chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a female pharmacist who in August 2007, was vaccinated intramuscularly in right deltoid with the first dose of GARDASIL. In October 2007 she received her second dose of 0.5mL dose intramuscularly of GARDASIL. There was no concomitant medication. Subsequently the patient experienced pain at the injection site for both injections, however she reported no problems after the vaccinations. The pharmacist stated that they loaded syringe "hurt" when it is administered, both doses hurt while being administered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia
Clinical narrative: Information has been received from a pharmacist (PHARM D) concerning a 21 year old female who in October 2007, was vaccinated with GARDASIL (lot# unknown). On an unspecified date the patient experienced cardiac arrythmias. Medical attention was sought at the physician's office. At the time of reporting it was unknown if the patient had recovered. No further information was available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in August 2007, was vaccinated with the second dose of GARDASIL (no lot# reported), 0.5mL injection. In October 2007, the patient experienced nasal symptoms, coughing and congestion. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Herpes simplex serology negative, Vaginal ulceration
Clinical narrative: Information has been received from a registered concerning an adolescent female with a history of not being sexually active who on an unspecified date was vaccinated with GARDASIL (lot# unknown) 0.5 mL injection. On an unspecified date three days later the patient developed vaginal sores. The vaginal sores went away but came back again at a later time (two episodes of this condition). Medical attention was sought. On an unspecified date two herpes virus cultures were performed and the results were negative. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a dose of Gardasil.  The patient after receiving the vaccine fainted.  The patient came to and was fine.  It was unknown whether medical attention was sought.  The patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Information has bee received from a health professional concerning a female who was vaccinated with the first dose of GARDASIL (lot# 658558/1061U).  The patient fainted within 10 minutes after receiving the vaccine.  The patient recovered well after resting.  No treatment required.  No product quality complaint was involved.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Computerised tomogram normal, Exophthalmos, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 28 year old female with no pertinent medical history or drug reactions/allergies who in March 2007, May 2007 and October 2007 was vaccinated with a first, second, and third dose of Gardasil (lot # unknown) respectively.  There was no concomitant medication.  Following each of the vaccinations the patient experienced headaches which generally lasted one or two weeks following each dose of Gardasil.  Medical attention was sought.  On an unspecified date the patient had a magnetic resonance imaging test (MRI) performed and was within normal limits.  No other information was available.  Follow-up information was received from the patient.  The patient reported as having experienced severe headaches after her second and third dose of Gardasil and did not have this experience after her first dose.  After the second dose of Gardasil, the headache lasted non-stop for three weeks.  The patient was told by her OB/GYN that the headaches were not a side effect of Gardasil.  The patient started experiencing severe headaches 45 minutes after the third dose and is still experiencing it as of today 06-NOV-2007.  The patient has had two magnetic resonance imaging tests (MRI's) and a computed axial tomography (CAT) scan and no abnormalities were determined.  On an unspecified date at an office visit with her primary care physician, her eyes were bulging and the physician thought the patient was having a stroke.  The patient feels like "she has a knife in her head" and finds it difficult to take care of her children.  No additional information was provided.  Additional information has been requested. Follow-up received 04/16/2008. Follow-up information was obtained from the physician's office. The dates of the vaccinations for GARDASIL were 23-MAR-2007, 25-MAY-2007 and 25-OCT-2007 respectively. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a physician's assistant concerning a female who was vaccinated with GARDASIL (date not provided). After this first vaccination, the patient developed a rash on her arm where injection was given, a rash on both legs and also in her mouth. The patient was treated with a dose of diphenhydramine hydrochloride (Benadryl). Subsequently, the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema nodosum
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 16-JUL-2007 was vaccinated with Gardasil (Lot no. 658094/0524U).  Concomitant therapy included Menactra.  On 24-JUL-2007 the patient experienced "erythrocythemia nodosum"  The patient sought medical attention.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who on 18-JUL-2007 was vaccinated with Gardasil. At around 2300 on the night of the vaccination, the patient developed a fever. Two days later, the patient recovered from fever. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 16 year old female who was vaccinated with GARDASIL, intramuscularly. Subsequently the patient fainted. The patient recovered on an unspecified date. This is one of two reported from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Information has been received from a licensed practical nurse (L.P.N.) concerning a 16 year old female who was vaccinated with GARDASIL, intramuscularly.  Subsequently the patient fainted.  The patient recovered on an unspecified date.  This is one of two patients reported from the same source.  Additional information has been requested.  Additional information from the nurse on 11-DEC-2007 indicated she was unable to identify the patients involved.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a nurse concerning her medical assistant colleague, who is a female in her thirties.  The medical assistant was vaccinating a patient with Gardasil on 06-NOV-2007.  Subsequently, the needle popped off the pre-filled syringe and the medical assistant was splashed in her eye.  The reporter did not know which eye was splashed.  The medical assistant went to the eye station and washed the splashed eye with water.  The reporter stated that this was staff error and not a product quality complaint.  The medical assistant is fine, but her eye feels irritated, which the caller says may be due to the washing and rubbing of it.  The medical assistant is recovering.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who was vaccinated with her first dose of Gardasil. Subsequently, the patient experienced tingling in her feet. It was reported that the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 13 year old female with a history of invasive meningococcal disease who on 27-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658490/0802U). Concomitant vaccination included Menactra. On 28-Jul-2007 the patient experienced rash within 24 hours of vaccination with Gardasil. The patient's outcome was not reported. There was no product quality complaint. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with no medical history and no drug allergies, who in June or July 2007, was vaccinated with a third dose of Gardasil.  There was no concomitant medication.  After the completion of the Gardasil series, on 21-SEP-2007 a Pap test was performed that was "equivocal or invalid for cervical cancer".  The test results were returned to the nurse practitioner on 03-OCT-2007.  It was reported that the Pap test would be repeated in six months.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who was vaccinated with her first dose of GARDASIL IM. The patient experienced a fever of 104. Subsequently, the patient recovered from the fever of 104. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a Licensed Practical Nurse (LPN) concerning a 15 year old female patient who was vaccinated with a first dose of Gardasil.  Patient received the second dose of Gardasil on an unknown date.  The nurse reported that the patient passed out after her first vaccination of Gardasil.  An ambulance was called and the patient went to the Emergency Room (ER).  It was unknown if she was admitted to the hospital.  The patient had no incidence after her second injection.  The outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL and tolerated it well. Subsequently the patient experienced facial hives and lip swelling after receiving the second dose of GARDASIL. Subsequently, the patient recovered from facial hives and lip swelling. The patient sought medical attention by calling the primary MD. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 01-NOV-2007 was vaccinated with her third dose of Gardasil IM.  On approximately 01-NOV-2007 the patient experienced "lightheadedness and had actually fainted".  It was reported that the patient did "hit her head when she fainted", but the fall did not require any further medical attention".  The patient outcome was not reported.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTAP, HPV4, MMR
Symptoms: Abdominal pain, Bronchospasm, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 10-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included measles-mumps-rubella vaccine, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 13-FEB-2007 the patient experienced abdominal pain and "bronco spasms". The patient had been seen by a physician on 13-FEB-2007, 23-FEB-2007, 05-MAR-2007 and on 07-MAR-2007. The patient had some visits to the Emergency Room however their is no information as to whether the patient was admitted. Patient outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with no medical history and no drug allergies, who on 24-APR-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  Concomitant therapy included hepatitis B virus vaccine (unspecified).  On 10-AUG-2007 the patient was vaccinated with a second dose of Gardasil (Lot #657737/0522U).  On 13-AUG-2007 the patient's period started.  The menstrual bleeding lasted for 3 weeks.  The patient's father contacted the office.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health care worker, via a company representative, concerning a 13 year old female, who on an unspecified date was vaccinated with the third dose of Gardasil (lot # not reported). Following the vaccination, the patient fainted. Subsequently, she recovered (duration not specified) and "was fine," with no medical action required.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female with no medical history and no drug allergies, who on 02-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 657737/0522U). Concomitant therapy included MENACTRA. In September 2007 the pant was vaccinated with a second dose of Gardasil (Lot# 658556/1060U). On 11-OCT-2007 the patient was vaccinated with a third dose of Gardasil (Lot# 658556/1060U). Subsequently, after dose three the patient experienced injection site pain that lasted about 24 hours. The patient was seen in the office. No laboratory diagnostics were performed. The patient recovered on 12-OCT-2007. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient (age unknown), who, on an unspecified date, was vaccinated with a third dose of GARDASIL. Subsequently, following the completion of GARDASIL series a pap test was performed that was "equivocal or invalid for cervical cancer." At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Influenza like illness, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of 0.5ml Gardasil vaccine (lot # not reported). Post vaccination, the patient developed flu like symptoms and pain in the leg (which leg not specified). Per the mother, the patient was sick in bed approximately 5 days. The patient did see unspecified medical attention and recovered from these events. Mother is unsure if her daughter will continue series of Gardasil. Additional information has been requested. Additional information has been received from a nurse stating that she was not aware of any AE for this patient. No additional informatin is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Skin nodule
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with no medical history and a penicillin allergy, Biaxin allergy, Cephalexin allergy, and sulfonamide allergy, who on approximately 18-OCT-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included ORTHO TRI-CYCLEN. Five days post vaccination on approximately 23-OCT-2007 the patient developed "small grape size" bumps under her skin. During the next three weeks the bums had appeared 6-10 times. The bums appeared in the morning and then resolved within 2-3 hours. The bumps were located either on the patient's lips, fingers, or feet. The patient was seen at the office. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Erythema, Pharyngeal oedema, Rash
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no pertinent medical history or concomitant medication use, who in August 2007 was vaccinated intramuscularly (site not reported) with 0.5ml GARDASIL (lot# not reported). Two weeks post vaccination, the patient developed a mild, red rash on her arms and legs. The patient also had a mild, transient, swelling in her throat that caused slight difficulty breathing. The patient sought unspecified medical attention and at the time of this report was recovering. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a female under the age of 25 who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st and 2nd dose of Gardasil (lot # not reported).  Subsequently, post vaccination, the patient developed flu-like symptoms.  At time of reporting, the patient's outcome was unknown.  This is one of 2 reports from the same source.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 17 year old female who was vaccinated with GARDASIL. Concomitant vaccinations included DTAP and MENACTRA. Subsequently the patient fainted. The patient recovered on an unspecified date. This is one of two patients reported from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Haemorrhage, Muscle spasms
Clinical narrative: Information has been received from a female nurse in her early 20's who was vaccinated (date, site and route not reported) with Gardasil (lot # not reported).  There was no concomitant medication.  The nurse experienced bleeding, severe cramping and back pain.  She completed the series, but it was not specified if the experience was after each dose or if it was after a specific dose.  The nurse received unspecified medical attention.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Aura, Dizziness, Headache, Pyrexia, Scotoma
Clinical narrative: Information has been received from a medical assistant and a physician assistant concerning a 13 year old female with no pertinent medical history, known drug allergies or routine medication use who on 09-AUG-2007 was vaccinated (site and route not reported) with the 1st 0.5 ml dose of Gardasil (lot # not reported) and had no adverse reaction.  On 08-NOV-2007, the patient was vaccinated (site and route not reported) with the 2nd 0.5 ml dose of Gardasil (lot # not reported) and experienced dizziness, blurred vision, fever, visual aura, and bilateral peripheral scotoma a few minutes post vaccination.  The bilateral peripheral scotoma resolved after 30 minutes and was followed by the onset of a bilateral frontal headache and lightheadedness.  The patient's vital signs were stable.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a medical assistant and a physician assistant concerning a 13 year old female with no pertinent medical history, known drug allergies or routine medication use who on 09-AUG-2007 was vaccinated (site and route not reported) with the 1st 0.5 ml dose of Gardasil (lot # not reported) and had no adverse reaction.  On 08-NOV-2007, the patient was vaccinated (site and route not reported) with the 2nd 0.5 ml dose of Gardasil (lot # not reported) and experienced dizziness, blurred vision, fever, visual aura, and bilateral peripheral scotoma a few minutes post vaccination.  The bilateral peripheral scotoma resolved after 30 minutes and was followed by the onset of a bilateral frontal headache and lightheadedness.  The patient's vital signs were stable.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling
Clinical narrative: Information has been received from a physician concerning a 25 year old black female who on 10-JUL-2007 was vaccinated with her first dose of GARDASIL (lot # 0469U). On 12-SEP-2007 the patient was vaccinated with her second dose of GARDISIL (lot # 654539/0742U). Subsequently on 31-OCT-2007, "about six weeks after receiving GARDASIL the patient's eyes were swollen." The patient recovered from swollen eyes and was seen by an allergist. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with GARDASIL. Subsequently the patient experienced nausea after receiving the vaccine. The patient sought unspecified medical attention and her outcome was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with intramuscularly in the arm with the first dose of GARDASIL (Lot # not reported). In approximately October 2007, the patient experienced menorrhagia. No other symptoms were reported. Patient outcome was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site scar
Clinical narrative: Information has been received from a health professional concerning a 17 year old white female who on an unspecified date was vaccinated with the first dose of Gardasil.  On 07-JUL-2007, the patient was vaccinated with the second dose of Gardasil (lot #0469U) in the left deltoid at 9:30 AM.  On 07-JUL-2007, at 10:00 AM, the patient developed a raised welt that left a scar at the injection site.  The patient recovered from the welt but the outcome of the scar was unknown. Addional information was received from a healthcare worker. When the welt resolved a permanent scar was left at the site. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL. The physician reported that the patient became pale and felt lightheaded and dizzy after getting the dose of GARDASIL. No other information was available. The patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Biopsy
Clinical narrative: Information has been received from a physician, concerning a 20 year old female patient with no pertinent medical history, who on unknown dates was vaccinated with the first, second, and third doses of Gardasil (lot #'s not provided).  There was no concomitant medication.  In October 2007 ("two to three weeks ago"), the patient visited the office, had a biopsy (unspecified) and was diagnosed with genital warts.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer, regarding her 20 year old granddaughter with no pertinent medical history, who on an unknown date was vaccinated IM with the second dose of GARDASIL (lot # not provided). There was no concomitant medication. After the vaccination, her granddaughter fainted. She recovered and "was fine" before she left the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Initial and follow up information has been received from a grandmother and mother, regarding their 20 year old daughter/grandaughter with no pertinent medical history, who on an unknown date was vaccinated IM with the first dose (previously reported as second dose by the grandmother) of GARDASIL (lot # not provided).  There was no concomitant medication.  After the vaccination the grandmother reported her grandaughter fainted.  She recovered and "was fine" before she left the office.  Follow up information from the mother indicated that this was the first time her daughter had ever passed out.  She commented that the grandmother had called because she was concerned about her grandaughter receiving further doses of the vaccine.  However, she added that her daughter proceeded to receive both the second and the third dose of GARDASIL (dates and lot # not provided), with no complication.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a registered nurse, concerning a 20 year old female patient, who on an unknown date was vaccinated in the dorsogluteal area with the third dose of Gardasil (lot # not specified).  The patient experienced pain with the vaccination.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 26 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced swelling, a bump and itching at injection site after receiving the vaccine.  Subsequently, the patient recovered from swelling, a bump and itching at injection site.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who in August 2006, was vaccinated with a 0.5 ml first dose of GARDASIL. About three weeks after beginning therapy the patient experienced a numb tongue, headaches, and a tingling sensation in her head and tongue. The patient experienced the same after receiving each of the three doses. This effect would slowly go away until the next shot and then the effect would begin again. Unknown medical attention was sought. In April, 2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Photophobia, Syncope
Clinical narrative: Information has been received from a pharmacist concerning his 17 year old daughter who on 21-JUN-2007 was vaccinated with her first dose of Gardasil.  On 31-AUG-2007 the patient was vaccinated with her second dose of Gardasil.  On approximately 09-OCT-2007 the patient experienced lingering headaches.  The headaches were described as painful enough to cause absence from school and with some light sensitivity.  The patient saw her pediatrician twice for the headaches.  No treatment or diagnostic workup specified.  Additionally the patient had syncopal episodes after both Gardasil injections.  The patient's lingering headaches and syncopal episodes persisted.  Additional information has been requested. Follow-up information was received from the physician's office. On an unspecified date the patient had a urinary tract infection with dysuria for 1 and 1/2 days at the time of vaccination. There was no discharge, fever, nausea or vomiting. Concomitant therapy included BACTRIM for UTI. On 21-JUN-2007 the patient's was vaccinated with a first dose of GARDASIL (lot# 0197U) at 8:58 PM IM in the left deltoid. On 21-JUN-2007 8:58 PM the patient walked out of clinic to the waiting room and leaned on her dad's shoulder and had one short episode of dizziness. On 21-JAN-2007 a physicial examination was performed. The patient's general appearance, abdomen, gentalia and neurology was within normal limits. On 22-JUN-2007 the patient had 4 to 5 mild short episodes of dizziness each just lasting a few seconds when rising from lying position. The patient's body temperature measurement was 97.8 degrees F, the blood pressure measurement was 115/55 and the pulse rate was 69. The patient's chest, abdomen, skin, neurology, back and extremities was within normal limits. The patient was alert and active. The patient had no injection site erythema or induration. On 22-JUN-2007 orthostatic blood pressure measurement was 112/65 sitting, 117/74, 71 standing, 111/74 and 76. Recommendations included reasurance, supportive care, increase fluids and to return/call office if dizziness persists. All episodes were resolved by 22-JUN-2007 (office visit at 4:40PM). Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female who on 31-AUG-2007 was vaccinated IM a first dose of Gardasil (lot #658554/0928U).  Concomitant therapy included birth control pills.  A few hours after the vaccine was given, the patient experienced dizziness, felt faint, itching on her legs and hives.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007 - Additional informaiton is not expected
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Skin discolouration
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female who on 20-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 658556/1060U). Concomitant therapy included DEPO-PROVERA. On 20-AUG-2007, the patient developed white spots and pain in her upper injection site arm. On 31-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 658488/1264U). On 31-OCT-2007, the patient developed white spots and pain in her upper injection site arm. The patient sought unspecified medical attention by mentioning it at an unrelated office visit. The patient is recovering from the white spots and pain. Additional information has been requested. Information has been received from a licensed practical nurse concerning an 18 year old female who in 20-AUG-2007 was vaccinated intramuscularly with her first dose of HPV vaccine (lot # 658556/10600). On 20-AUG-2007, the patient developed white spots and pain in her upper injection sitearm. On31-OCT-2007, the patient was vaccinated intramuscularly with her second dose of HPV (lot # 658488/1264U). On 31-OCT-2007, the patient developed white spots and pain in her upper injection site arm. The patient sought unspecified medical attention by mentioning it an an unrelated office visit. The patient is recovering from the white spots and pain. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who on approximately 01-SEP-2007 was vaccinated with her first dose of Gardasil. On approximately 15-SEP-2007 the patient experienced headaches and nausea after receiving the first dose. The patient still received the second dose of Gardasil. The patient's headaches and nausea persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female (D.M.) who on 26-OCT-2007 was vaccinated with the second dose of Gardasil (lot number not reported). On 26-OCT-2007 the patient experienced injection site pain which has persisted to today. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Information has been received concerning a 19 year old female who on 07-NOV-2007 was vaccinated intramuscularly with the first dose of 0.5mL of Gardasil (lot # reported as "12660"). Concomitant therapy included duloxetine hydrochloride (CYMBALTA) and topiramate (TOPAMAX). On 09-NOV-2007 the patient experienced redness at the injection site, swelling at the injection site and nausea. The patient received the Menactra several weeks ago and had the same reaction. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Colonoscopy, Diarrhoea, Dizziness, Haematemesis
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of environmental allergies to mold and mildew who on 04-SEP-2007 was vaccinated with her first dose of GARDASIL (Lot # 058558/1061U). Concomitant therapy included LOESTRIN. One month after vaccination, the patient developed weight loss(17 pounds since start of GI problems), diarrhea, nausea, vomiting (sometimes bloody), dizziness, abdominal pain, and motion sickness. On 31-OCT-2007 (also reported as 30-Oct-2007) the patient received the second dose of GARDASIL (Lot 3 658563/1063U), the symptoms of weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain and motion sickness worsened and she developed achy legs. The diarrhea is uncontrollable, the patient is throwing up 5 or more times a day, the abdominal pain has increased. The patient has tried lansoprazole, Phenergan, dicyclomine hydrochloride, unspecified antibiotic, and ondansetron hydrochloride, none of which helped. The patient was seen by a Gastroenterologist and no cause for the gastrointestinal problems can be found. The patient had a colonscopy and follow through procedure, magnetic resonance imaging(MRI), blood tests, and tests for Gallbladder functioning. The patient's weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain, motion sickness, and achy legs persisted. Additional information has been requested. 4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis.  4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis. krk  5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. FINAL DIAGNOSIS: Recurrent vomiting Post vaccination abdominal pain, nausea, vomiting and diarrhea. Later reports fatigue, fevers, chills, night sweats, myalgias, hematemesis, blood with diarrhea. Watery bowel movements. Symptoms worsen when she eats.   8/7/09 Medical records received DOS 9/4/07 to 10/30/07. Annual physical. Oral contraceptives.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Motion sickness, Nausea, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of environmental allergies to mold and mildew who on 04-SEP-2007 was vaccinated with her first dose of GARDASIL (Lot # 058558/1061U). Concomitant therapy included LOESTRIN. One month after vaccination, the patient developed weight loss(17 pounds since start of GI problems), diarrhea, nausea, vomiting (sometimes bloody), dizziness, abdominal pain, and motion sickness. On 31-OCT-2007 (also reported as 30-Oct-2007) the patient received the second dose of GARDASIL (Lot 3 658563/1063U), the symptoms of weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain and motion sickness worsened and she developed achy legs. The diarrhea is uncontrollable, the patient is throwing up 5 or more times a day, the abdominal pain has increased. The patient has tried lansoprazole, Phenergan, dicyclomine hydrochloride, unspecified antibiotic, and ondansetron hydrochloride, none of which helped. The patient was seen by a Gastroenterologist and no cause for the gastrointestinal problems can be found. The patient had a colonscopy and follow through procedure, magnetic resonance imaging(MRI), blood tests, and tests for Gallbladder functioning. The patient's weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain, motion sickness, and achy legs persisted. Additional information has been requested. 4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis.  4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis. krk  5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. FINAL DIAGNOSIS: Recurrent vomiting Post vaccination abdominal pain, nausea, vomiting and diarrhea. Later reports fatigue, fevers, chills, night sweats, myalgias, hematemesis, blood with diarrhea. Watery bowel movements. Symptoms worsen when she eats.   8/7/09 Medical records received DOS 9/4/07 to 10/30/07. Annual physical. Oral contraceptives.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of environmental allergies to mold and mildew who on 04-SEP-2007 was vaccinated with her first dose of GARDASIL (Lot # 058558/1061U). Concomitant therapy included LOESTRIN. One month after vaccination, the patient developed weight loss(17 pounds since start of GI problems), diarrhea, nausea, vomiting (sometimes bloody), dizziness, abdominal pain, and motion sickness. On 31-OCT-2007 (also reported as 30-Oct-2007) the patient received the second dose of GARDASIL (Lot 3 658563/1063U), the symptoms of weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain and motion sickness worsened and she developed achy legs. The diarrhea is uncontrollable, the patient is throwing up 5 or more times a day, the abdominal pain has increased. The patient has tried lansoprazole, Phenergan, dicyclomine hydrochloride, unspecified antibiotic, and ondansetron hydrochloride, none of which helped. The patient was seen by a Gastroenterologist and no cause for the gastrointestinal problems can be found. The patient had a colonscopy and follow through procedure, magnetic resonance imaging(MRI), blood tests, and tests for Gallbladder functioning. The patient's weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain, motion sickness, and achy legs persisted. Additional information has been requested. 4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis.  4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis. krk  5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. FINAL DIAGNOSIS: Recurrent vomiting Post vaccination abdominal pain, nausea, vomiting and diarrhea. Later reports fatigue, fevers, chills, night sweats, myalgias, hematemesis, blood with diarrhea. Watery bowel movements. Symptoms worsen when she eats.   8/7/09 Medical records received DOS 9/4/07 to 10/30/07. Annual physical. Oral contraceptives.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Movement disorder, Tremor
Clinical narrative: Information has been received from a physician concerning a female who on 06-SEP-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient called the physician on 29-OCT-2007 and stated that she experienced tremors on the same arm she received the Gardasil. The patient's tremors on the same arm she received the Gardasil persisted. The sought unspecified medical attention. Follow-up AE information 13-NOV-2007: Per the reporter, one month after receiving the first dose of Gardasil, the patient developed a movement disorder and tremors in the arm in which she was vaccinated. The symptoms have lasted three weeks and are ongoing. Concomitant therapy included montelukast sodium (MSD). The montelukast sodium (MSD) was discontinued and symptoms persisted. The patient has seen a neurologist who states that he has never seen a case like hers before. The neurologist also states that the condition resembles a "rubal tremor". Unspecified diagnostic studies were performed by the neurologist. Patient placed on prednisone treatment and is doing "a little better". Memo 30-NOV-2007: Per the physician, the patient developed tremors and movement disorders in the arm in which she was vaccinated with the first dose of Gardasil. The symptoms persisted for the past 4 weeks. The patient was treated with low dose prednisone and has recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Loss of consciousness
Clinical narrative: Information has been received from a company representative reporting an adverse event that she heard on a new station on 12-NOV-2007 concerning a 14 year old female who was vaccinated with her first dose of Gardasil by her pediatrician. On her way home she developed abdominal cramping and loss of consciousness. The patients mother contacted the pediatrician who gave them a fact sheet listing the side effects of Gardasil. The lot number was not provided and the pediatrician's name was not mentioned. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Lethargy, Pallor, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an 11 year old female, who was vaccinated with Gardasil. On 12-NOV-2007 the patient experienced flu-like symptoms. She was very pale, feverish, lethargic and throwing up. The patient's symptoms persisted. The patient did not have this reaction to her first or second dose. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pallor, Pyrexia, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who in approximately October 2007 (exact date not reported), was vaccinated (site and route not reported) with the 1st doses of the Gardasil (lot# not reported). Ten minutes post vaccination, the patient fainted, her face turned pale, became dizzy, nauseous and developed a fever. Patient recovered from syncope after 10 minutes. Per the patient father, the patient was "not herself" until 3 days after the vaccination. The patient did receive unspecified medical attention and subsequently recovered. No follow-up treatment was needed. No additional information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with a dose of Gardasil. Subsequently "few weeks ago" the patient experienced dizziness, headaches and blurred vision. Subsequently, the patient recovered from dizziness, headaches and blurred vision. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information has been received from a medical assistant concerning a 13 year old female who on 07-AUG-2007 was vaccinated IM in the left arm with a first dose of GARDASIL (lot# 653736/0014U). On 02-OCT-2007 the patient was vaccinated IM in the left arm with the second dose of GARDASIL vaccine. Subsequently the patient claimed "redness, swelling and soreness at injection site, fever, headache. Second dose reaction worse than first. Also dizziness and blurred vision. " Subsequently, the patient recovered from dizziness, headaches, blurred vision, redness at injection site, swelling at injection site, soreness at injection site and fever. No further information is available.