chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative concerning a 16 year old female who on 27-MAR-2007 was vaccinated with a first dose of Gardasil (lot # not reported) IM from a single dose vial. On 27-MAR-2007, the patient experienced an injection site reaction almost immediately where the injection site swelled up bright red, like a balloon. Medical attention was sought. The physician reported that they rubbed it and put ice on the area in an attempt to control the swelling. The reporter stated that the physician may have given the patient Benadryl to treat the experience, but was not 100% certain. At the time of reporting, the patient improved and "is fine". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Basilar migraine, Paraesthesia, Vertigo
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 26-OCT-2006 was vaccinated with a first dose of Gardasil. In February 2007, approximately 3 to 4 months after receiving Gardasil, the patient experienced a spinning sensation along with tingly, paralyzed feeling. The physician stated that it was possibly basilar artery migraine, and the physician referred the patient to a neurologist. The physician did not plan to continue the series of injections. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil, IM. Concomitant medication was not reported. On 23-MAR-2007, the patient got her period, it has not ended and it has been  14 days as of today. The patient sought unspecified medical attention. The outcome and action taken were not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Liver function test, Lymphadenopathy
Clinical narrative: Information has been received from the father of a 22 year old female consumer who on approximately 15-MAR-2007 (about three weeks ago) was vaccinated with the second dose of Gardasil, injection. Concomitant medication was not reported. On approximately 22-MAR-2007 a week after getting the second dose of Gardasil, the patient experienced swelling in her lymph nodes and shoulder nodes. The patient sought unspecified medical attention and her cells were checked for cancer and liver tests were performed. The patient's swelling in lymph nodes and shoulder nodes persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Headache, Nausea, Pyrexia, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning her 16 year old daughter who on 16-FEB-2007 was vaccinated with a dose of Gardasil (lot #655618/0186U). There was no concomitant medication. Subsequently, the patient became pregnant (date of conception was reported as 14-FEB-2007). The patient had a pregnancy test with positive results on 20-MAR-2007. it was reported that the patient experienced headache, nausea and may also have had a slight fever. Additional information has been requested. 07/08/2008 Initial and follow-up information has been received through the Merck pregnancy registry for GARDASIL from a health professional concerning her 16 year old daughter who on 16-FEB-2007 was vaccinated with a dose of GARDASIL (lot 655618/0186U). There was no concomitant medication. Subsequently, the patient became pregnant (date of conception was reported as 14-FEB-2007). The patient had a pregnancy test with positive results on 20-MAR-2007. It was reported that the patient experienced headache, nausea and may also have had a slight fever. Additional information is not expected. The patient was lost to follow-up.
Sex: F
Vaccine: HPV4
Symptoms: Fluid replacement, Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist, concerning a female patient with dyspepsia, who was vaccinated with a dose of GARDASIL (date and dose not specified). The pharmacist reported that several hours after the vaccine was administered, the patient experienced severe nausea and vomiting, and was hospitalized. Treatment included intravenous fluids and medication (unspecified) to treat the nausea and vomiting. At the time of this report, the pharmacist stated the patient was recovering. Severe nausea and vomiting was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site irritation, Injection site pain, Smear cervix
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient with an unspecified food allergy who on 19-JAN-2007 was vaccinated IM with a first dose of Gardasil lot #654702/0011U. Concomitant therapy included Yasmin and Advair. On 19-JAN-2007 the patient experienced some irritation around the injection site after the first injection. She reported soreness, burning, erythema at injection site. On 05-APR-2007 patient's father (a physician) administered the second dose of Gardasil lot #656372/0243U to the patient. Within 24 hours of receiving the second injection she developed hives which covered her entire body. The injection site was red, swollen, and burned. She was prescribed Benadryl. The patient was recovering. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient with an unspecified food allergy who on 19-JAN-2007 was vaccinated IM with a first dose of Gardasil lot #654702/0011U. Concomitant therapy included Yasmin and Advair. On 19-JAN-2007 the patient experienced some irritation around the injection site after the first injection. She reported soreness, burning, erythema at injection site. On 05-APR-2007 patient's father (a physician) administered the second dose of Gardasil lot #656372/0243U to the patient. Within 24 hours of receiving the second injection she developed hives which covered her entire body. The injection site was red, swollen, and burned. She was prescribed Benadryl. The patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 08-OCT-2007 was vaccinated with her first dose of Gardasil (lot # 653736/0689F). Concomitant therapy included Yasmin. The patient received her second dose of Gardasil (lot # 653736/0689F) on 08-DEC-2006 and her third dose (lot # 653736/0014U) on 03-APR-2007. The patient experienced insomnia after each dose was given. No lab diagnostics were performed. Subsequently she recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug exposure during pregnancy, Fatigue, Pregnancy test
Clinical narrative: Information has been received foe the Pregnancy Registry from an 18 year old female with penicillin allergy and sulfonamide allergy and a history of tonsillectomy who in January 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. The same day of vaccination, the patient felt dizzy and tired. These events only lasted for one day and the patient recovered. Subsequently the patient learned that she is pregnant. The exact date of conception is not known; however, she believes it was right around the time of vaccination (LMP 10-JAN-2007, EDD 17-OCT-2007). With regard to her pregnancy, she has not had any adverse symptoms. Therapy was stopped when she learned she was pregnant. Unspecified medical attention was sought. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Drug administered at inappropriate site, Stomach discomfort
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient with allergies to Sulfa, dust and mold who on 29-MAR-2007 was vaccinated IM into the left deltoid (previously reported as gluteus) with a first dose of Gardasil (lot # 656372/0243U). The patient became faint after the injection, but did not lose consciousness. The patient put her head down, used a cool cloth, spirits of ammonia and laid down in the exam table. The patient was give apple juice. The patient's blood pressure was 117/86 with a pulse of 63. On 30-MAR-2007, the patient returned to the office and stated that she had felt woosy and experienced a sensitive stomach the 24 hours following the vaccination. The patient recovered from her experience on 30-MAR-2007. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Hypersensitivity, Hypoaesthesia, Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, concerning a 19 year old female patient with an Bactrim allergy, who on 29-MAR-2007 was vaccinated IM in the left deltoid, with a dose, 0.5ml, of Gardasil (Lot #654702/0011U). Concomitant therapy included Yasmin. On 03-APR-2007, five days after the vaccine was administered, the patient was seen in the office as she had developed an "allergic reaction to (Gardasil)," with redness around the injection site. Treatment included ice and an antihistamine (unspecified). On 05-APR-2007, the nurse stated the patient was seen again, and the redness had not changed, but the patient then complained of burning in her lower arm, and "numbness past and below her elbow." The nurse reported that Gardasil had been discontinued. At the time of this report, it was unknown if the patient had recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUX, HPV4, TTOX
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning her 20 year old daughter who on 03-JAN-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included influenza virus vaccine (unspecified) and tetanus toxoid given in opposite arm where the Gardasil was given. On 03-JAN-2007 the patient experienced pain in the arm (which arm unknown) after receiving the first injection. As of 09-APR-2007 the patient had not received the second dose of Gardasil. Unspecified medical attention was sought. On 04-JAN-2007 the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Basilar migraine, Dizziness, Electroencephalogram normal, Fall, Gait disturbance
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with headache who on 09-OCT-2006 was vaccinated with a first dose 0.5 mL of Gardasil and on 04-DEC-2006 with a second dose 0.5 mL of Gardasil. In last week of January 2007, patient was dizzy, felt paralyzed, fell and needed to hold onto something to walk. This lasted for 5 minutes. This was immediately followed with nausea and a "wavy like vision that looked like a kaleidoscope." This lasted for 30 minutes, possible vasovagal reaction. On 04-DEC-2004 she also had her ears pierced. She was seen by her internist and then a neurologist. She had blood tests, magnetic resonance imaging (MRI) and electroencephalography (EEG), all were negative. Patient's diagnosis was basal artery migraine. She was treated with Periactin. The patient was reported as recovering. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test normal, Nausea, Nuclear magnetic resonance imaging normal, Syncope vasovagal, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with headache who on 09-OCT-2006 was vaccinated with a first dose 0.5 mL of Gardasil and on 04-DEC-2006 with a second dose 0.5 mL of Gardasil. In last week of January 2007, patient was dizzy, felt paralyzed, fell and needed to hold onto something to walk. This lasted for 5 minutes. This was immediately followed with nausea and a "wavy like vision that looked like a kaleidoscope." This lasted for 30 minutes, possible vasovagal reaction. On 04-DEC-2004 she also had her ears pierced. She was seen by her internist and then a neurologist. She had blood tests, magnetic resonance imaging (MRI) and electroencephalography (EEG), all were negative. Patient's diagnosis was basal artery migraine. She was treated with Periactin. The patient was reported as recovering. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who in approximately February 207, was vaccinated with the first dose of Gardasil. The patient complained of a sore arm for several weeks after the injection. The patient recovered from the sore arm. The patient does not want to return for the second dose. Medical attention was sought.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Diarrhoea, Dizziness, Inappropriate schedule of drug administration, Influenza like illness
Clinical narrative: Information has been received from a nurse practitioner (NP), concerning a 37 year old female patient with drug hypersensitivity to BACITRACIN, NEOSPORIN who on 11-AUG-2006 at 2:15 pm was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #653650/0702F), and on 11-OCT-2006 at 5:39 pm with the second dose, 0.5ml, IM, of Gardasil (Lot #654540/0800F). Concomitant therapy included FLONASE and IBUPROFEN. The NP stated when the patient called to schedule her third dose of Gardasil, she reported that on 12-AUG-2006 following the first vaccination, she experienced dizziness and had "flu-like symptoms," including nausea, vomiting, diarrhea, arthralgia, myalgia, sleeplessness and fever (specified as "not above 100F"); she recovered on 17-AUG-2006. In addition, on 11-OCT-2006 following her second vaccination, the patient experienced identical events, and recovered on 16-OCT-2006. The NP stated she was "not sure that the patient should receive her third dose of the Gardasil." The patient sought unspecified medical attention. No further information is expected.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse practitioner (NP), concerning a 37 year old female patient with drug hypersensitivity to BACITRACIN, NEOSPORIN who on 11-AUG-2006 at 2:15 pm was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #653650/0702F), and on 11-OCT-2006 at 5:39 pm with the second dose, 0.5ml, IM, of Gardasil (Lot #654540/0800F). Concomitant therapy included FLONASE and IBUPROFEN. The NP stated when the patient called to schedule her third dose of Gardasil, she reported that on 12-AUG-2006 following the first vaccination, she experienced dizziness and had "flu-like symptoms," including nausea, vomiting, diarrhea, arthralgia, myalgia, sleeplessness and fever (specified as "not above 100F"); she recovered on 17-AUG-2006. In addition, on 11-OCT-2006 following her second vaccination, the patient experienced identical events, and recovered on 16-OCT-2006. The NP stated she was "not sure that the patient should receive her third dose of the Gardasil." The patient sought unspecified medical attention. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site rash, Pallor, Palpitations, Urticaria
Clinical narrative: Information has been received from a medical assistant, a 26 year old female patient with asthma, who on 15-FEB-2007 was vaccinated IM with a dose, 0.5ml, of Gardasil. There was no concomitant medication. On 23-FEB-2007 the patient reported that she couldn't breathe, her heart and chest were pounding, and she looked really pale. She also reported that she developed a rash at the injection site with "rectangular" hives. The MA added that she laid down when the events occurred, and the symptoms went away "after half an hour." The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning female patients who were vaccinated with Gardasil. The patients had fainting episodes when seeing size of the syringe. Some had fainting episodes after receiving the vaccine. Subsequently, the patients recovered. Additional information has been requested. This is in follow-up to report previously sumitted on 5/14/2007. Information has been received from a physician concerning female patients who were vaccinated with GARDASIL. The patient had fainting episodes when seeing size of the syringe. Some had fainting episodes after receiving the vaccine. Subsequently, the patient recovered.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an 11 year old female patient who on 26-MAR-2007 was vaccinated with the first dose of 0.5 mL of Gardasil. The "patients became light headed and fainted after receiving the dose of Gardasil." The nurse reported that the patient had "experienced 2 weeks of injection site soreness." Unspecified medical attention was sought by the patient. Injection site soreness persisted. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 23 year old female patient with drug hypersensitivity to Wellbutrin who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2007, after the vaccine was administered, the patient fainted, the patient confirmed that she had not had breakfast before the vaccination was given. The physician reported that the patient recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician, concerning a 23 year old female patient with drug hypersensitivity to WELLBUTRIN, contact dermatitis and seasonal allergies, who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of GARDASIL (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2007, after the vaccine was administered, the patient felt dizzy and "had a syncopal episode". The patient, who confirmed that she had not had breakfast before the vaccination was given, was moved to the exam room, monitored and given a drink. The physician reported that the patient recovered "within a half hour". No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a healthcare worker concerning a 22 year old female with a penicillin allergy and Benadryl allergy and no pertinent medical history who on 21-MAR-2007 was vaccinated IM with 0.5 mL Gardasil (lot # 656372/0243U). There was no concomitant medication. On 25-MAR-2007 the patient developed a rash on her torso. No lab diagnostic studies were performed. The rash was treated with an injection of prednisone, and as of 29-MAR-2007 the patient was fully recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a physician concerning her daughter, who in September 2006, was vaccinated in the buttocks with the first dose of Gardasil, in November 2006, with the second dose of Gardasil, and in March 2007 with the third dose of Gardasil, in the arm. The physician reported that in March 2007, following the third vaccination, her daughter experienced slight pain in her arm at the injection site. At the time of this report, it was unknown if the patient had recovered from the injection site pain. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a Nurse Practitioner (N.P.) concerning a 16 year old female patient with Attention Deficit Hyperactivity Disorder (ADHD) who on 29-MAR-2007 was vaccinated with a first dose of Gardasil. The patient was upset and crying prior to the first injection, because of fear of vaccination. The patient said that when the injection was administered it felt as if they were injecting fire into her arm. The injection site immediately developed an erythematous raised area about 3 inches in diameter. The raised area was red and warm to touch. The patient's mother reported that there was a red area on the chest wall in addition to the reaction at the injection site. The nurse practitioner did not see the chest wall reaction. The patient was kept in the office and was given Benadryl 50 mg and ice was applied to the injection site. On 29-MAR-2007 the reaction subsided and the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Feeling hot, Nausea, Pyrexia, Ultrasound scan
Clinical narrative: Initial and follow up information has been received from Merck pregnancy registry and from a 17 year old female consumer who on 15-MAR-2007 was vaccinated with a first dose of Gardasil. Patient had an ultrasound and later it was determined she was pregnant. The LMP date was 16-FEB-2007, with an estimated due date of 23-NOV-2007. On 15-MAR-2007 the patient reported that she experienced a fever, feeling hot in the night time and little nausea. She also noticed a clear white discharge from the vagina. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a pregnancy registry, a nurse practitioner and a 17 year old female patient who on 15-MAR-2007 was vaccinated with a first dose of GARDASIL vaccine lot #653938/0954F. Concomitant therapy included ascorbic acid (+) cholecalciferol (+) folic acid (+) iron (unspecified) (+) vitamin A acetate (+) vitamin B complex (+) vitamin E acetate (NATAPORT PRENATAL VITAMIN. On 10-Apr-2007, patient had an ultrasound and later it was determined she was pregnant 71/weeks. Her last menstrual period (LMP) date was 16-FEB-2007, with an estimated due date of 23-NOV-2007. On 15-MAR-2007 the patient reported that she experienced a fever, feeling hot in the night time and little nausea. She also noticed a clear white discharge from the vagina. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Follow up information indicated that on 13-JUN-2007 maternalserum alfa fetoprotein (MSAFP) laboratory test was done and it was negative X 4. During the pregnancy on 10-JUL-2007 an ultrasound revealed anatomical survey was normal. In follow up the nurse practitioner reported that the patient had a low transverse cervical section (LTCS) was done for fetal bradycardia and nonreassuring fetal heart tones (FHT's). It was reported that she had 1 -> LTCS for persistant variable decelerations and "bradychardia ". On 27-NOV-2007 patient delivered a normal female baby who weighed 7 pounds, 4 ounces and 49 cm in length and she was "40.4/7" weeks from her LMP. The Apgar score of the baby was 7/9 and her head circumference was 33 centimeter. Upon internal review indication for Cesarean Section due to fetal bradycahrdia and persistance variable deceleration fetal heart tone were determined to be an other important medical events. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge
Clinical narrative: Initial and follow up information has been received from Merck pregnancy registry and from a 17 year old female consumer who on 15-MAR-2007 was vaccinated with a first dose of Gardasil. Patient had an ultrasound and later it was determined she was pregnant. The LMP date was 16-FEB-2007, with an estimated due date of 23-NOV-2007. On 15-MAR-2007 the patient reported that she experienced a fever, feeling hot in the night time and little nausea. She also noticed a clear white discharge from the vagina. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a pregnancy registry, a nurse practitioner and a 17 year old female patient who on 15-MAR-2007 was vaccinated with a first dose of GARDASIL vaccine lot #653938/0954F. Concomitant therapy included ascorbic acid (+) cholecalciferol (+) folic acid (+) iron (unspecified) (+) vitamin A acetate (+) vitamin B complex (+) vitamin E acetate (NATAPORT PRENATAL VITAMIN. On 10-Apr-2007, patient had an ultrasound and later it was determined she was pregnant 71/weeks. Her last menstrual period (LMP) date was 16-FEB-2007, with an estimated due date of 23-NOV-2007. On 15-MAR-2007 the patient reported that she experienced a fever, feeling hot in the night time and little nausea. She also noticed a clear white discharge from the vagina. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Follow up information indicated that on 13-JUN-2007 maternalserum alfa fetoprotein (MSAFP) laboratory test was done and it was negative X 4. During the pregnancy on 10-JUL-2007 an ultrasound revealed anatomical survey was normal. In follow up the nurse practitioner reported that the patient had a low transverse cervical section (LTCS) was done for fetal bradycardia and nonreassuring fetal heart tones (FHT's). It was reported that she had 1 -> LTCS for persistant variable decelerations and "bradychardia ". On 27-NOV-2007 patient delivered a normal female baby who weighed 7 pounds, 4 ounces and 49 cm in length and she was "40.4/7" weeks from her LMP. The Apgar score of the baby was 7/9 and her head circumference was 33 centimeter. Upon internal review indication for Cesarean Section due to fetal bradycahrdia and persistance variable deceleration fetal heart tone were determined to be an other important medical events. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from an RN concerning a female patient who was vaccinated with her first and second dose of Gardasil and subsequently developed 'a bit of urticaria/rash on the body after getting both the first and second dose." It was reported that medical attention was sought and that "the rash was not bad enough to discontinue the series yet". The patient's outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007.  Information has been received from a registered nurse concerning a 26 year old female who on 27-JAN-2007 was vaccinated with Gardasil (lot number "0284U" also reported as 0284J.  invalid lot #). Concomitant therapy included SEASONIQUE. On 07-APR-2007 the patient experienced a 1 cm tender nodule at the injection site (deltoid muscle) after receiving her second dose of Gardasil.  IM in her left delotid on 03-APR-2007 (previously reported as 04-APR-2007). The patient's tender nodule persisted. The patient's outcome was unknown.  Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 9 year old female with asthma who on 30-MAR-2007 was vaccinated with Gardasil (Lot # 65503/0012U). Concomitant therapy included montelukast sodium. On approximately 02-APR-2007, within three to four days of vaccination with Gardasil, the patient experienced itchy, papular rash on face, extremities and body. The patient sought unspecified medical attention. The patient was treated with Benadryl. As of 10-APR-2007, the patient was recovering from itchy, papular rash on face, extremities and body. This is one of two reports from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 10 year old female with a history of migraines who on 13-MAR-2007 was vaccinated with Gardasil. There was no concomitant medication. On approximately 16-MAR-2007, 'within 3 to 4 days", the patient developed an itchy, papular rash on her face, extremities and body. The patient sought medical attention and was treated with Benadryl. Subsequently, the patient was recovering. The product quality complaint unit was not involved. Additional information has been requested. The physician also provided information regarding another patient's experience with Gardasil (WAES#0704USA01626).
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on 22-MAR-2007 was vaccinated with Gardasil. It was reported that the patient had injection site pain after receiving the vaccination. On 10-APR-2007, the patient called the physician's office and reported that she was still having pain in the arm and shoulder which was aggravated when raising the arm. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. This is one of two reports received from the same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Upon follow-up it was reported by the physician that the patient received Gardasil, (Lot # "0011V") on 22-MAR-2007. The physician stated that after 4 weeks, the patient's injection site pain was gone. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Uveitis
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in the "beginning of March" on approximately 01-MAR-2007 was vaccinated with Gardasil. "Approximately one to two weeks after receiving the first dose of Gardasil on approximately 15-MAR-2007 the patient experienced symptoms of uveitis. The diagnosis was confirmed with the patient's eye doctor. The physician noted that it could be related to arthritis. Additional information has been requested. 05/25/07-records received. Ocular inflammation, with 3 week history of blurry vision in left eye. Impression. Acute bilateral uveitis seems most like pars planitis.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Computerised tomogram, Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a health professional concerning a 24 year old female patient with environmental allergy and migraine syndrome who in November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and allergenic extract. In November 2006, the patient developed episodes of headache and dizziness after receiving the first injection. The episodes lasted 10 minutes and reoccurred 1-2 times per week for unknown number of weeks. In December 2006, the patient was vaccinated with the second dose of Gardasil and then she experienced severe dizziness, nausea, vomiting lasting one week. Since the end of December 2006, the patient had experienced episodes of intermittent imbalance with increasing frequency. The patient had medical evaluation with blood studies, computed axial tomography (CT) scan and magnetic resonance imaging (MRI) of brain. Results of the testing was unknown. The patient has not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 24 year old female patient with environmental allergy and migraine syndrome who in November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and allergenic extract. In November 2006, the patient developed episodes of headache and dizziness after receiving the first injection. The episodes lasted 10 minutes and reoccurred 1-2 times per week for unknown number of weeks. In December 2006, the patient was vaccinated with the second dose of Gardasil and then she experienced severe dizziness, nausea, vomiting lasting one week. Since the end of December 2006, the patient had experienced episodes of intermittent imbalance with increasing frequency. The patient had medical evaluation with blood studies, computed axial tomography (CT) scan and magnetic resonance imaging (MRI) of brain. Results of the testing was unknown. The patient has not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Skin induration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported). The patient sought medical attention. On an unspecified date, the patient developed a "smallpox like mark" or skin indentation right below the injection site. At the time of reporting, the outcome was unknown. Additional information has been requested. Additional information was received. It was reported that they did not give the vaccination. The patient had the "bad experience" elsewhere. Follow up information received stated that on 09-OCT-2007 the patient was administered the second dose of GARDASIL (lot # not provided). The nurse who administered the vaccine reported that when she administered the vaccine some of the vaccine ran down the patienr's arm. She stated she believed it happened because of technigue and possible tense muscle. No symptoms or probllemms were noted, No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who "one to two months ago" was vaccinated IM with a dose of Gardasil. The patient developed numbness in her arm right after the injection. The patient was sent home. The patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 19-FEB-2007 was vaccinated with Gardasil (lot # 655618/0186U). There was no concomitant medication. On 19-FEB-2007, "about 2 hours after vaccination" the patient experienced a severe headache and nausea. The patient stayed home from work and took Tylenol. The patient subsequently recovered from the severe headache and nausea on 20-FEB-2007. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot
Clinical narrative: Information has been received from a certified medical assistant concerning a 24 year old female who on unspecified dates was vaccinated with the first and second doses of Gardasil. On 29-MAR-2007, the patient was vaccinated with a third dose of Gardasil. On 29-MAR-2007, the patient was feeling fine at first, within the next five minutes or so, the patient was feeling very hot. The outcome was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician office manager, via a company representative, concerning the office manager's 23 year old daughter, who was vaccinated with a dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient experienced dizziness and menstrual bleeding. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. No further information is expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 10-APR-2007 was vaccinated with Gardasil. Concomitant therapy included tetanus antitoxin USP. On 11-APR-2007 the patient experienced a sore arm, nausea and vomiting. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a female who on 14-MAR-2007 was vaccinated with the first dose of Gardasil, IM in the right deltoid (lot# 655503/0012U). Concomitant therapy included Mircette and vitamins (unspecified) (One-A-Day Essential Vitamins). Subsequently, immediately following the vaccination the patient experienced pain in the injection site arm. The patient recovered from the pain in "a day or two" but it returned on approximately 18-MAR-2007. This pain was described as a shooting pain in the injection site arm "down to the elbow" that occurred when the arm was moved. There was no pain on touch. It was reported that the pain was worst at the end of the day and immediately upon arising. The patient was treated with Advil which was reported to have helped the pain. The patient was examined at her physician's office on 26-MAR-2007 and was prescribed Tylenol with codeine. Subsequently, the patient called into the office on 09-APR-2007 and reported that the pain in the arm was still present and had worsened. The patient was referred to her primary care physician for further evaluation. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a "4th grader" female patient who was vaccinated with a first dose of Gardasil. The patient experienced pain in the injection site right after receiving her injection. It was unknown if she sought medical attention. The outcome was unknown at the time of this report. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: This is in follow-up to report (s) previously submitted 5/14/2007. Information has been received from a pharmacist, concerning an 18 year old female, who on 05-DEC-2006 was vaccinated with the first dose of Gardasil. The pharmacist reported that the patient was experienced mononucleosis (date unspecified). At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. Initial and follow up information has been received from a pharmacist, concerning an 18 year old female, who on 05-DEC-2006 was vaccinated with the first dose of GARDASIL. The pharmacist reported that the patient has experienced monoucleosis (date unspecified). At the time of this report, the patient had fully recovered (date not specified). Follow up information from the pharmacist orginally noted that he "did not think there was any connection" between the vaccination with GARDASIL and the mononuecleosis, however, additional follow up information added that it was "not known if illness was due to injection or not". On 12-APR-2007, after the patient had fully recovered, she received the second dose of GARDASIL. There were no problems reported following the second dose. The patient sought unspecified medical attention. No further information was expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a physician, concerning a 14 year old female patient, who on 02-MAR-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced a generalized, non-pruritic, maculopapular rash (date not specified). At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse, concerning a 13 year old female patient, who on 10-APR-2007 was vaccinated with the first dose of Gardasil (Lot #653938/0954F), and developed hives. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Paraesthesia
Clinical narrative: Information has been received from a consumer, a 25 year old female patient with high blood pressure, who on 30-MAR-2007 was vaccinated orally with the first dose, 0.5ml, of Gardasil. There was no concomitant medication. On 31-MAR-2007 the patient reported that she had experienced tingling in her hands and feet after the vaccine was administered. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.  6/25/07 Received office note from reporter which reveals patient called office on 4/16 to report having been seen in ER for complaints of body aches.  Tx w/anti inflammatory meds & felling well now.  Refused further HPV vaccine. FINAL DX: Adverse reaction to HPV vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse, concerning a female patient who was vaccinated with the first dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient experienced a sore arm, confirmed as the same arm of the vaccination. At the time of this report, the nurse confirmed that the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician, concerning a 16 year old female patient, who on 12-FEB-2007 was vaccinated with the first dose of Gardasil, and reported no symptoms or concerns. On 09-APR-2007, the patient was vaccinated with the second dose, 0.5ml, IM, of Gardasil (Lot #657617/0384U). Concomitant therapy included Augmentin. On 12-APR-2007, three days after the second vaccination was administered, the patient experienced urticaria all over her body, especially on her extremities and face. Treatment included Benadryl. At the time of this report, the physician confirmed the patient was recovering from the urticaria. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient who was vaccinated with the first dose of Gardasil (date unspecified). The physician reported that before the needle was withdrawn, the patient developed substantial swelling at the injection site. At the time of this report, the physician confirmed that the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chlamydia serology, Culture urine positive, Drug exposure during pregnancy, Streptococcal identification test positive
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with no known allergies who on 20-MAR-2007 was vaccinated with Gardasil (lot #655205/1426F). On 28-MAR-2007, the patient experienced abdominal pain. HCG was negative on that day. The patient was tested for Chlamydia, which was negative. The patient's urine was also tested which was cloudy and showed trace blood, epithelial cells and bacteria (Group B streptococcus). The patient was given a shot of ceftriaxone (ROCEPHIN) and azithromycin (ZITHROMAX) as a precaution. The patient's abdominal pain subsequently resolved. On 09-APR-2007, the patient took a home pregnancy test which was positive. The patient's last menstrual period was 01-MAR-2007 with a EDC of 06-DEC-2007. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis abnormal, Urine human chorionic gonadotropin negative, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with no known allergies who on 20-MAR-2007 was vaccinated with Gardasil (lot #655205/1426F). On 28-MAR-2007, the patient experienced abdominal pain. HCG was negative on that day. The patient was tested for Chlamydia, which was negative. The patient's urine was also tested which was cloudy and showed trace blood, epithelial cells and bacteria (Group B streptococcus). The patient was given a shot of ceftriaxone (ROCEPHIN) and azithromycin (ZITHROMAX) as a precaution. The patient's abdominal pain subsequently resolved. On 09-APR-2007, the patient took a home pregnancy test which was positive. The patient's last menstrual period was 01-MAR-2007 with a EDC of 06-DEC-2007. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a female patient who was vaccinated with a dose of Gardasil. She developed arm pain which radiated from the elbow to the 4th or 5th finger. She also experienced "pins and needles" in the fingers. The patient's outcome was unknown. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Smear cervix
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 21 year old female patient who in January 2007, was vaccinated IM with a first dose of Gardasil. The patient developed genital warts within one month. Patient was treated with trichloroacetic acid (TCA) 80% on 06-MAR-2007 and on 10-APR-2007. The outcome was unknown. Papanicolaou (PEP) test was performed, results unknown (done at another clinic). The NP reported two other patients who had a similar experience. She verbalized concern that she had seen 3 episodes of genital warts developing soon after Gardasil. She believed the patient's immune system can not handle the viral load. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Injection site pain, Syncope
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter who on 23-MAR-2007 was vaccinated with Gardasil. The patient fainted a few minutes after being vaccinated. No injury was noted due to the fall. The patient also stated that the vaccination was very painful. Medical attention was sought. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been requested.