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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This 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 BEXSERO. Concomitant products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 16th December 2015, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site lump and injection site warmth. On an unknown date, the outcome of the injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump and injection site warmth to be related to BEXSERO. Additional details were received as follows: The patient received the 1st dose in the series of BEXSERO. She also received a meningococcal vaccine on the same day (she believed it might have been brand name MENVEO, but was unsure). The 2 vaccines were administered in different arms. The patient developed a golf-ball sized lump at the site of the BEXSERO vaccine. The lump was red, warm to the touch, and sore for 1 month. The muscle soreness was severe enough to prevent the patient from driving. The patient attempted applying heat and ice, but the pain did not resolve. The patient also took over-the-counter pain medications to relieve the pain. When the patient presented to the clinic for the second BEXSERO injection, the lump had decreased in size, but was still present at the site of the previous injection. The patient''s mother requested that the second BEXSERO injection be administered slightly lower on the muscle and the patient did not have an adverse reaction to the second BEXSERO injection.
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