Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Myalgia, Respiratory tract congestion, Vaccination failure
Clinical narrative: Flu, type A; Vaccination failure; Swab test/ Flu, type A; Feeling sick; Extreme fatigue; Muscle ache; Chills; Cough; Congestion; This is a spontaneous case initially received from other non-health professional (consumer) on 31-Jan-2019, concerning a 39-year-old, adult female patient.  The patient had no medical history and had not received any concomitant medications.  On 08-Nov-2018, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid, dose, batch number, expiry date, trade name and manufacturer: not reported) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.   On 30-Jan-2019, 2 months and 22 days after vaccination, the patient started feeling sick with extreme fatigue, muscle ache, chills, cough and congestion. The patient had no fever. On the same day, the patient went to her physician's office for a consultation and a swab test was performed on the same day. The patient was diagnosed with type A flu (influenza A virus test positive) (explicitly coded as vaccination failure). The patient was treated with Tamiflu (oseltamivir phosphate) for 9 days (from 30-Jan-2019 to 08-Feb-2019).  The outcome of all the events was recovered on 07-Feb-2019.  The reporter assessed the case as non-serious.  Non-significant follow up received from the reporter on 12-Mar-2019: agency number (SEQ19-00699) was updated in the additional information tab. As there was no new information in the source document hence no changes were made in narrative.  Follow up received from other non-health professional (consumer) on 14-Mar-2019: The reporter's details (institution, email address and fax number) were added in the general tab. The patient's email address was added in the patient tab. The patient had no medical history and had not received any concomitant medications. Added new events vaccination failure, feeling sick, fatigue extreme, muscle ache, chills, cough and congestion in the event tab [start date: 30-Jan-2019 and stop date: 07-Feb-2019]. On 30-Jan-2019, swab test was performed which resulted positive for flu (influenza A virus test). Added treatment medication Tamiflu (oseltamivir phosphate) (start date: 30-Jan-2019 and stop date: 07-Feb-2019) was added in the product tab. The outcome of the event influenza A virus infection was changed from not reported to recovered in the event tab as the events resolved on 07-Feb-2019. The causality of the event influenza A virus infection was changed from 'unassessable' to 'related' in the event assessment tab. It was reported that the patient received the influenza vaccine at work and no further information was available to identify the vaccine administered. The narrative was amended accordingly.; Reporter's Comments: A 39-year-old female patient was diagnosed with type A flu (influenza), 2 months 22 days after vaccination with INN flu vaccine (considered as vaccination failure). The event influenza was confirmed as type A (positive for flu) by swab test. Time to onset is plausible following vaccination with the reported Influenza and vaccination failure events. Hence, company assessed the events as possibly related to suspect vaccine. The company assessed the case as serious (medically significant).