Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Skin warm, Somnolence
Clinical narrative: This spontaneous case was initially received on 26-Oct-2015. The case report was received from a(n) Non Health Professional and concerns a(n) 60 years old female patient. Weight: not provided, Height: 63.5 inches. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Afluria for indication Protection against the influenza virus on 20-Oct-2015 - 20-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 22-Oct-2015, after starting / treatment with Afluria the patient experienced Drowsiness (non serious, outcome: Not Recovered / Not Resolved), Malaise/Increased malaise (non serious, outcome: Not Recovered / Not Resolved), Chills (non serious, outcome: Not Recovered / Not Resolved), Felt warm/[Had a fever because] she was warm to touch/Feeling hot/Forehead was hot to touch (non serious, outcome: Not Recovered / Not Resolved). On 25-Oct-2015, after starting / treatment with Afluria the patient experienced Fever (non serious, outcome: Not Recovered / Not Resolved), Nasal congestion/Congestion in context of nasal congestion (non serious, outcome: Not Recovered / Not Resolved). On an unknown date, after starting / treatment with Afluria the patient experienced Rhinorrhoea (non serious, outcome: Not Recovered / Not Resolved). Action taken: discontinued. Event treatment: No antipyretic treatment. Patient treated with oxymetazoline. For relevant test results see appropriate report section. Reporter's assessment: ***Follow-up information received from a HCP on 06-Nov-2015: The reporter reported the term 'lack of effect' and assessed the causality as 'unlikely' in relation to Afluria. ***Case correction 08-Feb-2016: AE 8 'lack of effect' updated to core listed, AEs 1 to 8 upgraded to serious based on reported lack of effect. Sender's Comments: Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Malaise/Increased malaise, Chills and Fever are listed events of Afluria, the events Drowsiness, Felt warm/[Had a fever because] she was warm to touch/Feeling hot/Forehead was hot to touch, Nasal congestion/Congestion in context of nasal congestion and Rhinorrhoea are unlisted events of Afluria. Case Causality: Possible. Company's evaluation and comment 26-Nov-2015: no change in assessment. Company evaluation and comment: updated 11-Feb-2016. Seriousness criterion/criteria: Medically significant due Lack of effect. Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine, and the Afluria PI, drowsiness is unlisted. All other events (malaise, increased malaise and chills, warm to touch, feeling hot, forehead hot to touch, nasal congestion, congestion  and rhinorrhoea) are listed in context of Influenza like illness (ILI). Lack of effect is also listed as vaccine efficacy is not 100%. Causality: Possible. Time to onset is 3 days for initial events(drowsiness, malaise, chills, fever) and 6 days for respiratory tract symptoms. The time to onset is not consistent for lack of efficacy as seroconversion following immunisation takes at least 2 weeks. Additionally there is no lab data to suggest Influenza infection. The events most likely represent Influenza like illness which is defined as fever, in association with  upper respiratory tract symptoms (nasal congestion and rhinorrhoea) and 2 systemic symptoms (chills malaise). ILI can occur in the week following vaccination. Causality is considered possibly related for all events but not in context of vaccination failure. Causality is unrelated for event of Lack of effect.