Sex: U
Vaccine: FLU4
Symptoms: Parosmia, Peripheral swelling, Peroneal nerve palsy, Sensation of blood flow, Vertigo
Clinical narrative: Drop foot of the right side; Occipital headaches with pulsing on the back of head; Poor balance, many almost falls; one fall and many almost falls,; Worsening pain in the arms; Constant migraine with excessive gasoline smell; Nausea; Vertigo; immediately blood rush to the head; Sharp pain in the left armpit; Heart palpitation; Shortness of breath; Weakness of the limbs and weakness of the right Leg; Almost fainting sensation and Dizziness; Difficulty of urination; Swelling ankles; Swelling hands; Fluctuating BP; This case was reported by a consumer and described the occurrence of sensation of blood flow in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 7LX9G, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, less than a day after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced axillary pain, palpitation, shortness of breath, weakness of limbs, felt faint, urination difficulty, ankle swelling, hand swelling and blood pressure fluctuation. On 27th October 2021, the patient experienced sensation of blood flow. On 16th November 2021, the patient experienced migraine, nausea and vertigo. On an unknown date, the patient experienced foot drop, occipital headache, balance difficulty, fall and pain in arm. On 27th October 2021, the outcome of the sensation of blood flow was recovered/resolved. On 9th November 2021, the outcome of the foot drop was recovered/resolved. On 28th November 2021, the outcome of the migraine, nausea and vertigo were recovered/resolved. On an unknown date, the outcome of the axillary pain was recovered/resolved and the outcome of the palpitation, shortness of breath, weakness of limbs, felt faint, urination difficulty, ankle swelling, hand swelling and blood pressure fluctuation were unknown and the outcome of the occipital headache, balance difficulty, fall and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the sensation of blood flow, axillary pain, palpitation, shortness of breath, weakness of limbs, felt faint, urination difficulty, ankle swelling, hand swelling, blood pressure fluctuation, foot drop, migraine, nausea, vertigo, occipital headache, balance difficulty, fall and pain in arm to be related to Fluarix Quadrivalent 2021-2022 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 age at vaccination was not reported. On 27th October 2021, between 15:00-15:30, the patient received dose of Fluarix Quadrivalent 2021-2022 season in left deltoid and immediately experienced blood rush to the head which went away while sitting for a while. On 28th October 2021, around 5:00 am, the patient experienced sharp pain in the left armpit for a short while. On 28th October 2021 about 13:00, the patient experienced suddenly onset of heart palpitation, shortness of breath, dizziness, weakness of the limbs, almost fainting sensation, difficulty of urination, swelling ankles and hands, and fluctuating BP. From 29th October 2021 to 9th November 2021, all these symptoms continued and the patient also experienced drop foot of the right side and weakness of the right leg. From 16th November 2021, the patient started to experience constant migraine with excessive gasoline smell, nausea, dizziness and vertigo until 28th November 2021. Currently the patient had intermittent occipital headaches with pulsing on the back of head (at night), weakness in the right leg, dizziness, poor balance, one fall and many almost falls, swelling of hands and worsening pain in the arms. The reporter consented to follow up.