Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: hard to concentrate with nausea waves; patient woke with a fever and nausea; patient woke with a fever and nausea; hives show up with every vaccine; had started sharp pained feeling sensation in left hand; outer palm, pinky finger and ring finger has remained numb touch sensation/loss of motion, hypoaesthesia in same left 4th and 5th digits; tingle feeling/touch sensation felt numb like wearing a glove/left ring finger and outer palm as well as pinky finger were feeling pins and needles/ pins and needs sensation is constant/paresthsia in left hand; weakness in left hand; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS #811200) through a consumer referring to a 12-year-old male patient. Concomitant medications included cetirizine hydrochloride(ZYRTEC) and multi vitamins. Since birth, every vaccine (unspecified) had caused the patient to have hives and fever. Hives showed up with every vaccine after day 2 in a small patch that spread to most of the body by day. Hives usually lasted 7 days and fever 3 days. The patient had no other illnesses at the time of vaccination up to one-month and no allergies to medications, food or other products.   On 16-APR-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602281 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-JUL-2021) by intramuscular route in the right arm and with a first dose of meningococcal acyw conj vaccine (crm197)(MENVEO) lot# X17094, in the left arm by intramuscular route (strength, and dose, were not reported for both vaccines) for prophylaxis.   On 18-APR-2019, almost 30 hours after the shot given, the patient woke up with tingle in the left pinky finger. Pins and needles feeling and touch sensation felt numb like wearing a glove. The patient's hand was still functioning properly with proper grip strength. On the same day, almost 48 hours after shot given, the patient said left ring finger and outer palm, as well as pinky finger, were feeling pins and needles. Sensation of the left hand, outer palm, pinky finger and ring finger had remained numb touch sensation like wearing a glove. Grip strength remained normal and the function of hand was normal. Pins and needles sensation was constant. This sensation was still present at day 9 on 25-APR-2019. On 20-APR-2019, day 4 after shot, the patient woke with a fever and nausea. On the same day, the patient was hard to concentrate with nausea waves. Fever lasted for three days and nausea still preset on 25-APR-2019. Due to the events, the patient missed school due to symptoms.  The patient visited the physician's office to seek medical attention. The doctor evaluated the patient and said that since grip strength seemed fine, that we should let it rest and see what happened. The outcome of all the events was reported as not recovered. The causal relationship between the events and suspect vaccines was not reported.  Follow-up information has been received from a physician on 17-MAR-2020. The physician reported that on 16-APR-2019 (previously reported as on 18-APR-2020), the patient experienced paresthesia and weakness in the left hand. The physician also reported on an unknown date (previously reported as on 18-APR-2019), the patient also experienced pain, loss of motion and hypoesthesia in the same left fourth and fifth digits. On 16-JUL-2019 (reported as 3 months afterwards), paresthesia and weakness were becoming localized to the fourth and the fifth finger. On an unknown date, the patient still had no feeling in the left pinky finger and it could not straighten. The outcome of hand weakness was unknown. The physician stated that there was unknown mechanism of cause but there was clear temporal association between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The physician considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). According to the reporter, paresthesia and weakness in left hand and localized to 4th and 5th finger were determined to be permanent or significant disability/ incapacity.