Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash, Rash papular, Tonsillolith, Visual impairment
Clinical narrative: He was having headaches/ he has had headaches lately; always tired; joint pain; different aches and pains; stomach pains; a change in him/ he was sleeping more; alopecia areata/he has around 13 bald spots in his head/ hair loss/ patchy hair loss/ 10-12 small patches of partial to complete alopecia on the scalp; bump on patient's thumbnail/His toenail did it but looks normal now/Nail dystrophy secondary to trauma; nail dystophy secondary to trauma; She said that his vitiligo is back again below his eye; griseofulvine did not help at all; heart murmur; polyuria/urinary frequency; Patient reports itching and rash to left axilla again recently/ folliculitis barbae/left axillary rash/ in the left axillary area there were 4-5 flesh-tones papules/ axillary folliculitis; vision problems; Mom states that he has tonsil stones. Present X 2 months; He also has tlnea x 3-4 months.; pimekrolimus (ELIDEL) treatment with no noticeable changes; TMC cream - they have noticed minimal changes; 25(OH)D3 25(OH)D2: low; at least a 30 lb weight gain in the past year/unexpected weight change; Last year, patient was seen for a rash .to his axllla that was diagnosed at the time; Information has been received from a lawyer regarding a case in litigation and refers to a 11-year-old male patient (pt). As a baby, the pt was never camera shy. Even at a young age, he always smiled and took pride in his clothes and his hairstyles. He would talk with his mother's male coworkers about how to brush his hair to get the perfect wave pattern. He loved cars and had been collecting hot wheels since he was a toddler. He liked playing video games. His true love was playing basketball and football. Prior to vaccination he was very active and always had a ball in his hand. Before coronavirus 19 (Covid-19) caused everything to shut down his day started with school at 7:30 a.m. and ended around 7 p.m. He used to help out with basketball tournaments and he played in a few of the sponsored games the Club had. His medical history and concomitant medications were not reported.On 15-DEC-2020, the pt was vaccinated with the first (and only)HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On that day, the pt went in for his routine check-up. Since he was 11 years old, he was due for his school shots. The nurse came in and said "that he would be getting 3 shots required for school". The nurse never said which ones. Later, the pt's mother saw a reminder of when his 2nd dose of the suspect vaccine was due. She knew there had to be some sort of mistake because no one ever asked her if she wanted him to have the vaccine and it was not a required vaccine for school. The pt's mother was upset when she read this after visit summary showing that the nurse had given the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) shot to him that day without even asking her if she wanted him to have that vaccine. Soon after his (HPV) vaccination, his mother started noticing a change in him. He slept  more and was always tired. He did not want to go outside and play and he was not as active, was not always bouncing a ball or practicing his dribbles as before. He complained of joint pain and different aches and pains. He was having headaches and stomach pains. The pt also put on a lot of weight. His school uniforms were boys 16 husky and his basketball shorts were boys 18/20. By the following start of school, the pt's was a size men's 36 pants and a men's large shirt. He also kept getting tonsil stones. He was on his 7th one at the time of reporting and had never seen or even knew what those were before. In approximately August 2021, reported as this had been going on for 5-6 months, one thing that has happened after he received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that has impacted him for the worst is he was losing his hair. He had around 13 bald spots in his head. Prior to the vaccination, he never had problems with his hair growing. His mother did not make the connection to it being the suspect vaccine until speaking with his dermatologist. She asked what could cause the alopecia and was told that one of the things was vaccines. Along with the physical changes in the pt , there were other changes. He used to be outside constantly, but did not like to go out anymore. When he did, even when it was the hottest summer on record, he wore a hoodie to hide his head. He no longer asked to go to his sister's house like he used to even though he loved spending time with her, packing his duffle bag and spending a night or weekend with her. He did not like his picture taken anymore. When a picture had to be taken, his mother could see the worry and sadness behind his forced smile. His dermatologist prescribed a cream to hopefully help his hair grow back. His mother was able to pay his barber extra to come in early to cut his hair into a style right before school started so he would not be so embarrassed with the shop full of people. He had to go to the barber more often and came up with some designs to make the bald spots not look like they were bald spots. The pt was diagnosed with alopecia areata. His vaccine injuries were caused-in-fact by the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination and persisted for longer than six months. The outcome of the events was not provided. The reporter considered the events to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Information has been received on 18-SEP-2023 from medical records regarding a case in litigation and refers to a 11-year-old male pt. His concurrent conditions included seasonal allergic rhinitis/ allergies/ environmental allergies, slow transit constipation, anxiety and mild persistent asthma without complication. He also had Individualized Education Program (IEP) at school. He was using caffeine a few times a week, exercising a few times a week and was never smoker.  His concomitant therapies included polyethylene glycol (MIRALAX), albuterol, and ranitidine (ZANTAC). His historical vaccines included unspecified diphteria (+) tetanus (+) pertussis (DTaP), diphteria (+) tetanus (+) pertussis (+) polio (DTaP/IPV), hepatitis B immunoglobulin, hepatitis A, hepatitis B, Haemophilus influenzae type B (HiB), polio (IPV), influenza quadrivalent, influenza trivalent, unspecified influenza vaccine, measles (+) mumps (+) rubella (MMR), measles (+) mumps (+) rubella (+) varicella (MMRV), pneumococcal conjugate 7-valent, rotavirus pentavalent and varicella vaccines. His family history included alopecia in paternal grandmother and 2 paternal aunts, premature hair graying and arthritis in mother and lupus in maternal aunt. He had no surgical history. On 15-DEC-2020, the pt was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (previously reported as HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On the same date, he received also unspecified meningococcal conjugate and DTAP vaccines. The pt presented for an office visit on 27-MAY-2021 with a chief complaint of hair loss. Hair loss was first noticed by the pt's mother in approximately January 2021 (reported as 4 months prior to the visit). He had longer hair and pt's mother noticed round spots of hair loss. She changed the pt's barber due to lack of proper sanitation and requested low haircut at the new barber. She then noticed multiple areas of hair loss throughout pt's head. Pt's mother reported  family history of alopecla in paternal grandmother and 2 paternal aunts. She was unsure of family history of thyroid disease, but reported at least a 30 lb weight gain in the past year. Hair loss was treated at home with medicated hair grease. The pt denied pain, abdominal pain and headaches. Review of systems was positive for unexpected weight change and bald spots in the hair, body mass index (BMI) 32.84 kg/m2. Physicial examination of skin showed overlying the left parietal area there was a smooth bald patch approximately 3 cm in diameter, additional areas of hair toss noted to the right temporal and occipital regions. Diagnoses at the time of the visit included alopecia areata and weight gain. At the time of the visit, the pt's medications included polyethylene glycol (MIRALAX), albuterol, ranitidine (ZANTAC), mometasone (ELOCON) and mupirocin (BACTROBAN).The pt presented for an office visit on 04-JUN-2021. He put on a lot of weight during Covid. He was not obese before. He had headaches lately. The pt presented for an well-child office visit on 14-JUN-2021. Since April 2021, reported as present for 2 months, the pt had tonsil stones. He ate regular meals and was taking a "MVN" (no details reported). Also the pt was gargling, but still made tonsil stones. He also had patchy hair loss. He was een for this condition and referred to dermatology, but pt's mother did not hear back from the specialists. He continued to have patchy hair loss. Pt's mother noticed a stone that he coughed out. He ate  regular meals and stayed well hydrated. The pt's weight was 71.8 kg. Physical examination of skin showed multiple circular patches of hair loss on his scalp in various location. Some skin excoriation on certain patches. Mild hair regrowth was visible in other areas. Physical examination of neck showed that he had a small tonsil stone on the left posterior tonsil. The pt was counseled regarding nutrition and physical activity (weight management). At the time of the visit the pt's current medications included albuterol, cetirizine (ZYRTEC), polyethylene glycol (MIRALAX)and griseofulvin.The pt presented at office visit on 30-JUN-2021 at dermatologist with a chief complaint of hair loss. Previously prescribed griseofulvin by primary care physician (PCP) did not help at all. Impression included alopecia areata: 10-12 small patches of partial to complete alopecia on the scalp. The pt received triamcinolone acetonide (TMC) to apply to involved areas on scalp and advice to use minoxidil (ROGAINE) both once daily. At the time of the visit, his medications included treatment pimekrolimus (ELIDEL) and triamcinolone acetonide 0.5% (TMC) cream. The pt presented at office visit on 31-AUG-2021. Laboratory test were as follows: 25(OH)D3+25(OH)D2 low. The pt and his mother noticed only  minimal changes. The pt applied the triamcinolone acetonide 0.5% (TMC) cream with only minimal changes once daily and needed a refill. Impression included alopecia areata: there were patches of alopecia on parietal scalp, faint regrowth distributed on the scalp. Status was described as improved. Plan included intralesional triamcinolone (KENALOG). 3 lesions were injected (2.0 mg/cc of triamcinolone (KENALOG). The pt also was prescribed triamcinolone acetonide 0.5% topical cream to apply to involved areas on scalp once daily.At the time of the visit, the pt's current medications included triamcinolone acetonide (KENALOG), TMC cream, treatment pimekrolimus (ELIDEL) and vitaminum D. At the time of the visit, alopecia areata was improved (patches of alopecia on parietal scalp, no atrophy, faint regrowth distributed on the scalp).The outcome of the event of alopecia areata was recovering.  The outcome of remaining events was not provided. The relatedness between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.   Information received on 18-SEP-2021, contained the following adverse events: vision problems (onset 11-MAY-2021, the pt needed glasses, outcome and causality not reported), rash to the pt's axilla (onset ??-???-2020, outcome recovered, causality not provided), polyuria/urinary frequency (onset 27-MAY-2021), outcome and causality not reported), itching and rash to left axilla again recently, folliculitis barbae (onset 27-MAY-2021, treatment: mupirocin (BACTROBAN), outcome and causality not reported), tinea capitis (onset approximately ??-FEB-2021, reported as since 3-4 moths, treatment: griseofulvin, outcome and causality not reported), griseofulvin did not help at all (onset date: ??-JUN-2021, treatment, outcome and causality not reported), vitiligo below his eyes (onset ??-JUN-2021, treatment pimekrolimus (ELIDEL),vitaminum D3, outcome not recovered and causality not reported), pimekrolimus (ELIDEL) treatment with no  noticeable changes (onset ??-JUN-2021, outcome treatment and causality notreported), triamcinolone acetonide (TMC) - only noticed minimal changes (onset: ??-???-2021, outcome, treatment and causality not reported), bump on the pt's thumbnail/nail dystrophy due to trauma (onset ??-JUL-2021, treatment, outcome and causality were not provided).  All available medical records will be provided upon request.  This in one of 4 reports received from the same reporter.