chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Kawasaki's disease, Laboratory test, Platelet count increased, Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning a 20 week old male with no pertinent medical history or drug allergies, who on 13-MAR-2007, 15-MAY-2007, and 20-JUN-2007 was vaccinated PO with the first (lot# 656381/0875U) 2.0 ml doses of Rotateq. There was no concomitant medication. After the second dose of vaccination on 05-JUN-2007, the patient first experienced the symptoms of Kawasaki's disease and was hospitalized. Lab diagnostic studies performed included a "CBC," blood culture, urine culture, blood chemistry, and urinalysis. The patient was treated with "IVIG." It was noted by the physician that the vaccination series was completed after recovery in July 2007. There was no product quality complaint. Follow-up information has been received by the physician indicating that on 05-JUN-2007 the patient was seen for persistent fever, papular rash, bright red chapped lips, and right eye conjunctivitis. There was no evidence of strawberry tongue. On that same day blood chemistry results showed an abnormal sedimentation rate of 14 mm/h and urine culture results showed significant levels of staph aureus in urine. (10,000-30,000 range). The patient was treated with ZITHROMAX (dose not provided). On 07-JUN-2007 the patient was hospitalized for approximately 2 days and diagnosed with Kawasaki's disease by infectious disease specialists. Lab diagnostic tests performed in the ER included a normal blood culture and urinalysis, but the CBC revealed a platelet count of 525 x 10 3ml and an increased sedimentation rate to 22.9 mm/h. The patient was treated with IV ROCEPHIN and AUGMENTIN (dose not provided) but did not respond to antibiotic treatment. On 08-JUN-20007, an echocardiography was performed which revealed prominent left main coronary artery. The patient was then treated with IV immune globulin. On 20-JUN-2007 the patient was seen by the physician and was noted to be recovered. On 21-JUN-2007 a repeat echocardiography was performed and the results were normal. Additional information is not expected.  12/4/07 Received hospital medical records which reveal patient experienced fever x 6 days, rash x 4 days & conjunctivitis x 4 days. Seen by pcp & started on antibiotics.  Admitted 6/8-6/11/2007. On admit, hepatomegaly, cracked lips & red tongue, palmar erythema & rash noted.  ID & cardio consults done.  Tx w/IVIG & high dose ASA.  Improved & d/c to home on continued low dose ASA & f/u by ID & cardio. FINAL DX: Kawasaki disease.   1/11/08 Received vax record from provider which confirms RO dose & lot & adds additional vax: Daptacel #2, 02570BA; ActHib #2 UF091AA; Prevnar #2 B47442C; IPV #1, Sanofi, Y103Z.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Red blood cell sedimentation rate increased, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 20 week old male with no pertinent medical history or drug allergies, who on 13-MAR-2007, 15-MAY-2007, and 20-JUN-2007 was vaccinated PO with the first (lot# 656381/0875U) 2.0 ml doses of Rotateq. There was no concomitant medication. After the second dose of vaccination on 05-JUN-2007, the patient first experienced the symptoms of Kawasaki's disease and was hospitalized. Lab diagnostic studies performed included a "CBC," blood culture, urine culture, blood chemistry, and urinalysis. The patient was treated with "IVIG." It was noted by the physician that the vaccination series was completed after recovery in July 2007. There was no product quality complaint. Follow-up information has been received by the physician indicating that on 05-JUN-2007 the patient was seen for persistent fever, papular rash, bright red chapped lips, and right eye conjunctivitis. There was no evidence of strawberry tongue. On that same day blood chemistry results showed an abnormal sedimentation rate of 14 mm/h and urine culture results showed significant levels of staph aureus in urine. (10,000-30,000 range). The patient was treated with ZITHROMAX (dose not provided). On 07-JUN-2007 the patient was hospitalized for approximately 2 days and diagnosed with Kawasaki's disease by infectious disease specialists. Lab diagnostic tests performed in the ER included a normal blood culture and urinalysis, but the CBC revealed a platelet count of 525 x 10 3ml and an increased sedimentation rate to 22.9 mm/h. The patient was treated with IV ROCEPHIN and AUGMENTIN (dose not provided) but did not respond to antibiotic treatment. On 08-JUN-20007, an echocardiography was performed which revealed prominent left main coronary artery. The patient was then treated with IV immune globulin. On 20-JUN-2007 the patient was seen by the physician and was noted to be recovered. On 21-JUN-2007 a repeat echocardiography was performed and the results were normal. Additional information is not expected.  12/4/07 Received hospital medical records which reveal patient experienced fever x 6 days, rash x 4 days & conjunctivitis x 4 days. Seen by pcp & started on antibiotics.  Admitted 6/8-6/11/2007. On admit, hepatomegaly, cracked lips & red tongue, palmar erythema & rash noted.  ID & cardio consults done.  Tx w/IVIG & high dose ASA.  Improved & d/c to home on continued low dose ASA & f/u by ID & cardio. FINAL DX: Kawasaki disease.   1/11/08 Received vax record from provider which confirms RO dose & lot & adds additional vax: Daptacel #2, 02570BA; ActHib #2 UF091AA; Prevnar #2 B47442C; IPV #1, Sanofi, Y103Z.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Kawasaki's disease
Clinical narrative: Information has been received from a physician concerning an approximately 4-month-old patient who was vaccinated PO with the second dose of Rotateq. The physician reported that the patient subsequently developed Kawasaki's disease. The patient was seen by the physician and was subsequently hospitalized (duration unknown). The patient subsequently recovered. It was noted the third dose of Rotateq had not yet been given. Additional information has been requested. It has been determined that WAES #0709USA03450 is a duplicate of WAES #0710USA00261. Additional information is not expected.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Echocardiogram, Immunoglobulins, Kawasaki's disease, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on 21-MAR-2007 was vaccinated with the first oral dose Rotateq. On 16-MAY-2007, the patient was vaccinated with the second oral dose of Rotateq. On 19-JUL-2007, the patient was vaccinated with the third oral dose of Rotateq. All three doses were administered at a health clinic. After the patient received the third dose the patient went into the physician's office because he had a fever that was persistent for five days. The patient was then admitted to the hospital on 07-SEP-2007. On 08-SEP-2007, the patient was transferred to another hospital. The patient received two echocardiograms and also was treated for Kawasaki disease (the physician was unsure if the disease was confirmed). The patient was treated with antibiotics, aspirin, and IV immune globulin. The patient was discharged from the hospital but the date of discharge was not known. The outcome was reported as unknown. There was no product quality complaint. Additional information has been requested.  12/10/2007 MR received for DOS 9/8-11/2007 with Final DX: Incomplete Kawasaki, Enterovirus.  Infant developed fever of 102 on 9/2/07 with no other sx initially.  Fever continued and infant was treated with abx for pharyngitis and then an otitis media.  However, fever continued despite abx and anti-pyretics.  Child then began to experience diarrhea with one episode of blood in stool on the day prior to admission as well as non-productive cough.  No reports of rashes or swelling at this time, although infant was noted to have red eyes thought to be 2' to crying.  Admitted to local hospital where conjuctivitis, (non-purulent), and questionable dry, cracked lips and palmar erythema were noted, however this was not noted upon admission to transfer facility. Txd with IVIG and ASA for atypical Kawasaki's.  Pt tolerated IVIG well and improved symptomatically and clinically with reduction in fever by D/C
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from physician concerning an male infant who on 13-AUG-2007 was vaccinated with his first oral dose of ROTATEQ (Lot number was not known). On 15-AUG-2007 the patient developed diarrhea. The patient sought medical attention by contacting the physician and an office visit. The patient's diarrhea persisted. There was no product quality complaint. No other information was available from the physician. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old male with gastrooesophageal reflux precaution and no drug allergies, who on 05-SEP-2007 was vaccinated with a 2.0ml oral dose Rotateq (lot# 657660/0972U).  There was no concomitant medication.  On that same day, the patient spit up what looks like formula and clear liquid 5 minutes after vaccination.  Unspecified medical attention was sought.  The patient was noted "to be fine and went home."  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a physician concerning a 9-week-old patient with no medical history or allergies who on 06-SEP-2007 was vaccinated PO with a dose of ROTATEQ. There was no concomitant therapy. The physician reported that on 06-SEP-2007, about 20 seconds after being vaccinated, the patient regurgitated. The patient was examined in the physician's office. No laboratory/diagnostic tests were performed. The patient did not require treatment and fully recovered on that same day. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Cough, Diarrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first and second dose, respectively, of ROTATEQ. The physician reported that, a day after receiving the first and second dose of ROTATEQ, the patient developed diarrhea and a persistent cough. The physician's office was called on both occasions. The patient subsequently recovered after both instances while on therapy (unspecified). Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning her 6 month old daughter who was vaccinated with her third oral dose of Rotateq.  Two days post vaccination, the patient developed a fever, diarrhea and vomiting.  Unspecified medical attention was sought.  No labs or diagnostic studies were performed.  The patient was treated with an unspecified therapy.  Subsequently, the patient recovered.  The physician who vaccinated her daughter was unknown.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: Information has been received from a registered nurse concerning an infant who was vaccinated with an oral dose of Rotateq.  Subsequently, the patient spit up the dose.  Unspecified medical attention was sought.  There was no product quality complaint. Additional information has been requested.   .
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a consumer who is a certified medical assistant, through the Merck pregnancy registry concerning her 17 year old daughter with no pertinent medical history or drug reactions/allergies, who on 15-OCT-2006 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml).  There were no concomitant medications.  Subsequently the patient found out she was pregnant via a home pregnancy test.  The patient's mother stated that her daughter may have been pregnant at the the she received the vaccination, however it was uncertain of the exact date the patient conceived.  The patient's pregnancy was confirmed by subsequent visits to her OB/GYN in November 2006.  The patient had no symptoms.  Follow-up information received from the pregnancy registry revealed that this was the patient's first pregnancy and the estimated date of delivery was 11-JUL-2007.  On 27-JUN-2007, the patient gave birth to a normal male infant weighing 5 pound 6 ounces with a length of 19.5 inches.  There were no congenital anomalies and no other complications or abnormalities.  There were no complications during pregnancy, or labor and delivery, however it was reported that the patient experienced 2 or 3 urinary tract infections (no further details were provided).  No further information is expected.  Follow-up information received from the pregnancy registry revealed that this was the first pregnancy and the estimated date of delivery was 11-JUL-2007. On 27-JUN-2007, the patient gave birth vaginally to a normal male intact weghing 5 pounds 6 ounce with a length of 18.5 inches. The birth was reported as two weeks early (38 weeks). Apgar score was 8 at one minute and 10 at 5 minutes. There were no congenital anomalies and no other complications or abnormalities. The pregnancy was normal. There were no complications during pregnancy, or labor and delivery , however it was reported that the infant had a bruised caput one half inches nevue to the right forehead. It was also reported that the mother had experienced 2 or 3 urinary tract infections (no further details were provided). The baby was fed via bottle and was reported to have no developmental delays or other problems. No further information is expected. Pediatric medical records were received and reviewed; adverse experiences related to hepatitis B vaccine were indentified, and are described in WAES #080AUG00927.
Age: 17.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Maternal alcohol use, Nausea, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received for Pregnancy Registry for GARDASIL from a Registered Nurse (R.N.) concerning an 17 (previously reported as 18) year old female patient with a history of 0 pregnancy.  On 15-MAY-2007 was vaccinated with a dose of Gardasil Lot # 655205/1426F.  On 15-MAY-2007 concomitant suspect therapy included a dose of MMR II (MSD) lot #654893/1029F.  Other concomitant therapy included Tdap and MENACTRA.  Patient was found to be pregnant on 19-JUN-2007 and she had a positive urine lab test on that day.  Patient took PHENERGAN for nausea.  She took TYLENOL and ibuprofen therapy (OTC) for unspecified reason.  It was reported that "patient experienced 4 days of heavy alcohol use in June 2007 at graduation parties".  On 17-AUG-2007, maternal serum alpha-fetoprotein (MSAFP) test were done with normal result.  On 12-SEP-2007 an ultra sound was done with normal result.  Patient's last menstrual period was reported as 26-APR-2007 and expected delivery date would be 01-FEB-2007.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/18/2007. Initial and follow up information has been received for Pregnancy Registry for GARDASIL from a Registered Nurse (RN) concerning an 17 (previously reported as 18) year old white female patient with a history of 0 pregnancy. On 15-MAY-2007 was vaccinated with a dose of GARDASIL Lot # 655205/1426F. On 15-MAY-2007 concomitant suspect therapy included MENACTRA. Patient was found to be pregnant on 19-JUNE-2007 and she had a positive urine lab test on that day. Patient took PHENERGAN for nausea. She took TYLENOL and ibuprofen therapy (OTC) for unspecified reason. It was reported that "patient experienced 4 days of heavy alcohol use in June 2007 at graduation parties." On 17-AUG-2007, maternal MNAFP test were done with normal result. Patient's last menstrual period was reported as 26-APR-2007 and expected delivery date would be 01-FEB-2007. In follow up telephone call to doctor's office the physician reported that patient had a vaginal delivery in early February 2008. She did not know the exact date becasue she did not deliver the patient. The physician said that there no compications and the baby was healthy. On 04-MAR-2008 the patient was seen for her post partum visit and she received her second dose of GARDASIL at that time. No further information was available. Additional information is not available..
Age: 17.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received for Pregnancy Registry for GARDASIL from a Registered Nurse (R.N.) concerning an 17 (previously reported as 18) year old female patient with a history of 0 pregnancy.  On 15-MAY-2007 was vaccinated with a dose of Gardasil Lot # 655205/1426F.  On 15-MAY-2007 concomitant suspect therapy included a dose of MMR II (MSD) lot #654893/1029F.  Other concomitant therapy included Tdap and MENACTRA.  Patient was found to be pregnant on 19-JUN-2007 and she had a positive urine lab test on that day.  Patient took PHENERGAN for nausea.  She took TYLENOL and ibuprofen therapy (OTC) for unspecified reason.  It was reported that "patient experienced 4 days of heavy alcohol use in June 2007 at graduation parties".  On 17-AUG-2007, maternal serum alpha-fetoprotein (MSAFP) test were done with normal result.  On 12-SEP-2007 an ultra sound was done with normal result.  Patient's last menstrual period was reported as 26-APR-2007 and expected delivery date would be 01-FEB-2007.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/18/2007. Initial and follow up information has been received for Pregnancy Registry for GARDASIL from a Registered Nurse (RN) concerning an 17 (previously reported as 18) year old white female patient with a history of 0 pregnancy. On 15-MAY-2007 was vaccinated with a dose of GARDASIL Lot # 655205/1426F. On 15-MAY-2007 concomitant suspect therapy included MENACTRA. Patient was found to be pregnant on 19-JUNE-2007 and she had a positive urine lab test on that day. Patient took PHENERGAN for nausea. She took TYLENOL and ibuprofen therapy (OTC) for unspecified reason. It was reported that "patient experienced 4 days of heavy alcohol use in June 2007 at graduation parties." On 17-AUG-2007, maternal MNAFP test were done with normal result. Patient's last menstrual period was reported as 26-APR-2007 and expected delivery date would be 01-FEB-2007. In follow up telephone call to doctor's office the physician reported that patient had a vaginal delivery in early February 2008. She did not know the exact date becasue she did not deliver the patient. The physician said that there no compications and the baby was healthy. On 04-MAR-2008 the patient was seen for her post partum visit and she received her second dose of GARDASIL at that time. No further information was available. Additional information is not available..
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Full blood count normal, Pregnancy test negative, Ultrasound scan, Urinary tract infection
Clinical narrative: Initial and follow up information has been received through the Merck Pregnancy Registry from a licensed practical nurse concerning a 15 year old female with asthma, depression, no previous pregnancy, and who is a smoker, who on 29-MAY-2007 had a negative beta-human chorionic gonadotropin test (unspecified) and then was vaccinated IM with a 0.5 ml dose of Gardasil (lot # 654535/0960F).  Concomitant therapy included albuterol inhaler, and prenatal vitamins (unspecified).  Subsequently, the patient became pregnant.  Her last menstrual period was 12-JUN-2007 and the expected delivery date was 20-MAR-2008.  Unspecified medical attention was sought.  On 13-NOV-2007 the complete blood cell count was reported as normal.  On 16-AUG-2007 an ultrasound was performed in order to obtain the estimated delivery date.  On an unspecified date the patient developed a urinary tract infection.  On 11-SEP-2007 the patient was given MACROBID 100mg, two times a day for 7 days to treat the urinary tract infection.  The patient was also treated with multiple unspecified antibiotics for the urinary tract infections. At the time of the report, the patient's outcome was unknown.  Additional information has been requested. Follow-up information indicated that on 10-MAR-2008 at 38 1/2 weeks from her last menstrual period the patient delivered a male infant. The infant weighed 7 pounds 1.1 ounces, was 15 inches long, and had an apgar score of 9/10. The infant was normal with no congenital anomalies, complications, or abnormalities. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 21-JUN-2007 at 02:00 PM was vaccinated IM into left deltoid with a second dose of Gardasil lot #657737/0522U.  On 22-JUN-2007, the patient experienced flu like symptoms.  Subsequently, the patient recovered from flu like symptoms.  Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Antinuclear antibody, Full blood count, Generalised erythema, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse concerning a white patient with no medical history, who on 24-AUG-2007, at 1:00 p.m., was vaccinated into left arm with a second dose of GARDASIL (Lot# 658488/0930U). On 25-AUG-2007 the patient experienced facial stinging. It was reported that the patient felt better after going to a cool environment. On 27-AUG-2007 a rash erupted on the arms and hands and feet were swollen. The patient developed generalized erythema and a maculopapular rash. The patient underwent serum multiallergen radicallergosorbent, complete blood cell count and serum antinuclear antibodies (results not reported). At this reporting time the patient's outcome is unknown. Additional informtion is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Radioallergosorbent test, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a white patient with no medical history, who on 24-AUG-2007, at 1:00 p.m., was vaccinated into left arm with a second dose of GARDASIL (Lot# 658488/0930U). On 25-AUG-2007 the patient experienced facial stinging. It was reported that the patient felt better after going to a cool environment. On 27-AUG-2007 a rash erupted on the arms and hands and feet were swollen. The patient developed generalized erythema and a maculopapular rash. The patient underwent serum multiallergen radicallergosorbent, complete blood cell count and serum antinuclear antibodies (results not reported). At this reporting time the patient's outcome is unknown. Additional informtion is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning more than a dozen females who were vaccinated with the first dose of GARDASIL. Subsequently the patients experienced syncope after the injection. Medical attention was sought. Follow-up information was received from a nurse who reported that she did not have an exact number of patients but that is not more than 15 in the 3 months that they had given the vaccinations to their patients. Additional information was received from a nurse practitioner. She referenced the same group of approximately 15 patients which was previously reported by the physician and a nurse. She confirmed that over the past three months experienced syncope after immunization. She was unable to provide any further patient details or lot numbers. A licensed practical nurse states that they were not keeping track of lot numbers at that time. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced hives. The patient did not come back for a follow-up visit and their outcome is unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Blood pressure, Dermographism, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 11 year old female who was vaccinated with a first dose of GARDASIL (Lot #654535/0960F). Concomitant therapy included MENACTRA, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid) and VARIVAX at the same visit separate sites. Immediately after receiving the GARDASIL injection the patient developed a headache, dizziness, and urticaria at the injection site described as a rash with welts and dermatographism. The patient was given 50 mg of BENADRYL her blood pressure was recorded as 118/70. The patient was then observe for thirty minutes and then released and considered recovered. She was sent for an allergy referral. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 11 year old female who was vaccinated with a first dose of GARDASIL (Lot #654535/0960F). Concomitant therapy included MENACTRA, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid) and VARIVAX at the same visit separate sites. Immediately after receiving the GARDASIL injection the patient developed a headache, dizziness, and urticaria at the injection site described as a rash with welts and dermatographism. The patient was given 50 mg of BENADRYL her blood pressure was recorded as 118/70. The patient was then observe for thirty minutes and then released and considered recovered. She was sent for an allergy referral. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Loss of consciousness
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who was vaccinated with a dose of Gardasil. A few days after vaccination, the patient experienced headache, dizziness and passed out. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Initial and follow-up information has been received from a physician and a health professional concerning a 13 year old female who was vaccinated with 0.5 ml dose of Gardasil. Subsequently she received her first period the day after. The patient contacted the physician. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who was vaccinated with a first dose of Gardasil. Subsequently the patient complained of headaches when she came in for the second dose. On an unspecified date the headaches resolved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Back pain, Body temperature increased, Fatigue, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on 29-AUG-2007 at 4:45 PM was vaccinated in the left deltoid with the third dose of Gardasil (lot # 658556/1060U). On 29-AUG-2007, in the evening, the patient developed a temperature of 102 degrees, and experienced a backache and headache. It was reported that the patient was unable to go to work the next day on 30-AUG-2007 due to fatigue. The patient's physician was notified on 29-AUG-2007 and advised rest and TYLENOL. The patient was to call if symptoms persisted. There were no further problems reported. The patient subsequently recovered from the fever, backache, headache and fatigue on 30-AUG-2007. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Wheezing
Clinical narrative: Information has been received from a 25 year old female consumer with asthma who is allergic to nuts, egg, and wheat who on 10-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included albuterol, Metered-Dose inhaler. The patient reported that she received her first injection on 10-SEP-2007 and developed chest tightness, wheezing and shortness of breath. She was treated in her physician's office with BENADRYL and DECADRON. No other information was provided. The patient was recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure normal, Dizziness, Heart rate normal, Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient with penicillin allergy who on 16-JUL-2007 was vaccinated IM into the right arm with a first dose of Gardasil lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. The patient recovered quickly. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a female student with penicillin allergy (rash) who on 16-JUL-2007, at 10:45 AM was vaccinated IM into the right deltoid with a first dose of GARDASIL lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. In follow up it was reported that patient became dizzy, weak and had syncopal attack after the injection lasting few seconds. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. In follow up it was reported that her blood pressure (BP) was 100/68 and total heartbeat was 76. She was then watched for 15 minutes and then went home walking. The patient recovered quickly on 16-JUL-2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient with penicillin allergy who on 16-JUL-2007 was vaccinated IM into the right arm with a first dose of Gardasil lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. The patient recovered quickly. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a female student with penicillin allergy (rash) who on 16-JUL-2007, at 10:45 AM was vaccinated IM into the right deltoid with a first dose of GARDASIL lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. In follow up it was reported that patient became dizzy, weak and had syncopal attack after the injection lasting few seconds. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. In follow up it was reported that her blood pressure (BP) was 100/68 and total heartbeat was 76. She was then watched for 15 minutes and then went home walking. The patient recovered quickly on 16-JUL-2007. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Shock, Syncope, Urinary incontinence
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a second dose of Gardasil. The physician reported that post vaccination patient fainted and wet herself. She was monitored and recovered. She did not have this adverse event after her first dose of Gardasil. No other information was available. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a physician concerning a female patient who on 13-AUG-2007, at 01:00 PM was vaccinated with a second dose of GARDASIL lot #657872/0515U. The physician reported that post vaccination patient fainted and wet herself. She was monitored and recovered. She did not have this adverse event after her first dose of GARDASIL. No other information was available. In the follow up it was reported that "fainting resulted from shock of injection not from vaccine". Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female with a family history of, "mother fainting when blood is drawn or has a shot" who was vaccinated with a first dose of Gardasil. Subsequently the patient fainted. Subsequently on the same day as the vaccination the patient recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse concerning a 24 month old male child who on 10-SEP-2007 was vaccinated IM with a dose of GARDASIL 655849/0263U. Concomitant therapy included HAVRIX. The physician and the nurse reported that the patient was supposed to receive HAVRIX but was given GARDASIL by accident. The nurse who administered the vaccine reported that the child received GARDASIL and received HAVRIX afterwards. The patient also experienced a slight fever lasted until 11-SEP-2007. Unspecified medical attention was sought for the patient. The outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated
Clinical narrative: Information has been received from a physician concerning a 15 year old female with eczema and no drug allergies, who approximately "three weeks ago" on 21-AUG-2007 was vaccinated intramuscularly with a 0.5mL dose of GARDASIL. There was no concomitant medication. Subsequently, approximately "three weeks ago" on 21-AUG-2007 the patient experienced an eczema flair up from head to toe. The patient went to the office and was treated with an injection of cortisone for the symptoms. The patient went to the office. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil and experienced flu-like symptoms for a couple of days after the vaccination. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccination with a first dose of Gardasil. Subsequently the patient fainted. Subsequently, the patient recovered from fainted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash
Clinical narrative: Information has been received from a registered nurse concerning female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil. Subsequently on an unspecified date the patient developed a rash after the second dose. The chart was not available at the time of the report. At the time of reporting it was unknown if the patient had recovered. No other information was available from the reporter. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Follow-up information was received from a registered nurse. The patient reported that she did not have a reaction to the GARDASIL. The patient's dermatologist was treating her for the problem. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Informtion has been received from a concerning a 16 year old female who on 24-AUG-2007 was vaccinated with a first dose of GARDASIL (lot # 657737/0522U). Concomitant therapy on the same day included VARIVAX in the left arm and there was no adverse event involved with that arm. On 28-AUG-2007 the patient developed erythema, pain and minimal swelling at the injection site. The patient stated that the pain hurt from elbow all the way to the back of her neck. the physician recommended a warm compress and "benderly". On 29-Aug-2007 the patient called back and reported she  had a fever of 100.1. The physician stated that "it was due to perception of swelling to the wrist" and recommended ALVEVE. Medical attention was sought. At the time of reporting it was unknown of the patient had recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Informtion has been received from a concerning a 16 year old female who on 24-AUG-2007 was vaccinated with a first dose of GARDASIL (lot # 657737/0522U). Concomitant therapy on the same day included VARIVAX in the left arm and there was no adverse event involved with that arm. On 28-AUG-2007 the patient developed erythema, pain and minimal swelling at the injection site. The patient stated that the pain hurt from elbow all the way to the back of her neck. the physician recommended a warm compress and "benderly". On 29-Aug-2007 the patient called back and reported she  had a fever of 100.1. The physician stated that "it was due to perception of swelling to the wrist" and recommended ALVEVE. Medical attention was sought. At the time of reporting it was unknown of the patient had recovered.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Information has been received from a medical assistant concerning a 20-21 year old female who on 07-SEP-2007 was vaccinated intramuscularly with a second dose of GARDASIL. On 07-SEP-SEP within 12 minutes of leaving the office the patient reported "blacking out at the wheel" and was involved in a motor vehicle accident. The patient did not require hospitalization for the motor vehicle accident. The patient reporter feeling well when she left the office. There was no laboratory or diagnostic tests performed. The patient's father came to the physician's office 1 - 1 1/2 hours later to inform the physician. At the time of the report the patient's outcome unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, No reaction on previous exposure to drug, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with a history of vaginal infection (treated for this in August 2007) and no drug reactions/allergies who 08-MAR-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified). On 10-MAy-2007 the patient was vaccinated with a second dose of GARDASIL 0.5mL IM. There were no adverse events noted with the first and second dose. On 10-SEP-2007 the patient was vaccinated with third dose of GARDASIL (lot# 658558/1061U) 0.5mL IM. On 11-SEP-2007 the patient called the office and stated that in early AM she developed chills, fever and general aches. Medical attention was sought via phone. The patient's chills and fever and general aches persisted. no additional information at this time. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Heat rash, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 08-SEP-2007 was vaccinated with a third dose of Gardasil (656372/0243U). On approximately 11-SEP-2007 the patient developed a rash around her mouth, a heat rash down both arms, and a fever of 100.9 Fahrenheit. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who in July 2007 was vaccinated with a first dose of Gardasil. The patient may have been vaccinated with another unspecified vaccine in the opposite arm. Subsequently the patient fainted. Patient was monitored in the office and recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 07-AUG-2007 was vaccinated with a first dose of Gardasil. It was reported that the patient had a pap smear performed in November 2006 the results were positive for atypical squamous cells or undetermined significance but negative for human papillomavirus. On 27-AUG-2007 the patient had a follow-up pap smear. On 11-SEP-2007 the results were positive for the human papillomavirus. Unspecified medical attention was sought. Subsequently, the patient did not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies who on 08-JAN-2007 was vaccinated with a first dose of Gardasil (lot# unknown). Concomitant therapy included hormonal contraceptives (unspecified). The week of 08-MAR-2007 the second dose of Gardasil was administered. In March 2007, the patient developed a red bump at the injection site. The bump had gotten smaller; however it was not yet resolved. Medical attention was sought. Due to storage at incorrect temperatures, the patient was told that her first and second doses of Gardasil had to be readministered. On 11-MAY-2007, the series for Gardasil was restarted and a first dose was regiven. On 11-SEP-2007, the second dose was readministered. No further information was available. At the time of reporting the patient was recovering. No further information was given. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies who on 08-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 653735/0688Y) IM "RVG" at 4 PM.  Concomitant therapy included hormonal contraceptive (unspecified). The week of 08-MAR-2007 the second dose of GARDASIL vaccine was administered. In March 2007, the patient developed a red bump at the injection site. The bump had gotten smaller; however it has not yet resolved. Medical attention was sought. Due to storage at incorrect temperatures, the patient was told that her forst and second doses of GARDASIL vaccine had to be readministered. On 11-MAY-2007, the series for GARDASIL vaccine was restarted and a first dose was given. On 11-SEPT-2007, the second dose was readminstered. No further information was available. At the time of reporting the patient was recovering. No further information was given. Additional information has been requested. Follow-up information was received from the physician's office. The lot # and route was updated. There were no adverse events reported at the time of the visit on 08-JAN-2007. There were no phone calls from the patient reporting an adverse event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of Gardasil. Subsequently the patient fainted. The patient was seen by the physician. Subsequently, the patient recovered from fainted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fear of needles, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a health professional concerning a female who on 10-SEP-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. After the administration the patient passed out. Subsequently, the patient fully recovered within 10 seconds. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a registered nurse concerning a 16 year old female who on 10-SEP-2007 was vaccinated IM with a first dose of GARDASIL. There was no concomitant medication. After the administration, at approximately 10:30 am, the patient passed out and fainted. The patient was caught slumping forward and brought to a side-lying position where she quickly "came to." The patient verbalized she hated needled and just started to "feel funny." Subsequently, the patient fully recovered immediately within 10 seconds. Additional information is not expected.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Loss of consciousness
Clinical narrative: Information has been received a business manager via a friend concerning the daughter of the friend (age not reported) who on an unspecified date was vaccinated with Gardasil. The patient also received another unspecified vaccine at the same time. It was reported that the daughter passed out in the care after receiving Gardasil with another vaccine. The patient recovered and received pop afterwards. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of acne who on an unspecified date was vaccinated with the first dose of Gardasil which was tolerated well. On 31-AUG-2007, the patient was vaccinated with the second Gardasil. Concomitant therapy included albuterol, ALLEGRA and minocycline. No other vaccines were administered on 31-AUG-2007. In approximately August 2007, the patient experienced intermittent dizziness. The patient sought medical attention of the physician in the office. At the time of reporting, the patient's intermittent dizziness persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 09-AUG-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy also given on 09-AUG-2007 included MENACTRA. On 10-AUG-2007, "24 hours after receiving GARDASIL", the patient experienced swelling in her tongue and throat. The patient was admitted to the emergency room. On an unspecified date, the patient recovered. Additional information has been requested.