Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received 2 shots on Thursday and now there is a big circle/ lump on arm; A little itchy; The patient as having a softball sized swelling at vaccination site and itching; Information has been received from Food & Drug Administration (FDA) (VAERS # 856916) on 04-FEB-2022.   This spontaneous report has been received from a healthcare professional (also reported as staff), referring to an 11-year-old male patient.  The patient's medical history included bilateral otitis media acute(AOM) (on 20-NOV-2019) treated with amoxicillin (resolved at the time of vaccination with normal ear exam). The patient's concurrent conditions included dermatitis atopic, anemia, elevated blood pressure reading without a diagnosis of hypertension, obesity, elevated hemoglobin a1c, rhinitis allergic, and prophylaxis. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications, over-the-counter medications, dietary supplements, or herbal remedies.  On 08-JAN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1621929, expiration date: 06-DEC-2021, administered intramuscularly in the right arm for prophylaxis (dose not reported); the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX)lot number 3sn5b, administered intramuscularly in the left arm for prophylaxis (dose and expiry date were not provided); and the first dose of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO), Lot number amva193a, administered intramuscularly in the left arm for prophylaxis (dose and expiry date were not provided).   On 09-JAN-2020, after receiving two shots the patient experienced a big circle/ lump on arm. After talking with the patient's mother she stated that the bump in the left arm on 09-JAN-2020 (Limb mass), was a little itchy (Pruritus), and there was no pain. On 10-JAN-2020, the patient's mother found that it was large. No medicines were administered to the patient. It was noted that there were no other associated symptoms, no other rash, edema, oral changes, breathing changes, or fever. The patient's mother received the advice to administer diphenhydramine hydrochloride (BENADRYL) every 6-8 hours as needed and topically may use OTC hydrocortisone cream and ice pack/cold compress for the itch. The patient's mother was advised to consult the emergency department if any distress and urgent care if worsening skin symptoms or new concerns over the weekend. The patient was also referred to an allergist. No lab tests were performed.  On 13-JAN-2020, a call was performed to the patient's parent who mentioned that the symptoms were resolved, treatment with diphenhydramine hydrochloride (BENADRYL) helped. There were no additional concerns.  The causal relationship between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) were unknown.  Follow up information was received on 31-MAR-2022 from the physicians assistant. It was stated that she vaguely remembered the patient had a softball sized swelling at vaccination site (vaccination site swelling) and itching (event previously reported). Also, that the patient utilized diphenhydramine hydrochloride (BENADRYL) and maybe prednisone with good effects and resolution of swelling and itching. she would be unable to locate additional patient information without patient identifiers vaccination site.  The causal relationship between vaccination site swelling and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) were unknown.