used for unknown indication, Pruritus, Respiratory tract infection, Rheumatoid arthritis
Clinical narrative: ANAPHYLACTIC SHOCK; PRURITUS; VACCINATION SITE ERYTHEMA; VACCINATION SITE INFLAMMATION; VOMITING; WHEEZING; MALAISE; URTICARIA; ABDOMINAL PAIN UPPER; ARTHRITIS; ASTHMA; BLOOD PRESSURE SYSTOLIC INCREASED; DYSPNOEA; FEAR OF INJECTION; HUMIDITY INTOLERANCE; INSOMNIA; LOWER RESPIRATORY TRACT INFECTION; MOBILITY DECREASED; NASOPHARYNGITIS; OBSTRUCTIVE AIRWAYS DISORDER; ORAL CANDIDIASIS; OROPHARYNGEAL PAIN; PAIN IN EXTREMITY; POLLAKIURIA; RESPIRATORY TRACT INFECTION; RHEUMATOID ARTHRITIS; RHINORRHOEA; SENSITIVITY TO WEATHER CHANGE; SPEECH DISORDER; THROAT IRRITATION; THROAT TIGHTNESS; TOOTH ABSCESS; DRUG INEFFECTIVE; INCORRECT DOSE ADMINISTERED; A solicited report from a non-interventional study/data collection program has been received from the Consumer via regulatory authority. The report concerns a female patient of Unknown ethnic origin (age 72 years).    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown    Concomitant medication included amlodipine maleate for hypertension, budesonide for asthma, atorvastatin calcium for dyslipidaemia, phenytoin sodium for epilepsy, levothyroxine sodium for hypothyroidism, pantoprazole sodium for gastrooesophageal reflux disease, prednisone for asthma, cetirizine hydrochloride for asthma, montelukast sodium for asthma, tiotropium bromide monohydrate for asthma and salbutamol sulfate for asthma.     On an unknown date, the patient received Influenza (influenza vaccine), via unknown route, for product used for unknown indication.     On an unknown date, the patient started treatment with Cimzia (certolizumab pegol) 6.0 Months on an unknown date for rheumatoid arthritis and with Omalizumab (omalizumab) 225 mg every two weeks, subcutaneous, for asthma.     No malfunction has been reported for Influenza.      The report described a medication error for Influenza, Cimzia and Omalizumab. The reported term was incorrect dose administered (Preferred term: Incorrect dose administered). The report described lack of effect for Influenza, Cimzia and Omalizumab. The reported term was drug ineffective (Preferred term: Drug ineffective    On an unknown date, the patient experienced anaphylactic shock (preferred term: Anaphylactic shock), pruritus (preferred term: Pruritus), vaccination site erythema (preferred term: Vaccination site erythema), vaccination site inflammation (preferred term: Vaccination site inflammation), vomiting (preferred term: Vomiting), wheezing (preferred term: Wheezing), malaise (preferred term: Malaise), urticaria (preferred term: Urticaria), abdominal pain upper (preferred term: Abdominal pain upper), arthritis (preferred term: Arthritis), asthma (preferred term: Asthma), blood pressure systolic increased (preferred term: Blood pressure systolic increased), dyspnoea (preferred term: Dyspnoea), fear of injection (preferred term: Fear of injection), humidity intolerance (preferred term: Humidity intolerance), insomnia (preferred term: Insomnia), lower respiratory tract infection (preferred term: Lower respiratory tract infection), mobility decreased (preferred term: Mobility decreased), nasopharyngitis (preferred term: Nasopharyngitis), obstructive airways disorder (preferred term: Obstructive airways disorder), oral candidiasis (preferred term: Oral candidiasis), oropharyngeal pain (preferred term: Oropharyngeal pain), pain in extremity (preferred term: Pain in extremity), pollakiuria (preferred term: Pollakiuria), respiratory tract infection (preferred term: Respiratory tract infection), rheumatoid arthritis (preferred term: Rheumatoid arthritis), rhinorrhoea (preferred term: Rhinorrhoea), sensitivity to weather change (preferred term: Sensitivity to weather change), speech disorder (preferred term: Speech disorder), throat irritation (preferred term: Throat irritation), throat tightness (preferred term: Throat tightness), tooth abscess (preferred term: Tooth abscess).     It is unknown if any action was taken with Cimzia  and Omalizumab.     At the time of reporting, the event of abdominal pain upper, anaphylactic shock, arthritis, asthma, blood pressure systolic increased, drug ineffective, dyspnoea, fear of injection, humidity intolerance, incorrect dose administered, insomnia, lower respiratory tract infection, malaise, mobility decreased, nasopharyngitis, obstructive airways disorder, oral candidiasis, oropharyngeal pain, pain in extremity, pollakiuria, pruritus, respiratory tract infection, rheumatoid arthritis, rhinorrhoea, sensitivity to weather change, speech disorder, throat irritation, throat tightness, tooth abscess, urticaria, vaccination site erythema, vaccination site inflammation, vomiting and wheezing was ongoing.     The reporter assessed the event reported abdominal pain upper , arthritis ,asthma, blood pressure systolic increased ,,dyspnoea,fear of injection ,humidity intolerance,incorrect dose administered ,insomnia ,lower respiratory tract infection ,mobility decreased ,nasopharyngitis, obstructive airways disorder, oral candidiasis ,oropharyngeal pain,pain in extremity, pollakiuria, ,respiratory tract infection, rheumatoid arthritis ,rhinorrhoea, sensitivity to weather change, speech disorder ,throat irritation ,throat tightness, tooth abscess, urticaria, vaccination site erythema, vaccination site inflammation ,vomiting ,wheezing.pruritus ,malaise ,anaphylactic shock,drug ineffective to be serious due to important medical event criterion.       The company physician  did not consider that there was a reasonable possibility of a causal relationship between influenza and the following  event(S): abdominal pain upper , arthritis ,asthma, blood pressure systolic increased, dyspnoea, fear of injection ,humidity intolerance, incorrect dose administered ,insomnia ,lower respiratory tract infection ,mobility decreased ,nasopharyngitis, obstructive airways disorder, oral candidiasis ,oropharyngeal pain, pain in extremity, pollakiuria, ,respiratory tract infection, rheumatoid arthritis ,rhinorrhoea, sensitivity to weather change, speech disorder ,throat irritation ,throat tightness, tooth abscess, vomiting & wheezing & pruritus.        The company physician considered that there was a reasonable possibility of a causal relationship between influenza and the following event: (s) urticaria, vaccination site erythema, vaccination site inflammation, malaise, anaphylactic shock, drug ineffective      Device Information:     Combination Product Report: Yes    Product As Reported: Influenza  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Anaphylactic shock, vaccination site erythema and vaccination site inflammation are not listed in company core datasheet of Q/LAIV. Serious event of drug ineffective is also reported in the case. Due to limited information on date of vaccination, onset date of events, concomitant conditions, risk factors (allergies, autoimmune disorder), medical history (infection, trauma), relevant family history, circumstances leading to events, treatment given, detailed diagnostic and etiologic workup including baseline reports if available (blood work up, infection panel, imaging studies), the evaluation did not find the evidence to suggest a causal relationship between the event and Q/LAIV. The case is further confounded by polypharmacy.