Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Infertility, Mental disorder, Nausea, Night sweats
Clinical narrative: she has also been involved in a car accident with the police; abortion; admitted to a psychiatric home; STD; nausea; sweating at night (she gets hot); sweating at night (she gets hot); "bad outbreaks"; difficulty getting pregnant (infertility); she has been feeling tired and weak; she has been feeling tired and weak; she had previously received GARDASIL 9 as a child. However, she did not know that until after she had received it for a second time as an adult in March 2019; This solicited report has been received from a female patient referring to herself, who was 25-year-old at the time of the events, enrolled in a patient support program, conducted by phone visit. Her medical history included low vitamin D levels and high vitamin B-12 levels. She had no drug reactions nor allergies and has not been receiving any concomitant medications.  On an unspecified date (described as when she was a child), she was vaccinated with her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) one injection in the right arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis (described as the patient did not know about that administration until she had received the vaccine for the second time). On an unspecified date in March 2019, she received her second dose of the vaccine (one injection in the right arm; exact dose, route of administration, lot # and expiration date were not provided) (inappropriate schedule of product administration) and since then, she has been experiencing nausea, sweating at night (described also as she was getting hot), "bad outbreaks", difficulty getting pregnant (reported also as infertility), she has been feeling tired and weak. On an unknown date, she has been involved in a car accident with the police and due to that event, she was hospitalized. It was reported, that the patient received vitamin D as a treatment for the events. An unspecified blood test was performed, however no results were provided. The outcome of the car accident was unknown. At the time of the report, the patient did not recover from the remained events.  The patient stated that she have received a vaccine that her doctor knew might have caused future problems, such as infertility.  The causal relationship between the events and the suspect vaccine was not reported.  Follow-up information has been received from the patient on 25-JAN-2022.  The patient confirm that she received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) when she was a child, and on an unspecified date she contracted a sexual transmission disease that cant be not cured. Also she mention that she was trying to get pregnant but she could not, she had never had this problems before and had 2 children's already. The patient also experience an abortion on a unspecified date and was admitted in a psychiatric home (mental disorder).  The outcome of the events was not provided as well as the causality relationship with the suspect vaccine.  Upon internal review, abortion and mental disorder was determine to be medically significant. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of road traffic accident is considered unlikely related to GARDASIL 9 vaccine. The evidence is not sufficient to suggest a relationship between the GARDASIL 9 vaccine and the reported serious adverse event. Incidental road traffic accident constitutes a more plausible alternative explanation for the event   Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL 9 vaccine  and the reported event of abortion cannot be established. Missing information include patient's concurrent conditions, vaccination date, event onset date, additional clinical details and diagnostic evaluation  Company Comment- No changes to the product safety information are warranted at this time.  Merck and Co., Inc.,  continues to monitor the safety profile of the product.