Age: 51.0
Sex: F
Vaccine: FLU4, FLU4, UNK
Symptoms: Dysphonia, Dyspnoea, Swelling face, Swelling of eyelid
Clinical narrative: face swelling; could  not see her eyelids; Could not take a deep breath; She was hoarse; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 51-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number FZ453, expiry date 30th June 2023) 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 shot (had many past yearly flu shots, about 24 past yearly flu shots in past). Concurrent medical conditions included blood pressure and drug allergy (allergic to Propylene Glycol). Concomitant products included medication unknown (Blood Pressure Medication).   On 21st September 2022 13:45, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular). On 21st September 2022, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 21st September 2022, 15 min after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced facial swelling, swelling of eyelid, difficulty breathing and hoarse voice. The patient was treated with steroids nos (Steroid Shot (Nos)). On an unknown date, the outcome of the facial swelling and swelling of eyelid were recovering/resolving and the outcome of the difficulty breathing and hoarse voice were recovered/resolved.   The reporter considered the facial swelling, swelling of eyelid, difficulty breathing and hoarse voice to be related to Fluarix Quadrivalent 2022-2023 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 Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: The reporter was the patient.  The patient had a Fluarix shot yesterday in right deltoid and experienced a severe adverse reaction of face swelling. The event happened about 15 minutes after the shot.  The patient stated, they gave her Benadryl and within an hour patient was worse. Less than a day after receiving Fluarix and Benadryl, the patient was hoarse, and she could not take a deep breath.  The patient could breathe but she could not take a deep breath.  The patient called her allergy doctor and she called a friend to sit with her, while she waited for the allergy office to call her back.  The allergy office advised her to use her Epi-pen, but she did not have an Epi-pen because she had never had a reaction before. They also advised her to go to the emergency room, because she had mentioned not being able to take a deep breath, but she refused to go to the ER.  The patient did not take any more Benadryl yesterday because she was not advised to do so. The patient stated her face was still swollen today. The patient took 2 Benadryl at 7:00 am and 2 more Benadryl at 11 am on reporting day.  She went to the doctor on reporting day and received a steroid shot around 8:30 am and the doctor also wrote her a prescription for an Epi-pen and also prescribed prednisone tablets to start tomorrow if she needs them.  Her faced was still swollen but she could see some improvement.   The patient stated she could now saw her eyelids because, as of this morning, she could not saw her eyelids at all due to the swelling.   Patient said it was improving but it was still swollen. It was unknown if the reporter considered the difficulty breathing and hoarse voice to be related to Benadryl. The reporter consent to follow up. Additional Supportive Information: The co-suspect product Benadryl was only retained in narrative, as the ingredient was NOS which leads to report failure.