Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crying, Eye movement disorder, Fear of injection, Hyperhidrosis, Loss of consciousness
Clinical narrative: loss of consciousness; crying; rolling her eyes back and was unconscious; fear of injection/lady started sweating while looking at the needle; eyes fully open staring at me and started like shaking for 2 seconds,got pale/pallor; tremor/shaking for 2 second; lady started sweating while looking at the needle; she started having color or her skin; This serious case was reported by a physician via other manufacturer and described the occurrence of loss of consciousness in a 29-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T7245) for prophylaxis.   Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 6024MF012) for prophylaxis.   The patient's past medical history included tuberculosis (had tuberculosis test). Concurrent medical conditions included depression, anxiety and insomnia. Concomitant products included escitalopram and hydroxyzine.   On 13-SEP-2024, the patient received the 1st dose of Fluarix 2024-2025 season (intramuscular) and the 1st dose of Novavax COVID-19 Vaccine (intramuscular). On 13-SEP-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced loss of consciousness (Verbatim: loss of consciousness) (serious criteria GSK medically significant and other: serious as per reporter), crying (Verbatim: crying) (serious criteria other: serious as per reporter), eye movement disorder (Verbatim: rolling her eyes back and was unconscious) (serious criteria other: serious as per reporter), fear of injection (Verbatim: fear of injection/lady started sweating while looking at the needle) (serious criteria other: serious as per reporter), pallor (Verbatim: eyes fully open staring at me and started like shaking for 2 seconds,got pale/pallor) (serious criteria other: serious as per reporter), tremor (Verbatim: tremor/shaking for 2 second) (serious criteria other: serious as per reporter), sweating (Verbatim: lady started sweating while looking at the needle) (serious criteria other: serious as per reporter) and skin coloring (Verbatim: she started having color or her skin) (serious criteria other: serious as per reporter). On 13-SEP-2024, the outcome of the tremor was resolved (duration 2 min). The outcome of the loss of consciousness, crying, eye movement disorder, fear of injection, pallor, sweating and skin coloring were resolved.   The reporter considered the loss of consciousness, crying, eye movement disorder, fear of injection, pallor and tremor to be possibly related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the reporter considered the sweating and skin coloring to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the loss of consciousness, crying, eye movement disorder, fear of injection, pallor, tremor and skin coloring to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the sweating to be related to Fluarix 2024-2025 season and Fluarix 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 Information: GSK receipt date: 21-OCT-2024 The reporter reported that they gave the Fluarix shot first and after that, they gave the Novavax vaccine, after that the patient started sweating while looking at the needle, she was wearing her mask all the time, then started to be rolling her eyes back and was unconscious, but with the eyes fully open staring at them and started like shaking for 2 seconds, got pale. The reporter screamed to call 911 and get the epipen. They pulled her down to the floor, took her mask out and started to check for pulse and breathing. The reporter did not know how many seconds passed and she started having color or her skin, closed her eyes and then opened them, asking what happened and the reason she was on the floor. The reporter explained to her, and she started crying and wanted to get up. The reporter told her to stay on the floor, she did not want 911 to come. She said she was so embarrassed about that. She said it happened once while she got her TB (Tuberculosis test). She told him/her she should had warned that she was afraid of needles, and she had the same episode once already. The reporter mentioned that the 911 was on the phone, told to not come. The patient was normal, trying to stand up as soon as she could. The reporter did not want her to go home alone, she lives literally around the corner of pharmacy. Manager of the store and technicians were witnesses of what happened. The reporter told her to call us as soon as she gets home, and she did. She was ok according to the technician. At the time of reporting, the event outcome of loss of consciousness, crying, eye movement disorder, fear of injection, pallor, and tremor was recovered/resolved. No concomitant medications were reported. The reporter considered the loss of consciousness, crying, eye movement disorder, fear of injection, pallor and tremor to be possibly related to Novavax COVID-19 Vaccine.  It was unknown if the company considered the sweating and skin coloring to be related to Novavax COVID-19 Vaccine.; Sender's Comments: Loss of consciousness, Crying, Eye movement disorder, Fear of injection, Pallor, Tremor and Skin discolouration are unlisted events which are considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE. Hyperhidrosis is a listed event which, due to the following criteria (concurrent anxiety) is considered unrelated to GSK  vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.