chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning her daughter with sulfonamide allergy and penicillin allergy who in approximately August 2007, was vaccinated with the first dose of GARDASIL and in November 2007 was vaccinated with the second dose of GARDASIL and in mid January 2008 was vaccinated with GARDASIL.  In December 2007, the patient developed hives.  The hives are located around sweaty spots or around the bra.  On 26-Feb-2008 they were on the arm and on the back.  The patient had the hives since December 2007 and is being treated with levocetirizine dihydrochloride (XYZAL).  The antihistamine suppressed the hives but the hives regressed when the medication is discontinued.  The patient did not have resolution from the hives to date and noted that it developed close to the 24 hour period from the last dose of levocetirizine dihydrochloride (XYZAL).  At the time of reporting, unspecified laboratory diagnostic studies were pending.  Medical attention was sought from an allergist.  At the time of reporting the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submittted on 3/14/2008. Information has been received from a nurse concerning her daughter with an allergy to sulfonamide and penicillin who in approximately August 2007, was vaccinated with the first dose of GARDASIL vaccine and in November 2007 was vaccinated with the second dose of GARDASIL vaccine and in mid January 2008 was vaccinated with the third dose of GARDASIL vaccine. In December 2007, the patient developed hives. The hives are located around sweaty spots or around the bra. On 26-Feb-2008 they were on the arm and on the back. The patient had the hives since December 2007 and was being treated with XYZAL. The antihistamine suppressed the hives but the hives regressed when the medication was discontinued. The patient did not have resolution from the hives to date and noted that it developed close to the 24 hours period from the last dose of XYZAL. At the tme of reporting, unspecified laboratory studies were pending. Medical attention was sought from an allergist. At the time of reporting the patient had not recovered. No product quality compliant was involved. Follow up information was received from a nurse indicating that her daughter had hives after the second and third doses, but not after the first. The hives lasted for months after the administration of GARDASIL vacccine. Her daughter has breathing problems and an allergic response to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Additional information has been requested. Thisis in follow-up report (s) previously submittedon 3/14/2008, 7/8/2008. Follow-up information was received which reported that the patient is using XYZAL to treat her urticaria. She has had work up by and is under care with allergist. No additonal inforamtion is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Delivery, Drug exposure during pregnancy, Metrorrhagia, Muscle spasms
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 01-FEB-2008 was vaccinated with the first dose of Gardasil and is now pregnant.  Concomitant therapy included MIRALAX.  The patient is currently spotting and cramping which is relieved by rest.  Medical attention was sought at the school nurse.  Patient outcome is unknown.  No product quality complaint was involved.  Additional information has been requested.   This is in follow-up to report (s) previously submitted on 3/14/2008.  Additional information has been received from the physician who stated that the patient "had no complications from the vaccine" and she and the baby were fine.  The physician reported that the patient was diagnosed with pre-eclampsia and delivered at about 30-32 weeks gestation by cesarean section.  The physician also added the mother and the baby were both doing fine now.  The mother was physically fine.  The reporter also added that the baby had no anomalies "nothing untoward because of the vaccine".  Upon internal review, pre-eclampsia and delivered at about 30-32 weeks gestation by cesarean section were considered to be Other Important Medical Events.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pre-eclampsia
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 01-FEB-2008 was vaccinated with the first dose of Gardasil and is now pregnant.  Concomitant therapy included MIRALAX.  The patient is currently spotting and cramping which is relieved by rest.  Medical attention was sought at the school nurse.  Patient outcome is unknown.  No product quality complaint was involved.  Additional information has been requested.   This is in follow-up to report (s) previously submitted on 3/14/2008.  Additional information has been received from the physician who stated that the patient "had no complications from the vaccine" and she and the baby were fine.  The physician reported that the patient was diagnosed with pre-eclampsia and delivered at about 30-32 weeks gestation by cesarean section.  The physician also added the mother and the baby were both doing fine now.  The mother was physically fine.  The reporter also added that the baby had no anomalies "nothing untoward because of the vaccine".  Upon internal review, pre-eclampsia and delivered at about 30-32 weeks gestation by cesarean section were considered to be Other Important Medical Events.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Laboratory test, Malaise, Nausea, Urine analysis
Clinical narrative: Information has been received from a consumer concerning her daughter, a 12 year old female with no medical history reported, who on 17-JAN-2008 was vaccinated with the first 0.5 ml dose of Gardasil.  There was no concomitant medication.  On 18-JAN-2008 the patient experienced sickness, nausea, vomiting, and weight loss.  The patient missed ten days of school.  The patient sought unspecified medical attention.  Diagnostic laboratory tests included a blood test, upper GI and urinalysis but no results were reported.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, Weight decreased, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a consumer concerning her daughter, a 12 year old female with no medical history reported, who on 17-JAN-2008 was vaccinated with the first 0.5 ml dose of Gardasil.  There was no concomitant medication.  On 18-JAN-2008 the patient experienced sickness, nausea, vomiting, and weight loss.  The patient missed ten days of school.  The patient sought unspecified medical attention.  Diagnostic laboratory tests included a blood test, upper GI and urinalysis but no results were reported.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL and 15 days later developed a rash. The patient did receive other vaccines (unspecified which ones). Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. Additional information has been received from a physician indicating that no reaction occurred due to GARDASIL, at first she thought it might have been a reaction but clearly it was not a reaction to the GARDASIL because of the date the vaccine was given and the type of rash the patient had. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient with no medical history or allergies reported, who on 13-DEC-2007 and 13-FEB-2008 was vaccinated with the first 0.5 mL and second doses of Gardasil, (Lot #'s 658282/0929U (first dose), 658554/0928U, (second dose)), respectively.  There was no concomitant medication. The patient did not have any adverse events from the first dose.  Subsequently, the patient developed hives from the chest up after getting the second dose of Gardasil.  The patient sought unspecified medical attention.  At the time of the report, the patient had recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Metrorrhagia, Muscle spasms, Ultrasound scan
Clinical narrative: Information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN), concerning a 23 year old female patient, with a history of miscarriage at 13 weeks, who on 04-OCT-2007 was vaccinated with the first dose of Gardasil (lot # 655849/0263U).  On 20-NOV-2007 the patient experienced her last menstrual period, and became pregnant on approximately 04-DEC-2007.  On 04-DEC-2007, she was vaccinated with the second dose of Gardasil (lot # 655154/1210U).  On 08-JAN-2008, prenatal vitamins were initiated for the pregnancy.  On approximately 17-JAN-2008 the patient developed spotting and cramping; an ultrasound was performed, and the original estimated date of delivery of 26-AUG-2008 was changed to 01-SEP-2008.  The outcome of spotting and cramping was not specified.  No further details were provided.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan abnormal, Vaginal haemorrhage
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN), concerning a 21 year old female patient, with history of 1 pregnancy and 1 full-term live birth, who on 08-NOV-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot # 658563/1063U). Concomitant therapy included YASMIN 28. On 24-DEC-2007 the patient experienced her last menstrual period, and became pregnant. On 15-JAN-2008, the patient was vaccinated with the second dose, 0.5 ml. of GARDASIL (lot # 0530U). On 14-FEB-2008 the patient developed vaginal bleeding, and was seen in the emergency room. An ultrasound confirmed an intrauterine pregnancy of 5 weeks and 6 days gestation. The estimated date of delivery was 10-OCT-2008. The patient was discharged from the ER (details not provided). The outcome of vaginal bleeding was not specified. On 20-FEB-2008, prenatal vitamins and folic acid were initiated for the pregnancy. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nasopharyngitis, Ultrasound scan
Clinical narrative: Information has been received, via the Merck pregnancy registry, from a licensed practical nurse (LPN), concerning a 25 year old female patient with a history of 9 pregnancies resulting in 9 miscarriages (details not provided) and a colposcopy with biopsy indicating low grade squamous intraepithelial lesion (lgSIL), who on 27-NOV-2007 was vaccinated with the first dose of Gardasil (lot 3654540/1209U).  On 20-DEC-2007 the patient experienced her last menstrual period, and subsequently became pregnant.  On 29-JAN-2008, prenatal vitamins were prescribed for the pregnancy.  On 12-FEB-2008, an ultrasound was performed, and the estimated date of delivery was 25-SEP-2008.  On approximately 20-FEB-2008 the patient experienced cold symptoms, and was prescribed treatment with loratidine and azithromycin.  The outcome of cold symptoms was not specified.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan, Vaginal haemorrhage, Weight gain poor
Clinical narrative: Information has been received for the Merck Pregnancy Registry for Gardasil from a licensed practical nurse concerning a 25 year old female with a history of 2 pregnancies and 1 live birth who on 21-AUG-2007 was vaccinated with Gardasil (lot# 655849/0263U).  The patient's date of last menstrual period was 10-OCT-2007.  The patient became pregnant.  The estimated conception date was 24-OCT-2007.  On 29-NOV-2007 the patient experienced vaginal bleeding and insufficient weight gain and was in the emergency room.  On 24-JAN-2008 an ultrasound was performed for the second trimester and the results were IUP.  The estimated date of delivery is 16-JUN-2008.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 13 year old female, who, on  an unspecified date, was vaccinated IM with a dose of GARDASIL. Subsequently, the patient passed out. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date was vaccinated with 0.5 ml GARDASIL (lot # not reported) and fainted. Dose of series was unknown. Unspecified medical attention was sought. On unspecified date the patient recovered from fainting. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning two female patients (ages unknown), who, on unspecified dates, were vaccinated with doses of GARDASIL. Subsequently, the patient fainted in the office post vaccination. At the time of the report, the patients had recovered. No product quality complaint was involved.  Follow-up information received 4/16/2008. This is one of two reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine normal, Full blood count normal, Malaise, Nausea, Pain
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female with a recent upper respiratory tract infection and irritable bowel syndrome, a history of migraine, allergies to NIACIN and ZOMIG, who on 19-FEB-2008 was vaccinated intramuscularly with a dose of GARDASIL, (Lot # 659653/1448U). Concomitant therapy included TOPAMAX. A few minutes after the vaccination, the patient experienced nausea, general malaise and body aches. Laboratory diagnostic studies included creatine kinase and complete blood count, both within normal ranges. The symptoms have continued to the present. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a nurse concerning a female who on approximately 24-DEC-2007 was vaccinated with her first dose of GARDASIL (lot numbers not provided). It was reported that a "patient who received the GARDASIL (lot numbers not provided) had visited the physician a couple of days after being vaccinated because she had developed  case of warts." The patient's warts persisted. No further information is available. This is in follow-up to report(s) previously submitted on 3/14/2008.  Information has been received from a nurse concerning a female who on approximately 24-DEC-2007 was vaccinated with her first dose of GARDASIL (lot numbers not provided).  The patient received the second dose of GARDASIL (lot numbers not provided) in February 2008.  It was reported that a "patient who received the GARDASIL (lot numbers not provided) had visited the physician a couple of days after being vaccinated because she had developed an extensive case of warts."  Information received during follow up indicated that the onset date was 01-Feb-2008.  The patient's warts persisted.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 13-FEB-2008 was vaccinated with GARDASIL.  Concomitant therapy included MENACTRA, VARIVAX and DTaP (unspecified).  On 13-FEB-2008 the patient fainted.  Subsequently, the patient recovered "pretty quickly" after fainting.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who a few days ago was vaccinated IM with the second dose of GARDASIL (lot# 656607/0153U). Subsequently the patient experienced hives down her injection site arm within thirty minutes of receiving the vaccine. Unknown medical attention was sought. It was reported that the hives lasted for about days and then the symptoms resolved. no product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a female (age and gender unknown), who, on an unspecified date, was vaccinated with a 0.5mL first dose of GRADASIL.  Subsequently, the day after the vaccination the patient developed a rash and some hives. The patient called the office. The patient went to see a pharmacist and was given an unspecified medications to treat the hives. The medication helped to alleviate the symptoms. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 3/14/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no medical history, and no drug allergies, who 18-FEB-2007 was vaccinated IM with a 0.5mL first dose of GARDASIL (Lot# 659180/1758U). Concomitant therapy included ethinyl estradiol (+) norethindrone. On 19-FEB-2007 the patient developed a rash that started on the hands only but by the third day was all over the stomach and the rest of the trunk. It appeared to be more like hives. It was reported that there was no itching. The patient's mother called the office on 20-FEB-2008. The patient took ZYRTEC and by the 4th day the rash and hives went away (previously reported that the patient went to see a pharmacist and was given an unspecified medication to treat the hives and the medication helped to alleviate the symptoms). No laboratory diagnostics were performed. The patient recovered on an unspecified date. 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 registered nurse concerning her daughter (age unknown), who, on unspecified dates, was vaccinated with three different doses of GARDASIL. Subsequently the patient developed an abnormal pap. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 02-AUG-2007 was vaccinated with GARDASIL (dose unspecified). On 02-AUG-2007 the patient experienced fever and felt ill. Subsequently, this lasted 48-72 hours. The patient sought unspecified medical treatment. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Injection site anaesthesia, Muscular weakness, Pain
Clinical narrative: Information has been received from a health professional concerning a 28 year old who was IM vaccinated with her second dose of GARDASOL. Subsequently the patient experienced numbness in the arm where the vaccine was administered which lasted about 1 week and severe headaches about 2 weeks post vaccination. No further information is available. Additional information has been requested. This in in follow-up to report(s) previously submitted on 3/14/2008.  Initial and follow up information have been received from a licensed practical nurse concerning a 24 year old female secretary with no preexisting illness, and no drug allergies, who on an unspecified date received her first dose of GARDASIL (lot number, route and site not reported) and 10-OCT-2007 was vaccinated with her second dose of GARDASIL (Lot #557737/0522U) intramuscularly in the left deltoid.  There was no concomitant medication.  No illness was reported at the time of vaccination.  On an unspecified date the patient experienced numbness in the arm where the vaccine was administered which lasted about 1 week, and a severe headache about 2 weeks post vaccination.  On 17-OCT-2007 the patient called the physician's office complaining of left arm ache, arm feeling ded, and weakness after her GARDASIL injection.  The patient was instructed to use ice and IBUPROFEN (800 mg twice a day) or VICODIN if needed.  On approximately 24-OCT-2007, 2 weeks post vaccination, the patient developed severe headaches.  On 10-OCT-2007 the patient visited the physician's office complaining of arm pain and aching in the left arm.  It was reported that the patient stated that the pain had improved but at times continued to bother her.  There was restless annoying feeling in her elbow which was not a true pain.  When the patient moved her shoulder wrong it sent a sharp pain into her shoulder.  The injection site in the deltoid looked good.  There was no tenderness or swelling there.  The patient's rotator cuff muscles were pretty strong except for forward elevation was somewhat painful.  The patient could raise her arms above her head.  There was no crepitation of the shoulder and stretch reflexes in the forearm were normal.  Physical therapy was recommended for one to two weeks.  It was reported that the patient did seem to be having some rotator cuff symptoms which were probably unrelated.  The patient recovered from numbness in her arm.  The outcome for headache, injection site pain, muscular weakness, muskuloskeletal pain, and pain in extremity were unknown at the time of reporting as patient cancelled her follow-up appointment.  No product quality complaint was involved.  No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 28 year old who was IM vaccinated with her second dose of GARDASOL. Subsequently the patient experienced numbness in the arm where the vaccine was administered which lasted about 1 week and severe headaches about 2 weeks post vaccination. No further information is available. Additional information has been requested. This in in follow-up to report(s) previously submitted on 3/14/2008.  Initial and follow up information have been received from a licensed practical nurse concerning a 24 year old female secretary with no preexisting illness, and no drug allergies, who on an unspecified date received her first dose of GARDASIL (lot number, route and site not reported) and 10-OCT-2007 was vaccinated with her second dose of GARDASIL (Lot #557737/0522U) intramuscularly in the left deltoid.  There was no concomitant medication.  No illness was reported at the time of vaccination.  On an unspecified date the patient experienced numbness in the arm where the vaccine was administered which lasted about 1 week, and a severe headache about 2 weeks post vaccination.  On 17-OCT-2007 the patient called the physician's office complaining of left arm ache, arm feeling ded, and weakness after her GARDASIL injection.  The patient was instructed to use ice and IBUPROFEN (800 mg twice a day) or VICODIN if needed.  On approximately 24-OCT-2007, 2 weeks post vaccination, the patient developed severe headaches.  On 10-OCT-2007 the patient visited the physician's office complaining of arm pain and aching in the left arm.  It was reported that the patient stated that the pain had improved but at times continued to bother her.  There was restless annoying feeling in her elbow which was not a true pain.  When the patient moved her shoulder wrong it sent a sharp pain into her shoulder.  The injection site in the deltoid looked good.  There was no tenderness or swelling there.  The patient's rotator cuff muscles were pretty strong except for forward elevation was somewhat painful.  The patient could raise her arms above her head.  There was no crepitation of the shoulder and stretch reflexes in the forearm were normal.  Physical therapy was recommended for one to two weeks.  It was reported that the patient did seem to be having some rotator cuff symptoms which were probably unrelated.  The patient recovered from numbness in her arm.  The outcome for headache, injection site pain, muscular weakness, muskuloskeletal pain, and pain in extremity were unknown at the time of reporting as patient cancelled her follow-up appointment.  No product quality complaint was involved.  No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a female with a sulfonamide allergy who in December 2007, was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). There was no concomitant medication. The patient experienced nausea after receiving the first dose, but has recovered from the nausea. The patient discussed the nausea with her physician during a subsequent office visit. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Dysplasia, Prostatic acid phosphatase abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 24 year old female who in December 2006, was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). The patient received the other two doses on unspecified dates and was sexually active during the time frame when she received all three doses. The patient became sexually active in August of 2007 and had a negative STD screen. In January 2008, the patient experienced an abnormal pap that showed low grade squamous suspicion for high grade. In February 2008, the patient underwent a colposcopy and 2 sites were found with moderate dysplasia. The patient's abnormal pap smear persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Pregnancy test negative
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 20-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). On 28-FEB-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported). The patient feels she may be pregnant, but she has not missed her period or had a positive pregnancy test at the time of the vaccination. No problems reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis, Dizziness, Erythema, Inappropriate schedule of drug administration, Swelling face
Clinical narrative: Information has been received from a consumer concerning herself who on 28-NOV-2007 was vaccinated with her first dose GARDASIL (lot# not reported). Concomitant therapy included PRAVACHOL, ACIPHEX, BONIVA and KLONOPIN. On approximately 26-DEC-2007 the patient's face got red, swollen and had a little bit of dermatitis. The dermatitis cleared up after a couple days. On 03-FEB-2008 the patient experienced dizziness and tongue feeling thick. The patient reports the dizziness was better now better now, but at times when she leans over she gets dizzy. The patient's primary care physician ordered her to have a CT scan and an MRI in regards to the dizziness. The patient is recovering. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HPV4
Symptoms: Tongue disorder
Clinical narrative: Information has been received from a consumer concerning herself who on 28-NOV-2007 was vaccinated with her first dose GARDASIL (lot# not reported). Concomitant therapy included PRAVACHOL, ACIPHEX, BONIVA and KLONOPIN. On approximately 26-DEC-2007 the patient's face got red, swollen and had a little bit of dermatitis. The dermatitis cleared up after a couple days. On 03-FEB-2008 the patient experienced dizziness and tongue feeling thick. The patient reports the dizziness was better now better now, but at times when she leans over she gets dizzy. The patient's primary care physician ordered her to have a CT scan and an MRI in regards to the dizziness. The patient is recovering. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Vulvovaginal mycotic infection
Clinical narrative: Information has been received from a health professional concerning herself, a 24-26 year old female who was vaccinated intramuscularly with her third dose of GARDASIL on an unspecified date (lot# not reported). Subsequently the patient experienced injection site burning and "roaring" vaginal yeast infection. She took an over the counter medication for the vaginal yeast infection that did not help. she then called he doctor and was prescribed an unknown medication. The doctor told her they have heard of this many times. The patient received the first two doses of GARDASIL without any problem. The patient recovered on an unknown date. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin, Drug exposure during pregnancy, Injection site pain
Clinical narrative: Information has been received from a 24 year old female, for the pregnancy registry for Gardasil, concerning herself. The patient has a history of yeast infection and allergy to BACTRIM, reported as BACTRUM. On 21-FEB-2008 the patient was vaccinated with a single dose of Gardasil (Lot # unknown) and subsequently learned that she was pregnant (LMP = 23-FEB-2008). Concomitant therapy included fluconazole (unspecified) and metrnidazole (unspecified). She also said that after she received the vaccine, her arm was sore around area of injection site. The soreness went away after one day. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with allergic reaction to antibiotics (Amoxicillin Erythromycin) who on 14-NOV-2007 was vaccinated with her first dose of GARDASIL (lot# unspecified).  On 16-Jan-2008 the patient was vaccinated intramuscularly with her second dose of 0.5 ml of GARDASIL (lot# 659653/1448U).  A few hours post second vaccination, the patient developed a feeling of numbness on the left side of her body.  The patient also reported that she had joint aches in her left foot, knee and hand.  Unspecified medical attention was sought by calling the office.  Subsequently, the patient recovered from her experiences.  No other information was available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 10-OCT-2007 was vaccinated with GARDASIL (lot # not specified). On approximately 07-DEC-2007, the patient was vaccinated intramuscularly with her second GARDASIL (lot#658556/1060U). There was no concomitant medication. On 10-DEC-2007 (2-3 days later), the patient experienced pain in right bicep (it was hard for her to write). 5-7 days after she was still experiencing pain. Unspecified medical attention was sought. The physician told her to take ADVIL as an anti-inflammatory. The patient's pain in right bicep persisted. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: Initial and follow up information has been received from a physician concerning a 16 year old female who on 12-FEB-2008 (previously reported as 13-FEB-2008) at 4:30 PM was vaccinated IM in the left deltoid with her 1st dose of Gardasil (lot # 658556/1060U). There was no concomitant medication. On 14-FEB-2008 the patient experienced tightness in throat "like something was growing in her throat". The physician instructed the patient to take some BENADRYL. The patient sought unspecified medical attention. Subsequently, the patient recovered from tightness in throat the next day. Additional information has been requested. In follow-up it was reported that the patient experienced throat pain on 12-FEB-2008. Subsequently, on an unspecified date the patient recovered from the throat pain. Initially on 14-FEB-2004 (the next day) it was reported that the patient experienced tightness in throat "like something was growing in her throat" The patient sought medical attention at the doctor's office. It was reported that the patient had received her second dose of GARDASIL (Lot# not reported) without any complication. No additional information is expected.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Blood culture negative, Blood electrolytes normal, Febrile convulsion, Full blood count normal, Loss of consciousness
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of fever in a 1-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 April 2007, the subject received unspecified dose of HAVRIX (unknown). On 10 April 2007, 24 hours after vaccination with HAVRIX, the subject experienced fever. He was taken to the emergency room by ambulance. He was not admitted. The subject was seen on 11 April 2007 by his physician and was reportedly doing fine. The child did not require additional medicine or treatments. No further information was available. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 23 July 2007 via a physician, who reported that the subject experienced a febrile seizure on 10 April 2007. The physician indicated that the subject was hospitalized (duration unspecified). The HAVRIX immunization series was discontinued. The reporting physician considered the febrile convulsion to be possibly related to vaccination with HAVRIX, but also indicated that the event was possibly associated with the subject's medical history/concurrent illness (unspecified). At the time of reporting, the febrile seizure was resolved. Follow up information was received on 01 October 2007 via the physician, who reported that the febrile seizure was witnessed and was accompanied by loss of consciousness. It was uncertain whether the seizure was preceded by an aura or headache, or whether the seizure was accompanied by urine or fecal incontinence due to the subject's wearing of a diaper. All events resolved/resolved with sequelae on 10 April 2007, and the physician indicated that the HAVRIX vaccination series was discontinued "for now". The physician further indicated that the event was not serious, and that there was no planned follow up for the event.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of fever in a 1-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 April 2007, the subject received unspecified dose of HAVRIX (unknown). On 10 April 2007, 24 hours after vaccination with HAVRIX, the subject experienced fever. He was taken to the emergency room by ambulance. He was not admitted. The subject was seen on 11 April 2007 by his physician and was reportedly doing fine. The child did not require additional medicine or treatments. No further information was available. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 23 July 2007 via a physician, who reported that the subject experienced a febrile seizure on 10 April 2007. The physician indicated that the subject was hospitalized (duration unspecified). The HAVRIX immunization series was discontinued. The reporting physician considered the febrile convulsion to be possibly related to vaccination with HAVRIX, but also indicated that the event was possibly associated with the subject's medical history/concurrent illness (unspecified). At the time of reporting, the febrile seizure was resolved. Follow up information was received on 01 October 2007 via the physician, who reported that the febrile seizure was witnessed and was accompanied by loss of consciousness. It was uncertain whether the seizure was preceded by an aura or headache, or whether the seizure was accompanied by urine or fecal incontinence due to the subject's wearing of a diaper. All events resolved/resolved with sequelae on 10 April 2007, and the physician indicated that the HAVRIX vaccination series was discontinued "for now". The physician further indicated that the event was not serious, and that there was no planned follow up for the event.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Febrile convulsion
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of fever in a 1-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 April 2007, the subject received unspecified dose of HAVRIX (unknown). On 10 April 2007, 24 hours after vaccination with HAVRIX, the subject experienced fever. He was taken to the emergency room by ambulance. He was not admitted. The subject was seen on 11 April 2007 by his physician and was reportedly doing fine. The child did not require additional medicine or treatments. No further information was available. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 23 July 2007 via a physician, who reported that the subject experienced a febrile seizure on 10 April 2007. The physician indicated that the subject was hospitalized (duration unspecified). The HAVRIX immunization series was discontinued. The reporting physician considered the febrile convulsion to be possibly related to vaccination with HAVRIX, but also indicated that the event was possibly associated with the subject's medical history/concurrent illness (unspecified). At the time of reporting, the febrile seizure was resolved. Follow up information was received on 01 October 2007 via the physician, who reported that the febrile seizure was witnessed and was accompanied by loss of consciousness. It was uncertain whether the seizure was preceded by an aura or headache, or whether the seizure was accompanied by urine or fecal incontinence due to the subject's wearing of a diaper. All events resolved/resolved with sequelae on 10 April 2007, and the physician indicated that the HAVRIX vaccination series was discontinued "for now". The physician further indicated that the event was not serious, and that there was no planned follow up for the event.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Blood culture negative, Blood electrolytes normal, Febrile convulsion, Full blood count normal, Loss of consciousness
Clinical narrative: This case was reported by an other manufacturer via physician and described the occurrence of febrile seizure in a 18-month-old male subject who was vaccinated with Havrix (GlaxoSmithKline). On 9 April 2007 the subject received unspecified dose of Havrix (unknown). Twenty-four hours after vaccination with Havrix, on 10 April 2007, the subject experienced febrile seizure. The child was taken to the emergency room but was not admitted to the hospital. The child did not require additional medications or treatments. The child was seen by the physician on 11 April 2007 and it was reported that he was fine. This case was assessed as medically serious by manufacturer. On 11 April 2007, the event was resolved.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Pyrexia
Clinical narrative: This case was reported by an other manufacturer via physician and described the occurrence of febrile seizure in a 18-month-old male subject who was vaccinated with Havrix (GlaxoSmithKline). On 9 April 2007 the subject received unspecified dose of Havrix (unknown). Twenty-four hours after vaccination with Havrix, on 10 April 2007, the subject experienced febrile seizure. The child was taken to the emergency room but was not admitted to the hospital. The child did not require additional medications or treatments. The child was seen by the physician on 11 April 2007 and it was reported that he was fine. This case was assessed as medically serious by manufacturer. On 11 April 2007, the event was resolved.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Febrile convulsion
Clinical narrative: This case was reported by an other manufacturer via physician and described the occurrence of febrile seizure in a 18-month-old male subject who was vaccinated with Havrix (GlaxoSmithKline). On 9 April 2007 the subject received unspecified dose of Havrix (unknown). Twenty-four hours after vaccination with Havrix, on 10 April 2007, the subject experienced febrile seizure. The child was taken to the emergency room but was not admitted to the hospital. The child did not require additional medications or treatments. The child was seen by the physician on 11 April 2007 and it was reported that he was fine. This case was assessed as medically serious by manufacturer. On 11 April 2007, the event was resolved.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician (also the mother of the patient) and described the occurrence of abdominal cramp in a 15-year-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent medications included over the counter sinus medication.  On 8 June 2007 the subject received unspecified dose of HAVRIX at 0.5 ml.  At an unspecified time after vaccination with HAVRIX, the subject experienced abdominal cramping, fever less than 101 F, nausea and vomiting (once only).  At the time of reporting the events were improved.  The physician/mother reported that the events were not related to menstrual cramps and they were possibly related to treatment with HAVRIX.  Follow-up information was received from the physician on 21 June 2007.  Concurrent medications included Pepcid AC.  The events started on 08 June 2007, the same day as vaccination with HAVRIX.  The events resolved on 09 June 2007.  The physician considered the events were related to vaccination with HAVRIX.  The physician indicated that the immunization series with HAVRIX was not discontinued or delayed.
Age: 26.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by an office manager for a physician's office and described the occurrence of hepatitis A antibody negative in a 26-year-old male subject who was vaccinated with hepatitis A vaccine (manufacturer unspecified) and hepatitis B vaccine. Previous and/or concurrent vaccination included Havrix (GlaxoSmithKline) unknown given on 2 May 2007; Engerix B (GlaxoSmithKline) unknown given 2 May 2007. In 2002, the subject received unspecified dose(s) of hepatitis A vaccine (unknown). The subject also received dose(s) of hepatitis B vaccine (unknown), but it was unknown when the series was administered. The subject received the hepatitis A and hepatitis B vaccines in Singapore. In 2002, less that one year after vaccination with hepatitis A vaccine and an unspecified time after vaccination with hepatitis B vaccine, a titer was taken to detect both hepatitis A antibodies and hepatitis B antibodies. The hepatitis A titers were negative and the hepatitis B titers were positive. Additional titers were taken on 01 May 2007 and both titers for hepatitis A and hepatitis B were negative. On 02 May 2007, the subject received booster doses of Havrix (GlaxoSmithKline) and Engerix B (GlaxoSmithKline). No additional titers had been taken at the time of reporting. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEPA
Symptoms: No therapeutic response
Clinical narrative: This case was reported by the friend of a consumer and described the occurrence of a male subject of unspecified age not responding to therapy following vaccination with Havrix (GlaxoSmithKline). A physician or other health care professional has not verified this report. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Havrix (unknown).  At an unspecified time after vaccination with Havrix, the subject was tested and showed to be not responding to therapy based on post vaccination antibody levels (results not reported). At the time of reporting the outcome of the event was unspecified. No further details expected.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of numbness in a 20-year-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline, TYPHIM VI.  Concurrent medical conditions included drug allergy.  There were no concurrent medications.  On 20 June 2007 the subject received 1st dose of HAVRIX (1440 elisa unit, unknown) and unspecified dose of TYPHIM VI.  At an unspecified time after vaccination with HAVRIX and TYPHIM VI, the subject experienced numbness and tingling.  The events lasted for five days.  At the time of reporting the events were resolved.  Follow-up information was received from a pharmacy nurse on 09 July 2007.  HAVRIX was administered intramuscularly in the left deltoid.  TYPHIM VI was administered intramuscularly in the right deltoid.  On 21 June 2007, one day after vaccination with HAVRIX and TYPHIM VI, the subject experienced numbness and tingling.  The events resolved on 26 June 2007.  The pharmacy nurse considered the events to be serious.  The pharmacy nurse reported the case to a Regulatory Agency.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site reaction ion a 14-year=-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. On 4 June 2007, at 15:00, the subject inadvertently received 1st dose of HAVRIX (720 elisa unit, left arm) subcutaneously, rather than the indicated intramuscular route. At an unspecified time after vaccination with HAVRIX, the subject experienced injection site reaction and sought medical attention at the physician's office. At the time of reporting, the pharmacist was not able to provide further details about the event. At the time of reporting the outcome of the events was unspecified.