Age: 16.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMRV, MNQ, HEP, HPV9, IPV, MMRV, MNQ
Symptoms: Erythema, Product administered to patient of inappropriate age, Product prescribing error, Swelling face
Clinical narrative: prescribing error; dispensing error; preparation for administration; right side of face red and swollen; right side of face red and swollen; patient is 16 and age cut off is 12 for proquad; This spontaneous report as received from a health professional via FDA refers to a 16-year-old White male patient. It was reported that the patient had no pertinent medical history, no known allergies and drug reactions and did not take any concomitant medications.  On 30-JAN-2019 at 16:00, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R019469, expiration date not reported, but upon internal validation established as 10-APR-2021, dose 2, intramuscular in the left arm), measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHa (PROQUAD) (lot number R022564, expiration date not reported, but upon internal validation established as 04-FEB-2020, dose 2, subcutaneous in the right arm), hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) (lot number 27S5S, expiration date not reported, dose 3, intramuscular in the left arm), poliovirus vaccine inactivated (vero) (IPOL) (lot number P1A242M, expiration date not reported, dose 2, intramuscular in the right arm) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot number U6151AB, expiration date not reported, dose 2, intramuscular in the left arm), for prophylaxis. On 01-FEB-2019 at 07:00, the patient woke up with right side of face red and swollen. No treatment was given. No laboratory tests were performed. The symptoms went away after 5 hours. The outcome of the events was reported as recovered.  The relatedness between the events and suspect therapies was not reported.   Follow up information has been received from an unspecified reporter (vaccine provider) on 23-OCT-2019.   The patient's details were updated. The patient was vaccinated with hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) lot number 27S5S, expiration date: 20-OCT-2020, poliovirus vaccine inactivated (vero) (IPOL) lot number P1A242M, expiration date: 26-APR-2020, meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot number U6151AB, expiration date: 16-MAR-2020.  It was reported that upon inspection of the vaccines, it was found that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) was supposed to be given to patient's under 12 years of age and however the patient was 16 years old (product administered to patient of inappropriate age). It was also reported that there was an error happened during prescribing, dispensing, preparation for administration and administration of vaccine. It was reported that the vaccine was not available for return as it was used and discarded.  The reporter considered swelling face to be related (reported as most likely) to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD).   The reporter considered swelling face to be medically significant.