chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Biopsy skin, Dermatitis contact, Rash, Rash papular, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female who on unspecified dates was vaccinated intramuscularly in the arm with the first and second dose of Gardasil. Within 24 hours of receiving the first and second dose of Gardasil the patient developed a localized rash on the forearm. It was reported that the patient went to a dermatologist for the rash. It was reported that the events disappeared after a day or so. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a physician's assistant concerning a 14 year old female with acne vulgaris who on 26-OCT-2006 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL (653978/0955F). Concomitant therapy included the influenza vaccine. On 15-NOV-2006 and the 16-NOV-2006, the patient was seen in the physician's office with a rash on the left forearm with red, raised, tender patches. The patient used NEOSPORIN and was referred to a dermatologist. On 17-NOV-2006, the patient was seen by a dermatologist. A punch biopsy of the left dorsal forearm was done which was consistent with an irritant contact dematitis. The patient subsequently recovered. On 27-DEC-2006, the patient was vaccinated with the second dose of GARDASIL (655165/1425F). On 30-DEC-2006, the patient developed the same type of rash on her right leg. The rash lasted two weeks and then resolved spontaneously. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning a female patient with NKDA or preexisting medical conditions who on 22-DEC-2006, at 1:15 PM, the patient was vaccinated in the right arm with a 0.5 ml dose of GARDASIL (lot # 654389/0961F). Subsequently, several hours after the vaccination, she experienced localized right arm pain, developed a rash which was described as hives or her chin. Subsequently, on an unspecified date, the patient recovered from the events without treatment. The patient sought unspecified medical attention. Additional information is not expected.   Additional information has been requested
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning "several" patients who were vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patients subsequently complained of a little arm soreness after the vaccination. All patients recovered from arm soreness. On unknown dates, patients were vaccinated with second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patients experienced pain, swelling and irritation at injection site. The nurse noted that she used 3 or 4 different lots, and the patients were complaining that "it hurt quite a bit when the medicine was being injected into the arm". The nurse further commented that the patients did not complain about this with the first dose. The patients went home after the office visit.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after having the Gardasil vaccine.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Erythema, Injection site erythema, Rash, Urticaria
Clinical narrative: At 2:45 child received 4 vaccines: Pediarix and Hib in right thigh, influenza and PCV7 in left thigh.  At 3:00 mom returned to clinic with child in arms and reported appearance of rash.  Upon inspection, irregular and reddenned areas were noted on face, left ear, and back of neck.  3 visible hives present at approximately 5x2, 4x2, and 4x2 mL in size.  Left thigh appeared red around both injection sites, but no swelling noted.  No signs or symptoms of distress.  Respirations within normal limits.  Happy and content in mother's arms.  At 3:05, RN drew up 1.25 mL of children's benadryl per protocol and mother administered.  At 3:15 redness had diminished and hives were no longer well defined.  Staff consulted for doctor's appointment which was scheduled immediately with Dr. at Clinic.  Mother sent to Dr. with shot record, report of incident, and a map to the clinic.  Child left in mother's arms, smiling and content.
Age: 12.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Body temperature increased, Erythema, Rash, Streptococcal serology negative, Viral infection
Clinical narrative: Generalized rash faint lacey erythematous plaque. There was a tactile temperature. 24 hours after Rabies and tetanus vaccination. No other symptoms. Rapid strep is negative. Benadryl per oral at night.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site urticaria, Pruritus, Skin warm, Urticaria
Clinical narrative: on 2/1/07 noticed a hive approx les than 2 inch itching, hot.  On 2/2/07 hive got bigger, 2 inch itchy.  Called hotline #, took to Dr. on Sat 2/3/07 was giving Benedryl - did not relieve symptoms.  Dr. told to watch it, if s/s worsened consult Dr.  By Sun, lighter in color, Monday gone.  02/14/07 PC to RN @ HD location of hie at varicella injection site, left upper arm
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bacterial culture, Haematochezia, Occult blood positive, Rotavirus test, White blood cell count
Clinical narrative: vaccines administered on 2/9 and on 2/11 and 2/12 noted to have small amount of blood in the stool.  resolved thereafter but on guaic of stool on 2/14, heme positive.  no other symptoms.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Gastrointestinal necrosis, Septic shock
Clinical narrative: Pt with history of prematurity, non surgical necrotizing enterocoloitis and omphalocele.  Recieved routine 2 month immunizations - Pediarx, Hib, Prevnar and Rotateq on 11/28/06.  On 12/9/06 presented to ER isseptic shock secondary to necrotic bowel.  Patient dies.   2/16/07 Received medical records from reporter/provider which reveal patient was in usual state of health on day of vax.  Complicated PMH, see below.  Seen next on 12/5 for parental concern re pallor.  Afebrile, fussy, + weight gain, abdomen was mildly tympanic but soft w/+BS.  Return for vs on 12/7 & parents reported patient had improved at home, no further pallor episodes. temp stable, good appetite, no vomiting.  Had seen peds surgeon that day for f/u on omphalocele. Next scheduled visit was for 12/21. 2/16/07 Received Death Summary & Autopsy Report from reporter/provider which reveals on 12/9/06 patient experienced pallor, spitting up since afternoon of admit, fussy, irritable.  Exam in ER revealed rectal temp of 91.7, mottled skin, shallow breathing & in acute distress.  Had extremely rigid abdomen w/no bowel sounds.  Developed cardiac arrhythmias & seizures.  Transfused w/PRBCs.  Then omphalocele ruptured & had significant bleeding, continuing arrhythmias & finally asystole with unsuccessful resuscitation effort. Autopsy Report reveals probable COD is multisystem organ failure from septic shock secondary to ischemic small intestine within an unresolved omphalocele.
Age: 0.8
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: Patient had a high fever from the first shot (administered 12/27/06) of 100 degrees F. The degrees of the fever fluctuated between 100-102 degrees F. It did not end in the 1-2 days (proposed by the Inactivated influenza Vaccine handout 2006-07).It lasted for a week. Also, the patient's behavior was out of the ordinary.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Developed temp of 104.5 at about twenty-four hours after vaccination and had febrile seizure (first episode). had second short seizure. Seen in emergency dept at North Hawaii Community Hospital. No focus of infection. Observed and sent home.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Pt recived vaccine 5pm 2/8/07. Pt begain vomiting and diarrhea 4am 2/9/07. Pt had no fever. Pt given IV fluids.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Influenza like illness, Laboratory test abnormal, Myalgia
Clinical narrative: Patient developed flu like symptoms (muscle aches, fever) ONLY at night.  Symptoms resolved with use of APAP.  First shot given on 12/07/06, symptoms started 01/08/07 and lasted until 01/28/07.  Second shot was administered on 01/16/07.  Patient went to MD on 01/19/07 to get labs drawn, LFTs on this date were as follows AST 90, ALT 108 (uncertain if patient has ever had baseline tests drawn).  MD requested retest, this was done on 1/26/07; AST 198, ALT 311.  Patient had liver ultrasound that revealed no abnormalities.  Patient had labs drawn again on 2/8/07; AST 51 ALT 90.  Patient is to go back for retesting in about a month.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Ultrasound liver normal
Clinical narrative: Patient developed flu like symptoms (muscle aches, fever) ONLY at night.  Symptoms resolved with use of APAP.  First shot given on 12/07/06, symptoms started 01/08/07 and lasted until 01/28/07.  Second shot was administered on 01/16/07.  Patient went to MD on 01/19/07 to get labs drawn, LFTs on this date were as follows AST 90, ALT 108 (uncertain if patient has ever had baseline tests drawn).  MD requested retest, this was done on 1/26/07; AST 198, ALT 311.  Patient had liver ultrasound that revealed no abnormalities.  Patient had labs drawn again on 2/8/07; AST 51 ALT 90.  Patient is to go back for retesting in about a month.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT GOT SWELLING, REDNESS AND MILD PAIN ON VACCINATION SITE SAME DAY WHEN SHOT WAS GIVEN.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dyspnoea, Malaise, Oedema peripheral, Pyrexia, Rash
Clinical narrative: PT C/O MALAISE SWELLING AND RASH OF LEFT ARM AND FEVER AFTER RECEIVING THE VACCINES ON 2/8/07. WHEN SHE CAME INTO THE OFFICE THE DOCTOR DID NOT OBSERVE SWELLING AND RASH OF LEFT ARM. PT REPORTS MALISE AND SOB
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Lymphadenopathy
Clinical narrative: CELLULITIS WITH LYMPH NODE INVOLVEMENT OF LEFT ARM
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient found in bed unresponsive Saturday morning, Feb. 10, 2007.  3/1/07 Received autopsy report via email from CME office which reveals COD as SIDS.  Co-sleeping in full size bed w/parents.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test, Surgery, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Vomiting on 01-17-07 with subsequent hospitatlization for intussuception requiring surgical intervention. 3/15/07 Received medical records from hospital which reveal patient experienced acute onset irritability, vomiting & bloody diarrhea for 24 hrs prior to admit on 01/17/07. Be enema unsuccessful & patient taken to OR for surgical reduction & appendectomy.  Progressed well & was d/c to home on 01/18/07. Final Dx: Intussusception, surgically reduced; appendectomy.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test, Surgery, Vomiting, X-ray gastrointestinal tract
Clinical narrative: Vomiting on 01-17-07 with subsequent hospitatlization for intussuception requiring surgical intervention. 3/15/07 Received medical records from hospital which reveal patient experienced acute onset irritability, vomiting & bloody diarrhea for 24 hrs prior to admit on 01/17/07. Be enema unsuccessful & patient taken to OR for surgical reduction & appendectomy.  Progressed well & was d/c to home on 01/18/07. Final Dx: Intussusception, surgically reduced; appendectomy.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: 2/7 NOTE:  PATIENT'S ARM IS SWOLLEN AND RED - ABOUT THE SIZE OF A BASEBALL LAST NIGHT. TODAY AT 1:15P, IT IS ABOUT THE SIZE OF A GRAPEFRUIT AND LOOKS LIKE A RED RASH BUT IS NOT SWOLLEN
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Constipation, Haematochezia, Surgery, Vomiting
Clinical narrative: 5 month old male (s/p 2 doses of Rotateq), s/p surgery for intussuseption on 2/14/07.  He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days, and questionable blood in the diaper 4 days ago.  He is currently still in the hospital.  2/26/07 Received medical records from ER which reveal patient had vomiting x 2 days prior to admit, temp 100.2.  Abdomen was mildly distended w/quiet bowel sounds.  Tx w/IVF, NGT, IV antibiotics & transferred. FINAL DX: Vomiting, bowel obstruction; dehydration. 3/13/07 Reviewed medical records for 2/13-2/19 admission.  No D/C summary available.  Patient transferred for SBO after 3 day hx of emesis, temp max 102, no diarrhea.  Had mild URI s/s.  Exam at ER revealed distended abdomen & KUB showed 3-4 distended loops in midabdomen w/possible SBO.  Patient treated in ER w/IVF, antibiotics, NGT & then transferred.  Exam revealed hypoactive BS but no tenderness or masses.  Ped surgery consulted. Abd ultrasound & air contrast enema recommended. Final DX: None given. Will request D/C summary in a couple of weeks. 4/3/07 Received D/C summary which reveals admitted for vomiting & possible SBO.  Surgery on 2/14 revealed IS w/small nodule as lead point which frozen section revealed to be ectopic pancreas.  Necrotic bowel was removed & end to end anastomosis was done.  Received IV antibiotics throughout admission. FINAL DX: Ileoileal intussusception, resolved; vomiting, resolved; s/p bowel resection.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Constipation, Haematochezia, Infrequent bowel movements, Intussusception
Clinical narrative: 5 month old male (s/p 2 doses of Rotateq), s/p surgery for intussuseption on 2/14/07.  He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days, and questionable blood in the diaper 4 days ago.  He is currently still in the hospital.  2/26/07 Received medical records from ER which reveal patient had vomiting x 2 days prior to admit, temp 100.2.  Abdomen was mildly distended w/quiet bowel sounds.  Tx w/IVF, NGT, IV antibiotics & transferred. FINAL DX: Vomiting, bowel obstruction; dehydration. 3/13/07 Reviewed medical records for 2/13-2/19 admission.  No D/C summary available.  Patient transferred for SBO after 3 day hx of emesis, temp max 102, no diarrhea.  Had mild URI s/s.  Exam at ER revealed distended abdomen & KUB showed 3-4 distended loops in midabdomen w/possible SBO.  Patient treated in ER w/IVF, antibiotics, NGT & then transferred.  Exam revealed hypoactive BS but no tenderness or masses.  Ped surgery consulted. Abd ultrasound & air contrast enema recommended. Final DX: None given. Will request D/C summary in a couple of weeks. 4/3/07 Received D/C summary which reveals admitted for vomiting & possible SBO.  Surgery on 2/14 revealed IS w/small nodule as lead point which frozen section revealed to be ectopic pancreas.  Necrotic bowel was removed & end to end anastomosis was done.  Received IV antibiotics throughout admission. FINAL DX: Ileoileal intussusception, resolved; vomiting, resolved; s/p bowel resection.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Surgery, Vomiting
Clinical narrative: 5 month old male (s/p 2 doses of Rotateq), s/p surgery for intussuseption on 2/14/07.  He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days, and questionable blood in the diaper 4 days ago.  He is currently still in the hospital.  2/26/07 Received medical records from ER which reveal patient had vomiting x 2 days prior to admit, temp 100.2.  Abdomen was mildly distended w/quiet bowel sounds.  Tx w/IVF, NGT, IV antibiotics & transferred. FINAL DX: Vomiting, bowel obstruction; dehydration. 3/13/07 Reviewed medical records for 2/13-2/19 admission.  No D/C summary available.  Patient transferred for SBO after 3 day hx of emesis, temp max 102, no diarrhea.  Had mild URI s/s.  Exam at ER revealed distended abdomen & KUB showed 3-4 distended loops in midabdomen w/possible SBO.  Patient treated in ER w/IVF, antibiotics, NGT & then transferred.  Exam revealed hypoactive BS but no tenderness or masses.  Ped surgery consulted. Abd ultrasound & air contrast enema recommended. Final DX: None given. Will request D/C summary in a couple of weeks. 4/3/07 Received D/C summary which reveals admitted for vomiting & possible SBO.  Surgery on 2/14 revealed IS w/small nodule as lead point which frozen section revealed to be ectopic pancreas.  Necrotic bowel was removed & end to end anastomosis was done.  Received IV antibiotics throughout admission. FINAL DX: Ileoileal intussusception, resolved; vomiting, resolved; s/p bowel resection.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Bowel sounds abnormal, Constipation, Haematochezia, Infrequent bowel movements
Clinical narrative: 5 month old male (s/p 2 doses of Rotateq), s/p surgery for intussuseption on 2/14/07.  He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days, and questionable blood in the diaper 4 days ago.  He is currently still in the hospital.  2/26/07 Received medical records from ER which reveal patient had vomiting x 2 days prior to admit, temp 100.2.  Abdomen was mildly distended w/quiet bowel sounds.  Tx w/IVF, NGT, IV antibiotics & transferred. FINAL DX: Vomiting, bowel obstruction; dehydration. 3/13/07 Reviewed medical records for 2/13-2/19 admission.  No D/C summary available.  Patient transferred for SBO after 3 day hx of emesis, temp max 102, no diarrhea.  Had mild URI s/s.  Exam at ER revealed distended abdomen & KUB showed 3-4 distended loops in midabdomen w/possible SBO.  Patient treated in ER w/IVF, antibiotics, NGT & then transferred.  Exam revealed hypoactive BS but no tenderness or masses.  Ped surgery consulted. Abd ultrasound & air contrast enema recommended. Final DX: None given. Will request D/C summary in a couple of weeks. 4/3/07 Received D/C summary which reveals admitted for vomiting & possible SBO.  Surgery on 2/14 revealed IS w/small nodule as lead point which frozen section revealed to be ectopic pancreas.  Necrotic bowel was removed & end to end anastomosis was done.  Received IV antibiotics throughout admission. FINAL DX: Ileoileal intussusception, resolved; vomiting, resolved; s/p bowel resection.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Surgery, Vomiting
Clinical narrative: 5 month old male (s/p 2 doses of Rotateq), s/p surgery for intussuseption on 2/14/07.  He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days, and questionable blood in the diaper 4 days ago.  He is currently still in the hospital.  2/26/07 Received medical records from ER which reveal patient had vomiting x 2 days prior to admit, temp 100.2.  Abdomen was mildly distended w/quiet bowel sounds.  Tx w/IVF, NGT, IV antibiotics & transferred. FINAL DX: Vomiting, bowel obstruction; dehydration. 3/13/07 Reviewed medical records for 2/13-2/19 admission.  No D/C summary available.  Patient transferred for SBO after 3 day hx of emesis, temp max 102, no diarrhea.  Had mild URI s/s.  Exam at ER revealed distended abdomen & KUB showed 3-4 distended loops in midabdomen w/possible SBO.  Patient treated in ER w/IVF, antibiotics, NGT & then transferred.  Exam revealed hypoactive BS but no tenderness or masses.  Ped surgery consulted. Abd ultrasound & air contrast enema recommended. Final DX: None given. Will request D/C summary in a couple of weeks. 4/3/07 Received D/C summary which reveals admitted for vomiting & possible SBO.  Surgery on 2/14 revealed IS w/small nodule as lead point which frozen section revealed to be ectopic pancreas.  Necrotic bowel was removed & end to end anastomosis was done.  Received IV antibiotics throughout admission. FINAL DX: Ileoileal intussusception, resolved; vomiting, resolved; s/p bowel resection.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Possible local reaction to vaccine red area left thigh 3.5 x 2.2 cm
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area on left thigh is red and swollen at injection site. Pt was given Augmentin 400 mg/5ml and instructed to take Benadryl.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Left upper, outer arm, 4 cm induration with erythema. Benadryl, Motrin RTC
Age: 13.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Anorexia, Dizziness, Nausea, Pyrexia, Wrong drug administered
Clinical narrative: Dizziness, nausea, not hungry next morning at school. (>12 hr later) fever 24 hr later for less than 24 hr
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: fresh blood in stool
Age: 15.0
Sex: U
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Tremor
Clinical narrative: C/O dizziness "can't breath" observed tremor of hands states heart beating rapidly (AP=72/min)
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Vaccine given 2/12/07. 2/12/07 pm redness of L thigh increased today 2/14/07.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Pain in extremity, Throat tightness
Clinical narrative: Pt received Polio vaccine in R thigh and Dtap in L thigh at 11:30am. Mother gave Ibuprophen and child took nap. Child complained of leg pain when he woke up. Also complained of feeling like he had food in his throat. Bilateral swelling of thighs. Seen in ER given PO Benadryl and Prednisone.
Age: 13.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL concomitantly with a dose of MENACTRA and a dose of DTaP.  Subsequently the patient developed knot at the injection site where she received DTaP. It was reported that the patient with a knot or "raised area" that was 1 and 1/2 inches long. At the time of the report, the patient's outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 13 year old female who on 15-JAN-2006 was vaccinated, into the left deltoid, with a first dose of GARDASIL vaccine (lot #654389/0961F) concomitantly with a first dose of MENACTRA vaccine (lot #U1893AA) in the left deltoid and first dose of BOOSTRIX (lot #AC52B009AA) into the right deltoid. There were no concomitant medications. On 17-JAN-2007, the patient developed knot at the injection site where she received BOOSTRIX. It was reported that the patient presented with redness and a knot of "raised area" that was 1 and 1/2 inches long. Follow-up reported that the patient had mild erythema (no swelling) at the injection site of GARDASIL vaccine and MENACTRA. The patient was seen in the physician's office on 17-JAN-2007. At the time of the follow-up report, the patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise, Myalgia
Clinical narrative: Information has been received from a physician concerning a female who on 17-JAN-2007 was vaccinated with a 0.5 ml first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 17-JAN-2007 the patient experienced flu-like symptoms described as malaise and myalgia.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Flushing, Nausea
Clinical narrative: Information has been received from a health professional concerning a 21 year old white female with no medical history, who on 21-DEC-2006 was vaccinated in the left deltoid with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653735/0688F). There were no illnesses at the time of vaccination. On 21-DEC-2006, following vaccination, the patient felt faint and queasy and her face appeared flush. The patient's blood pressure was 102/60. The patient was given a cold drink of water and a cold compress and remained seated for 10 minutes and subsequently felt fine. The patient stated that "needles make her scared".  No further information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no past medical history and no drug allergies who on 08-NOV-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included minocycline HCl (MINOCIN). On 08-NOV-2006 the patient experienced skin discoloration around injection site.  The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms.  There were no relevant diagnostic tests performed.  Unspecified medical attention was sought.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 21 year old female with acne and no drug allergies who on 08-NOV-2006 at 1:20 PM was vaccinated with a first dose of GARDASIL (lot # 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included MINOCIN. On 08-NOV-2006 the patient experienced skin discoloration around left deltoid (injection site). The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms. The area was still noticed approximately 8 weeks after vaccination, and denied other adverse reactions. Subsequently on 26-JAN-2007, the area was inspected. C shape was now a complete circle with center the same color as surrounding skin. After close inspection, the area was the same size and shape by Band aide used to cover injection site with lightened area corresponding to the adhesive on the Band aide. The patient received a second dose of GARDASIL on 26-JAN-2007. There were no noticeable skin changes at the time of the report. There were no relevant diagnostic tests performed. it was reported to be unknown if the patient recovered. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies unspecified who on approximately 18-JAN-2007 was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast) (lot# not reported) 0.5 ml injection.  On approximately 18-JAN-2007, the patient experienced a rash on her wrist and forearm.  The patient sought medical attention.  At the time of reporting, the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a female who on 14-DEC-2006 was vaccinated by injection with the first dose of HPV vaccine (yeast). On 14-DEC-2006 the patient experienced fatigue after HPV vaccine (yeast) was administered.  The patient received the second dose of HPV vaccine (yeast) on 15-JAN-2007 and did not experience any further symptoms.  The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient had recovered.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on approximately 18-JAN-2007 was vaccinated with GARDASIL (lot # not reported) injection, 0.5 ml, in her left upper arm. There was no concomitant medication. On 18-JAN-2007, the patient developed pain and soreness in both sides of her hips. The patient sought medical attention.  No lab diagnostic tests were performed. The patient stated that as of 18-JAN-2007, she only feels pain when she touches the side of her hips. At the time of reporting the outcome was unspecified. No other information was provided by the physician. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Additional information was received from the physician via telephone call. The physician reported that the patient had not returned for follow-up visit, therefore it was unknown if the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Information has been received from an office manager concerning a 16 year old female who on 21-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of HPV vaccine (yeast). There was no concomitant medication. On approximately 21-DEC-2006, after receiving the vaccination, the patient developed a "knot" at the injection site. The patient sought unspecified medical attention. The "knot" at the patient's injection site persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure normal, Dizziness, Feeling hot, Visual acuity reduced
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no fever, otitis (diagnosed on 22-DEC-2006), mild sore throat, congestion, runny nose, amoxicillin and erythromycin allergy who on 22-DEC-2006 was vaccinated with the first dose of GARDASIL (lot # 653938/0954F), IM. Concomitant therapy included the first dose of MENACTRA (lot # U2141AA), IM.  On 22-DEC-2006 after the vaccine while at the check out window, the patient stated that she felt hot, felt her vision was fading and felt faint.  The registered nurse held her arm and walked with her back to an exam room where she had her lay down and elevated her legs on two pillows for 15 minutes.  The patient's feeling passed. When the patient first returned to the exam room the physician checked her and then checked her when she felt better. After 15 minutes of lying down, the patient then sat up for 5 minutes. Her blood pressure was taken and was normal 98/60. Subsequently, the patient recovered from the events that same day.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that there was no diagnostic work-up performed, the patient was not hospitalized nor was an outpatient and the patient fully recovered before she left the physician's office. On 21-FEB2007, the patient was vaccinated with the second dose of GARDASIL and had no side effects. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on approximately 05-JAN-2007 was vaccinated at another physicians office with HPV vaccine (yeast) (lot # not provided). On an unspecified date in January 2007, the patient was seen by the reporting physician for a suspected urinary tract infection (lab results not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 15-JAN-2007 was vaccinated, intramuscularly with the first dose of HPV vaccine (yeast), (lot # 654389/0961F). On 15-JAN-2007 the patient fainted after receiving the vaccination. The patient was seen in the Emergency Room (ER) following vaccination and "no problems were found".  At the time of the report, it was unspecified, if the patient recovered.  Additional information was received on 11-APR-2007. The registered nurse indicated that on 15-JAN-2007 the patient's blood pressure was 56/72 and heart rate was 104. On 15-JAN-2007, at 15:10, the patient was vaccinated with her first dose of Gardisil intramuscular (left deltoid), became pale immediately, laid down for approximately 5 minutes, got up, started walking down the hall, and passed out. The patient was taken to an ER, oxygen saturation was 99% (no other vital signs were taken). It was noted that the patient did report nausea. The patient did not experience rashes, hives, or difficulty breating. The patient was not ill at the time of vaccination. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with allergy to cefaclor (CECLOR) who on 22-NOV-2006 was vaccinated with the first dose of HPV vaccine (yeast). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING),  lansoprazole (PREVACID) and minocycline HCl.  On 03-JAN-2007, the patient had a cervical (PAP) smear.  The patient tested positive for Papilloma viral infection (HPV). On 11-JAN-2007, the patient was vaccinated with the second dose of HPV vaccine (yeast).  (Lot # 655617/1447F). The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injury, Loss of consciousness, Neurological examination normal
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a 16 year old female who, "the other night", was vaccinated with a first dose of HPV vaccine (yeast) (lot# not reported). The nurse reported that girl passed out in the office and hit her head after receiving a first dose of vaccine.  The girl was unconscious in the office waiting room 3 to 4 minutes.  It was reported that the patient was "revived" by using ammonia inhalant, and "seemed to take longer than expected to regain consciousness." The patient was administered an office neurological exam which was "ok and the patient was sent home", reported as recovered.  The nurse also reported that it was unclear if this injection was painful.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Body temperature increased, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female student with emotional issues (in counseling) who on 29-NOV-2006, at 4:00 PM, was vaccinated IM into the left arm with a first dose of HPV vaccine (yeast) (lot# 653938/0954F). There was no illness at the time of vaccination. It was reported that the vaccination was given while the patient was sitting.  A few second after the injection, the patient said "oh", and leaned to the right slowly to a reclined position and remained conscious but stiffened.  She was awake.  The doctor checked on her and stated that she was having a vagal response.  After reclining 5-10 minutes, she said she was ok.  Her blood pressure was 112/78 and temperature was 100.1F. The nurse noted that the patient was dressed in multiple layers and a hat and she had no had lunch.  The patient was considered recovered on the same day, 29-NOV-2006.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Flushing, Hot flush, Nausea
Clinical narrative: Information has been received from a mother of a 16 year old female patient with "cysts in her ovaries", and allergies to penicillin, sulfa, cefaclor (CECLOR) and erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 29-NOV-2006 was vaccinated with HPV vaccine (yeast), "in her hip". There was no concomitant medication.  Subsequently, "within 2 to 3 days after receiving the injection." the patient developed "hot flushes", fainted, felt dizzy, and nausea. The patient was also "red and flushed" in her face since receiving the injection. The patient was experiencing the "hot flushes" almost every day. It was also reported that the patient had been vaccinated with Tdap "whooping cough" injection (manufacturer unknown) on 05-JAN-2007 and the patient experienced swelling, itching and "a knot" at the injection site for the last "two to three weeks." At the time of the report, the patient was reportedly not recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a mother of a 16 year old female patient with "cysts in her ovaries", and allergies to penicillin, sulfa, cefaclor (CECLOR) and erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 29-NOV-2006 was vaccinated with HPV vaccine (yeast), "in her hip". There was no concomitant medication.  Subsequently, "within 2 to 3 days after receiving the injection." the patient developed "hot flushes", fainted, felt dizzy, and nausea. The patient was also "red and flushed" in her face since receiving the injection. The patient was experiencing the "hot flushes" almost every day. It was also reported that the patient had been vaccinated with Tdap "whooping cough" injection (manufacturer unknown) on 05-JAN-2007 and the patient experienced swelling, itching and "a knot" at the injection site for the last "two to three weeks." At the time of the report, the patient was reportedly not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pain
Clinical narrative: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of HPV vaccine (yeast). Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention.  At the time of this report, the patient had recovered from the event (date unknown). The nurse reported that there were a total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of HPV vaccine (yeast) out of 130 total doses administered by the office.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female between 15 and 16 year old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast).  After receiving the vaccine, the patient fainted.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted.  Unspecified medical attention was sought.  At the time of this 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 discolouration
Clinical narrative: Information has been received from a clinical trial coordinator concerning a female health care worker (age not reported) at a study site.  On 04-DEC-2006, the patient was vaccinated in the left deltoid with the first dose of HPV vaccine (yeast) outside of the study.  Subsequently, the patient developed discoloration. A band aid was placed over the injection site.  As of 12-JAN-2007, there was still obvious discoloration to the area with visible outline of the band aid.  The patient stated that she had never had this happen with a band aid before.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Oedema peripheral
Clinical narrative: Information has been received from a nurse in a doctor's office concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient's hands and feet swelled and had itchiness at the injection site. The patient refused to come in for the second vaccine.  The patient recovered.  Unspecified medical attention was sought.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with a penicillin, sulfonamide and cefaclor (CECLOR) allergy who on 29-NOV-2006 was vaccinated with a dose of HPV vaccine (yeast).  It was reported that ever since she was given the vaccine, the patient experienced hot flashes and nausea.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, No reaction on previous exposure to drug, Pain, Pharyngitis streptococcal
Clinical narrative: Information has been received from a immunization coordinator nurse concerning a 26  year old female nurse in her office who on 18-JAN-2007 was vaccinated in the arm with a second dose of HPV vaccine (yeast). Subsequently the patient experienced "general achiness" throughout her body and swollen lymph glands.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  It was reported that the patient "did not respond like this" after her first dose of HPV vaccine (yeast).  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/24/2007. On 19-JAN-2007, the patient was diagnosed with strep throat. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. It was reported that the patient "did not respond like this" after her first dose of GARDASIL. The registered nurse reported that the patient's strep throat was not related to GARDASIL. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter who in approximately December 2006, was vaccinated with her first dose of HPV vaccine (yeast).  Subsequently, the patient developed three nosebleeds. Medical attention was sought.  The patient was recovering.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: This is a follow up to report (s) previoulsy submitted on 2/14/2007. Information has been received from a nurse practitioner concerning a 20 year old female on contraception, and supplements with iron deficiency anaemia and no allergies, who on 18-JAN-2007 was vaccinated IM with a first dose of HPV vaccine (yeast) (lot# 655165/1425F).  Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN 24FE) and iron (unspecified).  Two hours after, the patient called the office and complained of nausea and vomiting.  The patient came into the office the next day because her vomiting lasted throughout the night and she stated that she passed out.  By the time she came to the office she was doing better.  No diagnostic studies were performed.  At the time of this report, the patient was  recovered.  No product quality complaint was involved.  Additional information has been requested. In follow-up it was reported that the patient's symptoms of nauea, vomiting and fainting lasted several hours and improved without treatment. The patient recovered on 18-JAN-2007. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Pallor
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL vaccine (lot number not provided). The nurse reported that after the patient received the vaccination she turned pale "within 10 minutes of vaccination".  The nurse reported that the patient's blood pressure was 120/80 prior to vaccination and her blood pressure dropped to 90/50 about ten minutes after the patient was vaccinated. The nurse reported that the patient was sent to the Emergency Room (ER) at the hospital nearby for treatment and observation. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and followup information has been received from a registered nurse concerning a 14 year old female who had finished menses and had heavey dysmenorrhea on 23-JAN-2007 was vaccinated IM in the left deltoid at 10:20 with her first dose of GARDASIL vaccine (Lot # 653918/0954F). Concomitant therapy included TOPRANIL. On 23-H+JAN_2007, at 10:30 the patient turned pale became dizzy and lightheaded after being vaccinated and her blood pressure fropped to 90/50 blood pressure prior to vaccination was 104/64. She was given fluids and something to eat and the dizziness did not improve. She was sent to the Emergency Room for evaluation. The ER report was normal. At the time of the report her blood pressure stayed under 100. No further informaion is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain of skin, Pruritus, Rash
Clinical narrative: Information has been received from an L.P.N. concerning a 13 year old female student with a congenital heart defect and allergy to contrast dye who on the morning of 05-JAN-2007 between approximately 9-11 a.m. was vaccinated in the left upper arm with her second dose of Gardasil (yeast), lot#654389/0961F. In the p.m. of 06-JAN-2007 the patient developed skin tender and some skin "bumps" with pruritis X 2 days. It was reported that on 09-JAN-2007, the patient recovered. No further information is available.