Age: 26.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site mass, Injection site pain, Soft tissue necrosis, Ultrasound scan abnormal
Clinical narrative: Ultrasound of right upper extremity (RUE) showed necrotic adipose tissue.; Patient seen 7/22/2019, complained of (c/o) tenderness in right (R) deltoid; Mass palpable 3 cm X 2cm.; Information has been obtained on request by the Company from the FDA on 18-AUG-2020, concerning a female patient of unknown age. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD). Her medical history and allergies to medications, food or other products were reported as none. Concomitant therapies included: Concomitant therapies included lycopene (+) minerals (unspecified) (+) vitamins (unspecified) (+) xanthophyll (CENTRUM WOMEN), drospirenone (+) ethinyl estradiol(YASMIN 28), omeprazole and selenium (unspecified).   On 28-JUN-2019 at 09:18, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose number in series reported as 4, administered intramuscularly (IM) in the right arm (dose and vaccine scheme not provided; lot number 1602284 has been verified to be a valid lot number, expiration date not reported, but upon internal validation was established as 26-SEP-2021), as prophylaxis; and with diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) dose number in series reported as 2, administered IM in the left arm (dose, vaccine scheme were not reported; lot number was reported as U6213M, expiration date not provided), as prophylaxis.  On 22-JUL-2019 at 14:02, the patient was seen in the doctor or other healthcare professional office/clinic visit and complained of (c/o) tenderness in right (R) deltoid (myalgia). The patient had a mass palpable of 3-centimeter (cm) x 2 cm. An ultrasound of right upper extremity (RUE): showed necrotic adipose tissue (Soft tissue necrosis). The area was improving, but patient told to see surgeon if improvement did not continue.  The outcome of the events and the causality assessment of the suspect vaccines with the aforementioned events were not provided.  Follow up received from the reporting health care professional during a phone call on 18-SEP-2002. The health care professional stated that original reporter had not worked for the office "over a year".  The health care professional reported that she was responsible for reporting adverse events and speaking with the patients "if they had any issues", but that because this patients name was anonymized, she cannot provide any information.  Upon internal review, the event of soft tissue necrosis was considered to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent