Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, IPV
Symptoms: Discomfort, Erythema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: the patient developed redness and swelling to site; the patient developed redness and swelling to site; Child continues to complain of pain with movement on left arm; Child complained of having discomfort with movement of left arm and pain at night; This spontaneous report was received from a health care professional, via Food & Drug Administration, referring to a  non-pregnant, 12-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.  On 05-FEB-2019 at 11:45 hours (hrs), the patient was vaccinated with first 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 N025429, expiration date was not reported but upon internal validation stablished as 21-JUL-2020). On the same date, the patient was also vaccinated with first dose of hepatitis A virus vaccine inactivated (HAVRIX), intramuscular route, in the left arm (dose was not reported; lot number 2GY7E, expiration date was not reported), and with poliovirus vaccine inactivated (vero) (IPOL) intramuscular route, on the left arm (dose and dosage number were not reported; lot number P1A171M, expiration date was not reported). All the suspect vaccines were given as prophylaxis.  On the same date, the patient was concomitantly vaccinated in the right arm with diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL), measles virus vaccine live (enders-edmonston), mumps virus vaccine live (jeryl lynn), rubella virus vaccine live (wistar ra 27/3) (M-M-R II) and hepatitis b virus vaccine rhbsag (yeast) (RECOMBIVAX).  On 05-FEB-2019 at 12:00 hrs, the patient experienced pain in site (pain in extremity); furthermore, the patient developed redness (erythema) and swelling in the site that lasted 2 weeks (approximately until 19-FEB-2019). The patient continued to complain about pain when moving the left arm.  On 26-FEB-2019, the patient was taken to the vaccination facility by his guardian. Upon physical examination, no redness or swelling in the site was noted. The patient complained of having discomfort when moving his left arm and pain at night (limb discomfort). No other problems were identified that day. No medical of laboratory test were performed.  The outcome of erythema and swelling was recovered. The outcome of limb discomfort and pain in extremity was not recovered. The relatedness between the aforementioned events and the suspect therapies, was not reported.  Follow-up information has been received from the health care professional on 14-JAN-2020. The expiration date of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as 21-JUL-2020, vaccinated in left deltoid. The expiration date of hepatitis A virus vaccine inactivated (HAVRIX) was reported as 07-AUG-2020, vaccinated in left deltoid. The expiration date of poliovirus vaccine inactivated (vero) (IPOL) was reported as 24-APR-2020, vaccinated in left deltoid. Unspecified days after vaccination, the patient was brought back by guardian. The patient complaint with pain and swelling to left upper arm. Light redness was noted, no swelling. No medication was given. The reporter considered the event was related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).