Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Periorbital swelling, Skin wrinkling, Swelling face, Visual impairment
Clinical narrative: where the vaccine was given, which was on the left hand, she had a big red knob,; where the vaccine was given, which was on the left hand, she had a big red knob,; her eyes were itching,; they were a little red but nothing severe,; eyes were completely swollen,; wrinkled; puffy eye; puffy face; could not see; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 19-AUG-2024, the patient received Bexsero (left arm). In AUG-2024, less than a day after receiving Bexsero, the patient experienced injection site lump (Verbatim: where the vaccine was given, which was on the left hand, she had a big red knob,), injection site erythema (Verbatim: where the vaccine was given, which was on the left hand, she had a big red knob,), eye pruritus (Verbatim: her eyes were itching,), eye red (Verbatim: they were a little red but nothing severe,), eye swelling (Verbatim: eyes were completely swollen,), wrinkles (Verbatim: wrinkled), puffy eyes (Verbatim: puffy eye), facial swelling (Verbatim: puffy face) and visual impairment (Verbatim: could not see). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the injection site lump, injection site erythema, eye pruritus and wrinkles were unknown and the outcome of the eye red, puffy eyes and facial swelling were not resolved and the outcome of the eye swelling was resolved and the outcome of the visual impairment was not reported.   The reporter considered the injection site lump, injection site erythema, eye pruritus, eye red, eye swelling, wrinkles, puffy eyes, facial swelling and visual impairment to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the injection site lump, injection site erythema, eye pruritus, eye red, eye swelling, wrinkles, puffy eyes, facial swelling and visual impairment to be related to Bexsero and Bexsero 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: 23-AUG-2024 The sales representatives called as they had a parent on the line who informed the following about a dose of Bexsero that was administered to their daughter on her left arm. They gave her the vaccine, she was fine, they monitored her for fifteen minutes, she was fine, they went home and she started stating in the night that her eyes were itching, they were a little red but nothing severe, and then the next day she woke up at 3 in the morning, her eyes were completely swollen, like swollen and wrinkled and she could not see from her eyes, and where the vaccine was given, which was on the left hand, she had a big red knob, like a ball, so it was definitely like a reaction from it. Then they saw the doctor, called the doctor they said it was a reaction, they had been doing Benadryl every 4 to 6 hours, but as the Benadryl would wear off it would become swollen again.  Yesterday (the day before reporting) was the first day where her face was still, her eyes are very puffy and red, but they are not swollen, but her face, her eyes actually are really red and puffy. Consented to follow up.