chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood pressure increased, Computerised tomogram, Dizziness, Headache, Migraine
Clinical narrative: Patient complained of severe HA approximately 1.5 hours after vaccine administration. She presented to ER with self-report of BP of 198/130, "dry heaves", HA that was "real hard and strong." She also reported to have "little bit" of light sensitivity and was "really dizzy." She was treated in ER for "migraine." At the ER she received "compazine" for nausea.
Age: 47.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Nausea, Photophobia, Retching
Clinical narrative: Patient complained of severe HA approximately 1.5 hours after vaccine administration. She presented to ER with self-report of BP of 198/130, "dry heaves", HA that was "real hard and strong." She also reported to have "little bit" of light sensitivity and was "really dizzy." She was treated in ER for "migraine." At the ER she received "compazine" for nausea.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Injection site calcification, Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: INJECTION SITE RED & SWOLLEN. CALCIFIED HEMATOMA. WARM COMPRESS & MASSAGE 3 X A DAY.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Blister, Eye swelling, Local swelling, Pyrexia
Clinical narrative: Afew days after recieving the vaccine the pt developed runny nose and swelling in the rt side of her neck. No fever at that time.  On June 10(22 days after dose) pt noted a "pimple on her face" followed on June 11th by 3 vesicles on her left arm, no fever.  She was seen by PMD and was treated with ibuprofen and augementin at that time.  By 6/15/08 lesions had spead to legs, trunk and face.  On 6/17/08 she developed a fever to 102 and was seen at ER.  She was started on acyclovir and her Mycophenolate was stopped that that time.  ON 6/19/08 she was again seen in the ER for worsening lesions including swelling of right eye.  She was admitted for IV acyclovir treatmetn at this time. 7/3/08-records received for DOS 6/19-6/25/08-DC DX: Varicella. SLE with nephritis. C/O generalized vesicles, pustules, fever, rash macular, right eyelid swelling, mild conjunctival injection. Vaccine administered on 5/24/08 and first presented on 6/17/08.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Virus culture
Clinical narrative: Afew days after recieving the vaccine the pt developed runny nose and swelling in the rt side of her neck. No fever at that time.  On June 10(22 days after dose) pt noted a "pimple on her face" followed on June 11th by 3 vesicles on her left arm, no fever.  She was seen by PMD and was treated with ibuprofen and augementin at that time.  By 6/15/08 lesions had spead to legs, trunk and face.  On 6/17/08 she developed a fever to 102 and was seen at ER.  She was started on acyclovir and her Mycophenolate was stopped that that time.  ON 6/19/08 she was again seen in the ER for worsening lesions including swelling of right eye.  She was admitted for IV acyclovir treatmetn at this time. 7/3/08-records received for DOS 6/19-6/25/08-DC DX: Varicella. SLE with nephritis. C/O generalized vesicles, pustules, fever, rash macular, right eyelid swelling, mild conjunctival injection. Vaccine administered on 5/24/08 and first presented on 6/17/08.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Condition aggravated, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging normal
Clinical narrative: 11/18/07 Neck and right shoulder pain, difficulty lifting right arm.  Determined to be acute right brachial neuritis.  Treated with physical therapy.  Is still not back to pre vaccine status, is begining to get some use back.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Radiculitis brachial
Clinical narrative: 11/18/07 Neck and right shoulder pain, difficulty lifting right arm.  Determined to be acute right brachial neuritis.  Treated with physical therapy.  Is still not back to pre vaccine status, is begining to get some use back.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Nervousness, Syncope, Syncope vasovagal, Unresponsive to stimuli
Clinical narrative: Vaso Vagal event:  Patient was very nervous prior to receiving vaccine.  Tolerated vaccination well, sat 10 minutes after receiving vaccine.  Mother was checking out and patient met mother at reception desk.  After 3 minutes or so patient fainted.  Hit back of head on exit door.  She was out for 10-15 seconds.  Patient came to, fundus was clear w/o PE.  Patient alert and responsive and appropriate when questioned.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: SYNCOPED EPISODE MONITORED BP CLIENT RESPONDED APPROP TO QUESTIONS BP 74/38 10:35 AM; 82/41 10:40; 10 45 88/54; 92/58 10:50 AM
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: INFANT IN BED WITH PARENTS AT TIME OF DEATH.  6/30/08 Autopsy report states COD as SID, pt found unresponsive in bed w/parents.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Wednesday evening dry blisters, on Thursday night some wet blisters in groin area.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 48 hours after receiving the Zostavax vaccine, the patient developed a red, itchy lump the size of a fist at the injection site.  While the entire lump was red and itchy, the symptoms were most sever at the actual site of the needle penetration.  Patient has been treating with Benadryl and hot compress.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 9 days after vaccinaton of the MMR vaccine child had fever of 100.5 and also presented with a rash on trunk and extremities.  Mother called on day 11 describing symptoms to nurse.  Pt does have a hx of egg allergy.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT BROKE OUT WITH SHINGLES LESIONS ON HANDS, ARMS, LEGS.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Fall, Intensive care, Nausea
Clinical narrative: Patient was lying down during administration of Twinrix #2 because she stated that she gets nauseous. After vaccine given patient was still lying down and drinking juice. When she left after reassuring the RN she was alright, she left the clinic and entered the waiting room and proceeded to fall straight back and hit the floor, passing out. Medical attention was given promptly by Dr. and the paramedics were called who transported patient to the ER. She called and talked to the supervising Public Health Nurse on 6-23-2008 and told her that she had been hospitalized for 2 days in the ICU. 7/11/08-records received for DOS 6/20-6/21/08-DX: Left occipital skull fracture. Presented to ED after a fall and striking head after vasovagal response. Neck pain, nausea and emesis.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased
Clinical narrative: The patient had transient elevated liver enzyme ( ALT) 3 days after being vaccinated. He recovers without any problems. Hew has no physical signs or symptoms.
Age: 23.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Burning sensation, Chest pain, Diagnostic procedure
Clinical narrative: Nausea for about a week,then felt good for about 3 week, then had burning sensation back of head and felt light headed and that lasted for about a week, then once again disappeared and then I got sick to my stomach, bad stomach pains that lasted about 6 weeks, then that went away then I had bad headaches with sharp shooting pains, burning sensations at the back and the front of the head, and had teethache even took trips to the dentist to find out everything was ok the duration of the headaches lasted about 3 1/2 months.  Then had leg/muscle pains for about 3 weeks, joint pain, andchest pain, sensation of not able to get enough air that take place on in off over the past 8 months, and tireness.  7/15/08 Reviewed vax & PCP medical records. Received HPV #1, lot# 0525U, RA on 8/28/07.  Records indicate patient tolerated HPV #1 well.    9/9/08 Reviewed additional PCP medical records. FINAL DX: none provided Records reveal patient experienced general good health on 8/28/07 but with bilateral ear discomfort & wisdom teeth coming in.  RTC 7/15/08 & seen by Rheum c/o feeling unwell since 10/2007 w/multiple complaints of lightheadedness, nausea, HA, abdominal pain, sensitive teeth, burning ears, arthralgias, paresthesias, chest discomfort, difficulty breathing, feelings of impending doom, .   Had been seen by GI & dx w/IBS.  Seen by Neuro & exam was WNL.  RTC 7/21/08 c/o nausea, tooth pain & increased heart rate, no diagnosis provided.  RTC 8/12/08 for intermittent dizziness x several months, achy & joint pain
Age: 23.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Fatigue, Headache, Laboratory test, Myalgia
Clinical narrative: Nausea for about a week,then felt good for about 3 week, then had burning sensation back of head and felt light headed and that lasted for about a week, then once again disappeared and then I got sick to my stomach, bad stomach pains that lasted about 6 weeks, then that went away then I had bad headaches with sharp shooting pains, burning sensations at the back and the front of the head, and had teethache even took trips to the dentist to find out everything was ok the duration of the headaches lasted about 3 1/2 months.  Then had leg/muscle pains for about 3 weeks, joint pain, andchest pain, sensation of not able to get enough air that take place on in off over the past 8 months, and tireness.  7/15/08 Reviewed vax & PCP medical records. Received HPV #1, lot# 0525U, RA on 8/28/07.  Records indicate patient tolerated HPV #1 well.    9/9/08 Reviewed additional PCP medical records. FINAL DX: none provided Records reveal patient experienced general good health on 8/28/07 but with bilateral ear discomfort & wisdom teeth coming in.  RTC 7/15/08 & seen by Rheum c/o feeling unwell since 10/2007 w/multiple complaints of lightheadedness, nausea, HA, abdominal pain, sensitive teeth, burning ears, arthralgias, paresthesias, chest discomfort, difficulty breathing, feelings of impending doom, .   Had been seen by GI & dx w/IBS.  Seen by Neuro & exam was WNL.  RTC 7/21/08 c/o nausea, tooth pain & increased heart rate, no diagnosis provided.  RTC 8/12/08 for intermittent dizziness x several months, achy & joint pain
Age: 23.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Nausea, Pain, Pain in extremity, Stomach discomfort, Toothache
Clinical narrative: Nausea for about a week,then felt good for about 3 week, then had burning sensation back of head and felt light headed and that lasted for about a week, then once again disappeared and then I got sick to my stomach, bad stomach pains that lasted about 6 weeks, then that went away then I had bad headaches with sharp shooting pains, burning sensations at the back and the front of the head, and had teethache even took trips to the dentist to find out everything was ok the duration of the headaches lasted about 3 1/2 months.  Then had leg/muscle pains for about 3 weeks, joint pain, andchest pain, sensation of not able to get enough air that take place on in off over the past 8 months, and tireness.  7/15/08 Reviewed vax & PCP medical records. Received HPV #1, lot# 0525U, RA on 8/28/07.  Records indicate patient tolerated HPV #1 well.    9/9/08 Reviewed additional PCP medical records. FINAL DX: none provided Records reveal patient experienced general good health on 8/28/07 but with bilateral ear discomfort & wisdom teeth coming in.  RTC 7/15/08 & seen by Rheum c/o feeling unwell since 10/2007 w/multiple complaints of lightheadedness, nausea, HA, abdominal pain, sensitive teeth, burning ears, arthralgias, paresthesias, chest discomfort, difficulty breathing, feelings of impending doom, .   Had been seen by GI & dx w/IBS.  Seen by Neuro & exam was WNL.  RTC 7/21/08 c/o nausea, tooth pain & increased heart rate, no diagnosis provided.  RTC 8/12/08 for intermittent dizziness x several months, achy & joint pain
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician who stated that she heard about a 17 year old female who was vaccinated IM with a second 0.5 ml dose of GARDASIL.  On 11-JUN-2008 she experienced a seizure in the physician's office.  The patient sought unspecified medical attention.  On 11-JUN-2008 the patient recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information is not expected.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Epilepsy
Clinical narrative: Information has been received from a representative as reported by four area physicians in different parts of the area concerning a "14-15 year old" patient who was vaccinated with a first dose of GARDASIL.  Physicians reported that they heard in the newspaper and possibly the local news station that the patient experienced an epileptic seizure.  At the time of reporting it was unknown if the patient had recovered.  There was no lot number provided.  No further information was available.  Upon internal review epileptic seizure is considered to be an other medical event.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who in January 2008, and February 2008 was vaccinated with the first and second doses of GARDASIL (lot#, route and dose not reported).  Concomitant therapy included (oral) hormonal contraceptives (unspecified).  In April 2008, the patient experienced leg pain in both legs and weakness and was hospitalized.  In May 2008 the patient was vaccinated via intramuscular route with a third dose of 0.5 mL GARDASIL (lot#, not reported).  No further information was provided.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Paraesthesia, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of GARDASIL, lot # not provided, on 30-NOV-2007.  This vaccination was well tolerated.  It was reported by the physician (who received the information from a patient's mother) that the 14-year-old female patient was vaccinated with a second dose of GARDASIL (lot # not reported) i.m. into the upper arm on 03-JAN-2008.  In the beginning of May-2008, the patient developed paresthesia, migraine and weight loss.  She was hospitalized for diagnostics; no reports on findings were made available to the reporter.  The events were ongoing at the time of reporting.  According to the patient's mother, "the symptoms improve while her daughter listens to loud music via an MP3-player."  The reporting physician does not see a causal relationship to the vaccination (P2).  Other business partner numbers included: E2008-05224.  No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, induration, pain around injection site  6/27/08 Reviewed PCP medical records of 6/18/08.  Vax given at hospital 6/12/08.  Pt seen s/p hospitalization for a burn of left leg & foot.  Pneumovax injection site in RUE w/erythema, pain & induration.  Was on oral antibiotics for burn & had continued to have difficulty walking due to burn.    7/4/08 Reviewed hospital medical records of 6/10-6/12/2008. FINAL DX: Records reveal patient experienced kitchen grease partial thickness burn to left foot on 6/4/2008 w/increasing pain & swelling by 6/9-10/2008 & developed cellulitis.  Failed oral antibiotics & was hospitalized for IV antibiotics.  Responded well w/improvement in foot
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Convulsion
Clinical narrative: Seizure x 2 7/10/08-records received for DOS 6/18-6/20/08-DX: seizures.Presented to ED after erratic breathing, shaking whole body. Crying.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Convulsion, Laboratory test
Clinical narrative: Seizure x 2 7/10/08-records received for DOS 6/18-6/20/08-DX: seizures.Presented to ED after erratic breathing, shaking whole body. Crying.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Blood test, Fibroadenoma of breast, Surgery, Ultrasound breast
Clinical narrative: surgical removal of giant fibroidenoma from left breast. Further plastic surgery required. Tumor was 14cm by 13cm by 6cm.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Fibroadenoma of breast, Surgery
Clinical narrative: surgical removal of giant fibroidenoma from left breast. Further plastic surgery required. Tumor was 14cm by 13cm by 6cm.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: Death  9/9/08 Death certificate states COD as idiopathic seizure disorder.  8/5/08 Reviewed ER medical records of 6/12/2008. Records reveal patient found unresponsive, prone on her bed when parent went to awake for school.  Last seen at bedtime.  Pupils fixed & dilated, cyanotic & pale, incontinent of urine, developed pulmonary edema during resuscitation. Unable to resuscitate.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Electroencephalogram normal
Clinical narrative: Immunizations administered 06-13-08, seizure-like activity 06-16-08. 6/27/08-records received for DOS 6/16/08-Presented to ED withC/O seizure, had two episodes one week apart with tonic clonic movements of upper and lower extremities, rolling back of eyeballs, stiffening of extremities.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Clinical narrative: ER visit to hospital Friday 6/13/08.  2nd ER visit to hospital on 6/20/08 - transferred to another hospital.  I have not received any medical charts. 6/26/08-records received for DOS 6/20-6/21/08-transferred with history of dehydration and metabolic acidosis on 6/14/08 with subsequent ER visit on 6/20 with similar symptoms. Developed difficulty breathing after 6/11/08 immunizations, with grunting and screaming on 6/12/08. In ED with respiratory distress including retractions, tachypnea, heart rate at 153.  On 6/19/08 at 2130 passed large diarrheal stool. Evening prior to admission developed limpness and refused p.o. feedings. Pale, gray and cold to touch. In ED with weak cry, heart rate of 200 and unobtainable blood pressure, respirations 60. Electrocardiogram revealed wide complex tachycardia.Intubated, ventilator Resuscitative efforts. Massive pulmonary edema. Expired at 2355. 12/23/08-autopsy report received-acute congestive heart failure with myocarditis probably viral. mild interstitial pneumonitis, hepatomegaly with centrilobular congestion and necrosis. serous effusions. stress changes in thymus. Diffuse cerebral edema and hyopxic ischemic injury.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Syncope- this pt actually passed out about 3 minutes after receiving the injection.  We had to use an ammonia inhalant to help her come to.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pallor, Syncope
Clinical narrative: Syncope - this patient got dizzy about 5 minutes after receiving the injection.  She told us and we sat her down - she then became very pale and nauseous along with the dizziness.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Depressed level of consciousness, Dizziness, Heart rate decreased, Oxygen saturation
Clinical narrative: After receiving injections, patient complained of stomach ache and feeling lightheaded, sat on floor at check out counter, then color changed, paler and became less responsive, carried to exam room.  Layed down, legs lifted, 02 99%, pulse 60, B/P 120/68 at 4pm.  Rev 10 mins, O2 100%, pulse 74 lay, sat up 80, stand 85.  With patient say felt better, sent home.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pallor
Clinical narrative: After receiving injections, patient complained of stomach ache and feeling lightheaded, sat on floor at check out counter, then color changed, paler and became less responsive, carried to exam room.  Layed down, legs lifted, 02 99%, pulse 60, B/P 120/68 at 4pm.  Rev 10 mins, O2 100%, pulse 74 lay, sat up 80, stand 85.  With patient say felt better, sent home.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Redness, whelp about 2cm around injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, swelling, itchiness, warmness at site of injection that grew to 2 inches in diameter.  Is now the size of 5mm diameter and feels fine.  Used ibuprofen and ice to self treat.  Patient reports similar reaction to TB test.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema multiforme, Rash generalised
Clinical narrative: Rash, all over body, erythema multiforme.  ? if related to vaccines.  No vomiting or diarrhea.
Age: 19.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Hyperhidrosis, Hypoaesthesia, Nausea, Pallor, Paraesthesia
Clinical narrative: Diaphoresis, pallor, nausea, numbness, paresthesia on bilateral fingers.
Age: 30.0
Sex: F
Vaccine: TYP, YF
Symptoms: CSF protein normal, Chills, Confusional state, Diarrhoea, Lumbar puncture
Clinical narrative: On Friday 6/18/08 at 10:00AM; patient got confused and progressively got worse.  Also experienced shaking chills, diarrhea and vomiting.  Patient didn't know where she's at at the time.  Was taken to ER; where a spinal tap and Cat scan were done.  Given DECADROM 10mg IV and 40mg qid p.o.  Diagnosis: toxic encephalitis. 7/14/08-records received for DOS 6/21/08-DX: acute delirium resolving likely from yellow fever. Altered mental status, unable to state her location.
Age: 30.0
Sex: F
Vaccine: TYP, YF
Symptoms: Tremor, Vomiting
Clinical narrative: On Friday 6/18/08 at 10:00AM; patient got confused and progressively got worse.  Also experienced shaking chills, diarrhea and vomiting.  Patient didn't know where she's at at the time.  Was taken to ER; where a spinal tap and Cat scan were done.  Given DECADROM 10mg IV and 40mg qid p.o.  Diagnosis: toxic encephalitis. 7/14/08-records received for DOS 6/21/08-DX: acute delirium resolving likely from yellow fever. Altered mental status, unable to state her location.
Age: 53.0
Sex: M
Vaccine: JEV
Symptoms: Rash pruritic
Clinical narrative: Pt. developed pruritic rash on forearm & abdomen ~1 day after receiving 2nd JE vaccine.  No other complaints.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash erythematous
Clinical narrative: VARIVAX to R thigh received 6/11/08, pt developed indurated red area 3cm diameter on R thigh at injection site, seen by me 6/20/08, then 6/22/08 developed a spotty red rash on legs/trunk reported by mother.  No fever.  No vesicles.  No treatment given.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt received a VARIVAX injection on 6/9/08 in Lt upper arm SC at 2:30 pm. Pt returned on 6/10/08 at 4 pm with a 5x7 cm indurated red warm area (urticarial lesion) past (L) arm. BENADRYL 50 mg every 6 hours PRN per MD.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abscess, Erythema
Clinical narrative: Vaccination date 06-19-08.  On 06-20-08 at 07:30am patient's mother noticed a red spot (dime size) on right arm.  06-21-08 spot spread around upper arm (inch wide, 2 3/4 inches long).  Patient taken to clinic to be seen by a physician.  Patient diagnosed with an abscess.  Treated with cephalexin 125mg.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Musculoskeletal stiffness, Skin warm, Swelling
Clinical narrative: Swelling, redness-2" in diameter, hot to the touch, arm stiffness.  Started 1-2 days after injection was given.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Blister, Malaise, Rash pustular, Skin lesion
Clinical narrative: 7 vesicles-pustulous lesions on the legs & arm 6 days after imm.  No fever, mild malaise.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Pain in extremity
Clinical narrative: 6/20/08 noticed while charting vaccine, TD had been given instead of TDAP that was ordered and expiration date on TD was 3/20/08.  Patient had already left and was going to another doctor's appointment.  Doctor states patient not to be given TDAP on 6/20/08, CDC called on 6/22/08 and patient notified to return on 7/1/08 and will received TDAP.  Arm where shot received was sore.
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Band neutrophil percentage decreased, Blood alkaline phosphatase increased, Blood culture negative
Clinical narrative: Hepatitis B immunization was given on 6/20/08 1800.  Less than 24 hours later, he was hypothermic and a poor feeder.  Complete sepsis work-up done.  Results continue to be negative.
Sex: M
Vaccine: HEP
Symptoms: CSF culture negative, Culture urine negative, Feeding disorder neonatal, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Hepatitis B immunization was given on 6/20/08 1800.  Less than 24 hours later, he was hypothermic and a poor feeder.  Complete sepsis work-up done.  Results continue to be negative.
Sex: M
Vaccine: HEP
Symptoms: Hypothermia, Lymphocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, White blood cell count normal
Clinical narrative: Hepatitis B immunization was given on 6/20/08 1800.  Less than 24 hours later, he was hypothermic and a poor feeder.  Complete sepsis work-up done.  Results continue to be negative.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Computerised tomogram, Convulsion, Nuclear magnetic resonance imaging
Clinical narrative: APPARENT SEIZURE ON 2-14-2008. TAKEN TO EMERGENCY ROOM AND WAS HELD IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. PATIENT WAS TRANSFERRED TO HOSPITAL. SHE WAS SEEN IN THE EMERGENCY ROOM BY PEDIATRIC NEUROLOGIST, STARTED ON PHENOBARBITAL AND WILL RETURN TO SEE HIM ON 4-14-2008.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Blood test, Diplopia, Fatigue, Hypoaesthesia
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Leukoencephalomyelitis, Lumbar puncture, Nerve injury, Nuclear magnetic resonance imaging abnormal, Sensation of heaviness
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Tremor, VIth nerve paralysis
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Diplopia, Leukoencephalomyelitis, Nuclear magnetic resonance imaging
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Diplopia, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoaesthesia, Leukoencephalomyelitis, Lumbar puncture, Multiple sclerosis, Muscular weakness
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Physiotherapy, Sensation of heaviness, Spinal disorder, Tremor
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: VIth nerve paralysis, Vaginal disorder, Visual impairment
Clinical narrative: Mom states that as a result of the child receiving the HPV vaccine her child began with double vision and was hospitalized and diagnosed with ADEM-Acute Disseminated Encephalomyelitis. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy. MRI abnormal. Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Initial and follow up information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 06-AUG-2007 was vaccinated intramuscularly in the deltoid with the first dose of GARDASIL (lot # 657622/0388U). It was reported that at the time of vaccination the patient was not pregnant. It was reported that the patient's last menstrual period was on 01-AUG-2007 and not on 01-AUG-2006 as it was previously reported. Four weeks after vaccination the patient was involved in a motor vehicle accident. After the motor vehicle accident the patient found out that she was pregnant. The pregnancy was confirmed (method unknown). At the time of the report it was unknown how far along the patient was in her pregnancy. On 12-JUN-2008 a telephone call was made to the doctor's office to obtain pregnancy outcome information and a message was left. On 13-JUN-2008 the nurse called back and reported that the patient "had a miscarriage early on in her pregnancy." She had no further information. Upon internal review patient having a miscarriage in her early pregnancy was determined to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry from a health professional concerning a female consumer with a history of being hearing impaired, abnormal pap smears, positive for high-risk HPV and an elective termination of previous pregnancy (7 weeks from LMP) who on 30-APR-2007 was vaccinated with the first dose of GARDASIL. The patient received the second dose of GARDASIL on 31-May-2007 and the third dose of GARDASIL on 20-Sep-2007. Subsequently, it was learned that the patient was probably pregnant at the time she received the third dose. The pregnancy was confirmed by a pregnancy test (LMP=27-Aug-2007). The patient sought unspecified medical attention. The patient did not have any adverse side effects. The outcome was unknown. The patient has transferred to another OB/GYN. On 17-JUN-2008 a follow up telephone call was made to the doctor's office for pregnancy outcome of the patient. The nurse reported that the patient had a scheduled primary Cesarean Section for anticipated size greater a than dates at 38+6 weeks estimated gestational age. She mentioned that patient had a healthy and normal female baby, weighing 8 lbs, 15 Oz. Both mother and baby were doing "fine". Upon internal review patient having Cesarean Section for anticipated size greater than 38+6 weeks was determined to be an other important medical event. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound scan normal, Urinary tract infection
Clinical narrative: Information has been received from a 25 year old female health professional with no drug reactions/ allergies and a history of 2 pregnancies (1 live birth and one elective abortion) who on 20-JUL-2007 was vaccinated with her first dose of GARDASIL, 0.5mL injection. There was no concomitant medication. On 28-SEP-2007 the patient received her second dose of GARDASIL, 0.5ml injection. On 08-OCT-2007 the patient found out that she was 8 to 9 weeks pregnant after getting the first and second doses of GARDASIL. On 27-NOV-2007 an ultrasound was performed with a normal result, "uncertain EDD", estimated to be 31-MAy-2008. Estimated conception date was 24-Aug-2007. The patient sought medical attention. Follow-up information reported that the patient had 2 previous pregnancies. One of those ended in a full term delivery, the other in a miscarriage 8 weeks from LMP. Follow-up information was received. The father of the baby was a cousin with congenital heart problems. On an unspecified date the patient had a urinary tract infection and was given MACROBID. On 27-NOV-2007 and 17-DEC-2007 the patient had a maternal serum alpha-fetoprotein test performed and the results were negative. The reason for the test was the baby's half-brother has downs syndrome. On 28-MAY-2008 a 9 pound 5 ounce baby boy was born. The length was 20 inches and 39 and 4/7 weeks from LMP. The baby's head circumference was 14 inches. The baby was large for the dates and in respiratory distress secondary to pulmonary edema and right pneumothorax. Upon internal review respiratory distress, pulmonary oedema and pneumothorax was considered to be an other medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Congenital anomaly, Drug exposure during pregnancy, Live birth, Sinusitis, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from the Merck Pregnancy Registry from a physician concerning a 15 year old white female with penicillin allergy and no reported medical history who on 21-AUG-2007 was vaccinated with her first dose of GARDASIL (Lot #6578621/0387U) and was pregnant (noted as her first pregnancy). ECD is 12-MAY-2007 and patient's LMP was 06-AUG-2007. Concomitant therapy included azithromycin (manufacturer unspecified). Lab tests included a prenatal screen (no results reported). On 04-SEP-2007 the patient experienced sinusitis. From October 2007 to May 2008 the patient took prenatal vitamins daily. On 18-OCT-2007 an ultrasound was performed to assess fetal development and was normal. Follow up information reported that on 30-APR-2008 the patient vaginally delivered a full term, live born, normal and healthy female who weighed 7 pounds 6 ounces, 19 3/4 in length apgar score 9/9 and a head circumference of 13 3/4. It was reported that the infant had a small congenital anomaly. According to the nurse, the physician's notes also indicated "bilateral hands with rudimentary 6th digit." The nurse stated that it was also noted that there is a positive family history of similar digits. There were no other anomalies and no complications for mother or baby. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Smear cervix, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from the Merck Pregnancy Registry for GARDASIL and a nurse practitioner concerning an 18 year old female with a history of gonorrhoea and vaginitis who on 01-FEB-2008 was vaccinated with a first dose of GARDASIL (Lot number 658556/1060U). Concomitant therapy included LOESTRIN 24 FE and FLAGYL. On 28-APR-2008 the patient was vaccinated with a second dose of GARDASIL (Lot number 660387/1967U) and at same visit was found to be pregnant after a positive urine pregnancy test (LMP=02-Apr-2008). At the same visit the patient also had a regular pap test. It was reported that the patient was vaccinated in right leg. No problems reported. On 31-MAY-2008 the patient terminated the pregnancy. Upon internal review, terminated pregnancy was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Emotional distress, Haemorrhage
Clinical narrative: Information has been received from the mother of a consumer and a health professional for the pregnancy registry for GARDASIL, concerning a 17 year old female with pertinent medical history reported as unremarkable, who on an unspecified date in April 2008, was vaccinated with the first dose of GARDASIL, IM in the arm. There was no concomitant medication. On 22-MAY-2008 the patient received the second dose of GARDASIL. Subsequently, she became pregnant. The patient sought unspecified medical attention and had blood work. No results were provided. On 29-MAY-2008, the patient had a fetal ultrasound which revealed that the fetal pole was not identified and there was "no gestational sac." The patient's last menstrual period or weeks of gestation were not reported. The patient had a miscarriage on 11-JUN-2008. At the time of the report, the daughter was still having clots and bleeding due to the miscarriage, and was emotionally distressed. No other information was provided. Upon internal review it was determined that miscarriage was an other important medical events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Ultrasound scan abnormal
Clinical narrative: Information has been received from the mother of a consumer and a health professional for the pregnancy registry for GARDASIL, concerning a 17 year old female with pertinent medical history reported as unremarkable, who on an unspecified date in April 2008, was vaccinated with the first dose of GARDASIL, IM in the arm. There was no concomitant medication. On 22-MAY-2008 the patient received the second dose of GARDASIL. Subsequently, she became pregnant. The patient sought unspecified medical attention and had blood work. No results were provided. On 29-MAY-2008, the patient had a fetal ultrasound which revealed that the fetal pole was not identified and there was "no gestational sac." The patient's last menstrual period or weeks of gestation were not reported. The patient had a miscarriage on 11-JUN-2008. At the time of the report, the daughter was still having clots and bleeding due to the miscarriage, and was emotionally distressed. No other information was provided. Upon internal review it was determined that miscarriage was an other important medical events. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Convulsion, Vaccine positive rechallenge, Weight decreased
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of Apgar score low and congenital hearing loss who in May 2007, was vaccinated with a first dose of GARDASIL 0.5 mL IM.  Concomitant therapy included LOESTRIN.  In June 2007, the patient experienced a grand mal seizure.  The patient received her second dose of GARDASIL in July 2007.  In July 2007 and August 2007 the patient experienced a seizure again and was hospitalized.  The patient was seen by a neurologist.  The neurologist prescribed the patient KLONOPIN.  Subsequently the patient experienced 15 pound weight loss and amenorrhea.  The patient was then seen by a psychiatrist who stated that he believed the seizures were due to physiological and prescribed additional medications (therapy unspecified).  At the time of reporting the patient was recovering.  No additional information was available.  The reporter considered the events of grand mal seizure, seizure, weight loss and amenorrhea to be other medical events.  Additional information has been requested. 7/9/08-records received-evaluation 1/4/08-fainting spells and seizures-Impression:conversion disorder with mixed presentation with symptoms of motor and sensory deficits as well as psychogenic seizures. Experiencing extreme psychological stress unable to deal with, derives secondary gain from the symptoms and gain attention. 7/10/08-records received for DOS 8/13/07- 8/17/07-Assessment:spells, these do not seem to be seizure with maintined consciousness during the spells. Consider psychosomatic etiology. Onset of syncope 2 years ago, circumstances of syncope burning sensation followed by altered sensorium, recalls the entire envents which last 10-12 minutes). Increasing in frequency, college entrance examination. Developed stuttering speech pattern, crying spells and jerking spell while in waiting room.  8/31/07-Condition improved.  7/10/08-records received for DOS 8/9-8/12/07-DC DX: epilepsy. Prolonged complex seizures. Somnolent due to phenobarital.
Sex: U
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a health professional "that heard of" a patient (age unknown), who, on an unspecified date, was vaccinated with a dose of GARDASIL.  Subsequently, the patient experienced temporary paralysis of her legs.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Upon internal review temporary paralysis of her legs was considered to be an other important medical event.  This is one of two reports from the same source.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning an approximately 8 week old patient with no pertinent medical history who in June 2008, was administered their first oral dose of ROTATEQ.  There was no concomitant medication.  Within 5 days of vaccination, the patient experienced hematochezia.  The patient was seen in an office visit. Upon internal review, hematochezia was considered to be an other important medical event.  No product quality complaint was involved.  Additional information has been requested. 6/26/08-spoke with PCP office-as of 6/17/08 patient recovered. Final DX: haematochezia with suspected cow's milk colitis.
Sex: M
Vaccine: HEP
Symptoms: HIV infection
Clinical narrative: Information has been received from a male who in approximately 1978 participated in a study for and was subsequently vaccinated with RECOMBIVAX HB.  In approximately 1978, the patient developed human immunodeficiency (HIV) virus.  At the time of the report, the patient had not recovered.  The consumer considered HIV virus to be immediately life-threatening.  The consumer felt that HIV virus was related to RECOMBIVAX HB therapy.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a registered nurse concerning a female with a history of ace inhibitor cough who on an unspecified date was vaccinated with ZOSTAVAX (Oka/Merck).  The nurse reports that a physician has a patient that developed an adverse reaction following vaccination with ZOSTAVAX (Oka/Merck).  The vaccination was administered at another site and the nurse did not have information about the administration.  The adverse reaction was believed to be the development of Bells palsy.  No time frame for development was available.  At the time of the report the outcome of the patient was unknown.  There was no product quality complaint.  Bells palsy was considered to be disabling.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Tinnitus
Clinical narrative: Patient got the flu, her ears got stopped up, could not hear nothing but a buzzing.  Patient went to the doctor to see why and said she had a cold.  Medicine did not help.  Kept on going to the doctor's getting medicine for ears.  Patient went about 6 or 8 times then went to (ENT) about two times.  Second time went in the hospital. 7/28/08-records received for DOS 5/9/08-C/O ear infection since last fall, lost some hearing, on multiple antibiotics, chronic cough. Tubes in ears. No reaction from previous flu vaccine.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: CSF test, Computerised tomogram normal, Convulsion, Dyskinesia, Electroencephalogram
Clinical narrative: Abnormal jerky movement, followed by convulsion for which he was admitted and received Phenobarbital 9/10/08-records received for DOS 6/13/08-presented to ED with C/O legs twitching intermittently since vaccines. Myoclonic jerks noted mainly upon waking. Assessment: Myoclonic jerks. Heat rash. Discharged home.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count, Laboratory test abnormal, Nuclear magnetic resonance imaging brain
Clinical narrative: Abnormal jerky movement, followed by convulsion for which he was admitted and received Phenobarbital 9/10/08-records received for DOS 6/13/08-presented to ED with C/O legs twitching intermittently since vaccines. Myoclonic jerks noted mainly upon waking. Assessment: Myoclonic jerks. Heat rash. Discharged home.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Electroencephalogram normal, Febrile convulsion, Injection site abscess sterile, Muscle twitching
Clinical narrative: Patient was given PEDIARIX (LT), HIB (LT), PREVNAR (RT) & ROTATEQ vaccines on 6/17/08 and went to the ER that evening for seizure (strange twitching). She was admitted to the hosp with fever 103.3, sterile abscess to (L) leg and febrile seizure.7/7/08-ER records received for DOS 6/18/08-DX:Immunization reaction. Subjective fever, crying and jerking this morning. Small sterile abcess right upper thigh.