chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Parasite stool test negative, Rash erythematous, Rash papular, Weight increased
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who was vaccinated with the third dose of oral Rotateq. Subsequently the patient experienced significant diarrhea. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a physician concerning a 6-month-old white female who on 06-MAR-2007 (1521) and 07-MAY-2007 (1151) was vaccinated PO with the second and third 2.0 mL doses, respectively, of ROTATEQ (Lot #656191/1365F).  Concomitant vaccinations administered on 07-MAY-2007 included the third 0.5 mL, IM dose in the left thigh of PREVNAR (Lot #B08670K), the thrid 0.5 mL IM dose in the right lateral thigh of ACTHIB (Lot #UE923AA) and the third 0.5 mL IM dose in the left lateral thigh of PEDIARIX (Lot #AC218092AA).  There was no illness at the time of vaccination.  Prior vaccinations administered on 06-MAR-2007 included the second 0.5 mL dose in the right thigh of PREVNAR (Lot #B0B670K) and the second 0.5 mL IM dose in the left lateral thigh of PEDIARIX (Lot #AC21B092AA).  On 07-MAY-2007, a few hours after being vaccinated, the patient developed significant diarrhea.  On 15-MAY-2007, the patient was seen by the physician.  At that time, the patient had no abdominal pain, hematocheria or nausea, fever or vomiting.  She was noted to have a stool frequency (diarrhea) of every 1-2 hours.  The patient was also noted to have a good appetite and had gained weight.  Clear liquids had been tried without improvement.  She had no known contact with contaminated food.  Bowel sounds were normal.  There was no tenderness, organomegaly, masses or hernia.  A large erythematous rash on her buttocks was noted characterized by several pinpoint erythematous papules on her entire genitourinary region.  A diagnosis of gastroenteritis and diaper dermatitis (suspect yeast component) was made.  A stool test for ova and parasitos and culture was negative.  It was recommended that A&D ointment with monistat cream be applied to the diaper region.  Diet as tolerated.  On 16-MAY-2007, the patient recovered.  Additional information is not expected.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 week old patient who was vaccinated with the first oral Rotateq. There was no concomitant medication. Subsequently, the patient experienced diarrhea and vomiting for twenty four hours after the vaccination. The outcome was reported as unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 31-MAY-2007 was vaccinated with a third dose of Rotateq. On 31-MAY-2007 the patient experienced vomiting. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 13-month-old male with no medical history of allergies who on 12-JUL-2006, 15-SEP-2006 (Lot #653754/0139F) and 03-NOV-2006 (Lot #655484/1032F) was vaccinated PO with the first, second and third doses, respectively, of Rotateq. There was no concomitant therapy. The RN reported that on 10-JUN-2007, the patient developed fever, vomiting and diarrhea. Unspecified medical attention was sought. On 12-JUN-2007, a rotavirus test was positive. At the time of this report, the patient was noted to be recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a registered nurse (RN) concerning a 13-month-old male with no medical history or allergy who on 12-JUL-2006 at 3:00PM (Lot #653754/0139F), 15-SEP-2006 at 3:15 PM (Lot #653754/0139F) and 03-NOV-2006 at 4:30 PM (Lot #655484/1032F) was vaccinated PO with the first, second and third doses, respectively, of ROTATEQ.  There was no illness at the time of vaccination.  There was no concomitant therapy.  The RN reported that on 10-JUN-2007, the patient developed fever, vomiting and diarrhea.  Unspecified medical attention was sought.  On 12-JUN-2007, a rotavirus test was positive.  At the time of this report, the patient was noted to be recovering.  There were no adverse events following prior vaccinations of the patient or his siblings.  Follow up informtion indicated that the patient had rotavirus with fever and vomiting despite vaccination with ROTATEQ.  The outcome was recovered.  No additional information is expected.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 4-week-old patient who on 18-JUN-2007 was vaccinated PO with the first dose of Rotateq. It was unknown if medical attention was sought. No adverse experience was related to the event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 10-week-old male who was vaccinated PO with the first dose of Rotateq. The physician reported that, shortly after vaccination, the patient developed persistent diarrhea. Unspecified medical attention was sought. The physician indicated that he was planning to run tests (not further specified) to determine if the diarrhea is related to Rotateq. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5, UNK
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old male who was vaccinated with a first oral dose of Rotateq (no lot number was given). Concomitant vaccines included "all the other recommended vaccinations given at 2 months of age." In the late afternoon, after receiving Rotateq, the patient experienced vomiting and diarrhea. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.26
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with ROTATEQ. Subsequently, the patient experienced diarrhea and abdominal cramping. Subsequently, the patient recovered from diarrhea and abdominal cramping. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a male who on 26-FEB-2007 was vaccinated with the first dose of Rotateq. On approximately 11-JUN-2007 (16 weeks after the first dose of Rotateq)) the patient was vaccinated with the second dose. No problems reported. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Eye swelling, Rash, Swelling face, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on 05-MAR-2007 was vaccinated PO with the second dose of Rotateq (Lot #655175/0849F). Concomitant vaccinations administered on that same day included a dose of PEDIARIX and a dose of HIBTITER. The physician reported that in 2007, the patient developed urticaria, a rash, swelling of the face and both eyes. Unspecified medical attention was sought. On 21-MAY-2007, the patient was vaccinated PO with the second dose of Rotateq (Lot #656105/1232F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified) and a dose of hepatitis B virus vaccine (+) HIB conj vaccine. On 22-MAY-2007 the patient again developed urticaria, rash and swelling of the face and both eyes. The patient was referred to an allergist. Subsequently, the patient recovered. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a pharmacist concerning a 6-month-old patient who was vaccinated with the second dose of Rotateq (1st dose given at 2 months of age). Unspecified medical attention was sought. No symptoms or problems were noted. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 5 month old patient who was vaccinated with Rotateq 2 mL PO. The nurse reported that the 5 month old infant was given the second dose of Rotateq late. The second dose was given 12 weeks after the first dose. It was reported that therapy with Rotateq was stated "at two months old".
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Blood culture negative, Culture, Full blood count normal, Gram stain positive, Rash
Clinical narrative: Information has been received from a physician concerning a 9 weeks old female, with no medical history, who on 08-MAY-2007, at 12:30 p.m., was vaccinated with a first oral dose of Rotateq (Lot# 656385/0030U). The same day the patient received other vaccines as well as getting her ears pierced. Concomitant vaccines administered at the same time included a first dose in the left thigh of TRIPEDIA (Lot# C2628AA), a first dose in the right thigh of COMVAX (Lot# 655548/1243F) and a first dose in the left thigh of IPOL. There was no illness at the time of vaccination. It was noted that after getting her ears pierced the physician put lidocaine/prilocaine (EMLA) cream which had warnings of having the side effect of redness and rash. At 3:00 p.m., on 08-MAY-2007 the patient developed a rash that started on her face and front. It was reported that by midnight the patient's parents called the physician because the rash had gotten really bad. Then by 12:01 a.m. the patient went to the emergency room. At the emergency room the patient was given prednisolone sodium phosphate (ORAPRED). The physician saw the patient again on 10-MAY-2007 and 11-MAY-2007, but the rash was still very bad. It was noted that there was no fever and no wheezing. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Respiratory syncytial virus test negative, Staphylococcal infection
Clinical narrative: Information has been received from a physician concerning a 9 weeks old female, with no medical history, who on 08-MAY-2007, at 12:30 p.m., was vaccinated with a first oral dose of Rotateq (Lot# 656385/0030U). The same day the patient received other vaccines as well as getting her ears pierced. Concomitant vaccines administered at the same time included a first dose in the left thigh of TRIPEDIA (Lot# C2628AA), a first dose in the right thigh of COMVAX (Lot# 655548/1243F) and a first dose in the left thigh of IPOL. There was no illness at the time of vaccination. It was noted that after getting her ears pierced the physician put lidocaine/prilocaine (EMLA) cream which had warnings of having the side effect of redness and rash. At 3:00 p.m., on 08-MAY-2007 the patient developed a rash that started on her face and front. It was reported that by midnight the patient's parents called the physician because the rash had gotten really bad. Then by 12:01 a.m. the patient went to the emergency room. At the emergency room the patient was given prednisolone sodium phosphate (ORAPRED). The physician saw the patient again on 10-MAY-2007 and 11-MAY-2007, but the rash was still very bad. It was noted that there was no fever and no wheezing. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 15-MAY-2007 was vaccinated with Rotateq (Lot # 656186/1235F). On 26-JUN-2007, the patient experienced diarrhea. The patient sought unspecified medical attention. The patient's diarrhea persisted. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with Rotateq. Subsequently, the patient received the second dose of Rotateq late, the dose was given 28 weeks and 1 day after the initial dose. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female infant who was vaccinated with Rotateq. Subsequently five days after vaccination, the patient experienced ten to twelve episodes of diarrhea in a day. Subsequently, the patient recovered. The same this happened after the second dose. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information ahs been received from a health authority concerning a 4 month old infant who on 16-APR-2007 was vaccinated with a first 2 ml oral dose of Rotateq (Lot# 654663/0942F). The patient was not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Rotateq. Subsequently, the patient experienced diarrhea for a couple of days after the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who was vaccinated with Rotateq first dose po. The patient was administered the first dose of Rotateq at 18 weeks of age. The nurse reported that there was no adverse experience related to this event. Additional information is expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has bee received from a medical assistant (MA) concerning a 2-month-old male who on 29-JUN-2007 was vaccinated PO with a dose of Rotateq. The MA reported that on 29-JUN-2007, the patient spit up the dose after being vaccinated. Unspecified medical attention was sought. No other side effects were noted. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 4-month-old patient who in approximately April 2007, was vaccinated PO with the first dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of COMVAX, a dose of poliovirus vaccine inactivated and a dose of PREVNAR. The physician reported that in approximately April 2007, a day after being vaccinated, the patient developed vomiting and diarrhea. The patient subsequently recovered. It was noted that the patient's mother refused the second dose. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 19-week-old female who on 29-JUN-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. It was unknown if medical attention was sought. The patient did not experience any difficulties. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 mL dose of Rotateq (lot number not provided). The physician reported that the patient subsequently developed severe diarrhea. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Rotateq. Subsequently, the patient experienced diarrhea and abdominal cramping. Subsequently, the patient recovered from diarrhea and abdominal cramping. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Constipation, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated PO with the first and second 2mL doses of Rotateq. Subsequently, after each dose, the patient was constipated for about 3 days. At the time of the report, the patient was "about 6-months-old and received his third dose but the physician did not know if the adverse experience repeated". No medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested. This is one of several reports received from the same source.
Age: 44.0
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Eye irritation, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 44 year old female health professional with a history of migraines and hypertension who on 06-JUN-2007 was administering a 2mL dose of Rotateq. Subsequently, the infant coughed/sneezed the vaccine into the health professional's eye. Her eyes were copiously irrigated following the event. Some burning in both eyes was reported. No redness or discharge was noted. There was no product quality complaint. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning approximately 2 infants who were vaccinated with first doses of Rotateq at an age greater than recommended. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chorioamnionitis, Drug exposure during pregnancy, Pregnancy, Premature labour, Ultrasound scan
Clinical narrative: Information has been received from the Merck pregnancy registry via a physician concerning a 16 year old female with attention deficit/hyperactivity disorder with a history of 0 pregnancies and 0 live births who on 17-AUG-2006 was vaccinated with a first dose of Gardasil (lot # 653937/0637F). On 26-OCT-2006, the patient was vaccination with a second dose of Gardasil (lot #653938/0954F). Concomitant therapy included CONCERTA. Subsequently, she became pregnant. Last menstrual period was 24-AUG-2006 and estimated date of delivery was 29-MAY-2007. On 09-NOV-2006 and ultrasound reported that the patient was 11 weeks and 3 days. On approximately 07-MAY-2007 the patient developed pre-term labor and chorioamnionitis. On 07-MAY-2007, the patient gave birth to a normal male. Other medications used during this pregnancy included KEFLEX. On 18-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot #657736/0389U). No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Amniocentesis normal, Blood glucose increased, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received for the pregnancy registry for Gardasil from a 24 year old female healthcare worker with a childhood history of anaemia who on 11-DEC-2006 was vaccinated IM with a first dose Gardasil. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR). Subsequently the patient found out she was about 5 weeks pregnant (estimated LMP 10-JAN-2007, EDD 17-OCT-2007). The patient was scheduled to see her physician on 26-FEB-2007. On 22-JUN-2007 follow up information was received from a physician concerning the hispanic patient with a history of low grade squamous intraepithelial lesion (August 2004) and cryosurgery to cervix (September 2004) and 0 previous pregnancies. The patient underwent amniocentesis on 09-MAY-2007 (negative) and ultrasound on 23-MAY-2007 (19 weeks). Maternal serum alpha-fetoprotein (MSAFP) was 4; the patient also had an increased random glucose of 239. She was put on a 2000 kcl ADA diet. Her outcome was not reported. Additional information has been requested. Follow up information has ben received from an obstetrician concerning the patient with gestational diabetes since 09-MAY-2007 when screening chemistry panel revealed glocuse 239. On that date she received MACROBID 100 mg BID x 7 days as empiric Rx for urinary frequency. The patinet received glyburide 2.5 mg BID from 31-AUG-2007 to 12-SEP-2007, and 5 mg BID from 13-SEP-2007 to 13-OCT-2007. On 13-OCT-2007 a liveborn female infant was delivered at 39 plus weeks from LMP. Weight was 8 pounds, length 18 1/2 inches, APGAR score 3/3. The patient received prenatal vitamins from 26-FEB-2007 to 15-OCT-2007. Pediatric medical records were received and reviewed and the following experience was identified: the child was born with the congenital anomaly of mongolian spots. The infant subsequently experienced adverse events following vaccination with hepatitis B vaccine. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Gestational diabetes, Pollakiuria, Ultrasound scan
Clinical narrative: Information has been received for the pregnancy registry for Gardasil from a 24 year old female healthcare worker with a childhood history of anaemia who on 11-DEC-2006 was vaccinated IM with a first dose Gardasil. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR). Subsequently the patient found out she was about 5 weeks pregnant (estimated LMP 10-JAN-2007, EDD 17-OCT-2007). The patient was scheduled to see her physician on 26-FEB-2007. On 22-JUN-2007 follow up information was received from a physician concerning the hispanic patient with a history of low grade squamous intraepithelial lesion (August 2004) and cryosurgery to cervix (September 2004) and 0 previous pregnancies. The patient underwent amniocentesis on 09-MAY-2007 (negative) and ultrasound on 23-MAY-2007 (19 weeks). Maternal serum alpha-fetoprotein (MSAFP) was 4; the patient also had an increased random glucose of 239. She was put on a 2000 kcl ADA diet. Her outcome was not reported. Additional information has been requested. Follow up information has ben received from an obstetrician concerning the patient with gestational diabetes since 09-MAY-2007 when screening chemistry panel revealed glocuse 239. On that date she received MACROBID 100 mg BID x 7 days as empiric Rx for urinary frequency. The patinet received glyburide 2.5 mg BID from 31-AUG-2007 to 12-SEP-2007, and 5 mg BID from 13-SEP-2007 to 13-OCT-2007. On 13-OCT-2007 a liveborn female infant was delivered at 39 plus weeks from LMP. Weight was 8 pounds, length 18 1/2 inches, APGAR score 3/3. The patient received prenatal vitamins from 26-FEB-2007 to 15-OCT-2007. Pediatric medical records were received and reviewed and the following experience was identified: the child was born with the congenital anomaly of mongolian spots. The infant subsequently experienced adverse events following vaccination with hepatitis B vaccine. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Anxiety, Poor quality drug administered, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a white female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot number unknown) IM that was stored at 10 degree C for 12-14 hours. Follow-up information was received from a nurse practitioner. The patient fainted for 2 to 3 minutes after the injection was given. The nurse practitioner stated that this may have been "fear of needles". The nurse practitioner does not know if it was related to Gardasil but it has occurred with other immunization too. The patient recovered. Additional information was not provided. Further information is not  available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy, Pregnancy test positive, Spinal X-ray normal
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 02-MAY-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included AMITRIPTYLIN (manufacturer unspecified, start date unspecified, but prior to vaccination with Gardasil). Post vaccination client had a Home pregnancy test and it was found out that the client was pregnant. Patient also had an x-ray of the lumbar spine on or about 07-MAY-2007. No other information reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication, No adverse effect
Clinical narrative: Initial and follow up information has been received from a Nurse Practitioner (N.P.), who reported when she went to administered a dose of Gardasil (Lot # 0469U) from a prefilled syringe, it "shot off across the room" and hit the wall. The syringe fell apart. The NP confirmed that no patients were involved, and no one was injured. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received concerning a 17 year old female who on 08-JUN-2007 was vaccinated with a dose of Gardasil. Subsequently, the patient experienced pain at the injection site. At the time of the report, the patient was recovered by 10-JUN-2007. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Electromyogram normal, Headache, Myalgia
Clinical narrative: Information has been received from a physician concerning a 27 year old female who was vaccinated IM with Gardasil. Subsequently the patient had pain syndrome described as myalgia and arthralgia. Additional information has been requested. Follow up information has been received from the reporting neurologist, concerning the 34 year old female patient who in January 2007 received her first IM dose of GARDASIL. The neurologist was not able to report lot number as she had received the vaccination from her OB/GYN. Concomitant therapy included ATIVAN. Within 2-3 days of the vaccination the patient experienced dizziness, headache, and myalgia. The neurologist performed a work up including an EMG, which was negative. In March 2007 the patient received her second dose of GARDASIL. The myalgias, dizziness and headache returned. By May 2007 the dizziness and headache resolved and the patient experienced the myalgia after exercise (and was still experiencing myalgia post-exercise at the time of reporting). Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 27 year old female who was vaccinated IM with Gardasil. Subsequently the patient had pain syndrome described as myalgia and arthralgia. Additional information has been requested. Follow up information has been received from the reporting neurologist, concerning the 34 year old female patient who in January 2007 received her first IM dose of GARDASIL. The neurologist was not able to report lot number as she had received the vaccination from her OB/GYN. Concomitant therapy included ATIVAN. Within 2-3 days of the vaccination the patient experienced dizziness, headache, and myalgia. The neurologist performed a work up including an EMG, which was negative. In March 2007 the patient received her second dose of GARDASIL. The myalgias, dizziness and headache returned. By May 2007 the dizziness and headache resolved and the patient experienced the myalgia after exercise (and was still experiencing myalgia post-exercise at the time of reporting). Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Influenza like illness, Vomiting
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 20 year old female with no known drug allergies and flu-like symptoms who on  12-JAN-2007 was vaccinated IM with her first dose of Gardasil (Lot # 653650/0696F). There was no concomitant medication. On 08-JUN-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 0210U). The patient had no problems after she received her first dose of Gardasil. Immediately following her second vaccination, she vomited (unknown to the office staff). The patient continued to vomit and had diarrhea throughout the weekend. The patient noted that her whole family was sick with flu-like symptoms. At the time of this report, it is unknown if the patient recovered from the vomiting and diarrhea throughout the weekend (09-Jun to 10-Jun). The patient noted that her whole family was sick with flu-like symptoms when she was vaccinated. The patient recovered on an unspecified date. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced flu-like symptoms such as a high fever and chills which lasted for a few hours. Subsequently, the patient recovered from flu-like symptoms. No further details were provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site irritation
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a medical assistant concerning a 25 year old female with drug hypersensitivity to KETEK and latex allergy and a history of hypoglycaemia, anxiety, panic attacks and a syncopal attack who on 21-MAY-2007 at 9:00 am, was vaccinated IM in the left upper quadrant of the buttocks with her first dose of 0.5 ml of GARDASIL (Lot # 655617/1447F). Illness at the time of vaccine was stress. Concomitant therapy included LEXAPRO, hormonal contraceptives (unspecified) and NASACORT AQ. On 21-MAY-2007 at 09:00 am, the patient complained of burning at injection site for a couple of minutes. Subsequently, the burning resolved on its own. No laboratory or diagnostic tests were performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who on 28-MAY-2007 was vaccinated with Gardasil. On 30-MAY-2007 the patient experienced rash. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from rash. No further details were provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a radiology technician concerning an 11 year old female who was vaccinated with Gardasil. Subsequently the patient experienced severe abdominal cramping. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from severe abdominal cramping. No further details were provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Lip swelling
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 11-MAY-2007 was vaccinated with first dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). On 12-MAY-2007 the patient developed swelling of her lips. She did go to the emergency room, however she was not admitted to the hospital. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 08-JUN2007 was vaccinated Intramuscularly with a first dose of Gardasil. On 9-JUN-2007, the patient called the office to report that her lymph nodes was swollen on her neck. The patient read the information that mentions swollen lymph nodes as one of the side effects of the vaccine but called the doctor's office to confirm. The patient did not see the doctor but was advised to call back if the symptoms worsened and no laboratory diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/14/2007. Initial and follow up information has been received from a nurse concerning a 19 year old female with an allergy to codeine, who on 07-JUN-2007 (previously reported as 08-JUN-2007) in the morning was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot# 653978/0955F). On 08-JUN-2007, the day after vaccination, (previously reported as 09-JUN-2007), the patient called the office to report that her lymph node was swollen on her neck. The patient read the information that mentions swollen lymph nodes as one of the side effects of the vaccine but called the doctor's office to confirm. The patient did not see the doctor but was advised to call back if the symptoms worsened and no laboratory diagnostic studies were performed. At the time of the report, the patient's outcome was unknown (also reported as recovered). No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history or allergies, who on 11-JUN-2007 was vaccinated with a 0.5mL first dose of Gardasil. There was no concomitant medication. After receiving the vaccination the patient passed out for about five minutes and when she "came to", she began to vomit. The patient did go to the emergency room. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female (age unknown) who, on an unspecified date, was vaccinated with a 0.5mL dose of Gardasil. Subsequently the patient experienced injection site pain that had persisted for over a month after receiving the vaccination. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a 29 year old female drug representative with no medical history or drug allergies, who in "November or December" of 2006 was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included LO/OVRAL. On 23-FEB-2007 she received a second dose of Gardasil. On 25-MAY-2007, the patient had a pap smear test which was reported to be positive for high risk HPV. On 11-JUN-2007, she received the results. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash generalised
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a mother who reported her 16 year old daughter with no pertinent medical history, who on 05-JUN-2007 was vaccinated IM with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included ADVIL and CLARITIN. Subsequently the patient developed an injection site reaction. She developed a red "knot" on her deltoid arm, "not even big as a penny". Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient's recovered from the red "knot". It was reported that the patient had no reaction to the first injection and that the third dose will be given in the future. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a certified medical assistant concerning a mother who reported her 16 year old daughter with no pertinent medical history, who on 05-JUN-2007 was vaccinated IM with a second dose of GARDASIL (lot # 657737/0522U). Concomitant therapy included ADVIL and CLARITIN. Subsequently the patient developed an injection site reaction. She developed a red "knot" on her deltoid arm, "not even big as a penny". Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient's recovered from the red "knot". It was reported that the patient had no reaction to the first injection and that the third dose will be given in the future. On approximately 19-JUN-2007 the patient developed a rash all over the body. The patient was examined by a dermatologist. The dermatologist reported that the rash was not related to the GARDASIL but viral in origin. At the time of the report, the outcome of the rash all over her body was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash
Clinical narrative: Initial and follow-up information has been received from a health professional and a physician concerning a 25 year old white female graphic designer with acne who on 24-MAY-2007 received the first dose of the Gardasil (lot # 657737/0522U), 0.5 ml, intramuscularly in the left deltoid. Concomitant therapy include minocycline. On 11-JUN-2007, the patient developed a mild pink rash on her chest, per patient and dermatologist. The patient sought unspecified medical attention. It was reported that the patient recovered "soon after". The physician reported that the rash may or may not be related to the vaccine injection. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse, concerning a 16 year old female patient, who on 11-JUN-2007 was vaccinated with a dose of Gardasil (Lot # not provided). On 11-JUN-2007, following the vaccination, the patient turned pale white, and then fainted. At the time of this report, the patient was recovering from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Nausea, Pharyngeal oedema
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 17 year old, female student, with penicillin allergy, whose reported weight was 132 pounds and whose reported height was 65 inches with no illness at the time of vaccination who on 07-MAR-2007 at 4:00 p.m., the patient was vaccinated, intramuscularly into the left deltoid muscle with the first dose GARDASIL (Lot # 654389/0961F). It was reported that on 07-MAR-2007 the patient became nauseated, lightheaded, sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. On 23-MAY-2007, at 4:30 p.m., the patient was vaccinated, intramuscularly into the right deltoid muscle with the second dose of GARDASIL (Lot # "616867/0243D"). It was reported that on 23-MAY-2007, the patient became nauseated, lightheaded, and sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 17 year old, female student, with penicillin allergy, whose reported weight was 132 pounds and whose reported height was 65 inches with no illness at the time of vaccination who on 07-MAR-2007 at 4:00 p.m., the patient was vaccinated, intramuscularly into the left deltoid muscle with the first dose GARDASIL (Lot # 654389/0961F). It was reported that on 07-MAR-2007 the patient became nauseated, lightheaded, sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. On 23-MAY-2007, at 4:30 p.m., the patient was vaccinated, intramuscularly into the right deltoid muscle with the second dose of GARDASIL (Lot # "616867/0243D"). It was reported that on 23-MAY-2007, the patient became nauseated, lightheaded, and sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site atrophy, Pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 11-JAN-2007 received the first dose of the Gardasil (lot # 655619/1427F) intramuscularly at the right hip. On 11-JAN-2007, the patient developed subcutaneous fat atrophy, a 2 cm x 1 cm atrophic "dimpled" site in the right hip. On an unspecified date, the patient returned for the second injection and wished to proceed. The patient reported redness and pain with the injection, but did not return for follow-up exam. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dyspnoea, Injection site pain, Pyrexia
Clinical narrative: Information has been received from an other health professional concerning an 18 year old white female patient with allergies to aspirin and ibuprofen who on 27-MAR-2007, at 15:00 was vaccinated IM into the left deltoid with a first dose of Gardasil (Lot# 656051/0244U). Concomitant therapy included ORTHO EVRA. That evening, the patient experienced fever, weakness, trouble breathing and pain at injection site. The patient stated that she was in bed for about two days. It was reported that the patient did not report these reactions until she came in for her second injection which was not given. Unspecified medical attention was sought. On 29-MAR-2007, it was reported that the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Heart rate decreased, Syncope vasovagal, Tremor
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with no pertinent medical history who on 08-JUN-2007 received her first dose of Gardasil (lot #657868/0523U), 0.5 ml, intramuscularly. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After the receiving the vaccination, the patient began shaking and was confused. Her vital signs were assessed and the pulse rate was noted as low (48-52). The patient was transported to the emergency room and diagnosed with a vasovagal response. It was reported that she was discharged from the emergency room and experienced no further symptoms. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the Gardasil, 0.5 ml. Subsequently, the patient developed a fever sore on her mouth after receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 11-JUN-2007 was vaccinated with Gardasil. On 11-JUN-2007, immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said that she felt better before leaving the office. Additional information has been requested. Information has been received from a nurse concerning an 18 year old female with a history of migraines and exercise induced allergies/asthma who on 11-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # 657868/0523U) in the left arm IM. On 11-JUN-2007, immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said that she felt better before leaving the office. Follow-up information was received. The patient's age, medical history and concurrent conditions were updated. The headache lasted for 3 to 5 minutes in duration. On 11-JUN-2007 the patient had recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated with the first dose of Gardasil. The patient experienced redness and swelling behind the injection site of the lower part of her tricep, closer to the elbow, after receiving the injection. Medical attention was sought. Additional information has been requested.