Age: 63.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Off label use, Palpitations
Clinical narrative: feeling tired and wiped out; uncontrolled crying; high anxiety; boost of energy; heart was racing; she is not sleeping; have taken FLULAVAL QIV whilst on prednisone; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 63-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and prednisone for product used for unknown indication.   Concurrent medical conditions included ulcerative colitis and asthma.   On 23rd November 2021 07:45, the patient received FluLaval Quadrivalent 2021-2022 season. On 23rd November 2021, the patient started Flulaval Tetra Pre-Filled Syringe Device. In November 2021, the patient started prednisone 60 mg at an unknown frequency. On 23rd November 2021, the dose was changed to 40 mg at an unknown frequency. On 23rd November 2021, less than an hour after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced tiredness, crying uncontrollable, anxiety, energy increased, heart racing, insomnia and off label use. The dose of prednisone was decreased. On an unknown date, the outcome of the tiredness, crying uncontrollable, anxiety, energy increased, heart racing and insomnia were recovered/resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the tiredness, crying uncontrollable, anxiety, energy increased, heart racing and insomnia to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of FluLaval Quadrivalent 2021-2022 season at her physician office this (day of reporting) morning at 7.45am and within an hour she experienced some side effects like boost of energy, heart was racing, high anxiety, uncontrolled crying, and is now feeling tired and wiped out that lasted about 1.5 hours. The patient was currently taking Prednisone and was on day 4 of a tapering regimen. The reporter also stated that she had been taking Prednisone 60mg for 3 days and today (day of reporting) she took 40mg.  The patient was not sleeping due to taking Prednisone. The reporter stated that she did contact her clinic and spoke to the nurse. The reporter would like to know if she should not have taken FLULAVAL QIV whilst on prednisone.  The reporter was given medical disclaimer and referred to HCP. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. It was unknown if the reporter considered the tiredness, crying uncontrollable, anxiety, energy increased, heart racing to be related to prednisone. The reporter considered insomnia to be related to prednisone.