Sex: F
Vaccine: MMRV, UNK
Symptoms: Dark circles under eyes, Decreased activity, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: we noticed a spot that looked like a bug bite on her left thigh around where she had the injection for the VAXELIS.; the area was all swollen, red, and warm to the touch.; the area was all swollen, red, and warm to the touch; the area was all swollen, red, and warm to the touch; She hasn't been playing like she usually does; she's had these bags of dark circles under her eyes; her leg was hurting; She had the PROQUAD vaccine a few weeks ago and had a reaction to that too; This spontaneous report has been received from a Consumer regarding a female patient of unknown age.   The patient's medical history included vaccination adverse reaction. The patient's concurrent conditions, concomitant therapies and allergies were not reported.  On an unknown date in 2024 (also reported as a few weeks ago), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter as a two dose series, administered intramuscularly. (lot number and expiration date were not provided). On 31-OCT-2024, the patient was vaccinated with the third dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter as a three dose series, administered intramuscularly (lot number, and expiration date were not provided); both administered for an indication reported as vaccine protection against.   On 02-NOV-2024 (also reported as by Saturday morning), the patient experienced a spot that looked like a bug bite on her left thigh around where she had the injection for diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (Injection site urticaria). By the afternoon, the patient told her parents that her leg was hurting (Pain in extremity), thus, her father checked on it a noticed the area was swollen, red and warm to the touch (Vaccination site swelling, Vaccination site erythema and Vaccination site warmth). It was reported that she hasn't been playing like she usually does (Decreased activity) and that she has these bags of dark circles under her eyes too (Dark circles under eyes). On that same date (reported as Saturday), the reporter (the patient's father) called the on call doctor for her Pediatrician's office and they told him to just keep monitoring her and that he could give her paracetamol (TYLENOL) as treatment for her leg pain. It was stated that the patient hasn't had fever, but the redness and swelling are still there, therefore, her father has been marking the area and measuring her thigh to see if the circumference changes at all. On 04-NOV-2024 (also reported as this morning), the reporter spoke with her Pediatrician and they refer them to a specialist like an allergist. The reporter mentioned that the patient had a reaction when she was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) a few weeks ago (Immunisation reaction) (captured in MARRS# 2410USA010329). No additional information was provided.   At the time of the report, the patient had not recovered from any of the events.   The causal relationship between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) regarding the events of Injection site urticaria, Pain in extremity, Vaccination site swelling, Vaccination site erythema, Vaccination site warmth, Decreased activity, Dark circles under eyes was not provided. The causal relationship of the event of Immunisation reaction was considered to be related to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), while with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid and (VAXELIS) was not related.; Sender's Comments:  US-009507513-2410USA010329:MSD