Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Arthralgia, Immediate post-injection reaction, Product administered at inappropriate site
Clinical narrative: sharp pain in the left shoulder, up to 5/10; Bursitis Infective/inflammatory; Tendinosis or low-grade interstitial tearing; Vaccine administered at inappropriate site; Patient experienced Immediate severe pain, 10/10.; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS # 819102) referring to a 16-year-old male patient.   The patient had no prescriptions, over-the-counter medications, dietary supplements or herbal remedies being taken at the time of vaccination. He had no known allergies to medications, food or other products; the patient had no other illnesses at the time of vaccination or up to one month prior, neither had chronic or long-standing health conditions. Patient historical vaccinations included varicella on 29-APR-2003, which cause a local reaction at the thigh injection site that improved on its own.  On 26-NOV-2018, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular route, in the left arm (dose was not reported, lot number reported as  N035857 was verified not to be valued, expiration date was not reported) as prophylaxis. On the same date and time, the patient was vaccinated with the third dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) intramuscular route, in his the left arm (dose not reported; lot number U6153AA, expiration date and indication were not reported).  At the aforementioned time, the patient was vaccinated too high on the left arm (vaccinated administered at inappropriate site), immediately experienced a severe pain (pain), on an unspecified dates the patient continues to have sharp pain in the left shoulder (musculoskeletal pain).  On 07-DEC-2018 the patient saw his Primary Care Physician (PCP) and was referred to orthopedic, on an unknow date the patient saw the orthopedic surgeon, when pain films were negative, and received Meloxicam as treatment.   On 16-MAY-2019 the patient returned on his PCP, there was performed a MRI that showed mild to moderate diffuse thickening of the subacromial subdeltoid bursa (bursitis infective), and possible mild tendinosis or low-grade interstitial tearing in the anterior infraspinatus tendon (tendon disorder).   On 06-NOV-2019 the patient started physical therapy (physiotherapy) for left shoulder impingement/bursitis.   On 06-DEC-2019 the patient was referred back to the orthopedic surgeon, there was collected markes of inflammation.   The outcome of pain, musculoskeletal pain, bursistis infective and tendon disorder was not recovered. The relatedness between the aforementioned events and the suspect therapies, was not reported.  Followup inforamtion has been received from  the physician on 20-NOV-2020. The lot # was updated to a valid number reported as N035957(previously reported as "N035857"), expiration date not reported, but upon internal validation established as 10-OCT-2020. 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.; 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 meet the criteria for Reportability