Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness, Memory impairment, Musculoskeletal stiffness, Pallor
Clinical narrative: For about a minute before waking up; Very clammy; Fell backward; He did not know where he was; When suddenly he went stiff; Went sheet white; anxiety attack; How bad the medicine in the shot hurt; The patient will not received the second dose; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. The primary reporter was the patient's mother. The report referred to an 11-year-old male patient. The patient had no current illness, concomitant medications nor medical history. On 26-DEC-2018, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot number and expiration date not reported), in the left arm for prophylaxis. Other suspect therapy included meningococcal acyw conj vaccine (crm197) (MENVEO) administered on the same day in the right arm (dose, route, lot number and expiration date not reported). On the same day, the patient was telling the nurse how bad the medicine in the shot hurt (injection site pain), when suddenly he went stiff (musculoskeletal stiffness), fell backward (fall), went sheet white (pallor) for about a minute before waking up (loss of consciousness) very clammy (cold sweat) and very pale. He said he felt asleep when he woke up. He did not know where he was (memory impairment). The patient ate breakfast but had no lunch at the time of the vaccination. The physician gave him a popsicle, popcorn and checked his blood pressure (result not reported). The mother fed him a big lunch and he was fine since then. The patient will not receive the second dose (incomplete course of vaccination). The appointment was at 11:10, the shot was given around noon. The patient had recovered from the events on the same day.  The causal relationship between cold sweat, pallor, musculoskeletal stiffness, memory impairment, loss of consciousness, injection site pain, fall, therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and meningococcal acyw conj vaccine (crm197) (MENVEO) was not reported.  Follow-up information was received on 03-JUL-2019. The patient was an 11-year-old male patient. The patient does not have any allergies or chronic health conditions or illness at the time of vaccination. He was not on any prescription, over to counter medications, dietary supplements or herbal remedies at the time of vaccination. On 26-DEC-2018 at 12:00, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Other suspect therapy also included Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) in the right arm (administered within one month of the suspect vaccine) (dose, route, lot number and expiration date not reported). On 26-DEC-2018 at 12:02, the patient experienced the events (as described above).  It was reported that the patient never experienced an adverse event following vaccination previously.   Additionally, vaccine administration details were updated.  Follow-up information was received from a physician on 07-AUG-2019. On 26-DEC-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from lot # R023607 (expiration date not reported, but upon internal validation established as 06-MAY-2021).  It was reported that the patient experienced an anxiety attack on 26-DEC-2018 (at 12:02). The patient had recovered from the anxiety attack. Causality assessment was not provided by the reporter.  This case has been downgraded. The health authority considered the events to be non-serious.  Additionally, Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) has been updated to concomitant therapy as health authority did not initially consider it as suspect therapy.