Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Injection site mass, Injection site pain, Magnetic resonance imaging abnormal, Muscle disorder
Clinical narrative: Greater than 2 months of pain at injection site/ painful lump in left deltoid; Vaccination site nodule; Arm infection; Information has been received from FDA (agency # 856906-1) on 04-FEB-2022  This spontaneous report was received from a healthcare professional and refers to a 16-year-old, no pregnant female patient. The patient's concurrent condition included allergy to penicillin, the patient developed hives. Concomitant therapy was not reported.  On 10-OCT-2019 at 10:30, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the left arm, lot # 1621926, expiration date 28-NOV-2021 (dose and indication were not reported). On the same date, the patient received third dose of influenza vaccine inact split 4v(FLUZONE QUADRIVALENT) intramuscularly in the left arm, lot # UT6681JA (dose, expiration date and indication were not reported).  On 10-OCT-2019, the patient experienced pain at injection site (vaccination site pain). The pain at injection site lasted greater than 2 months. On 04-NOV-20219, the patient with painful lump in the left deltoid was re-evaluated in the office and cephalexin was prescribed for 10 days. Next, the patient was reviewed again at the orthopedic office for a different concern, but the lump and painful shoulder brought the doctor attention. The pain continued and the orthopedist ordered magnetic resonance imaging (MRI) of the shoulder with a result of "small abnormality in the left deltoid presumably related to the patient's recent injection. The left humerus and left shoulder joint appear normal".  At the time of the report, the outcome of vaccination site pain was unknown.  Vaccination site pain was presumably related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and influenza vaccine inact split 4v(FLUZONE QUADRIVALENT).  Follow-up information has been received from a nurse manager on 22-FEB-2022.  The caller reported the patient's name, date of birth and the patient's address. She reported details about person who administered the vaccine, also the date and the site of vaccination was specified as left deltoid for previously mentioned third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and influenza vaccine inact split 4v(FLUZONE QUADRIVALENT). The caller said it was a privately funded vaccine. It was reported that patient sought medical attention 04-NOV-2019, and complained for pain and a nodule in her left arm and obtained previously described treatment with cephalexin, because the arm was treated as a possible infection. The caller stated the patient did not take any daily medications. It was reported that the patient was again at the office on 09-MAR-2020, and did not complain of continued pain at the injection site. The outcome of vaccination site nodule and localized infection was unknown.  Vaccination site nodule and localized infection were presumably related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and influenza vaccine inact split 4v (FLUZONE QUADRIVALENT).