chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound kidney normal, Ultrasound liver normal, Ultrasound pelvis, Ultrasound scan normal, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a registered office nurse manager and a consumer concerning her 12 year old daughter who on 19-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660387/1967U) intramuscularly in her right deltoid. The patient's mother reported that her medical doctor noted she was in good physical condition at the time the vaccine was administered. She also reported that the patient's vaccine site was extremely tender and sore for a complete week after she received the vaccination. Within a few days of receiving the vaccine, in February 2008, the patient began complaining of persistent stomach cramps and nausea. The nurse office manager reported that the patient developed stomach cramps and nausea after the vaccination. According to the nurse, the patient was treated as the physician's office as follows: on 07-MAR-2008 for a diagnosis of bronchitis (treatment unspecified) on 23-APR-2008, for symptoms of a left ankle sprain (treatment unspecified), on 15-MAY-2008 for symptoms of stomachache. On 16-MAY-2008, an ultrasound of the liver, kidney, pelvis and spleen were performed and the results were within the normal range. On 23-MAY-2008, upper gastrointestinal air contrast, hematology test, routine immunology test, blood chemistry test were performed and the results reported to be within the normal range except for serum Epstein-Barr virus antibody test positive for EBV IgG, EBV IgM and EBV nuclear antigen. Results suggested recovery or reactivation. The provider will recommend a gastrointestinal consult. No other symptoms or treatment noted. The patient's mother reported that the patient's stomach cramps and nausea continued until the time of this report despite a series of medical testing. The outcome of the patient's bronchitis, L ankle sprain and positive mononucleosis test was unknown. The patient sought medical attention.. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Colonoscopy, Diarrhoea, Stool analysis
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with no known drug allergies and asthma, who on 14-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # not reported). On 17-OCT-2007, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (Lot # not reported). On 27-FEB-2008, the patient received the third dose of GARDASIL vaccine (yeast) (Lot # not reported), 0.5 mL by injection. There was no concomitant therapy. The mother reported that on approximately 27-MAY-2008, three months after receiving the third dose of GARDASIL vaccine (yeast), her daughter experienced severe chronic diarrhea which had been occurring for the next two months. The patient sought medical attention. A colonoscopy, blood work, and stool sampling were performed (dates and results not reported). At the time of the report the patient had not recovered. Additional information has been requested. Follow up information was received from a physician which reported that the 16 year old patient received her first, second, and third dose of Gardasil into her left deltoid. The physician reported that in May 2008, the patient was diagnosed with Crohn's disease. At the time of the report the patient had not recovered. Additional information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Myalgia, Photophobia
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female with seasonal allergies, no medication allergies and no previous side effects with the previous GARDASIL vaccinations, and a history of adenoidectomy and ear tubes who on 14-JUL-2008, approximately at 9:40 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # 0152X) into the left arm intramuscularly. Concomitant therapy included montelukast sodium (MSD), FLONASE and ZYRTEC. On 14-JUL-2008, the patient experienced headaches, muscle aches and light sensitivity. The patient sought medical attention by a phone call to the nurse practitioner. The patient's outcome was not reported. Additional information has been requested.  No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Conversion disorder
Clinical narrative: Information has been received from a physician concerning her daughter who was vaccinated with a dose of GARDASIL vaccine (yeast) and manifested pseudoseizures. At the time of the report the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female with a history of fainting with drawing of blood and other vaccines, who on 14-JUL-2008 was vaccinated with the the third dose of GARDASIL vaccine (yeast) and fainted in the hallway after walking out of the office. The patient sought medical attention. She sat down and was given orange juice and was fine 5 minutes later. It is unknown if this occurred with the first and second doses of GARDASIL vaccine (yeast). No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL vaccine (yeast). On an unknown date the patient's mother said that her daughter developed a growth or some type of warts. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 10-JUL-2008 was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 660389/1968U). On the same date the patient also received meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and hepatitis A vaccine (inactive) (HAVRIX). After receiving the first dose the patient immediately became pale, lost her color and her arm felt numb at top of the arm. The patient was recovered after 15 minutes. The patient sought unspecified medical attention in office. This is one of two reports received from the same source. Additional information has been request.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 07-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659055/1522U) and also with varicella virus vaccine live (Oka/Merck) in her arm. Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). The physician reported that the patient experienced pain and weakness in her arm after receiving GARDASIL vaccine (yeast) (Lot # 659055/1522U) and varicella virus vaccine live (Oka/Merck). The vaccines were administered in the same arm on the same day and the symptoms are being experienced in the same arm that the vaccines were administered. The patient's pain and weakness in her arm persisted. No further information was provided. The patient sought medical attention, seen by the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided), who on unspecified dates was vaccinated with first and second doses, respectively, of GARDASIL vaccine (yeast)(Lot #s not provided). It was reported that post vaccination of the second dose of GARDASIL vaccine (yeast) the patient fainted and "almost went into seizure". At the time of this report the outcome was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 28-APR-2008 was vaccinated with her third dose of GARDASIL vaccine (yeast) (lot# not reported). On 12-MAY-2008 the patient experienced a headache. Subsequently, the patient recovered from the headache. The patient sought unspecified medical attention with a phone call on an unspecified date.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Eye irritation, Inappropriate schedule of drug administration, Vision blurred
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a registered nurse concerning a 16 year old female patient who was vaccinated with the first dose of GARDASIL vaccine (yeast) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (date not reported). The patient developed burning of the eyes and blurred vision four days after vaccination. The patient was getting over a virus at that time. The patient received the second dose of GARDASIL vaccine (yeast) this week (approximately 07-JUL-2008) and no adverse were not reported. Subsequently, the patient recovered from burning of the eyes and blurred vision. Follow-up information received on 28-AUG-2008, from a nurse which reported no additional adverse event information provided. No additional information is available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with chlamydial infection who on approximately 16-JUN-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). Concomitant therapy included doxycycline. The patient had experienced vomiting and nausea for the last three weeks (from approximately 20-JUN-2008). The patient's vomiting and nausea persisted. No further information is provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Thyroid function test abnormal, Thyroiditis, Weight increased
Clinical narrative: Information has been received from a physician concerning an approximately 16 year old female with no pertinent medical history, who on 29-JUN-2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 658100/0525U). On 07-JAN-2008, the patient received the second dose of GARDASIL vaccine (yeast) (Lot # 659439/1267U), and on 03-JUL-2008 the patient received the third dose of GARDASIL vaccine (yeast) (Lot # 660391/0063X). Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX) and "acne medicines". The physician reported that he saw the patient who had developed thyroiditis after receiving GARDASIL vaccine (yeast), and complained of weight gain and fatigue. A titer test for thyroid was performed, and the patient was found to have antibodies against thyroid. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature normal, Pharyngolaryngeal pain, Pyrexia, Streptococcal identification test
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 659964/1978U) at approximately 4:15 pm. On 21-MAY-2008, the patient developed a 102F fever after vaccination and a sore throat. On 22-MAY-2008, patient sought medical attention at the physician's office where a rapid strep test was negative. Treatment was acetaminophen (TYLENOL) and ibuprofen. On an unknown date, the patient recovered. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Additional information was received from the registered nurse. At the time of vaccination, the patient had fatigue. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysgeusia, Nausea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly on an unspecified date with a dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently the patient experienced nausea, dizziness and an "abnormal taste sensation in her mouth" sometime after the vaccination. The patient sought medical attention by calling the office. The patient's outcome was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning an about 18 year old female who in approximately May 2008 was vaccinated with GARDASIL vaccine (yeast). That same day, the patient developed injection site soreness which was still sore one week after vaccination. The patient sought medical attention by a phone call. The patient outcome was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a mother concerning her 24 year old daughter who in May 2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), injection form, (Lot # was not available). Concomitant therapy included hormonal contraceptives (unspecified). In approximately May 2008, 2 to 3 weeks after receiving the first dose of GARDASIL vaccine (yeast) the patient developed warts on her hand. The patient's warts on hand persisted. The patient sought medical attention of a dermatologist. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTP, HPV4, MNQ
Symptoms: Agitation, Blood pressure increased, Dizziness, Syncope, Urinary retention
Clinical narrative: Information has been received from a physician concerning a "14 year old" female who on approximately 11-MAY-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# not reported). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On approximately 11-MAY-2008 the patient felt dizzy, agitated, had elevated blood pressure, was holding in urine and fainted. Subsequently, the patient recovered from feeling dizzy, agitated, elevated blood pressure, holding in urine and fainting. The patient sought unspecified medical attention on an unspecified date. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Movement disorder, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning her 14 year old female daughter was vaccinated on an unspecified date with her first dose of GARDASIL vaccine (yeast). A week later she the patient experienced fever of about 103 degrees, had a headache and her left arm had pain and difficulty moving. Subsequently, the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5ml. Subsequently the patient developed hives. Subsequently, the patient recovered from hives. The patient sought medical attention with a telephone call. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with the third dose of GARDASIL vaccine (yeast) (lot#, therapy route and dose not reported). On the same day of vaccination of the third dose, the patient had arm pain and achiness down the length of the arm from the shoulder down to the hand. Which arm unspecified. The patient's arm hurt a couple of days after vaccination then it went away and then came back. The patient did not have any problems with the first and second doses of GARDASIL vaccine (yeast). The patient came into office to seek medical attention. The patient was prescribed unspecified medications for the achiness. As of 15-JUL-2008, the arm pain persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Injection site reaction, Peripheral coldness
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who on 15-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). The physician reported that post-vaccination, the patient complained of headache and that her arm was cold at the injection site. The patient was given ibuprofen (ADVIL) and felt better. The patient was sent home. At the time of the report the patient was recovering. The patient sought medical attention at the physician's office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician assistant concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL vaccine (yeast), 0.5ml, intramuscularly for HPV prevention. The physician assistant reported that the patient fainted after receiving the vaccine. The patient recovered on the same day of the vaccination. The patient sought unspecified medical attention. Additional information has been requested. \
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 14 year old female patient who was vaccinated with the entire series of GARDASIL vaccine (yeast). The nurse reported that the patient experienced muscle spasms after each of her HPV vaccine doses. It is not known when the spasms began or how long they lasted. At the time of the report the patient had recovered. The patient sought medical attention by phone. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Dizziness, Ophthalmological examination
Clinical narrative: Information has been received from a physician concerning a 24 year old female healthcare worker with dizziness and sleep disorder and a history of pain who on 02-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included ROZEREM. Subsequently, the patient experienced more severe dizziness after her first dose. The patient sought medical attention, saw a physician and had an eye check performed. At the time of reporting, the patient's dizziness persisted. No additional AE information provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Allergy to metals, Bacterial infection, Biopsy skin, Dyspnoea
Clinical narrative: Information has been received from a 26 year old female with an allergy to TYLENOL who in 2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) prior to a spinal fusion surgery in August 2007. Two weeks after the surgery she broke out in a serious rash all over her body that was red, itchy and oozy. She went back to her surgeon who thought she may have caught a bacterial infection while in the hospital. After the treatment for that, the rash did not go away and patient was thought to have a staph infection. The rash was getting worse and she started having difficulty breathing and had to be taken to ER. It was determined she may have an allergic reaction to the nickel hardware that was placed in her spine. After that she was sent to an allergist who performed some tests, however the patient was taking allergy medication at the time and the test came back inconclusive. She did receive a second and third dose of GARDASIL vaccine (yeast) and was also scheduled for a second spinal fusion to replace the hardware with stainless steel. The patient is still experiencing a rash, that comes and goes depending on whether she puts the cream on it or not. She will bring the package insert for GARDASIL vaccine (yeast) with her to the allergist office to look at the ingredients and perform some tests to see if she could be allergic to any of the components. At time of report, the patient had not recovered from her rash. The outcome of the difficulty breathing, bacterial staph infection and allergic reaction to nickel hardware is unknown. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash generalised, Rash pruritic, Skin irritation
Clinical narrative: Information has been received from a 26 year old female with an allergy to TYLENOL who in 2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) prior to a spinal fusion surgery in August 2007. Two weeks after the surgery she broke out in a serious rash all over her body that was red, itchy and oozy. She went back to her surgeon who thought she may have caught a bacterial infection while in the hospital. After the treatment for that, the rash did not go away and patient was thought to have a staph infection. The rash was getting worse and she started having difficulty breathing and had to be taken to ER. It was determined she may have an allergic reaction to the nickel hardware that was placed in her spine. After that she was sent to an allergist who performed some tests, however the patient was taking allergy medication at the time and the test came back inconclusive. She did receive a second and third dose of GARDASIL vaccine (yeast) and was also scheduled for a second spinal fusion to replace the hardware with stainless steel. The patient is still experiencing a rash, that comes and goes depending on whether she puts the cream on it or not. She will bring the package insert for GARDASIL vaccine (yeast) with her to the allergist office to look at the ingredients and perform some tests to see if she could be allergic to any of the components. At time of report, the patient had not recovered from her rash. The outcome of the difficulty breathing, bacterial staph infection and allergic reaction to nickel hardware is unknown. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersomnia
Clinical narrative: Information has been received from a consumer, concerning her 19 years old daughter, who was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot #, site and route of administration not reported) in Jun 2008 (reported as "three weeks ago"). When the patient got the first injection she went home and immediately fell asleep for 15 hours. She was very worried about getting the shot before it happened. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 14-JAN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659653/1448U) and on 14-MAR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 660387/1967U). Concomitant therapy included hormonal contraceptives ALEESE. The physician reported that on 18-APR-2008, the patient developed Bell's palsy after administration of two doses of HPV vaccine. The nurse reported that the patient was nit evaluated in her office. The patient was evaluated by her family physician. Subsequently, the patient recovered from BELL'S palsy. The patient sought medical attention via telephone. Additional information has been requested. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood magnesium decreased, Hypoaesthesia, Hypomagnesaemia, Nausea, Viral infection
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 09-JUL-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL vaccine (yeast) (lot # 660553/0070X) intramuscular. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The Nurse reported that on 11-JUL-2008, the patient experienced nausea, vomiting, numbness throughout her body after receiving the dose of GARDASIL vaccine. The patient was brought to the emergency room were it was determinate that the symptoms were due to a virus and low magnesium level. Subsequently, the patient recovered from nausea, vomiting, numbness, virus infection and low magnesium level. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 09-JUL-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL vaccine (yeast) (lot # 660553/0070X) intramuscular. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The Nurse reported that on 11-JUL-2008, the patient experienced nausea, vomiting, numbness throughout her body after receiving the dose of GARDASIL vaccine. The patient was brought to the emergency room were it was determinate that the symptoms were due to a virus and low magnesium level. Subsequently, the patient recovered from nausea, vomiting, numbness, virus infection and low magnesium level. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood test, Muscular weakness
Clinical narrative: Information has been received from a consumer concerning to his daughter who on 27-JUN-2008 was vaccinated with 0.5 ml of GARDASIL vaccine (yeast) (batch and lot numbers not reported) intramuscular. Concomitant therapy included PROZAC and CLONOPIN. About a week after she got the vaccine (on approximately 04-JUL-2008) the patient experienced stomach pain and muscle weakness. The patient had blood work done (results not reported). The patient was recovering from stomach pain and muscle weakness. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Condition aggravated, Gastrointestinal disorder
Clinical narrative: Information has been received from a registered nurse concerning her daughter with an unspecified gastrointestinal disorder who was vaccinated with GARDASIL vaccine (yeast) (Lot # not reported). The nurse reported that her daughter developed a worsening of a gastrointestinal disorder after receiving GARDASIL vaccine (yeast). The patient experienced increased abdominal bloating. The patient sought medical attention at physician's office. At time of report, the patient's gastrointestinal disorder and increased abdominal bloating persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with no known drug allergies or pertinent medical history who on 27-MAY-2008 was vaccinated IM with the first dose of GARDASIL vaccine (yeast) (lot n. 654272/0073X). Concomitant therapy included an unspecified birth control pill. The patient received the first dose of GARDASIL vaccine (yeast) and immediately fainted. She was unconscious for 5-10 minutes. The patient sought medical attention at the office. No treatment was required and the patient recovered on 27-MAY-2008. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Iritis
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a cough and history of migraine who on 30-JUN-2008 was vaccinated with the first dose GARDASIL vaccine (yeast) (Lot number 660555/0279X). There was no concomitant medication. On 07-JUL-2008, seven day later, she was diagnosed with iritis. She was seen by an ophthalmologist and received an unnamed treatment. She was also scheduled to see a rheumatologist. She had a cough before receiving GARDASIL vaccine (yeast) and still had the cough. At the time for this reporting, the patient's iritis persisted. Additional information has been requested.  1/12/2009 MR received from 7/10/08-11/25/08 with DX:  Chronic anterior uveitis, both eyes, without uveitic complications.  Hx of migraine episodes.  Sinus disease. Chronic cough.  Elevated CRP and ESR. Proteinuria. Pt initially presented 7/10/08 with c/o 1 wk hx of intermittent blurred vision of the L eye and 3 week hx of cough. PE (+) for conjunctival injection with 2+ cells in anterior chamber.  Impression:  Acute Iritis OS of unknown etiology.  Early myopia. F/U 7/16/2008 now bilateral Iritis. Consult 8/19/08 with another ophth.  Referred for eval and mgmt of uveitis, both eyes due to little response to previous tx with topical steroid. ? TINU (Tubulo-interstitial nephritis and uveitis) being considered 2' to proteinuria.  2/2/09 MR received from rheumatology and nephrology consults.  Seen 7/16/08 with c/o blurry eyes, decreased vision, red eyes, recent chest pain and cough and congestion. PE (+) for mild scoliosis. DX:  Iritis.  Cough and congestion. Wegener's Granulomatosis. Increased Sed rate, (+) ANA. Mild scoliosis. Proteinuria. F/U visit Dx changed to Likely TINU-Tubulo-interstitial nephritis: mild uveitis and nephritis.  Hemangioma T4 spinal vertebra.  Sinusitis.  Seasonal allergies. Now c/o back pain-lower back and T12 to L1-4. Referred to nephrology for proteinuria. Uveitis slowly improving with steroid drops. Proteinuria resolved.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a nurse practitioner concerning a 13 year old female who on16- May 2008, was vaccinated IM in the left arm with the first dose of GARDASIL vaccine (yeast) (lot 660389/1968U). There was no concomitant medication. On 17-May 2008, the patient developed a fever of 102c the day after the first dose of GARDASIL vaccine (yeast). Subsequently, the patient recovered from fever of 102c. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Activities of daily living impaired, Asthenia, Computerised tomogram normal, Convulsion, Dizziness
Clinical narrative: This is in follow-up to report (s) previously submitted on 8/14/2008. Information has been received from a physician concerning her daughter (age not reported) who on an unspecified date was vaccinated IM with the first dose of GARDASIL vaccine (lot not reported). Her daughter became weak, dizzy and stayed in bed for two days after vaccination. The outcome was not reported. Additional information has been requested.  11/18/08 Reviewed ER medical records of 3/4/2008. FINAL DX: viral syndrome Records reveal patient experiencec felt faint x 1 day, fever, vomiting, cough, loss of appetite, abdominal pain, reduced oral intake.  Tx w/IVF & meds, improved & d/c to home, instructed not to go to school next day. Follow up information has been received from the physician concerning her 17 year old daughter who on 28-FEB-2008 was vaccinated IM with the first dose of GARDASIL vaccine. On 29-FEB-2008 the patient started feeling nauseous, had a headache and was very tired. Her mother took her to the ER. The patient stayed there for the whole day. She received IV fluids for dehydration. She had a CT scan, blood work and other tests that were all negative. She was diagnosed as having a reaction to the GARDASIL vaccine with a semi-seizure. She is not going to received the 2nd or 3rd dose. She has since recovered. The physician mentioned that her other daughter had received GARDASIL without any problems. The lot# was unknown because the patient was vaccinated at another office. Upon internal reveiw, semi-seizure was considered to be an other important medical event. Additonal information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Haematology test normal, Headache, Laboratory test normal, Nausea
Clinical narrative: This is in follow-up to report (s) previously submitted on 8/14/2008. Information has been received from a physician concerning her daughter (age not reported) who on an unspecified date was vaccinated IM with the first dose of GARDASIL vaccine (lot not reported). Her daughter became weak, dizzy and stayed in bed for two days after vaccination. The outcome was not reported. Additional information has been requested.  11/18/08 Reviewed ER medical records of 3/4/2008. FINAL DX: viral syndrome Records reveal patient experiencec felt faint x 1 day, fever, vomiting, cough, loss of appetite, abdominal pain, reduced oral intake.  Tx w/IVF & meds, improved & d/c to home, instructed not to go to school next day. Follow up information has been received from the physician concerning her 17 year old daughter who on 28-FEB-2008 was vaccinated IM with the first dose of GARDASIL vaccine. On 29-FEB-2008 the patient started feeling nauseous, had a headache and was very tired. Her mother took her to the ER. The patient stayed there for the whole day. She received IV fluids for dehydration. She had a CT scan, blood work and other tests that were all negative. She was diagnosed as having a reaction to the GARDASIL vaccine with a semi-seizure. She is not going to received the 2nd or 3rd dose. She has since recovered. The physician mentioned that her other daughter had received GARDASIL without any problems. The lot# was unknown because the patient was vaccinated at another office. Upon internal reveiw, semi-seizure was considered to be an other important medical event. Additonal information has been requested.
Age: 0.1
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 4 week old patient who on 16-JUL-2008 was vaccinated with ROTATEQ vaccine live (human-bovine). There were no adverse events reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated po with the third dose of ROTATEQ vaccine live (human-bovine) (date unspecified). The patient subsequently, experienced prolonged diarrhea (date, duration unspecified). It was reported that the patient sought unspecified medical attention. The outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old female patient with no known allergies or pertinent medical history who on 14-JUL-2008 was vaccinated orally with "1 tube" of ROTATEQ vaccine live (human-bovine) (lot # 660600/0281X). There was no concomitant medication. Subsequently, two days post vaccination on 16-JUL-2008 the patient developed vomiting and diarrhea. Medical attention was sought in the office. There were no lab studies performed. At the time of the report, the patient was recovering. It was reported that the vomiting had improved. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/24/2008. Follow-up information has been received from a physician concerning an 12 week old female infant who on 14-Jul-2008 at 2:00 pm was vaccinated orally with a first dose of ROTATEQ (lot # 060608/0281X). On 18-Jul-2008 (also reported as 14-Jul-2008) the patient developed vomiting and diarrhea. There were no lab studies performed. At the time of the report, the patient recovered on 24-Jul-2008. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a registered nurse concerning a 8 week old female patient with no known allergies and irregular heartbeat who on 18-JUL-2008 was vaccinated with ROTATEQ vaccine live (human-bovine) (lot # 660679/0407X). Concomitant therapy included MYLANTA. Subsequently, the patient regurgitated her first dose of ROTATEQ onto her face a few minutes after administration. Medical attention was provided during the office visit. There were no lab studies performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test
Clinical narrative: Information has been received from a physician concerning a patient, who is a twin, who on 02-JUL-2008 was vaccinated with an oral first dose of ROTATEQ vaccine live (human-bovine). Within days of receiving the vaccination the twin experienced severe diarrhea, approximately 10 times per day. The physician reported that the twin was being tested for rotavirus (no information was provided). No lot number was provided. No product quality complaint was involved. This is one of two reports from the same source. The patient's twin was administered an oral first dose of ROTATEQ vaccine live (human-bovine) and had a similar experience (WAES# 0807USA02912). Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 13 week old female patient who on 21-JUL-2008 was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). There were no adverse effects reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Regurgitation, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a patient who was vaccinated with a second dose of ROTATEQ vaccine live (human-bovine). Concomitant therapy included TYLENOL. The child was given the second dose of vaccine and spit up. The child had a reaction around the mouth that looked like "hives" after vaccine administration. BENADRYL INJECTION was administered to the child and the child recovered. The third dose of ROTATEQ vaccine live (human-bovine) will not be given. No product quality complaint was involved. Additional information has been received from a physician concerning a 4 month old female who on 05-MAY-2008 was vaccinated with the first oral dose of ROTATEQ (lot # 659917/0017X) at 10:08. On 05-MAY-2008, the patient developed hives on chin and neck. The patient recovered date of recovery unknown.  Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated date was vaccinated orally with a third dose of ROTATEQ vaccine live (human-bovine) two weeks too late. It was reported that instead of the vaccine being given after 32 weeks it was given after 34 weeks. There were no adverse effects reported. At the time of the report  the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Fluid replacement, Nasal congestion, White blood cells stool negative
Clinical narrative: This is in follow-up to report (s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 2 month old male who 3-4 weeks ago was vaccinated with the first dose of ROTATEQ vaccine live (human-bovine), 2 ml orally. The patient experienced prolonged diarrhea for 14 days. It required an Emergency Room visit for rehydration with intravenous fluids administered. The physician considered prolonged diarrhea for 14 days to be an other important medical event. It was reported that the patient recovered. No product quality complaint. Additional information has been requested. Additional information has been received from a physician indicating that the patient received the first oral dose of ROTATEQ vaccine (Lot # 680290/0143X) on 20-JUN-2008 in the a.m. Concomitant therapy included the first dose of PREVNAR (Wyeth) (Lot # C6328), IM in the left leg and the first dose of PEDIATRIX (GSK) (Lot # AC21B142AA), IM in the right let. On approximately 20-JUN-2008, the patient developed watery diarrhea and lasted for 3 weeks. No fever or vomiting was reported. The child had a slight nasal congestion only at the time of vaccinations. It was reported that the patient recovered from the event on 10-JUL-2008. Stool for WBC was negative and stool culture for Salmonella, Shigella, E. coli Yersinia, Campylobacter and Aeromanas were also negative. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 30-JUN-2008 was vaccinated with the first dose of ROTATEQ vaccine live (human-bovine) and on 22-JUL-2008 was vaccinated with the second dose of ROTATEQ vaccine live (human-bovine).The nurse reported that the patient received ROTATEQ vaccine live (human-bovine) in shorter than recommended interval. The patient also was vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on an unknown date which was reported as too early also. No adverse effect reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 6 month old female who was vaccinated with their third dose of oral ROTATEQ vaccine live (human-bovine), 2 ml, who experienced projectile vomiting within 4 hours of receiving the vaccine. Concomitant therapy included "routine vaccinations." It was reported that the "patient is fine now." Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a 15 week old patient who will receive their first dose of ROTATEQ vaccine live (human-bovine) on 30-JUL-2008. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who on 31-JUL-2008 was vaccinated with their first dose of oral ROTATEQ vaccine live (human-bovine), 2 ml, at 24 weeks of age. No averse effect reported. No product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with an unspecified dose of ROTATEQ vaccine live (human-bovine). It was noted that the patient spit most of "it" up. At the time if the report, the patient's status was unknown. There was no product quality complaint involved. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 08/14/2008. Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with an unspecified dose of ROTATEQ. It was noted that the patient spit most of "it" up. At the time if the report, the patient's status was unknown. There was no product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 26 day old patient who on 05-MAY-2008 was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Cough, Eye pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse (RN) concerning herself who on an unspecified date had some ROTATEQ splashed into her eye when the baby spit out some of the vaccine. She felt little sting in her eye when she was splashed. Additional information has been requested. Follow up information has been received from the R.N. who was an approximately 53 year old female with hypertension and an allergy to penicillin reported that in a morning of an unspecified date as she was administered the ROTATEQ (lot #65741/1052U) to a 2 month old infant it coughed splashing the ROTATEQ into the corner of the left eye. There was a little sting to the left eye. She called for instructions. She washed the eye out for 30 minutes. No ill effects were reported. She had no problems since. It was reported that the nurse recovered from the sting in the left eye. Additional information is not expected.
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 26 day old female infant who on 05-MAY-2008 was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). It was noted that the patient received her second dose of ROTATEQ vaccine live (human-bovine) (lot # 657668/1390U) on 30-JUN-2008. There were no problems reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea
Clinical narrative: Information has been received from a physician concerning her 54 day old son with no known allergies or pertinent medical history who on 21-JUN-2008 was vaccinated orally with a first "full dose" of ROTATEQ vaccine live (human-bovine). Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine (manufacturer unknown), PREVNAR vaccine (CRM197) and Hib conj vaccine (OMPC) (manufacturer unknown). Subsequently, on 21-JUN-2008 the patient developed diarrhea. It was noted that the patient has 8-10 episodes a day since he received the vaccination. It was also noted that on 23-JUN-2008 the patient developed a decreased appetite. Medical attention was sought. There were no lab studies performed. The patient's pediatrician suggested that the patient be changed from soy formula to soy formula with fiber. It was noted that the patient's stools became more formed, but the frequency of the stools was the same. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information has been received from a physician concerning this 54 day old infant who developed "strong" diarrhea the day after vaccination. It was reported that there was no bleeding, but the patient still has diarrhea. At the time of the report the patient had not recovered. There was no product quality compliant involved. Additional information has been requested.