Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Inappropriate schedule of product administration, Injection site induration
Clinical narrative: Pain; where she received the shot, has a hard knot with pain and was feeling hot.; where she received the shot, has a hard knot with pain and was feeling hot.; has hard knot; where she received the shot, has a hard knot with pain and was feeling hot.; left arm, on the outer area, wasred,; Warm to touch/like it had fever; whole arm is swollen; first dose was administered August of last year/2nd dose on 29th Sep 2021; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in August 2020).   On 29th September 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 5th October 2021, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and feeling of warmth. On 6th October 2021, the patient experienced injection site pain, injection site nodule, injection site induration and injection site warmth. On an unknown date, the patient experienced pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site nodule, injection site induration, injection site warmth and pain were not recovered/not resolved and the outcome of the erythema of extremities was recovering/resolving and the outcome of the feeling of warmth and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site nodule, injection site induration, injection site warmth, pain, erythema of extremities and feeling of warmth 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 details were provided as follows: The reporter stated that, the patient received a 2nd dose of Bexsero on 29th September 2021, later than the recommended interval which led to lengthening of the vaccine schedule. The patient experienced pain 2 to 3 days after receiving the vaccine.  Tuesday night, on 5th October 2021, it was bad, the patient whole left arm, on the outer area, was kind of looking red, swollen (extensive swelling of vaccinated limb), and warm to touch, like it had fever.  The patient called yesterday on 6th October 2021 and the redness was not there, but the lower part of the left arm was pink, and where she received the shot, has a hard knot with pain and was feeling hot. The patient was coming back today on 7th October 2021 for a follow up, and physician told her to take Ibuprofen.  The reporter asked, should she tell the patient that this was a just a local reaction. The reporter was concerned with the length of time of the reactions.  The reporter stated that, she usually sees reactions within 48 hours after the vaccine, but for this patient was worse on day 6.  The reporter consented to follow up via email.