Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Full blood count, Headache, Hepatobiliary scan, Malaise
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who was in the remission of rheumatoid arthritis, with allergies to KEFLEX, MORPHINE and Phenergan (manufacturer unknown) and a history of having 2 periods per month. The patient on 09-JUN-2009 was vaccinated with GARDASIL. There was no concomitant medication. Within 30 minutes of the vaccination, the patient experienced fever, chills and vomiting. She was taken to office the next day and she was diagnosed with a bladder infection. She was prescribed antibiotics (unspecified); however, the antibiotics were not taken as the mother was concerned with the side effects affecting the muscles as the daughter was in remission for rheumatoid arthritis. Also, the day prior, the daughter did not show positive for a bladder infection. So the mother did not feel that the daughter had a bladder infection. After 4 days of daily vomiting, her daughter began to feel better. The fever, chills, muscle aches and cramps subsided; however, the vomiting continued to occur occasionally. On 17-JUL-2009, her daughter was taken to the emergency room due to the vomiting. She was discovered to have pelvic inflammatory disease. Tests for gonorrhea and chlamydia were negative. She was given PEPCID and NEXIUM for nausea and treatment of an ulcer which resulted from her vomiting. She was not admitted at this time. By the second week of July, the patient was throwing up a lot. On 21-JUL-2009, the mother took her daughter to the hospital. The patient was having headaches and throwing up at least once everyday. The patient was admitted and treated for dehydration from vomiting. (She also could not take the prescribed antibiotics for PID due to the vomiting). In the hospital, the patient was given intravenous antibiotics for 4 days for the abdominal pain. Various labs and diagnostic testing were done. Upper GI, CAT scan of the liver, kidneys and appendix were all normal. The patient was discharged with antibiotics (unspecified) for 10 days. She was scheduled for a scope in August. The cause of her vomiting was still unknown. At the time of report the patient's status was not recovered. The mother was inquiring whether there was additional information regarding her daughter's symptoms including the time of resolution and the long term effect on daughter's health. On 07-AUG-2009 attempts to obtain additional information was unsuccessful. On 10-AUG-2009 follow-up information was received from a clinical supervisor indicated that the physician planned to ask the patient to come into the office for a follow-up visit. They were very busy and she could not continue the conversation. Additional information has been requested.   9/25/09 Received PCP & vaccine records which reveal patient in usual state of heath on day of vaccination & requested BCPs.  RTC 6/11 not feeling well, ears & throat pain, stuffy nose, cough, fatigue, & aching all over w/fever, LBP, nocturia & nausea x 1 day.  Dx w/viral illness; pharyngitis; otalgia; & UTI.  Rx w/oral antibiotics but parent refused.  RTC for pap smear & had irritability as only complaint.  Transferred to new PCP 8/20/09.  10/5/09 Hospital records, DC summary, DOS 7/22/09 to 7/25/09. Assessment: Acute vomiting, dehydration, constipation, pelvic inflammatory disease. Seen at ER several days earlier for vaginal discharge, foul odor, adnexal tenderness, diagnosed with PID. Patient presents with daily vomiting, worsening abdominal pain, and 15 lb weight loss. Oral contraceptives. Body aches. Continued vaginal discharge. (Uterine) Cervical motion pain.  ICD-9 Codes: 530.01, 535.50, 614.9, 787.03, 564.00  10/15/09 DC summary received for dates 7/22/09 to 7/25/09. DC DX: Acute vomiting resolved, dehydration resolved, constipation resolved, PID under treatment.   10/21/09 GI Consultations received for Dates of Service 8/17/09 and 9/11/09: Dx:  Abdominal pain and vomiting continued. Assessment:  Seen by GI for c/o abdominal pain, cramping, nausea, vomiting and distension.  Referred to OB/GYN for further follow up of PID. Follow-up: Pt began to see Dr. on Tuesday, June 9, 2009. She had a 3:00 appointment. I had just made an appointment to get her on birth control. All test done in the doctor's office, urine sample and blood work, came back normal. The nurse practitioner asked if I wanted to get her started on the GARDASIL vaccine and assured me that the ONLY adverse reaction was redness or rash at the injection site. I agreed to begin the vaccine for that appeared to be the best interest of my 14 year old daughter. By the time we were in the car heading home, within 30 minutes, pt began complaining of nausea and a headache. Within a two hour span, she began running a temperature of 101.2, was aching all over, chills, migraine, vomiting and diarrhea. On the second day she complained of numbness in her right shoulder and right jaw. I phoned the doctor's office and told them of her condition. I asked them again if it could have been the vaccine, again, they stated that it was not possible and that she probably picked up a bug in the office. They did not have an opening for that day, so I made an appointment for 10:30 a.m. Thursday, on June 11, 2009. The nurse practitioner said that her urine showed signs of a slight bladder infection and gave her a prescription. I had the prescription filled, but did not give her the first pill because the most common side effect for that medication was severe tendon damage. My daughter had been in remission for Rheumatoid Arthritis for a year and I did not want to give her anything that could possibly re injure her joints. I again called the doctor's office and asked them if there was anything else she could call in due to the side effect. (my daughter commonly gets rare side effects) They stated that it was the only thing to treat it, besides, the mg's were too low to hurt her. I opted to call her pediatrician, the following Monday to see if he could call her in something else. A follow up appointment was on Monday, June 15th. Her urine was tested again and showed clear of any infection. My daughter was continuing to vomit periodically, but I thought it was from something she had eaten or that she was becoming lactose intolerant. She went for her summer visit with her father on June 20, 2009. On or about June 30th, pt's older sister called to tell me that pt kept throwing up while she was at her house. I phoned her father and he did not return my call. I phoned pt and she again stated that she thought it was from something she ate. She had eaten fish, although she has never gotten sick off of fish. I believe that it may have been the fish itself and dismissed it. On July 5, 2009 pt was staying at my mother's home. My mother is a retired nurse and called me stating that she was concerned about pt. She said that she was vomiting frequently. She had initially believed that it could be lactose intolerance, but she had cooked non lactose products for the last 3 days and she still has bouts of vomiting. I decided to go and get her early in case it was something bad, as I was afraid that her health insurance would not pay for treatment. I finished my current accounts with my job and left on July 7,2009 at 3:30. July 10,2009 on the drive back, she only vomited once. I thought that perhaps she had had a bug and was recovering. I wanted to see how she felt before calling the doctor again. For the next week, being a teenager, she had friends wanting her to go and do things with them, so she hid the vomiting from me and said that she felt better. However, on July 17th she her friends spent the night here at home. On the 18th, her friend told me that pt had been vomiting all night. I went into her room to check on her and she was complaining of her lower abdomen hurting. It was then that she admitted hiding the vomiting. It had only been occasional, but was now after each meal. That evening I took her to the emergency room. The Dr. was the physician on call and he ordered the test as follows: (I have copies of her records if you need them). Lab work for: BMP, CBC, PREG-QUANT, SED RATE AND BASIC METABOLIC PANEL. She had an x-ray that showed nothing abnormal, she had a vaginal ultrasound that showed a slight amount of fluid, but normal. She had a pelvic exam and was later that morning diagnosed with PID (pelvic inflammatory disease). At this point she was tested for: C-Tracomatis Amplified: DNA not detected. N.Gonorrhea Amplified: DNA not detected. (these two test were not completed and returned until July 23, 2009). Dr discharged her with several prescriptions...antibiotics for the PID, he gave her PEPCID for an undiagnosed ulcer and something for nausea that did not work in the hospital that 9 hour morning. I asked him what I was suppose to do for her vomiting. He said that they were concerning with the pain and that I would need to follow up with her PCP, but, that if it get worse, to bring her back in. She was unable to take her medications as they were to be taken with meals, she could not hold the pill down nor the water to take it with, much less a meal. I began calling Dr.'s office at 11:00 am on Monday, July 20,2009, as we did not get in from the emergency until 5:00am, and left 3 unanswered messages. That evening she was still vomiting and complaining of her stomach hurting, so I took her back in, hoping that this time they could treat her for the vomiting. At 12:30am, 51/2 hours of sitting in the emergency, pt told me that she just wanted to go home and see the doctor the next day as it did not seem that we would get in to a room due to over crowding. I again phoned Dr.'s office the next morning at 9:00am. They were short handed and could not see her until the following afternoon at 3:00pm. I took the appointment, but later found my daughter in my bathroom floor, she was vomiting, crying, dizzy, dehydrated and in need of immediate help. I started to call an ambulance, but they would have brought her to hospital, and I felt that she needed to go to children hospital. I drove the 45 minutes on Tuesday, July 21st. We went through the emergency room, but was admitted later that morning for I.V. antibiotics and further testing. She was in hospital until Saturday July 25th. We were discharged with instructions to follow up with her PCP as well as Dr. The tests done are as follows: Upper GI.....tested normal. Hide a Scan...tested normal. More x-rays...tested normal. (I do not have those records yet to know exactly what else they did). Once we were home pt began vomiting again, but only once a day, sometimes skipping a day or two all together. Out of frustration from all testing coming back "normal" I began to do further research on GARDASIL side effects. On August 6, 2009 I found a GARDASIL side effects site from Merck that showed some of the very rare side effects they found during there studies. Four of them in particular caught my attention. Headaches, Gastroenteritis, vomiting and Pelvic Inflammatory Disease. I located a phone number for Merck and called. After many transfers, I finally spoke to a woman. She took down all of our information. I explained to her that I just really need to know from the others that had this rare side effect, how long does it last and when can I tell my daughter that she should start feeling normal. She told me what I basically already had found on the internet, and said that they would not give me further information, however, our doctor could call on her behalf, and they could tell him, in which he cold relate back to us. Her reference # 1-3344487593. I phoned Dr.'s office and only met rebellion from the staff when asking them to call the number. I spoke to a nurse that stated that she had the reference book right in front of her and that PID was NOT a side effect of GARDASIL. I explained to her that I just got off the phone with Merck and would she just please call. She said that it could be the following week, as it was a Friday that I called, and the doctor had already gone for the day. The following week I heard nothing, and no one returned my calls. I then spoke to pt's case coordinator for her health care insurance and told her of the problems that I had been having with our PCP. She then got on the phone and found her a new PCP Dr. Who said that they could see her on August 19, 2009. On August 17, 2009 we kept her follow up appointment for Dr. Upon this visit, his examination and finding that pt was still vomiting and having abdominal pains, lab work was done and an appointment was set for a colonoscopy and upper scope for August 31, 2009. August 19, 2009, she saw the new PCP Dr. Upon receiving records from hospital (her pediatrician) but not Dr.'s office, she did her own evaluation, a pelvic exam and a urine test since pt had blood test done at the lab just two days before. Her appointment was set Thursday, September 10,2009 for another pelvic ultrasound. Today, August 24, 2009. Pt is almost back to vomiting after every meal again. Her headaches are still daily. Her urinalysis from Dr.'s office from the 19, came back today, showing bacteria in her urine. She called in some BACTRIM today. On the request for the lot number for the vaccine. It looks like either 32170 or 32H0. I tried, as well as Dr.'s office, to get someone at Dr.'s office to confirm which one it is and they just patch me through who refuses to call me back. Sorry for any inconveniences that their un professionalism may cause you. Feel free to call them yourself. I will be happy to sign any release needed to find out the answers as to when my kid can be a kid again!!!! If you need the results to the upcoming test, just call me and I will get that to you. Thank you so much for your concern and consideration.