chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash, Rash papular, Troponin
Clinical narrative: Pt c/o chest pain and fever 10 days post-vaccination. EKG - anterior fascicular block (no old EKG for comparison. Hospitalized on ward in ship, enzymes remained normal throughout course of treatment. Treated with Motrin for presumed pericarditis. Pain resolved over 4 days, remained afebrile. PE - diffuse, multiformed papular rash, non-pruritic over trunk.  8/18/08 Email received with case summary included.  Pt presented with chest pain 12 days s/p smallpox vax. Earlier he had developed an erythema multiforme reaction several days after the vax. 12/8/08 Additional MR received. Pt presented 5/9/08 with c/o substernal chest pressure and pain, dyspnea on exertion and erythma multiform rash. ST elevations noted on EKG. PE (+) for T= 100.3'F. DX:  Pericarditis. Chest pain resolved w/in 24 hrs.  F/U 6/18/08 with c/o increasing fatigue and SOB with exertion. Unable to complete daily exercises as before. Chest soreness follwing exercise. PE (+) for raspy airway sounds, otherwise WNL. Feeling tired and poorly. Polycythemia noted 7/14/08.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Rash
Clinical narrative: Pt rec'd vaccine in 11/07 - states had 2 stripes on flank that looked like shingles lasted 4-5 mos.
Age: 6.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Nasopharyngitis, Rash generalised, Rash vesicular
Clinical narrative: Pt presented to office on 5/21/08 with hx of cold sx and rash all over x 3 days. Exam: 50-75 vesicular lesions scattered all over. No history of fever. Aveeno, Benadryl, Calamine recommended. No ASA. Isolate, recheck prn.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Started with odd breathing and hives 12 hours after vaccines - initially seen in ER (no meds given).  At F/U 24 hours vaccine had extensive urticaria.  BENADRYL received.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Developed 10x11 erythematous, indurated painful area around site of injection in deltoid.  Rx'd with KEFLEX in case of cellulitis.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt. came in to triage urgent care 5/26/08 c/o L arm swelling and pain, had tetanus given 5/21/08 from primary care doctor's office, L arm warm to touch.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & redness at injection site.  Treated with BENADRYL & cool compresses, TYLENOL prn.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Inflammation, Pruritus, Rash, Urticaria
Clinical narrative: Raised welty rash (itching, inflamed) 6" width on inner thigh and hip and inner elbow.
Age: 50.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Electromyogram, Facial palsy, Guillain-Barre syndrome, Laboratory test
Clinical narrative: Facial tingling started 4/1/07.  Total bilateral facial paralysis of sudden onset.  Diagnosis: Guillain-Barre syndrome (GBS) Miller Fisher facial variant.  Multiple related facial, cranial nerves, vision, whole body, etc.  Impairments & symptoms.
Age: 50.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Miller Fisher syndrome, Nerve injury, Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: Facial tingling started 4/1/07.  Total bilateral facial paralysis of sudden onset.  Diagnosis: Guillain-Barre syndrome (GBS) Miller Fisher facial variant.  Multiple related facial, cranial nerves, vision, whole body, etc.  Impairments & symptoms.
Age: 50.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Visual disturbance
Clinical narrative: Facial tingling started 4/1/07.  Total bilateral facial paralysis of sudden onset.  Diagnosis: Guillain-Barre syndrome (GBS) Miller Fisher facial variant.  Multiple related facial, cranial nerves, vision, whole body, etc.  Impairments & symptoms.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute myeloid leukaemia, Biopsy bone marrow abnormal, Hepatic enzyme increased, Malaise, Nausea
Clinical narrative: Information has been received from a consumer's mother concerning her 19 year old daughter with no pertinent medical history or drug reactions/allergies who at the end of March 2008, was vaccinated with a third dose of GARDASIL 0.5 mL injection.  There was no concomitant medication.  On 05-MAY-2008 the patient was diagnosed with acute myelogenous leukemia and was hospitalized on 07-MAY-2008, and remained in the hospital at the time of the report.  On an unspecified date the patient had a diagnostic laboratory test and a bone marrow biopsy performed.  Results of the tests were unknown.  The patient's acute myelogenous leukemia persisted.  Additional information has been requested. Follow-up: Recurrent acute myelogenous leukemia in spite of chemotherapy.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pancytopenia, Vomiting, Weight decreased
Clinical narrative: Information has been received from a consumer's mother concerning her 19 year old daughter with no pertinent medical history or drug reactions/allergies who at the end of March 2008, was vaccinated with a third dose of GARDASIL 0.5 mL injection.  There was no concomitant medication.  On 05-MAY-2008 the patient was diagnosed with acute myelogenous leukemia and was hospitalized on 07-MAY-2008, and remained in the hospital at the time of the report.  On an unspecified date the patient had a diagnostic laboratory test and a bone marrow biopsy performed.  Results of the tests were unknown.  The patient's acute myelogenous leukemia persisted.  Additional information has been requested. Follow-up: Recurrent acute myelogenous leukemia in spite of chemotherapy.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute myeloid leukaemia, Biopsy bone marrow, Laboratory test
Clinical narrative: Information has been received from a consumer's mother concerning her 19 year old daughter with no pertinent medical history or drug reactions/allergies who at the end of March 2008, was vaccinated with a third dose of GARDASIL 0.5 mL injection.  There was no concomitant medication.  On 05-MAY-2008 the patient was diagnosed with acute myelogenous leukemia and was hospitalized on 07-MAY-2008, and remained in the hospital at the time of the report.  On an unspecified date the patient had a diagnostic laboratory test and a bone marrow biopsy performed.  Results of the tests were unknown.  The patient's acute myelogenous leukemia persisted.  Additional information has been requested. Follow-up: Recurrent acute myelogenous leukemia in spite of chemotherapy.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pruritus, Rash, Skin irritation
Clinical narrative: Suffering from extensive, very itchy skin rash over whole body.Haveee consulted primary Dr. and Dermatologist. Treated with 1 week of prednasone, and benedryl, diflorasone Diacetate, Zyrtex, and clobetasol without relief
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Suffering from extensive, very itchy skin rash over whole body.Haveee consulted primary Dr. and Dermatologist. Treated with 1 week of prednasone, and benedryl, diflorasone Diacetate, Zyrtex, and clobetasol without relief
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Red itchy bumps over back of hands, wrists, knees, ankles, and elbows
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Fatigue, Rash
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently on an unspecified date, the patient "experienced a rash." The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female student with a history of childhood asthma and childhood pneumonia who on 19-JUN-2007 was vaccinated intramuscularly with a second dose of GARDASIL (lot # not reported). Subsequently on an unspecified date, the patient developed fatigue and abdominal pain, originally reported as "a rash". The patient sought unspecified medical attention. On an unspecified date the patient recovered. This is one of several reports from the same source. Initially the physician reported that the patient experienced a rash on an unspecified date. The patient outcome was unknown. Additional follow-up information received from the physician stated that on an unspecified date the patient experienced fatigue and abdominal pain. On an unspecified date the patient recovered from the fatigue and abdominal pain. No further information is expected.
Age: 1.0
Sex: F
Vaccine: DTAP, MNQ, PNC
Symptoms: Body temperature increased, Fall, Febrile convulsion, Head injury, Loss of consciousness
Clinical narrative: Subject number: 01700084.  Initial report received on 14 May 2008 from an investigator participating in a trial under the reference number MTA37.  A 15-month-old female subject experienced a febrile seizure 93 days after receiving a second intramuscular right thigh injection of MENACTRA (lot number U2172AA) and an intramuscular left thigh injection of PREVNAR (Wyeth, lot number B53981A); vaccines were administered on 29 January 2008.  On 30 January 2008, the subject had experienced a febrile seizure, captured in case number 2008-00331.  Upon physical exam following the seizure, she was diagnosed with acute suppurative otitis media.  On 29 April 2008, the subject presented to her physician for her 15-month well-child visit.  Physical exam was within normal limits, and the subject received her fourth intramuscular left thigh dose of DAPTACEL (lot number C2800AA).  On 01 May 2008, the subject fell one step off a porch and hit her forehead.  The subject subsequently lost consciousness for approximately 20 minutes, and was transported via ambulance to the hospital.  Physical exam upon arrival noted a temperature of 100.8 degrees, and the subject was diagnosed with febrile seizure and treated with TYLENOL.  She was not admitted to the hospital.  She was seen in follow-up by her physician on 02 May 2008, and physical exam at that time was also within normal limits.  The subject was seen again by her physician on 03 May 2008, and at that time was diagnosed with "viral syndrome unspecified".  Treatment medications included TAMIFLU and AURALGAN ear drops.  Of note, the subject was a twin, and had been born prematurely.  According to the investigator, the event was related to DAPTACEL, and was not related to the study vaccine.  Documents held by sender: ER notes, office notes.
Age: 1.0
Sex: F
Vaccine: DTAP, MNQ, PNC
Symptoms: Otitis media acute, Reaction to previous exposure to any vaccine, Viral infection
Clinical narrative: Subject number: 01700084.  Initial report received on 14 May 2008 from an investigator participating in a trial under the reference number MTA37.  A 15-month-old female subject experienced a febrile seizure 93 days after receiving a second intramuscular right thigh injection of MENACTRA (lot number U2172AA) and an intramuscular left thigh injection of PREVNAR (Wyeth, lot number B53981A); vaccines were administered on 29 January 2008.  On 30 January 2008, the subject had experienced a febrile seizure, captured in case number 2008-00331.  Upon physical exam following the seizure, she was diagnosed with acute suppurative otitis media.  On 29 April 2008, the subject presented to her physician for her 15-month well-child visit.  Physical exam was within normal limits, and the subject received her fourth intramuscular left thigh dose of DAPTACEL (lot number C2800AA).  On 01 May 2008, the subject fell one step off a porch and hit her forehead.  The subject subsequently lost consciousness for approximately 20 minutes, and was transported via ambulance to the hospital.  Physical exam upon arrival noted a temperature of 100.8 degrees, and the subject was diagnosed with febrile seizure and treated with TYLENOL.  She was not admitted to the hospital.  She was seen in follow-up by her physician on 02 May 2008, and physical exam at that time was also within normal limits.  The subject was seen again by her physician on 03 May 2008, and at that time was diagnosed with "viral syndrome unspecified".  Treatment medications included TAMIFLU and AURALGAN ear drops.  Of note, the subject was a twin, and had been born prematurely.  According to the investigator, the event was related to DAPTACEL, and was not related to the study vaccine.  Documents held by sender: ER notes, office notes.
Age: 13.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Blepharospasm, Facial palsy, Hypoaesthesia facial
Clinical narrative: Initial report was received from another manufacturer (ID# B0519583A), who received the report from an investigator participating in their clinical trial. Verbatim from the report: "This female subject was enrolled an a prophylactic open study. On 03 April 2007, the subject received the 1st dose of HPV (IM, left upper deltoid) and the dose of BOOSTRIX (IM, right upper deltoid). On 14 May 2007, the subject received the 2nd dose of HPV (IM, left upper deltoid) and the dose of MENACTRA (IM, right upper deltoid). On 12 September 2007, the subject received the 3rd dose of HPV (IM, left upper deltoid). On 19 February 2008, five months after the 3rd dose of HPV 16-18, nine months after the 1st dose of MENACTRA, 10 months after the 1st dose of BOOSTRIX, this 13-year-old subject developed bell's palsy. the event was disabling. The subject was treated with ACYCLOVIR and PREDNISOLONE. The event was unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the bell's palsy may have been caused by HPV 16-18, MENACTRA and BOOSTRIX. Investigator comments: On 19 February 2008, left eyelid started twitching. The eyelid felt numb + left side of face was numb. she could not close her eyes, mouth angle twists to right when smiling. Continues to worsen. On 20 February 2008, patient given ZOVIRAX and PREDNISOLONE. On 28 February 2008, patient returned to clinic for recheck - no improvement - referred for a neurology consult - patient did not get a neuro consult. On 09 April 2008, recheck in clinic - Bell's Palsy worsening. On 25 April 2008, patient had not improved, worsened. Patient is receiving physical therapy. On 01 May 2008, no improvement. On 08 May 2008, the Bell's Palsy is probably related to the study. On 20 February 2008: Exam in clinic - findings: left eyelid cannot be approximated, numbness left cheek. Exam reveals facial asymmetry left facial palsy. Patient never seen by neurologist - referral by neurologist office for physical therapy." No further information was provided.
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Injection site cellulitis, Swelling
Clinical narrative: Information has been received from a medical assistant (MA) concerning a male patient with asthma who on 07-MAY-2008 was vaccinated IM into the right deltoid with a dose of PNEUMOVAX 23 (lot #657143/0380U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), TENORMIN, ezetimibe (MSD), unspecified therapy ("CELZONE"), NEXIUM, ADVAIR, VENTOLIN, DIAZEPAN, prednisone and unspecified therapy ("HYOSEYMINE"). The MA reported that the patient contacted the office on 09-MAY-2008 and reported that he was experiencing anxiety. On 10-MAY-2008 he visited the emergency room and he was admitted to the hospital. He was discharged on 11-MAY-2008. He had developed cellulitis at the site of the deltoid-bicep area and the "underneath area" of the right arm. He was given an unspecified antibiotic. On 14-MAY-2008, he was seen by his physician in the office. The patient complained of swelling. There was no redness or signs of cellulitis. No further information was available. The patient was recovering. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 2-month-old female who in approximately February 2008 ("at two months of age"), was vaccinated orally with a second dose of ROTATEQ.  On an unspecified date, post vaccination, the patient experienced bloody stools.  The patient was taken to the emergency room but was not admitted.  It was reported that intussusception was ruled-out.  The patient had only one occurrence of bloody stools.  On an unspecified date the patient recovered.  A product quality complaint was not involved.  Upon internal review "bloody stools" was considered an other medically important event (OME).  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 58-day-old male who on 28-APR-2008 was vaccinated orally with a first 2 ml dose of ROTATEQ (lot # 660597/0209X). Concomitant vaccines administered on 28-APR-2008 included a dose of ACTHIB (lot # OF259AA), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # C2951BA), dose of PREVNAR (lot # C63112), a dose of IPOL (lot # A0452-2) and a dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD) (lot # 657898/1622U). On 01-MAY-2008 the patient had a very small amount of blood in his stools one time only. The physician instructed the patient's mother to observe the patient and to obtain a stool sample. The patient's mother called the physician the following day and stated that the patient's bloody stools had resolved. The patient's mother canceled the patient's stool sample and reported that the patient's symptoms had resolved and the patient had recovered. No further symptoms. The patient sought medical attention via a phone call. There was no diagnostic labs performed. A product quality complaint was not involved. Upon internal review "blood in stools" was considered an other medically important event. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Abasia, Gait disturbance
Clinical narrative: Information has been received from a physician concerning a 15 month old patient who on 14-MAY-2008 was vaccinated with "one dose" of VARIVAX (Oka/Merck). On 17-MAY-2008 the patient couldn't walk. Patient went to a hospital on 17-MAY-2008 (unspecified if patient was admitted into hospital). As of 19-MAY-2008, patient was walking but with an abnormal wobble. Upon internal review, can not walk was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from the Merck Pregnancy registry for GARDASIL from a female who was vaccinated with a first dose of GARDASIL. Subsequently the patient became pregnant and had a miscarriage. The patient required an doctor office visit. The patient reported that she felt her "doctor was inept and responsible for this." Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of GARDASIL.  The physician reported that the patient did not know she was pregnant, she had a miscarriage.  Follow up phone call information provided by a physician's assistant reported that the patient experienced a spontaneous abortion sometime after the first dose of GARDASIL, and prior to the second dose of GARDASIL.  The physician's assistant was unable to provide the administration date, dose, or lot numbers.  It was reported that the patient's outcome was unknown.  Upon internal review, spontaneous abortion was determined to be an other important medical event.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Colitis ulcerative, Fatigue, Haematochezia, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history or drug allergies reported, who on 27-JUL-2007, 02-SEP-2007 and 06-FEB-2008 (3rd dose also reported as 27-JUL-2008 administered intramuscularly) was vaccinated with the first, second and third doses of GARDASIL, respectively.  There was no concomitant medication.  In August 2007, after the physician reviewed the patient's past medical history, he noticed that the patient experienced bloody stools in the beginning of August 2007 after her first dose of GARDASIL.  On 04-JAN-2008 the patient saw her physician and stated that she was experiencing constant fatigue and tiredness.  A blood test was taken and showed that the patient was anemic.  The patient was diagnosed with ulcerative colitis and was hospitalized on 08-MAY-2008 (the number of days spent in the hospital were unspecified).  At the time of this report the patient has not recovered.  No product quality complaint was involved.  Ulcerative colitis was considered to be disabling.  Additional information has been requested. 6/20/08-records received for DOS 5/7-5/12/08-DC DX:Ulcerative colitis. Blood in stools. Admitted for a flare with worsening bloody stools and crampy  lower abdominal pain over past 2-3 weeks.Emesis, diminished urine output.  Diagnosed with ulcerative colitis 2/08. Began having blood in stool in 7/07, hid her symptoms, determine to be anemic.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Cyanosis, Fall, Jaw fracture, Oxygen saturation, Syncope
Clinical narrative: Information has been received from a physician concerning a 11 year old female with a history of fainting, who on 12-MAY-2008 was vaccinated with a first dose of GARDASIL. Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 12-MAY-2008 the nurse had the patient wait for around five minutes post vaccination. The nurse left the room for a second. The patient fainted and fell off of the exam table. The patient was found lying face down and started to turn blue, but had a pulse. The patient was rushed to the hospital and ended up having a maxillary fracture. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. The physician considered the fainting, fall off the exam table, turning blue, and maxillary fracture to be other important medical events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient with no medical history or allergies reported, who on 12-MAY-2008 was vaccinated intramuscularly with the first dose 0.5 ml dose of GARDASIL (Lot #655604/0052X). Concomitant therapy included oral contraceptives (unspecified). On 12-MAY-2008, "within a few minutes of receiving her first dose," the patient became lightheaded, pale, developed a cold sweat and nausea. No diagnostic laboratory testing was performed. On 12-MAY-2008 the patient recovered while in the office. No product quality complaint was involved. The reporter considered lightheadedness, pale, cold sweat and nausea to be disabling for a short time while the patient was in the office. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Breech delivery, Caesarean section, Chlamydia serology positive, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received for the Pregnancy Registry for GARDASIL from a registered nurse concerning a 17 year old female who on 21-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # unknown).  On 21-MAY-2007, a cervical smear was performed and the results were within normal limit.  A gonorrhea test, HIV test and a rapid plasma reagin card (RPR) test was performed and the results were negative.  A Chlamydia test was performed and the results were positive.  The date of the patient's last menstrual period was 31-MAY-2007.  Medical attention was sought.  On 24-JUL-2007, the patient had a beta-human chorionic gonadotropin test (unspecified) that showed positive results for pregnancy.  On 24-Jul-2007, the patient was vaccinated with a second dose of GARDASIL (lot# unknown).  On 24-JUL-2007, the patient was treated with one gram of ZITHROMAX and 125 mg of ceftriaxone sodium for Chlamydial infection.  An HIV and rapid plasma reagin card (RPR) test were also performed and results are pending.  The estimated date of delivery is 6-MAR-2008.  Follow-up information was received from the physician's office from a health professional.  It was reported that the patient delivered a normal, healthy baby girl on 18-FEB-2008 via C-section (baby was breech).  The baby weighed 6 pounds 7 ounces.  The patient did not breastfeed the infant.  The infant developed reflux shortly after birth.  No additional information was available.  Upon internal review breech presentation was considered to be an other medical event.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: HIV test negative, Pregnancy test positive, Smear cervix normal, Syphilis test negative
Clinical narrative: Information has been received for the Pregnancy Registry for GARDASIL from a registered nurse concerning a 17 year old female who on 21-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # unknown).  On 21-MAY-2007, a cervical smear was performed and the results were within normal limit.  A gonorrhea test, HIV test and a rapid plasma reagin card (RPR) test was performed and the results were negative.  A Chlamydia test was performed and the results were positive.  The date of the patient's last menstrual period was 31-MAY-2007.  Medical attention was sought.  On 24-JUL-2007, the patient had a beta-human chorionic gonadotropin test (unspecified) that showed positive results for pregnancy.  On 24-Jul-2007, the patient was vaccinated with a second dose of GARDASIL (lot# unknown).  On 24-JUL-2007, the patient was treated with one gram of ZITHROMAX and 125 mg of ceftriaxone sodium for Chlamydial infection.  An HIV and rapid plasma reagin card (RPR) test were also performed and results are pending.  The estimated date of delivery is 6-MAR-2008.  Follow-up information was received from the physician's office from a health professional.  It was reported that the patient delivered a normal, healthy baby girl on 18-FEB-2008 via C-section (baby was breech).  The baby weighed 6 pounds 7 ounces.  The patient did not breastfeed the infant.  The infant developed reflux shortly after birth.  No additional information was available.  Upon internal review breech presentation was considered to be an other medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy, Laboratory test, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received through the pregnancy registry from a certified nurse midwife concerning an 18 year old female, with no pertinent medical history, who in November 2006, was vaccinated with a dose of GARDASIL. In January 2006, the patient was vaccinated with a second dose of GARDASIL. On 20-MAY-2007, the patient was vaccinated with a third dose of GARDASIL. There was no concomitant medication. Subsequently, the patient became pregnant. In follow up it was reported that on 28-JUN-2007 patient had an ultrasound which was within normal limits. Prenatal lab testing was done, results not reported. The last menstrual period was 20-MAR-2007, with an estimated date of delivery was 25-DEC-2007. Ultrasound done on 28-JUN-2007 for date was reported to be within normal limits. Follow up information was received from a health care professional at the nurse midwife's office on 04-APR-2008. She reported that the baby was normal and healthy. The birthdate was 05-DEC-2007. She didn't have any more information. Follow up information was received from the doctor's office that on 07-DEC-2007, patient had a cesarean section for breech presentation and delivered 39 weeks from her last menstrual period. This information was conflicting with the previously reported information that patient had a normal delivery on 05-DEC-2007. Upon internal review patient's breech baby delivery which required a cesarean section delivery was determined to be an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies on 27-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# 654335/0960F) 0.5mL. The date of the last menstrual period was 03-JUN-2007. On 26-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 658094/0524U). On the same day a urine pregnancy test was performed prior to vaccination and the results was negative for pregnancy. On 12-JUL-2007 a urine test was performed and the results was positive for pregnancy. Medical attention was sought. The estimated date of delivery is 09-MAR-2008. No symptoms have been reported. Follow-up information was received from a health care professional. The HCP indicated that the patient either had a miscarriage or an elective abortion on 02-AUG-2007. No additional information was available. Upon internal review unspecified abortion is considered to be an other medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal labour, Anaemia, Caesarean section, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with asthma, infection, nausea and oppositional defiant disorder (ODD).  On an unspecified date the patient was vaccinated with the first dose of GARDASIL (lot number unknown).  Follow up information was received.  The nurse practitioner reported that on 11-MAY-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) and then became pregnant.  The date of the last menstrual period was approximately 20-APR-2007.  Concomitant therapy included XOPENEX, ZITHROMAX and PENERGAN TABLETS/SUPPOSITORIES.  There was no adverse event reported.  Medical attention was sought.  On 15-JUN-2007 the patient had an ultrasound that revealed 8 weeks on date.  Additional information was not provided.  The estimated date of delivery is 25-JAN-2008.  Follow-up information was received from a nurse practitioner.  The NP reported that on 22-JAN-2008 the patient had a healthy baby boy weighing 7 pounds 13 ounces and 39 3/7 weeks from LMP.  The patient had a primary c-section for failure to descend.  The patient also had anaemia during pregnancy.  Other medications used during the pregnancy included CLARITIN for allergies, ZOFRAN for hyperemesis and ferrous sulfate for anaemia.  Upon internal review primary c-section for (failure to descend) was considered to be an other medical event.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with asthma, infection, nausea and oppositional defiant disorder (ODD).  On an unspecified date the patient was vaccinated with the first dose of GARDASIL (lot number unknown).  Follow up information was received.  The nurse practitioner reported that on 11-MAY-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) and then became pregnant.  The date of the last menstrual period was approximately 20-APR-2007.  Concomitant therapy included XOPENEX, ZITHROMAX and PENERGAN TABLETS/SUPPOSITORIES.  There was no adverse event reported.  Medical attention was sought.  On 15-JUN-2007 the patient had an ultrasound that revealed 8 weeks on date.  Additional information was not provided.  The estimated date of delivery is 25-JAN-2008.  Follow-up information was received from a nurse practitioner.  The NP reported that on 22-JAN-2008 the patient had a healthy baby boy weighing 7 pounds 13 ounces and 39 3/7 weeks from LMP.  The patient had a primary c-section for failure to descend.  The patient also had anaemia during pregnancy.  Other medications used during the pregnancy included CLARITIN for allergies, ZOFRAN for hyperemesis and ferrous sulfate for anaemia.  Upon internal review primary c-section for (failure to descend) was considered to be an other medical event.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: DTAP, HEPA, MNQ
Symptoms: Chest pain, Face oedema, Hemiplegia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date in March 2008, was vaccinated with VAQTA.  Concomitant therapy included MENACTRA and DTAP (unspecified) ("1 dose only").  The patient's sister was reported to have MS.  On an unspecified date in March 2008 "within 24 hours after the vaccines were given", the patient became paralyzed in half of her body, and that same night, she developed chest pains and facial edema.  The patient sought medical attention and was hospitalized.  Diagnostic lab studies were performed, but unspecified.  At the time of this report, the patient was hospitalized and recovering, but was still experiencing problems with her right foot and was undergoing physical therapy.  The reporter considered the events of paralyzed in half of her body, chest pains and facial edema to be also disabling.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood bicarbonate decreased, Blood sodium increased, Hypernatraemia, Pyrexia
Clinical narrative: Fever at 24 hrs.  Diarrhea at 48 hrs of vaccination.  Moderate hypernatremic dehydration.  Hospitalized for IV rehydration.  5/29/08 Reviewed PCP medical records & vax record which confirms vax as reported.  Patient w/sickle/beta (+) thalassemia otherwise in good health & progressing well on day of vax.  5/29/08 Reviewed hospital medical records for 5/19-5/22/2008. FINAL DX: hypertonic dehydration; metabolic acidosis; diarrhea; hemoglobinopathy. Records reveal patient experienced fever, vomiting, watery diarrhea & lethargy day after receiving vaccines.  Improved & d/c to home on oral PCN for hemoglobinopathy & to f/u by heme & PCP.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood pressure, Depressed level of consciousness, Eye movement disorder, Hypotonia, Oxygen saturation normal
Clinical narrative: 4:15pm vaccines given.  ~2 min later, infant became abruptly hypotonic & almost unresponsive.  O2 sat 97-98%, color pink, BP 70/palp.  Eyes flickered open with vigorous physical stimulation, then returned to sleeping & limp.  At 440PM, suddenly returned to normal.  Went to ER via ambulance.  6/6/08 Reviewed hospital medical records for 5/19-5/20/2008. FINAL DX:hypotonic-hyporesponsive reaction to vaccinations. Records reveal patient experienced altered mental status & sudden onset increased hypotonia & unresponsive to stimuli lasting appro 4 min s/p vaccinations.  Then returned slowly to baseline.  Twin had no reaction.  Patient had local erythema w/prior vaccinations.  Transported by ambulance from PCP office & admitted for overnight observation.  No further episodes while hospitalized & d/c to home.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin discolouration
Clinical narrative: 4:15pm vaccines given.  ~2 min later, infant became abruptly hypotonic & almost unresponsive.  O2 sat 97-98%, color pink, BP 70/palp.  Eyes flickered open with vigorous physical stimulation, then returned to sleeping & limp.  At 440PM, suddenly returned to normal.  Went to ER via ambulance.  6/6/08 Reviewed hospital medical records for 5/19-5/20/2008. FINAL DX:hypotonic-hyporesponsive reaction to vaccinations. Records reveal patient experienced altered mental status & sudden onset increased hypotonia & unresponsive to stimuli lasting appro 4 min s/p vaccinations.  Then returned slowly to baseline.  Twin had no reaction.  Patient had local erythema w/prior vaccinations.  Transported by ambulance from PCP office & admitted for overnight observation.  No further episodes while hospitalized & d/c to home.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood electrolytes normal, Blood glucose normal, CSF cell count normal, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: Seizure 5/17/08. 5/17/08 Sent to hospital. 5/18/08 Transfer to another hospital.  6/23/2008 MR received for DOS 5/18-20/2008 with DX: Seizures. Infant presented after an episode of unresponsiveness following what was thought to be a choking episode. Infant had been unually sleepy prior to incident. In ER, pt had another episode of flailing of arms and legs followed by unresponsiveness, which self resolved. Had a 3rd event lasting 15-20 minutes. Loaded with Phenobarb with gradual return to baseline.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Full blood count normal, Laboratory test normal
Clinical narrative: Seizure 5/17/08. 5/17/08 Sent to hospital. 5/18/08 Transfer to another hospital.  6/23/2008 MR received for DOS 5/18-20/2008 with DX: Seizures. Infant presented after an episode of unresponsiveness following what was thought to be a choking episode. Infant had been unually sleepy prior to incident. In ER, pt had another episode of flailing of arms and legs followed by unresponsiveness, which self resolved. Had a 3rd event lasting 15-20 minutes. Loaded with Phenobarb with gradual return to baseline.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, HEPA, MEN, PPV, SMALL, TYP, YF
Symptoms: Dermatitis, Folliculitis, Rash
Clinical narrative: A- skin rash - 072003, B- dermatitis 2004, C- folliculitis, D- treatment is being by facility. Pt has had a rash since receiving vax in 2003.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Flushing, Rhinorrhoea, Urticaria, Vomiting
Clinical narrative: Anaphylactic reaction within 20 minutes of MMR - rhinorrhea, flushing, urticaria, wheezing & emesis - given epinephrine, PRELONE & BENADRYL.  Observed in office x 2 1/2 hours.  D/c'd on prednisone & BENADRYL. 5/30/08-office notes received for DOS 5/22/08-15 minutes after MMR started having rhinorrhea, mild cough. 5 minutes later emesis, wheezing and total body urticaria. Immediate resolution after epinephrine. 45 minutes later developed worsening urticaria, redness, increase in HR, treated with benadryl with improvement. Observed 2 hours with no increase in symptoms, and improvement of pruritis and urticaria. 5/27/08 Possible gelatin allergy. MMR allergy.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: Anaphylactic reaction within 20 minutes of MMR - rhinorrhea, flushing, urticaria, wheezing & emesis - given epinephrine, PRELONE & BENADRYL.  Observed in office x 2 1/2 hours.  D/c'd on prednisone & BENADRYL. 5/30/08-office notes received for DOS 5/22/08-15 minutes after MMR started having rhinorrhea, mild cough. 5 minutes later emesis, wheezing and total body urticaria. Immediate resolution after epinephrine. 45 minutes later developed worsening urticaria, redness, increase in HR, treated with benadryl with improvement. Observed 2 hours with no increase in symptoms, and improvement of pruritis and urticaria. 5/27/08 Possible gelatin allergy. MMR allergy.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Atrial fibrillation, Blood magnesium normal, Bundle branch block right, Cardiac enzymes normal
Clinical narrative: New onset A-Fib within 2 days of receiving his smallpox vaccine (SPV).  On 3/26/08, pt received his 1st SPV in his left arm (more than 3, but less than 15 jabs).  He reports normal vaccine site progression with a "take".  On 3/28/08, before lunch while laying down, pt noted sudden onset "racing, strong heart beat".  When he stood up, he felt weak.  He felt lightheaded with position changes and felt like he was out of breath and felt like he was "panting like after running".  Initially, he talked to a corpsman who thought this was probably related to electrolytes and instructed pt to increase fluid intake and "take it easy".  On the a.m. of 3/30/08, pt continued to experience palpitations, lightheadedness, dyspnea and weakness.  He sought medical evaluation and was hospitalized through 3 April.  There, he was placed on atenolol and ASA.  His heart rate slowed, but he still felt lightheaded, tired easily and was dyspneic.  With any activity he was aware of a significant increase in his heart rate and noted his heart pounding in his chest.  He denies any type of chest pain.  He noted generalized body aches and fatigue between post-SPV day 3 and 10.  He was transferred on 4/6/08 where his evaluation and treatment continued.  Around 10 April, all his symptoms had essentially resolved.  On 4/12/08, pt was transferred to NMCSD for additional evaluation.  He is currently in Medical Hold.  He is asymptomatic on atenolol.  Pt received his 2nd anthrax vaccine in his right arms on 3/21/08 (documented) and also typhoid IM vaccine on 3/7/08.  He did not experience unusual or prolonged local or systemic symptoms over the next week.  He denies any personal history of palpitations, HTN, valvular disease, angina, thrombus, TIAs, vascular disease or pulmonary disease.  His CVD RFs are all negative.  He has family hx of A-Fib on his mother's side (GF, GM and uncle), but no family history of CAD, drownings, MVAs, seizures or sudden death.  Prior to deployment, pt was running about 3 times per week.  Symptoms: Palpitations, Dyspnea (shortness of breath), Dizziness Weakness. 6/18/08-records received-3/29/08-C/O palpitations and racing strong heart beat, weakness, lightheadedness and dyspnea. 3/30/08-symptoms continued which showed A-fib. Admitted to hospital from 3/30-4/3/08- symptoms resolved.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Dyspnoea, Echocardiogram normal, Ejection fraction decreased, Electrocardiogram abnormal
Clinical narrative: New onset A-Fib within 2 days of receiving his smallpox vaccine (SPV).  On 3/26/08, pt received his 1st SPV in his left arm (more than 3, but less than 15 jabs).  He reports normal vaccine site progression with a "take".  On 3/28/08, before lunch while laying down, pt noted sudden onset "racing, strong heart beat".  When he stood up, he felt weak.  He felt lightheaded with position changes and felt like he was out of breath and felt like he was "panting like after running".  Initially, he talked to a corpsman who thought this was probably related to electrolytes and instructed pt to increase fluid intake and "take it easy".  On the a.m. of 3/30/08, pt continued to experience palpitations, lightheadedness, dyspnea and weakness.  He sought medical evaluation and was hospitalized through 3 April.  There, he was placed on atenolol and ASA.  His heart rate slowed, but he still felt lightheaded, tired easily and was dyspneic.  With any activity he was aware of a significant increase in his heart rate and noted his heart pounding in his chest.  He denies any type of chest pain.  He noted generalized body aches and fatigue between post-SPV day 3 and 10.  He was transferred on 4/6/08 where his evaluation and treatment continued.  Around 10 April, all his symptoms had essentially resolved.  On 4/12/08, pt was transferred to NMCSD for additional evaluation.  He is currently in Medical Hold.  He is asymptomatic on atenolol.  Pt received his 2nd anthrax vaccine in his right arms on 3/21/08 (documented) and also typhoid IM vaccine on 3/7/08.  He did not experience unusual or prolonged local or systemic symptoms over the next week.  He denies any personal history of palpitations, HTN, valvular disease, angina, thrombus, TIAs, vascular disease or pulmonary disease.  His CVD RFs are all negative.  He has family hx of A-Fib on his mother's side (GF, GM and uncle), but no family history of CAD, drownings, MVAs, seizures or sudden death.  Prior to deployment, pt was running about 3 times per week.  Symptoms: Palpitations, Dyspnea (shortness of breath), Dizziness Weakness. 6/18/08-records received-3/29/08-C/O palpitations and racing strong heart beat, weakness, lightheadedness and dyspnea. 3/30/08-symptoms continued which showed A-fib. Admitted to hospital from 3/30-4/3/08- symptoms resolved.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Full blood count normal, Laboratory test normal, Liver function test normal, Pain
Clinical narrative: New onset A-Fib within 2 days of receiving his smallpox vaccine (SPV).  On 3/26/08, pt received his 1st SPV in his left arm (more than 3, but less than 15 jabs).  He reports normal vaccine site progression with a "take".  On 3/28/08, before lunch while laying down, pt noted sudden onset "racing, strong heart beat".  When he stood up, he felt weak.  He felt lightheaded with position changes and felt like he was out of breath and felt like he was "panting like after running".  Initially, he talked to a corpsman who thought this was probably related to electrolytes and instructed pt to increase fluid intake and "take it easy".  On the a.m. of 3/30/08, pt continued to experience palpitations, lightheadedness, dyspnea and weakness.  He sought medical evaluation and was hospitalized through 3 April.  There, he was placed on atenolol and ASA.  His heart rate slowed, but he still felt lightheaded, tired easily and was dyspneic.  With any activity he was aware of a significant increase in his heart rate and noted his heart pounding in his chest.  He denies any type of chest pain.  He noted generalized body aches and fatigue between post-SPV day 3 and 10.  He was transferred on 4/6/08 where his evaluation and treatment continued.  Around 10 April, all his symptoms had essentially resolved.  On 4/12/08, pt was transferred to NMCSD for additional evaluation.  He is currently in Medical Hold.  He is asymptomatic on atenolol.  Pt received his 2nd anthrax vaccine in his right arms on 3/21/08 (documented) and also typhoid IM vaccine on 3/7/08.  He did not experience unusual or prolonged local or systemic symptoms over the next week.  He denies any personal history of palpitations, HTN, valvular disease, angina, thrombus, TIAs, vascular disease or pulmonary disease.  His CVD RFs are all negative.  He has family hx of A-Fib on his mother's side (GF, GM and uncle), but no family history of CAD, drownings, MVAs, seizures or sudden death.  Prior to deployment, pt was running about 3 times per week.  Symptoms: Palpitations, Dyspnea (shortness of breath), Dizziness Weakness. 6/18/08-records received-3/29/08-C/O palpitations and racing strong heart beat, weakness, lightheadedness and dyspnea. 3/30/08-symptoms continued which showed A-fib. Admitted to hospital from 3/30-4/3/08- symptoms resolved.