Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
Numbness, pain and needles in both feet which quickly moved to her entire legs and arms, by the evening, her entire body was numb/ patient was no longer able to walk on her own/ She could not read/Guillain-Bane syndrome; her oxygen were low; her pulse was from 150 beats per minute to 120 per minute; Brian fog; Bloody stools; Autoimmune injuries/autoimmune dsorder; ice cold legs, feet, and hands; Her pupils were not changind size/her puplis wer not responding; Her reflex were not responding to any of the tests; paresthesia; pelvic pain/endometriosis; cough and pain in her chest/persistant cough, chest pain, shortness of breath and wheezing /Acute bronchitis; Lethargic, chills, swats, and chest hurt/pneumonia; small fiber neuropathy; she was having constant diarrhea, nausea and could not keep any food down/Irritable bowe syndrome*irritable bowel syndrome (IBS); Pleurisy; gastroesophageal reflux disease (GERD),; Elevated ANA; Chronic headache; Sleeping even more; severe abdominal pain/appendicitis; She had lost 20 pounds/weight loss; Being extremely tired after the vaccination; Information has been received from a lawyer regarding a case in litigation and refers to a 14-year-old female patient (pt). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 12-Aug-2019, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (strength, dose, frequency, lot #, and expiration date were not reported). Healthcare provider recommended pt receive the vaccine, which was touted as a safe and effective vaccine for preventing cercal cancer. Following her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections, pt went to urgent care due to a cough and pain in her chest. She was diagnosed with bronchitis and prescribed medicine but after finishing the medicine, she did not improve and returned to urgent care. She had a persistent cough, chest pain, shortness of breath and wheezing. She was again treated for bronchitis with antibiotics and steroids, but her condition continued to worsen, and she returned to urgent care. She was treated for acute bronchitis and pneumonia with antibiotics and steroids. Thereafter, she went to her family doctor as she was lethargic, had chills, sweats, and her chest hurt so badly that it brought her to tears. She was given different antibiotics, and the steroids were increased. Pt remained in pain, and it was later thought that she had pleurisy. With the approval of her doctor, she went on a family trip, but she was physically unable to do any of the planned outings. Thereafter, she saw a pulmonary specialist, but he could not determine what was causing her chest pain. Elevated ANA levels were noted. Pt continued experiencing chronic chest pain, chronic headaches, and sore throats. She started sleeping even more and her grades started to drop. Not aware that Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), could be the cause of her condition, on 09-Mar-2020, she was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (strength, dose, frequency, lot #, and expiration date were not reported). Following her second dose of vaccine, pt's condition worsened. She complained of being extremely tired after the vaccination. Her chest continued to hurt but her stomach started hurting as well. On an unspecified date, pt again went to the emergency room (ER) with severe abdominal pain, and it was thought that she had appendicitis, and she had her appendix removed. She had lost 20 pounds because she was having constant diarrhea, nausea and could not keep any food down. Thereafter, she had upper and lower scopes, and the doctors thought she had irritable bowel syndrome, but the medicines she took for this condition did not help. Even though her classes were virtual, she missed school because she was unable to concentrate. Next, pt began having numbness, pins and needles in both feet which quickly moved to her entire legs and arms. By the evening, her entire body was numb. On an unspecified date (also reported as the following month), pt was no longer able to walk on her own. She could not read. Her pupils were not changing size. She had a neurological workup in the hospital and her reflexes were not responding to any of the tests. She was admitted to the hospital with a diagnosis of Guillain-Barre syndrome and started on IVIG treatments. She was discharged but her condition deteriorated. She went back to the hospital, and it was determined that she also had small fiber neuropathy. Next, pt had pins and needles pain in her arms and legs, and it was so severe that once again she could not walk. She was sent to the hospital again and had chest pain, and her pupils were not responding. Her oxygen levels were low, and her pulse was from 50 beats per minute to 120 per minute all while lying in the hospital bed. She was cared for by rheumatology, internal medicine and neurology specialists and eventually released from the hospital. Shortly after returning home from the hospital, she had to return to the ER and was admitted again. Pt ultimately ended up having to use a walker and a wheelchair. She required help going to the toilet and dressing herself. Pt continued to have episodes every few weeks and continues to have severe abdominal pain. She continued to be seen by doctors for the various symptoms that started after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination. As the months progressed, so did pt's symptoms. She was seen by multiple physicians and specialists for her complaints of fatigue, headaches, brain fog, chest pain, back and neck pain, severe abdominal pain, weight loss, numbness, pins and needles pain to both arms and legs, difficulty walking, weakness, pelvic pain, diarrhea and bloody stool, ice cold legs, feet, and hands. As a result of her post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, patient has been unable to engage in activities that a normal young person would enjoy. Prior to receiving the Gardasil vaccinations, she was active, energetic, she played on the girl's lacrosse and golf team, she often rode a bike 25 miles round trip three to seven days a week. She excelled in junior high and her first year of high school as she was in advanced classes, she was an honor roll student. It was her intent to enlist in the National Guard, and to attain a BSN to become a travel nurse. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, pt had been diagnosed with various medical conditions, including but not limited to, Guillain-Barre syndrome, small fiber neuropathy, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), endometriosis, and paresthesia. Pt contended that her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to Guillain-Barre syndrome, small fiber neuropathy, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), endometriosis, paresthesia, fatigue, headaches, brain fog, chest pain, severe abdominal pain, weight loss, numbness, pins and needles pain to both arms and legs, difficulty walking, weakness, pelvic pain, diarrhea and bloody stool, ice cold legs, feet, and hands, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by Gardasil or otherwise linked to her Gardasil-induced autoimmune disorder. At the time of reporting the outcome of the events was not provided. Causal assessment with all the events was related. Upon internal review, the events pneumonia, appendicitis, and haematochezia was considered as medically significant. The events Guillain-Barre syndrome, small fibre neuropathy, irritable bowel syndrome, paresthesia, asthenia, pleurisy, and autoimmune disorder were considered as disabling events. This is one of several reports from the same reporter.