Age: 33.0
Sex: F
Vaccine: HEP, HEPA, HPV9
Symptoms: Hypoaesthesia, Vaginal haemorrhage, Vulvovaginal discomfort
Clinical narrative: Vaginal bleeding also occurred after 1st and 2nd doses of GARDASIL 9; vaginal bleeding (unrelated to menses); chills; numbness; abdominal pain; vaginal irritation; eye pain; headaches; difficulty breathing; Vaginal bleeding also occurred after 1st and 2nd doses of GARDASIL 9; This spontaneous report has been received from a pharmacist (a local pharmacist that the patient contacted; the pharmacist did not administer any of the vaccines in this report) referring to a 33-year-old non-pregnant female patient. The patient's medical history included depression. The patient's historical vaccine included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP). The patient's concurrent conditions included reaction to allergy medicine (product unknown). Concomitant medications included aripiprazole (ABILIFY).  In July 2022 (reported as 2nd dose delivered 7 months after 1st dose), the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly for human papillomavirus (HPV) prevention at a Pharmacy. In February 2023 (reported as 3rd dose delivered 3 months after 2nd dose), the patient was vaccinated with 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly for HPV prevention at a Pharmacy (both 0.5 milliliter; strength, lot#, expiry date and anatomical location were not reported). Diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) was administered simultaneously with 2nd hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose.  After 1st and 2nd doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced vaginal bleeding.   On 01-MAY-2023, the patient was vaccinated with the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter; strength, lot#, expiry date and anatomical location were not reported) intramuscularly for HPV prevention at a Pharmacy. The patient was also vaccinated with hepatitis a vaccine, inactivated (manufacture unknown) and hepatitis b vaccine (recombinant) (manufacture unknown) at time of 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (both strength, dose, lot #, expiry date, route of administration and anatomical location were not provided).  Since 01-MAY-2023, the patient experienced adverse events chills, numbness, abdominal pain, vaginal irritation, vaginal bleeding (unrelated to menses), eye pain, headaches and difficulty breathing, which had worsened over time. The patient felt like she was dying.  It was reported the consumer received 5 doses of diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) within 5 years from different medical centers with no reaction. The consumer sought medical attention at Urgent Care and obstetrician-gynecologist (Ob/GYN) (information unknown). Ob/GYN offered birth control/hormone shot to alleviate vaginal reaction, but the consumer denied this treatment. There was no lab diagnostic or studies were performed. The outcome of events chills, numbness, abdominal pain, vaginal irritation, vaginal bleeding (onset date 01-MAY-2023), eye pain, headaches and difficulty breathing was not recovered. The outcome of events vaginal bleeding (after 1st and 2nd doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)) was not reported.   The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all the events was unknown. The causality assessment between hepatitis a vaccine, inactivated (manufacture unknown) and hepatitis b vaccine (recombinant) (manufacture unknown) and events chills, numbness, abdominal pain, vaginal irritation, vaginal bleeding (onset date 01-MAY-2023), eye pain, headaches and difficulty breathing was unknown. The causality assessment between hepatitis a vaccine, inactivated (manufacture unknown) and hepatitis b vaccine (recombinant) (manufacture unknown) and events vaginal bleeding (after 1st and 2nd doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)) was not related.