Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rhinorrhoea
Clinical narrative: Feeling hot; Feeling really tired; Itchiness (mainly around the neck area); Runny nose; Injection site was really swollen; Injection site was really / red; Injection site was really / painful; Pain had spread across to the shoulder; Severe headache; Hot flashes; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 237PS, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine (received flu vaccine (containing egg) twice, on an unknown date and had bad experience) and Flu vaccine (received flu vaccine (without containing egg)). Concurrent medical conditions included food intolerance.   On 4th December 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 4th December 2020, less than a day after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling, injection site erythema, injection site pain, shoulder pain, headache, hot flashes, tiredness, pruritus and runny nose. On an unknown date, the patient experienced feeling hot. On an unknown date, the outcome of the injection site swelling and feeling hot were unknown and the outcome of the injection site erythema, headache, hot flashes, tiredness, pruritus and runny nose were recovered/resolved and the outcome of the injection site pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, shoulder pain, headache, hot flashes, feeling hot, tiredness, pruritus and runny nose to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix 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 had an intolerance to eggs and could eat baked goods with eggs. She previously vaccinated with the flu vaccine (containing egg) twice, and having a bad experience from them. The patient stated the third time she was vaccinated was fine since she received a formulation that was egg-free. The patient received the flu vaccine in her upper left arm at her work and reported that she had an unpleasant experience after receiving the flu vaccine last Friday.  The patient stated the injection site was really swollen, red, and painful. Later on that day the pain had spread across to the shoulder, and she also experienced a severe headache, hot flashes/feeling hot, feeling really tired, itchiness (mainly around the neck area), and a runny nose (lasted all weekend).  The patient reported not breaking out into hives.  The reporter did not consent to follow-up. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR243269:Same reporter. US-GLAXOSMITHKLINE-US2020AMR244107:Same reporter