chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Peritoneal fluid analysis, Platelet count normal, Rash macular, Urine analysis, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an approximately 6 year old female who on 11-AUG-2007 was vaccinated SC with a 0.5 ml dose of Varivax. On 13-AUG-2007, two days after vaccination the patient experienced acute abdominal pain. The patient was admitted to the local hospital and a clinical diagnosis of acute appendicitis was made. The patient underwent an appendectomy. The appendix was found to be "normal" but there was redness of the peritoneum as well as free fluid in the abdomen. Culture of the free peritoneal fluid revealed no growth. The patient's white blood cell count was elevated to more than 20,000. The patient was discharged on amoxicillin and Lortab. The patient was examined in the office, post-operatively on 20-AUG-2007 and the exam revealed hemorrhagic macular lesions on both lower extremities and the right elbow. A diagnosis of Henoch-Schonlein purpura was made. The patient's white blood cell count remained elevated to 20,000, the platelets were normal and the patient was afebrile. A urinalysis was also undertaken (results not provided). A follow-up appointment was scheduled for 22-AUG-2007 but the patient did not report to the office for follow-up. At the time of the report the patient had not recovered. A product quality complaint was not involved. The patient's experiences were considered to be disabling and life threatening by the reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Diarrhoea haemorrhagic, Intussusception, Pyrexia, Surgery, Vomiting
Clinical narrative: Patient was seen in the center with a 4 day history of abdominal pain, vomiting, and fevers.  She was found to have an intusseseption. Patient sustained a perforation when air contrast enema was attempted and she was taken emergently to the OR for surgical repair.  Patient had a small amount of ileum resected in the OR.  She did well post operatively and was discharged home.   This patient was seen in our Emergency department.  I do not have the details regarding the dates of administration and specific details regarding the vaccine itself
Age: 0.5
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Intussusception
Clinical narrative: Patient was seen in the center with a 4 day history of abdominal pain, vomiting, and fevers.  She was found to have an intusseseption. Patient sustained a perforation when air contrast enema was attempted and she was taken emergently to the OR for surgical repair.  Patient had a small amount of ileum resected in the OR.  She did well post operatively and was discharged home.   This patient was seen in our Emergency department.  I do not have the details regarding the dates of administration and specific details regarding the vaccine itself
Age: 0.5
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Abdominal pain, Enema administration, Intestinal perforation, Intussusception, Pyrexia
Clinical narrative: Patient was seen in the center with a 4 day history of abdominal pain, vomiting, and fevers.  She was found to have an intusseseption. Patient sustained a perforation when air contrast enema was attempted and she was taken emergently to the OR for surgical repair.  Patient had a small amount of ileum resected in the OR.  She did well post operatively and was discharged home.   This patient was seen in our Emergency department.  I do not have the details regarding the dates of administration and specific details regarding the vaccine itself
Age: 0.5
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Surgery, Ultrasound abdomen, Vomiting
Clinical narrative: Patient was seen in the center with a 4 day history of abdominal pain, vomiting, and fevers.  She was found to have an intusseseption. Patient sustained a perforation when air contrast enema was attempted and she was taken emergently to the OR for surgical repair.  Patient had a small amount of ileum resected in the OR.  She did well post operatively and was discharged home.   This patient was seen in our Emergency department.  I do not have the details regarding the dates of administration and specific details regarding the vaccine itself
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Computerised tomogram, Nephrolithiasis
Clinical narrative: Patient complained of back & abdominal pain. Catscan was done in ER.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 65-year-old male who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently, on an unspecified date, the patient was admitted to the hospital with chicken pox. It was determined that the patient had "symptoms associated with acute varicella and not shingles." No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Drug hypersensitivity, Idiopathic thrombocytopenic purpura, Laboratory test, Platelet count
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female with a history of xylocaine allergy, and a splenectomy after idiopathic thrombocytopenia, who in "mid June 2007" was vaccinated SC with a dose of Zostavax. Concomitant therapy included gemfibrozil, lisinopril (manufacturer unknown), Tricor, atenolol and aspirin. The patient was seen by the doctor on 25-JUN-2007 with a 4-5 day history of bruising. The doctor prescribed prednisone as treatment. Lab studies included blood work and platelet counts, results were not reported. The patient also received platelets on multiple occasions as an outpatient. The patient was diagnosed with idiopathic thrombocytopenia "17 days after vaccination." The patient saw a hematologist and an allergist. The patient recovered "about three weeks ago" on approximately 02-AUG-2007. No other information was provided. There was no product quality complaint involved. The reporter considered idiopathic thrombocytopenia to be serious, life threatening, and other important medical events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who in approximately July 2007 ("about a month ago"), was vaccinated with the first dose of Gardasil (Lot # not provided). Within 48 hours of the vaccination, she developed a rash which "started on her arms and moved down to the legs, then back up to her arms again." She was hospitalized for "a day and a half." Treatment included intravenous therapy (unspecified). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Culture stool positive, Diarrhoea, Haematochezia, Irritability
Clinical narrative: Information has been received from a registered nurse concerning an 18 week old male patient who on 18-JUN-2007 was vaccinated with the first dose of Rotateq (Lot # not reported) and the second dose on 20-AUG-2007 (lot # not provided). Concomitant therapy included lactulose. On 25-AUG-2007, five days after receiving the second dose, the patient developed high fever (104.5 degrees/F), vomiting, diarrhea, and irritability. The patient was taken to a hospital emergency room in the night of 25-AUG-2007 to 26-AUG-2007. A stool culture was taken (outcome not specified) and an antibiotic injection administered (unspecified antibiotic). The patient's stool tested positive for blood. The patient was rehydrated in the hospital and was discharged to home. At the time of the report, the patient was at the physician's office for re-evaluation. The patient continued with a 100.4 degree/F fever. No other symptoms or treatment were reported. High fever (104.5), vomiting, diarrhea, irritability and stool tested positive for blood were considered to be immediately life-threatening. Additional information has been requested.  9/5/07 Received fax from pcp w/RO lot # handwritten.  No other medical records.  VAERS database updated w/same.  9/11/07  Reviewed ER records 8/26/07 which reveal patient experienced fever, projectile vomiting & diarrhea x 1 day.  Temp in ER was 104.7. FINAL DX: Febrile illness & viral infection. Patient did not improve & returned to ER later same day with continued fever & blood in stool.  Temp in ER 101.4  Given dose of IM antibiotic & d/c to home.  Stool c/s became (+) on 8/31 & parent & pediatrician notified of same & pcp to treat/follow. FINAL DX: febrile illness, diarrhea.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Occult blood positive, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an 18 week old male patient who on 18-JUN-2007 was vaccinated with the first dose of Rotateq (Lot # not reported) and the second dose on 20-AUG-2007 (lot # not provided). Concomitant therapy included lactulose. On 25-AUG-2007, five days after receiving the second dose, the patient developed high fever (104.5 degrees/F), vomiting, diarrhea, and irritability. The patient was taken to a hospital emergency room in the night of 25-AUG-2007 to 26-AUG-2007. A stool culture was taken (outcome not specified) and an antibiotic injection administered (unspecified antibiotic). The patient's stool tested positive for blood. The patient was rehydrated in the hospital and was discharged to home. At the time of the report, the patient was at the physician's office for re-evaluation. The patient continued with a 100.4 degree/F fever. No other symptoms or treatment were reported. High fever (104.5), vomiting, diarrhea, irritability and stool tested positive for blood were considered to be immediately life-threatening. Additional information has been requested.  9/5/07 Received fax from pcp w/RO lot # handwritten.  No other medical records.  VAERS database updated w/same.  9/11/07  Reviewed ER records 8/26/07 which reveal patient experienced fever, projectile vomiting & diarrhea x 1 day.  Temp in ER was 104.7. FINAL DX: Febrile illness & viral infection. Patient did not improve & returned to ER later same day with continued fever & blood in stool.  Temp in ER 101.4  Given dose of IM antibiotic & d/c to home.  Stool c/s became (+) on 8/31 & parent & pediatrician notified of same & pcp to treat/follow. FINAL DX: febrile illness, diarrhea.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Radiculitis brachial, Sensory loss
Clinical narrative: Initial report received on 21 August 2007 from a physician. A 50-year-old female patient, with a past medical history of "MVP" (mitral valve prolapse), "HTN" (hypertension) and chronic hepatitis C with normal "LFTS" (liver function tests); and who had concurrent illnesses of chronic thoracic neuropathy, and "quiet" rheumatoid arthritis, had received a left deltoid, intramuscular dose of Adacel, lot number C2734AA, on 12 June 2007. The patient had not received any other vaccinations within four weeks. Two days post-vaccination, the patient developed right upper brachial neuropathy with associated sensory loss. A neurology evaluation was completed, however the results of the evaluation were not reported. Treatment, diagnostic testing, and laboratory data were not provided. At the time of this report, the patient had not recovered.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itchy red raised rash at injection site 3x3 in.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Blood creatine phosphokinase, Full blood count, Laboratory test, Myalgia, Pain in extremity
Clinical narrative: 15 yo with brain tumor S/P VP shunt who  developed leg pain, muscle aching.
Age: 19.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: Soon after immunizations, patient fell off bed after sudden syncope and sustained a laceration in frontal area. Regained consciousness promptly was given stack position.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt reports within 24 hours developed red raised area at site of injection, very itchy - 7x5cm. No other problems.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt reports within 24-48 hours noted red raised area at site of injection 3x5cm area, no pain, no fever, no pruritus.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: Local rxn with mild cellulitis - left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Anorexia, Pyrexia, Vomiting
Clinical narrative: Grandmother states had fever, vomiting, no appetite, which continued through to noon of next day after receiving vaccines. (Grandmother did not actually check temp.)
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: local redness at site (L) arm upper site red and swollen warm to the touch itchiness Increased pain after rec DTaP
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pruritus, Rash, Skin warm, Urticaria
Clinical narrative: Warm to the touch, itchiness, hives "everywhere", no respiratory distress. Rash occurred 45 min after receiving vaccines. DTaP...
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: local redness at site of DTaP inj. warm to the touch 3: diam. at inj. site itchiness (L) arm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Local redness at site left arm after DTaP vaccination, itchiness a lot.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Pruritus, Skin warm
Clinical narrative: Local redness at site 2" around inject. site, warm to the touch, itchiness. Left arm reaction to DTaP.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: (L) thigh Local redness at site-developed "hives" warm to the touch itchiness reaction to DTaP "large area of thigh"
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Pain, Pruritus, Skin warm
Clinical narrative: Local redness at site left arm, warm to the touch - size - palm of his hand, itchiness and soreness.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash papular
Clinical narrative: On 8/21/07 developed fever and a few small red raised papules on abd and trunk. She then awoke 8/22/07 with a diffuse rash trunk and extremities - no fever - no other physical concerns.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Injection site nodule, Pyrexia, Rash, Skin lesion
Clinical narrative: 8/23/07 Developed fever of 102.4 and started to break out in rash. 8/27/07 Numerous random and wide spread macropapular reddish lesions, erythematous knot at injection site on left and right upper arm.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Allergy to vaccine
Clinical narrative: Immunization card stated that child allergic to pertussis,  Dtap given. No adverse symptoms reported post injection and nine days later.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Induration, Pyrexia, Skin warm, Tenderness
Clinical narrative: cellulitis 3x3 inch induration, warm to touch, fever, tender.  Doubled in size in 24 hours.  Treated with Omnicef
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Nausea
Clinical narrative: patient complained of dizzyness, nausea and mild lower abdominal pain without fever for 2 days after vaccination.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Dysphagia, Pruritus, Urticaria
Clinical narrative: Within 24 hours client complained of itching, but didn't seek medical care.  By Friday, August 24th, hives appeared on his back.  He then went to a local medical clinic and was treated with a Medrol dose pack and Zrtec.  By Monday,August 27th, the hives had spread from his neck to his knees and complained of difficulty swallowing.  He then received an injection of Prednisone 20mg and then oral Prednisone 20mg for 9 days and then a decreasing dose there after.  As of August 30th he is seeing a disappearance in the hives.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: site of injection resulted in 30 mm induration with warmth but no fever by 2 days post vaccination; increased to 40 mm by 3-4 days post vaccination still without fever with soreness;  1 week post vaccination, 5 mm induration, no warmth and pain is minimal
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Feeling abnormal, Injection site erythema, Injection site oedema
Clinical narrative: Mother reports that on 8-11-97 in the a.m. child complained left arm felt "funny".  On the a.m. of 8-12-07, left arm had edema and erythema, not hot to the touch.  Mother gave child Tylenol and applied ice pack to left arm with relief.  Mother called and reported to HD on 8/13/07.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Erythema, Oedema
Clinical narrative: PT NOTICED LOCALIZED EDEMA AND ERYTHEMIA ONE DAY AFTER INOCULATION (PT VISIT WAS 2 DAYS AFTER INOCULATION). NO PAIN OR TENDERNESS TO AREA. PT WAS AFEBRILE. INPECTION REVEALED LOCAL AREA TO BE 14.5 CM. NO ASSOCIATED SXS. PT WAS TREATED WITH CEPHALEXIN 500MG, TID, F10D. WILL RETURN TO CLINIC IS SXS ARE DO NOT RESOLVE.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Abdominal pain upper, Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Mother stated that she started having left arm swelling and redness on 8/29/2007. Arm was swollen and red from shoulder to elbow. She also had low grade fever, decrease appetite and stomach ache
Age: 28.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Dizziness, Nausea, Swollen tongue, Throat tightness, Tremor
Clinical narrative: Nausea, tight throat, swollen tongue, lightheadedness, shaking
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: Pustules on opposite arm of vaccine. Tx - IV fluids, observation, Benadryl.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Cold sweat, Pallor, Skin warm, Syncope
Clinical narrative: After receiving injection pt. fainted upon leaving the exam room. Face pale, skin warm and clammy to touch.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: 8-23-07 TC from mother. Noticed rash on child last evening around 9 PM after coming home from football practice. Rash on stomach area only. This morning noticed rash around injection site on left arm, torso, back, buttocks, and thigh. Mom says it looks like chicken pox. No fever, slept well. Refer to MD if needed.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: My shoulder swelled up initially to the size of a softball. It then moved down my arm and stayed swollen for a week. I went to the emergency room only to be told to see my doctor on base.
Age: 17.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: None stated.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling left arm for 2 days.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Induration, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 24 hours after injection developed redness, rash, swelling at injection site. Measured 10x11cm by 3x3cm indurated area, temp 101.3 at exam 48 hours after admin.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Mother reported onset watery diarrhea evening of 8-9-07.  On 8-13-07, watery diarrhea after taking bottle continues.  8-13-97 Instructed to have evaluation ASAP today dx high risk dehydration.  Numerous phone call attempts and messages left requesting return phone call without answer since contact 8-13-07.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Muscular weakness, Nausea, Reaction to previous exposure to any vaccine, Visual disturbance
Clinical narrative: Patient complained of dizziness and not being able to see properly after she stepped out of the clinic, 10 minutes after receiving a  second dose of varivax:  manufacturer is Merck & co.; Lot number 1149F;Expiry date 09/28/2008.  She also complained of  weakness in her legs, nausea but no headache. Bp (lying) was 110/78 Pulse 72, respirations non-labored and regular.  Mom stated then that she had experienced a similar response to a previous vaccine but could not recall the name of the vaccine or date it was administered. Pt was allowed home after 20 minutes of observation as symptoms had disappeared with rest and a drink of cold water.  Mother was instructed to notify the Health Department if concerned or take her to the E.R. if symptoms reoccurred.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Vital capacity
Clinical narrative: Patient complained of dizziness and not being able to see properly after she stepped out of the clinic, 10 minutes after receiving a  second dose of varivax:  manufacturer is Merck & co.; Lot number 1149F;Expiry date 09/28/2008.  She also complained of  weakness in her legs, nausea but no headache. Bp (lying) was 110/78 Pulse 72, respirations non-labored and regular.  Mom stated then that she had experienced a similar response to a previous vaccine but could not recall the name of the vaccine or date it was administered. Pt was allowed home after 20 minutes of observation as symptoms had disappeared with rest and a drink of cold water.  Mother was instructed to notify the Health Department if concerned or take her to the E.R. if symptoms reoccurred.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Dizziness, Headache
Clinical narrative: per mom, child awoke next morning with complaints of headache, stomachache, and dizziness.  Temp by mouth ran between 99 - 100 degree F.  States Advil did not help headache.  Child remained in be all day, went to school today but mom states she was dragging.  Did not see doctor.  Mom denies illness before shot or problem with any prior vaccines.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Patient reported that at 4 am the day after he recieved twinrix vaccine, about 15 - 16 hours after vaccine, he woke with generalized itching and hives. Pt took benadryl and symptoms resolved
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal pain upper, Barium double contrast, Enema administration, Haematochezia, Intussusception
Clinical narrative: Intusseption, bloody stool, vomitting of bile, stomach cramps, pain 8/31/07 Received vax record from pcp.  VAERS database updated w/same./ss 9/28/07 Vax record faxed to CDC.  10/5/07 T/C to hospital to check status of request.  States records faxed directly to CDC on 10/2/07.  10/5/07 Received hospital medical records which reveal patient experienced pallor, decreased bowel sounds, bilious vomiting, blood in stool & abdominal pain.  Admitted 8/18-8/19/2007 for observation.  Surgery consult done. reduction.  Progressed well & d/c to home. FINAL DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Pain, Vomiting, X-ray
Clinical narrative: Intusseption, bloody stool, vomitting of bile, stomach cramps, pain 8/31/07 Received vax record from pcp.  VAERS database updated w/same./ss 9/28/07 Vax record faxed to CDC.  10/5/07 T/C to hospital to check status of request.  States records faxed directly to CDC on 10/2/07.  10/5/07 Received hospital medical records which reveal patient experienced pallor, decreased bowel sounds, bilious vomiting, blood in stool & abdominal pain.  Admitted 8/18-8/19/2007 for observation.  Surgery consult done. reduction.  Progressed well & d/c to home. FINAL DX: Intussusception.
Age: 35.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Herpes zoster
Clinical narrative: Pt rec'd MMR and Tdap on 8/24/07; two days later developed herpes zoster.  Likely unrelated, but wanted to report.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Herpes zoster, Injection site pain, Rash vesicular
Clinical narrative: 08/20/07 VARICELLA VACCINATION GIVEN.08/22/07 PATIENT HAD SHARP PAIN IN RIGHT ARM THAT SHE DESCRIBED AS INSIDE AND FEELING LIKE KNIFE STABBING AS WELL AS ELECTRICITY FLOWING THROUGH HER ARM. NO REDNESS OR FEVER ON SHOT SITE. MOTHER CALLED DR OFFICE, BUT THEY WERE OUT, SPOKE WITH ANOTHER MD'S RN AND WAS TOLD THAT THE VARICELLA VACCINE DOESN'T CAUSE NERVE DAMMAGE, BECAUSE IT IS GIVEN "RIGHT UNDER THE SKIN AND THE THE NEEDLE IS TOO SMALL" WAS INSTRUCTED TO GIVE TYLENOL AND ICE IT, BUT TO CHECK FOR REDNESS OR FEVER AROUND SITE.  ON 08/24/07 THERE WAS A BLISTERED RASH ON RIGHT SHOULDER BLADE THAT WAS IN THE SHAPE OF A PATCH AND APPEARED TO HAVE WATER BLISTERS ON IT.  OVER THE WEEKEND PATIENT'S RIGHT ARM HAD AT LEAST X3 MORE OF THE BLISTERED PATCHES GOING FROM SHOULDER TO WRIST. ON 08/27/07 FATHER CALLED DR OFFICE AGAIN AND WAS TOLD THAT IT WAS A REACTION FROM THE VACCINE WHICH IS COMMON AND TO GIVE TYLENOL NOT IBRUPROFEN. MOTHER CALLED BACK BECAUSE SHE WANTED TO TELL THEM THAT THE RASH WAS BLISTERED AND THAT PATIENT NEEDED TO BE SEEN.  SHE WAS SEEN AND DR AND DR DETERMINED THAT IT WAS SHINGLES CAUSED BY THE VACCINATION.  PATIENT WAS IN EXCRUTIATING PAIN FROM 08/22/07-08/29/07.  SHE HAD A SEVERE HEADACHE AND THE TYLENOL DID NOT APPEAR TO HELP.  DR DID PRESCRIBE TYLENOL 3 WHICH HELPED HER SLEEP AND WITH THE HEADACHE.  THE PAIN HAS SOMEWHAT SUPSIDED AND THE RASH IS IMPROVING.  SHE DID HAVE TO MISS SCHOOL AND THIS WAS THE FIRST WEEK THAT SCHOOL WAS IN SESSION. PATIENT HAS A TWIN SISTER AND A BROTHER THAT HAD THE VACCINATION ON THE SAME DAY, BUT SISTER AND BROTHER DID NOT HAVE A REACTION.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: 08/20/07 VARICELLA VACCINATION GIVEN.08/22/07 PATIENT HAD SHARP PAIN IN RIGHT ARM THAT SHE DESCRIBED AS INSIDE AND FEELING LIKE KNIFE STABBING AS WELL AS ELECTRICITY FLOWING THROUGH HER ARM. NO REDNESS OR FEVER ON SHOT SITE. MOTHER CALLED DR OFFICE, BUT THEY WERE OUT, SPOKE WITH ANOTHER MD'S RN AND WAS TOLD THAT THE VARICELLA VACCINE DOESN'T CAUSE NERVE DAMMAGE, BECAUSE IT IS GIVEN "RIGHT UNDER THE SKIN AND THE THE NEEDLE IS TOO SMALL" WAS INSTRUCTED TO GIVE TYLENOL AND ICE IT, BUT TO CHECK FOR REDNESS OR FEVER AROUND SITE.  ON 08/24/07 THERE WAS A BLISTERED RASH ON RIGHT SHOULDER BLADE THAT WAS IN THE SHAPE OF A PATCH AND APPEARED TO HAVE WATER BLISTERS ON IT.  OVER THE WEEKEND PATIENT'S RIGHT ARM HAD AT LEAST X3 MORE OF THE BLISTERED PATCHES GOING FROM SHOULDER TO WRIST. ON 08/27/07 FATHER CALLED DR OFFICE AGAIN AND WAS TOLD THAT IT WAS A REACTION FROM THE VACCINE WHICH IS COMMON AND TO GIVE TYLENOL NOT IBRUPROFEN. MOTHER CALLED BACK BECAUSE SHE WANTED TO TELL THEM THAT THE RASH WAS BLISTERED AND THAT PATIENT NEEDED TO BE SEEN.  SHE WAS SEEN AND DR AND DR DETERMINED THAT IT WAS SHINGLES CAUSED BY THE VACCINATION.  PATIENT WAS IN EXCRUTIATING PAIN FROM 08/22/07-08/29/07.  SHE HAD A SEVERE HEADACHE AND THE TYLENOL DID NOT APPEAR TO HELP.  DR DID PRESCRIBE TYLENOL 3 WHICH HELPED HER SLEEP AND WITH THE HEADACHE.  THE PAIN HAS SOMEWHAT SUPSIDED AND THE RASH IS IMPROVING.  SHE DID HAVE TO MISS SCHOOL AND THIS WAS THE FIRST WEEK THAT SCHOOL WAS IN SESSION. PATIENT HAS A TWIN SISTER AND A BROTHER THAT HAD THE VACCINATION ON THE SAME DAY, BUT SISTER AND BROTHER DID NOT HAVE A REACTION.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Local reaction, Nodule, Swelling
Clinical narrative: PT. RECEIVED #1GARDASIL VACCINE ON 5/31/07 AND HAD A SMALL LOCAL REACTION AND A SMALL NODULE THAT SHE IGNORED AND DID NOT REPORT TO US. #2 GARDASIL GIVE ON 8/1/07. SHE DEVELOPED SIGNIFICANT SWELLING 3 DAYS AFTERWARDS WITHOUT BRUISING OR REDNESS. THE SWELLING HAS DECREASED OVER THE PAST 4 WEEKS BUT TODAY THERE WAS A PALPABLE 3.5 X 2.5 CM. MASS AT THE INJECTION SITE. NO EVIDENCE OF CELLULITIS. NO REDNESS. THE AREA IS SLIGHTLY TENDER
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV
Symptoms: Oedema peripheral
Clinical narrative: Pt's mother called clinic advice nurse on 8/29/07 at 18:05 PM. States went to ER 8/28 left arm swollen from wrist to shoulder, right arm has quarter size swelling. Pt. received vaccines on 8-27-07.
Age: 13.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Pt with induration and cellulitis at site of injection. No W, no U, no fever/chills.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Administer shot (Zostavax) to 2 patients on 8-12-07 and one patient following week. On 8-23-07 started with breakout that looks like shingles on scalp and forehead. Very mild case too.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure, Pain, Rash
Clinical narrative: Administer shot (Zostavax) to 2 patients on 8-12-07 and one patient following week. On 8-23-07 started with breakout that looks like shingles on scalp and forehead. Very mild case too.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Phone call from mother on 8/30/07. Client got hives on trunk of body 1/2 hr to 45 min after injection. Symptoms subsided with Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Erythema, Induration, Swelling
Clinical narrative: Right thigh redness, swelling, induration. Advised - Tylenol and cold compressions.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Erythema, Induration, Swelling
Clinical narrative: Redness, swelling, induration 13x15 cm. Advised cold compresses and Tylenol.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Pruritus, Pyrexia, Rash, Varicella
Clinical narrative: Client had chicken pox with blisters, itching, rash, low grade fever at age 12.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster outbreak. Dermatome 3/4 right chest. 8/25/07.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Left arm swelling, redness. Rx Orapred 15/5 7ml po daily x 4d. Cephalexin 250/5 5ml q 6 hrs x 7 days.
Age: 38.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Pruritus, Skin lesion, Urticaria
Clinical narrative: Pt is a 38 year old male who received both AVA # 1 and the typhoid vaccine on 14 Oct 04 in the am. When he got home that pm he noticed a few "hives" on his trunk that increased in number throughout the pm and was associated with slight itching. He denied, wheezing, SOB, swelling or GI symptoms. He stated he had hives before but they were not like this. When asked to describe the lesions he stated they were little red raised bumps approx 1-2 mm in size. He denied weeping, pustules, vesicles or welts. Stated they were just tiny red raised spots. He stated he had over 100 lesions that night and he took only one Benadryl. There was no worsening in the morning and after 2-4 days the lesions cleared and have not returned since. He stated he had no problems with swelling to his arm where shots were administered and he denied fever, and other systemic symptoms. He denies any triggers and has not had a reaction since. He is currently due for AVA and the typhoid vaccines in preparation for deployment.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Large redness and swelling size of arm. Warm to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Eye rolling, Hypotonia, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Received PPD, IPV 4, DTaP 4, and MMR 2. Selected stickers as reward after shots - about 1-2 minutes after shots turned pale, eyes rolled up in head, body stiffened, then went limp and unresponsive. Laid flat with legs elevated, MD in to eval, by which time pt responding appropriately to questions. HR 70, POX 97-98%. Rested and observed x 15 minutes with no further episodes. D/C home alert and playful. HR 98-100s, POX 94%, BP 90/50.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Gaze palsy, Hypotonia, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
Clinical narrative: Received PPD, IPV 4, DTaP 4, and MMR 2. Selected stickers as reward after shots - about 1-2 minutes after shots turned pale, eyes rolled up in head, body stiffened, then went limp and unresponsive. Laid flat with legs elevated, MD in to eval, by which time pt responding appropriately to questions. HR 70, POX 97-98%. Rested and observed x 15 minutes with no further episodes. D/C home alert and playful. HR 98-100s, POX 94%, BP 90/50.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red, swollen spot on left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: 1 1/2" DIAMETER, RED,RAISED,WARM,TENDER, ITCHY AREA ON RIGHT THIGH.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Appetite disorder, Chills, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: Received Tdap vaccine in left deltoid at 3:30PM on 8/27/07. 5 hours later, began experiencing fatigue, hunger and pain in left deltoid. She went to bed and woke up 8/28 with very painful, swollen deltoid, but not inflamed. The hunger persisted throughout the day and she developed chills with no fever. Malaise, but no headache. "I felt like crap." Facial sinuses felt "full." "I felt twinges in my submaxillary nodes." No headache. 8/29- still fatigued. No treatment required
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Malaise, Sinus congestion
Clinical narrative: Received Tdap vaccine in left deltoid at 3:30PM on 8/27/07. 5 hours later, began experiencing fatigue, hunger and pain in left deltoid. She went to bed and woke up 8/28 with very painful, swollen deltoid, but not inflamed. The hunger persisted throughout the day and she developed chills with no fever. Malaise, but no headache. "I felt like crap." Facial sinuses felt "full." "I felt twinges in my submaxillary nodes." No headache. 8/29- still fatigued. No treatment required
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm very red swollen hard and hot to touch.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives developed 2 days after administration.  Benadryl.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: recurrent intussusception 8-18-07 (initial episode 6-07).  9/7/07 Received vax record from pcp which confirm vax all given on 7/27.  Vaers database updated w/same.  9/7/07 Reviewed 2nd hospital medical records which reveal patient seen 8/18/07 for 2nd episode of IS.  Initial episode 6/07.  Presented on 8/18 w/abdominal pain, vomiting & had currant jelly stool in outlying ER.  Transferred to higher level of care from 2nd hospital. 9/7/07 Reviewed 3rd hospital medical records which reveal patient admitted 8/18-8/19/07 for abdominal pain, screaming & drawing of legs to chest.  Previous IS of 6/07 reduced w/air enema at same facility. Progressed well & was d/c to home. FINAL DX: Intussusception, enema reduced.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Asthenia, Hypokinesia
Clinical narrative: 6 hours after Gardasil immunization (second dose) was given, patient had an episode where she felt weak and she felt that she could not move her arms or legs secondary to weakness. This was transient. She then developed severe joint pain in bilateral elbows, hips and knees, severe enough to go to the Hospital ER the following day for it.  Pain improved after patient was given ibuprofen 400mg, and then resolved completely, and has not returned.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Swelling
Clinical narrative: 6 hours after Gardasil immunization (second dose) was given, patient had an episode where she felt weak and she felt that she could not move her arms or legs secondary to weakness. This was transient. She then developed severe joint pain in bilateral elbows, hips and knees, severe enough to go to the Hospital ER the following day for it.  Pain improved after patient was given ibuprofen 400mg, and then resolved completely, and has not returned.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: left hand numbness, question Gullian Barre Syndrome.  09/12/2007 MR received for OV 8/30/2007 for c/o finger numbness x several weeks.  Finger numbness began ~20 days s/p Gardasil vax.  No trauma.  Numbness noted in 4th and 5th fingers which spread down into lateral hand.  Currently only in 5th finger and tip of 4th. PE (+) for decreased sensation to light touch and pin prick in R 5th finger. Otherwise WNL. Impression:  Neuropathy, Idiopathic Peripheral NOS.  Uncertain if very mild Guillain-Barre Syndrome from Gardasil vaccine.
Age: 4.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Upper outer left leg has a small red spot where injxn given and pink rash 1"x1" around site. Denies rash elsewhere, denies SOB, denies fever. Normal activity level. Mild itching at site where Varicella vaccine was given.  Reaction is not as bad as brother's rxn.  No treatment tried. Reviewed common mild reactions w/mom soreness/swelling at injxn site, fever, rash, reviewed what to watch for for moderate, severe rxn. Advised add 4 T baking soda to bath tonight. Can give Tylenol.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Pruritus, Rash, Wheezing
Clinical narrative: Mom reporting rash about 2 inches by 1 inch, upper right outer thigh, small red bump at injection site, size of a pea. Complaining of itching. Denies fever. Denies SOB, wheezing. No rash elsewhere on body. Playing, normal disposition.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site rash
Clinical narrative: RT THIGH RASH/HIVES MEASURING 11.5CM X 8CM ONSET WITHIN 24 HRS OF HEP A
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Patient's right arm became swollen and warm to the touch on 8/29/07.  Patient also c/o "itchy" feeling.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm became swollen and warm to the touch the evening the vaccine was administered.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Eye rolling, Feeling cold, Hyperhidrosis
Clinical narrative: After aproximately 5 minutes of the shoots she felt nauseated and started to jerk her body around almost falling down, her eyes rolled back this lasted about 45 seconds. She was pale and sweating cold and felt dizzy. She was taken to a different room to lie down where her vital sign were checked. her blood pressure was higher than at the time of examination.She was given apple juice to raise her blood sugar level according to the nurse.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Pallor
Clinical narrative: After aproximately 5 minutes of the shoots she felt nauseated and started to jerk her body around almost falling down, her eyes rolled back this lasted about 45 seconds. She was pale and sweating cold and felt dizzy. She was taken to a different room to lie down where her vital sign were checked. her blood pressure was higher than at the time of examination.She was given apple juice to raise her blood sugar level according to the nurse.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Proctalgia, Rash erythematous, Screaming
Clinical narrative: About 30 hours after our daughter recieved the Rota Teq oral vaccine, she got diarrhea accompanied by a bright red rash around her anus. The rash is extremely painful when touched or when she has a bowel movement, which leads to her screaming and crying for about 30 min each time. There was previously absolutely no rash in the affected area. There were no other changes in diet or routine except Rota Teq oral vaccine.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Flushing, Injection site pain, Skin test
Clinical narrative: Pt is a 24 year old male who received a total of AVA x2 while deployed in 2006. He received AVA #1 22 Sep 06 and reported on problems with the injection other than slight soreness at the injection site. He denied any swelling or other sx. He received AVA #2 on 21 Nov 06 and within 2 hrs his commander told him that his neck was red, and pt noted that he was red from the nipple line of anterior chest, upper arms, and with reddness extending up to his neck. He denied any raised lesions, resp problems, wheezing, itching or GI symptoms. His commander took him immediately to the ER where he received IV fluids and Benadryl. He stated the reddness cleared within 15 min after intervention. He denied any new foods, lotions or other products. He reported he had a similar reaction years ago when he received IV contrast for a CT scan. He stated at that time he had flushing on his back only, with no itching, or resp problems. He denies any problems with any previous vaccination. He reported he has food allergies to include carrots, onions, and celery and he is allergic to grass pollen. He stated with his food and grass allergies he feels that his throat is tightening and may get a runny nose. He carried an epi pen but has never used it. Symptom: Erythema Start: 11/21/2006 End: 11/21/2006 Comment: Flushing from nipple line to neck, ant only
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Deafness unilateral
Clinical narrative: On July 31, 2007 at 2:30 PM, my PCP gave me a shingles vaccination. Later, the same day at 10 PM I noticed a ringing in my right ear. Early the next day (Aug 1, 2007) about 2 AM I lost all hearing in my right ear.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Deafness unilateral, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: On July 31, 2007 at 2:30 PM, my PCP gave me a shingles vaccination. Later, the same day at 10 PM I noticed a ringing in my right ear. Early the next day (Aug 1, 2007) about 2 AM I lost all hearing in my right ear.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Gaze palsy, Respiratory arrest, Resuscitation
Clinical narrative: Per ER call to on call physician 8/11. Last night he stopped feeding and then his eyes rolled back and he stopped breathing.  911 called and CPR initiated. Coded for 1-1/2 hours (paramedics and ER) without success.  9/4/07 Received pcp medical records which included vax record which confirmed RO dose & lot #s as reported.  Office note of 8/9 indicates well child visit on day of vax excep for thrush & umbilical hernia.  1/8/08 Reviewed autopsy report which states COD as sudden unexplained infant death syndrome due to dilated cardiomyopathy & primary endocardial fibroelastosis, dilated form.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Arthralgia, Computerised tomogram normal, Concussion, Convulsion, Dizziness
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no known drug allergies, who on 20-AUG-2007 was vaccinated with Gardasil (lot # 658282/0929U). Prior to administration of Gardasil, the patient was given a TB test, blood was drawn and ADACEL was given in the right arm. The patient received Gardasil and became light headed, fell forward off the exam table and hit her head on the floor. The patient's eyes rolled back and there was brief seizure activity and foaming at the mouth. The patient had an abrasion on the nose from the fall and a bump/swelling on the top of the head. The patient complained of pain in the left wrist. The patient was taken to the emergency room and a CAT scan was found to be "okay" and no bloodwork was done. The patient was diagnosed with a mild concussion and was released from the emergency room. The patient was seen in the office on 22-AUG-2007 and the swelling on the forehead improved and the patient was recovered (also reported as recovered on the night of 20-AUG-2007. Upon internal review, brief seizure activity was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Excoriation, Fall, Foaming at mouth, Gaze palsy, Head injury
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no known drug allergies, who on 20-AUG-2007 was vaccinated with Gardasil (lot # 658282/0929U). Prior to administration of Gardasil, the patient was given a TB test, blood was drawn and ADACEL was given in the right arm. The patient received Gardasil and became light headed, fell forward off the exam table and hit her head on the floor. The patient's eyes rolled back and there was brief seizure activity and foaming at the mouth. The patient had an abrasion on the nose from the fall and a bump/swelling on the top of the head. The patient complained of pain in the left wrist. The patient was taken to the emergency room and a CAT scan was found to be "okay" and no bloodwork was done. The patient was diagnosed with a mild concussion and was released from the emergency room. The patient was seen in the office on 22-AUG-2007 and the swelling on the forehead improved and the patient was recovered (also reported as recovered on the night of 20-AUG-2007. Upon internal review, brief seizure activity was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Swelling, Swelling face
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no known drug allergies, who on 20-AUG-2007 was vaccinated with Gardasil (lot # 658282/0929U). Prior to administration of Gardasil, the patient was given a TB test, blood was drawn and ADACEL was given in the right arm. The patient received Gardasil and became light headed, fell forward off the exam table and hit her head on the floor. The patient's eyes rolled back and there was brief seizure activity and foaming at the mouth. The patient had an abrasion on the nose from the fall and a bump/swelling on the top of the head. The patient complained of pain in the left wrist. The patient was taken to the emergency room and a CAT scan was found to be "okay" and no bloodwork was done. The patient was diagnosed with a mild concussion and was released from the emergency room. The patient was seen in the office on 22-AUG-2007 and the swelling on the forehead improved and the patient was recovered (also reported as recovered on the night of 20-AUG-2007. Upon internal review, brief seizure activity was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Electroencephalogram, Grand mal convulsion, Heart rate increased
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a positive family history of seizure within the family and who was vaccinated with Gardasil on her right arm. There was no concomitant medication. After being vaccinated with Gardasil, the patient was dizzy, passed out and had a tonic clonic seizure. The seizure lasted 2-3 minutes long and had urinary continence afterward. Unspecified medical attention was sought and the patient's blood pressure was 100/70, her pulse was 120 and the physician did a respiratory rate, which was 25. The patient was also sent for an electroencephalography (EEG) (results not provided). As of 22-AUG-2007, the patient was recovering from dizziness, increased heart rate, passing out and her tonic clonic seizure. Product Quality Complaints (PQC) were not involved. Upon internal review, tonic clonic seizure was determined to be an other important medical event. Additional information has been requested.