Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Injection site rash, Lip swelling, Pruritus
Clinical narrative: Long rash on left arm; Arm pain (at the injection site); Allergic reaction on left side; Allergic-type reaction:  lip swelling; Face got really itchy; Felt like lump in her throat; Extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 30th 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 Covid vaccine with an associated reaction of injection site rash (received on an unknown date and experienced rash at the injection site after Covid 19 shot). Concurrent medical conditions included allergic reaction and epipen (has an allergic history/has an epi-pen). Concomitant products included galcanezumab (Emgality).   On 12th August 2021, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 12th August 2021, less than an hour after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain, allergic reaction, lip swelling, pruritus facial, lump feeling in throat and fatigue. On 19th August 2021, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl Oral), dexamethasone (Dexamethasone Oral) and steroids nos (Steroid (Not Specified)). On 19th August 2021, the outcome of the allergic reaction, lip swelling, pruritus facial, lump feeling in throat and fatigue were recovered/resolved. On an unknown date, the outcome of the injection site pain and rash were not recovered/not resolved.   The reporter considered the injection site pain, allergic reaction, lip swelling, pruritus facial, lump feeling in throat, fatigue and rash 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 case was reported by the mother of the patient. The reporter is the mother. The patient is the daughter. The patient received dose 1 of Bexsero (BEXSERO SUSP 1D/O.5ML PFS X10 10 PFS/CARTON) intramuscularly in the left deltoid. The reporter stated that, the patient would not be getting dose 2, Within 30 minutes of the injection the patient experienced an allergic-type reaction, lip swelling, face got really itchy, she felt like she had a lump in her throat, extreme fatigue almost instantly, and left arm pain (at the injection site).  The patient was taken to urgent care where she was given oral Benadryl and oral dexamethasone. The reporter stated that, these medications helped, none of her symptoms got worse, most of her symptoms got better (everything except the arm pain) but they did not resolve entirely.  The patient was sent home with steroid tablets, two days later she was still reacting/still itchy,so she took one of the steroid tablets and that cleared it up again.  As of today on 19th August 2021) all of the mentioned symptoms have fully resolved except for the arm pain.  The patient has had significant arm pain (at the injection site) for the past week.  Today on 19th August 2021, the patient has a rash on her left arm, the rash showed up today.  The rash was not exactly where the injection was given but slightly toward the inside of her upper arm. It was a long rash, this has not resolved. The reporter consented to follow up.