Age: 68.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Breast mass, Breast pain, Cough, Disability assessment scale score increased, Dry eye
Clinical narrative: ASTHENIA; FATIGUE; HEADACHE; NASAL CONGESTION; ARTHRALGIA; ASTHMA; BLOOD PRESSURE DIASTOLIC ABNORMAL; BLOOD PRESSURE SYSTOLIC ABNORMAL; BREAST MASS; BREAST PAIN; COUGH; DISABILITY ASSESSMENT SCALE SCORE INCREASED; DRY EYE; DYSPNOEA; FALL; HEART RATE DECREASED; ILLNESS; INFLUENZA; INFUSION RELATED REACTION; INSOMNIA; NASOPHARYNGITIS; OEDEMA; OEDEMA PERIPHERAL; OROPHARYNGEAL PAIN; OXYGEN SATURATION DECREASED; PAIN IN EXTREMITY; PRODUCTIVE COUGH; PYREXIA; RESPIRATORY TRACT CONGESTION; SINUSITIS; STRESS; URINARY TRACT INFECTION; WEIGHT DECREASED; WRIST FRACTURE; WEIGHT INCREASED; RHINORRHOEA; INTENTIONAL PRODUCT USE ISSUE; OFF LABEL USE; A solicited report from a non-interventional study/data collection program has been received from the consumer via regulatory authority concerning a female patient of Unknown ethnic origin (age 68 years, weight 67 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    Concomitant medication included paracetamol for product used for unknown indication and acetylsalicylic acid for product used for unknown indication.     On an unknown date, the patient received Influenza Vaccines (influenza vaccine) unknown, via unknown route for unknown indication.    The patient started treatment with Actemra (tocilizumab) 520 mg every four weeks, intravenous (not otherwise specified), on an unknown date for rheumatoid arthritis, with Folic Acid (folic acid) with Methotrexate (methotrexate) and with Pneumococcal Vaccine (pneumococcal vaccine)for unknown indication.     No malfunction has been reported for INFLUENZA VACCINES.    The report described off-label use for Influenza Vaccines ,Actemra ,Folic Acid, Methotrexate and Pneumococcal Vaccine. The reported term was intentional product use issue (Preferred term: Intentional product use issue) and off label use (Preferred term: Off label use).     It was reported that on an unknown date, the patient experienced asthenia (preferred term: Asthenia), fatigue (preferred term: Fatigue), headache (preferred term: Headache), nasal congestion (preferred term: Nasal congestion), arthralgia (preferred term: Arthralgia), asthma (preferred term: Asthma), blood pressure diastolic abnormal (preferred term: Blood pressure diastolic abnormal), blood pressure systolic abnormal (preferred term: Blood pressure systolic abnormal), breast mass (preferred term: Breast mass), breast pain (preferred term: Breast pain), cough (preferred term: Cough), disability assessment scale score increased (preferred term: Disability assessment scale score increased), dry eye (preferred term: Dry eye), dyspnoea (preferred term: Dyspnoea), fall (preferred term: Fall), heart rate decreased (preferred term: Heart rate decreased), illness (preferred term: Illness), influenza (preferred term: Influenza), infusion related reaction (preferred term: Infusion related reaction), insomnia (preferred term: Insomnia), nasopharyngitis (preferred term: Nasopharyngitis), oedema (preferred term: Oedema), oedema peripheral (preferred term: Oedema peripheral), oropharyngeal pain (preferred term: Oropharyngeal pain), oxygen saturation decreased (preferred term: Oxygen saturation decreased), pain in extremity (preferred term: Pain in extremity), productive cough (preferred term: Productive cough), pyrexia (preferred term: Pyrexia), respiratory tract congestion (preferred term: Respiratory tract congestion), sinusitis (preferred term: Sinusitis), stress (preferred term: Stress), urinary tract infection (preferred term: Urinary tract infection), weight decreased (preferred term: Weight decreased), wrist fracture (preferred term: Wrist fracture), weight increased (preferred term: Weight increased), and rhinorrhoea (preferred term: Rhinorrhoea).     It was unknown if any action was taken with Influenza Vaccines, Actemra ,Folic Acid, Methotrexate and Pneumococcal Vaccine.    At the time of reporting, the outcome of the events asthenia, fatigue, headache, nasal congestion, arthralgia, asthma, blood pressure diastolic abnormal, blood pressure systolic abnormal, breast mass, breast pain, cough, disability assessment scale score increased, dry eye, dyspnoea, fall, heart rate decreased, illness, influenza, infusion related reaction, insomnia, nasopharyngitis, oedema, oedema peripheral, oropharyngeal pain, oxygen saturation decreased, pain in extremity, productive cough, pyrexia, respiratory tract congestion, sinusitis, stress, urinary tract infection, weight decreased, wrist fracture, weight increased, rhinorrhoea, intentional product use issue and off label use was reported as not recovered.    The reporter considered the events asthenia, fatigue, headache, nasal congestion, arthralgia, asthma, blood pressure diastolic abnormal, blood pressure systolic abnormal, breast mass, breast pain, cough, disability assessment scale score increased, dry eye, dyspnoea, fall, heart rate decreased, illness, influenza, infusion related reaction, insomnia, nasopharyngitis, oedema, oedema peripheral, oropharyngeal pain, oxygen saturation decreased, pain in extremity, productive cough, pyrexia, respiratory tract congestion, sinusitis, stress, urinary tract infection, weight decreased, wrist fracture, weight increased, rhinorrhoea, intentional product use issue and off label use as serious due to seriousness criteria of important medical event.     The company physician considered that there was a reasonable possibility of a causal relationship between Influenza Vaccines and the following events: fatigue, nasal congestion, headache and asthenia.     The company physician did not considered that there was a reasonable possibility of a causal relationship between Influenza Vaccines and the following events: breast mass, influenza, oedema, rhinorrhoea, arthralgia, intentional product use issue, dry eye, cough, blood pressure diastolic abnormal, fall, disability assessment scale score increased, wrist fracture, illness, nasopharyngitis, breast pain, stress, oedema peripheral, oropharyngeal pain, infusion related reaction, asthma, dyspnoea, insomnia, productive cough, blood pressure systolic abnormal, oxygen saturation decreased, weight decreased, pain in extremity, sinusitis, heart rate decreased, respiratory tract congestion, pyrexia, urinary tract infection and off label use.     Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINES  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect