chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site oedema, Injection site vesicles, Pruritus
Clinical narrative: A physician's office manager reported that a 25 year old female inadvertently received an intradermal injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 05/07/2001. On 05/09/2001, the pt developed an injection site reaction characterized by a swollen area "the size of a grapegruit," a "dime sized blister," inflammation, and itching. The physician prescribed application of Lidex cream.
Sex: U
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A healthcare professional reported that a pt inadvertently received an intradermal injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 07/15/2001. The pt subsequently experrienced an injection site reaction characterized by redness and swelling. Additional reports will be generated when information is provided.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Alopecia, Back pain, Cough, Dyspnoea, Epistaxis
Clinical narrative: Information has been received on 08/07/2001 from a consumer. On 09/09/1997, the 44 year old male pt received an injection of TD vaccine following a cut to her right hand. On 10/27/1997, the pt experienced a "stabbing pain in the middle of her back that radiated up the right side of her shoulder blade and neck with muscle spasms." Since that time, the pt has experienced hair loss, blurred vision, enlarged lymph nodes, flu-like symptoms, shortness of breath, cough, and nasal bleeding.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Lymphadenopathy, Muscle spasms, Neck pain, Rheumatoid factor
Clinical narrative: Information has been received on 08/07/2001 from a consumer. On 09/09/1997, the 44 year old male pt received an injection of TD vaccine following a cut to her right hand. On 10/27/1997, the pt experienced a "stabbing pain in the middle of her back that radiated up the right side of her shoulder blade and neck with muscle spasms." Since that time, the pt has experienced hair loss, blurred vision, enlarged lymph nodes, flu-like symptoms, shortness of breath, cough, and nasal bleeding.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Vision blurred
Clinical narrative: Information has been received on 08/07/2001 from a consumer. On 09/09/1997, the 44 year old male pt received an injection of TD vaccine following a cut to her right hand. On 10/27/1997, the pt experienced a "stabbing pain in the middle of her back that radiated up the right side of her shoulder blade and neck with muscle spasms." Since that time, the pt has experienced hair loss, blurred vision, enlarged lymph nodes, flu-like symptoms, shortness of breath, cough, and nasal bleeding.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: A nurse reported that a 49-year-old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 04/09/2001. The next day, she developed an injection site reaction measuring 4-inches in diameter characterized by being raised and red. the patient also experienced weakness and body aches. The reporter indicated that 2 pt experienced these events.  (See HQ 2658928JUN2001)  No further information was available at the date of the report.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Pain
Clinical narrative: A nurse reported that a 54 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 5/11/01 and subsequently developed an injection site reaction measuring 4" in diameter characterized by being raised and red. The pt also experienced weakness and body aches. The reporter indicated that 2 pts experienced these events (See HQ2486325JUN2001). No further information was available at the date of this report.
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: A pharmacist reported that a female in her 30's received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and subsequently developed a localized injection site reaction and an elevated temperature. No further information was available at the date of this report.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year old female who on 02/16/1996 was vaccinated with Varicella virus vaccine live subsequently in the right arm. On 03/24/2001, the pt developed chicken pox with greater than 100 lesions covering the entire body and temperature of 104 degrees F. Subsequently, the pt recovered. Unspecified medical is expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Diarrhoea, Insomnia, Irritability, Pyrexia, Vomiting
Clinical narrative: Information has been received regarding a 12 month old male, with no known illness at the time of vaccination, who on 01/18/2001 was vaccinated with the first dose of varicella virus vaccine live, in the deltoid. Concomitant therapy, that day, included the first dose of MMR and Prevnar vaccines. There were no additional concomitant medications. Within 24 hrs post-vaccination, the pt developed a fever that peaked at 103 degrees F, vomiting, diarrhea, difficulty sleeping and irritability. It was reported that on 01/20/2001, the pt recovered from vomiting and the fever was declining to 102 deg F. The mother reported that the child's pediatrician does not believe the symptoms are related to immunization with Prevnar. She also reported that her sister's child had a similar but "much worse" reaction. Upon follow-up, it was reported that the pt was well, on an unspecified data, when seen in the pediatrician's office, but had a candida diaper rash. It was also reported that he was not seen for complaints of fever or history of reaction to vaccine. It was further noted on 03/14/2001, that the pt was never seen "in our office for complaints of Prevnar reaction" and that the reporter was unable to provide any further info. No further information is available.
Age: 1.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 15 month old male with no past medical history who on 03/27/2001 at 11:45 was vaccinated SQ int he RLT with a first dose of varicella. Concomitant vaccine therapy included a first dose IM in the LLT of Prevnar. Other concomitant medication included Immodium AD. It was noted that the pt was recovering from a "viral gastroenteritis" and had diarrhea at the time of vaccination. The pt also received a "multi-prick T.B. skin test" on the same day. Within 24 hrs, the pt experienced hives on his face, chest, back, and legs. It was noted that on 03/23/2001 the child was taken to his pediatrician's office where it was noted that the "hives were fading." Follow-up info has been received from a licensed practical nurse that states on 03/23/2001 in the morning, the pt had "red blotches on face and legs." The event was described as "urticarial rash secondary to varicella vaccine or Prevnar." The pt was treated with Pediapred oral liquid for 6 days, methylprednisolone sodium succinate, Solumedrol 20 mg IM, and Benadryl 3/4 tsp every 6 hrs. On 03/23/2001 the pt recovered. No further info is expected.
Age: 23.0
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Blister, Chills
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old male with no known medical history or drug allergies who on 03/07/2001 was vaccinated with first dose of varicella vaccine. Concomitant vaccination the same day included a first dose of MMR and a first dose of DT vaccines. There was no other concomitant medication. There was no illness at the time of vaccination. On 03/19/2001 the pt developed chills, a fever and 50+ vesicular lesions that included multiple fluid filled spots on the stomach, legs and his entire body. Unspecified medical attention was sought. There was no relevant diagnostic tests and lab data. Subsequently, the pt recovered on 03/24/2001. Additional info is not expected.
Age: 24.0
Sex: M
Vaccine: MEN, TYP
Symptoms: Abdominal pain, Lethargy, Meningitis, Musculoskeletal stiffness, Pyrexia
Clinical narrative: From telephone correspondence received on 5/9/02, it was reported that a 24 year old member of the Peace Corps, currently in Burkina Faso, who was supposedly vaccinated with a single dose entity of Menomune (lot UA160AA) on 6/14/00, upon arrival to Burkina Faso, was dx'd with bacterial meningitis on 4/26/02. The pt presented with symptoms of high fever (not recorded), severe stiff neck (unable to flex), abdominal pain and lethargy. Spinal fluid grew gram negative cocci. Pt treated with Malarone and IV ceftriaxone. Pt is improving and recovering per report from Burkina Faso. From follow up correspondence received at manufacturer on 5/7/02; it was reported that "a meningitis outbreak (occurred) which they believe was the w-135 strain." From follow up it was reported unable to confirm serotype for this patient. Gram negative coci but no growth on spinal fluid culture. Patient was treated with Rocephin and did recover. *Follow-up report on 9/18/02: From follow-up phone contact made by manufacturer on 5/21/02 to an MD of military, it was reported unable to confirm serotype for this PT. Gram negative cocci but no growth on spinal fluid culture. PT was treated w/Rocephin and did recover. Confirmed date of adverse event was 4/24/02 and date of vax was 6/14/00. No other military volunteers w/Meningitis. During the outbreak of miningitis in PT's station from 1/28/02 to May 02, there were 12, 587 reported cases w/1447 deaths. A large amount were serotype W-135 but unable to obtain all serotypes. MD also reported that there is saved spinal fluid and serum stored if needed for add'l testing. He will contact manufaturer if any add'l info becomes available. From follow-up (#3) correspondence received on 9/9/02, add'l info was provided by the reporter. It was reported that the PT received the following vax's: Menomune A/C/Y/W-135 on 6/14/00 in the deltoid; Typhoid on 6/14/00, Yello Fever on 6/12/00, Diphtheria / Tetanus on 6/13/00, MMR on 6/12/00 (?); Poliomyelitis on 6/12/00, Imovax on 6/16/00, 6/23/00 and 7/7/00; Hep A on Feb. 98 and Jul 00; Hep B on 8/27/92, 9/24/92, and 8/25/93. No further info expected, case closed.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Rheumatoid arthritis
Clinical narrative: The pt developed fever of 102-103 deg. F, myalgia, and headache. Within a few weeks, hand and joint pain started. The pt was diagnosed with rheumatoid arthritis on 04/02.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Rheumatoid factor
Clinical narrative: The pt developed fever of 102-103 deg. F, myalgia, and headache. Within a few weeks, hand and joint pain started. The pt was diagnosed with rheumatoid arthritis on 04/02.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Hypotonia, Pallor, Somnolence, Stupor
Clinical narrative: Extreme pallor and collapse, several minutes post vax. Mom picked baby up and color returned and he cried. Then when laid down again, he became pale and limp. She picked him up and color came back to normal. Ate well 1/2 hour later but more sleepy than normal. Had a 3rd episode in the car. He was admitted to the hospital. PMD's post hospitalization follow-up note refers to this event as a 'hypotonic hyporesponsive episode'.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Syncope
Clinical narrative: Extreme pallor and collapse, several minutes post vax. Mom picked baby up and color returned and he cried. Then when laid down again, he became pale and limp. She picked him up and color came back to normal. Ate well 1/2 hour later but more sleepy than normal. Had a 3rd episode in the car. He was admitted to the hospital. PMD's post hospitalization follow-up note refers to this event as a 'hypotonic hyporesponsive episode'.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Autism, Crying, Drug toxicity, Neurodevelopmental disorder, Pyrexia
Clinical narrative: The pt developed speech problems, regression, and developmental delay. Diagnosed with Autistic Spectrum disorder. A follow up report received 5/17/2002 adds: Developed fever and screaming syndrome 1 day after vaccine. Behavior changes began.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Screaming, Speech disorder
Clinical narrative: The pt developed speech problems, regression, and developmental delay. Diagnosed with Autistic Spectrum disorder. A follow up report received 5/17/2002 adds: Developed fever and screaming syndrome 1 day after vaccine. Behavior changes began.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Feeding disorder neonatal, Irritability, Nasal congestion, Pyrexia
Clinical narrative: The pt developed fever and extreme irritability for two days and beginning two hours after vaccine administration. He also developed increased nasal congestion, poor nursing.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site reaction
Clinical narrative: The pt developed redness, swelling, and a knot around the DTaP injection site (x2 days). Eight days later, the size decreased.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The pt developed a fluffed blotches of red areas at injection site post receiving vaccines. Resolved spontaneously within 1 hour.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: The pt saw a physician on 04/23/2002 for left leg red, swollen with hive looking raised from hip to knee. Right leg had a less severe local reaction. Physician advised to give Benadryl and apply cook compresses.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Skin necrosis
Clinical narrative: The pt developed fat necrosis on right thigh (2x2cm) area reported on 03/26/2002 visit.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Eye swelling, Face oedema, Injection site erythema, Urticaria
Clinical narrative: Immediately after MMR vaccination, the area got red. Then the pt developed hives, swollen face, swollen eyes; no respiratory problems. The pt went to ER and received Benadryl and Prelone. Only a few hives reported by mother on 05/10/2002.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Nausea
Clinical narrative: The pt developed swollen, red area below deltoid muscle above elbow. He also felt feverish and was slightly nauseated immediately after the injection. He also had a flew shot the same day.
Age: 65.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Unevaluable event
Clinical narrative: A skunk was involved with an altercation with two of his dogs. The skunk turned out to be rabid. In the process of separating the animals, he sustained a small laceration on his left hand near the thumb.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abasia, Coma, Convulsion, Diarrhoea, Injection site pain
Clinical narrative: The pt developed red cheek rash on 04/29/2002. On 05/01/2002, he developed loose stools and crying when lifting legs. On 05/04/2002, he developed temp of 101 deg. F. On 05/05/2002 pm fever of 102 deg. F, and seizure (no response, loss of consciousness) noted. He then was taken to a medical center and he could not stand or walk. He was admitted to the hospital and continued to have leg pain. Intermittantly, spinal tap and blood done all reports were negative.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Loss of consciousness, Pyrexia, Rash
Clinical narrative: The pt developed red cheek rash on 04/29/2002. On 05/01/2002, he developed loose stools and crying when lifting legs. On 05/04/2002, he developed temp of 101 deg. F. On 05/05/2002 pm fever of 102 deg. F, and seizure (no response, loss of consciousness) noted. He then was taken to a medical center and he could not stand or walk. He was admitted to the hospital and continued to have leg pain. Intermittantly, spinal tap and blood done all reports were negative.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt presents with palm sized red area surrounding injection site indurated, warm to touch. Left leg Varivax given. Tx: Augmentin 4 wks 3 lg Hp BID, Benadryl 1 tsp 96 hours
Age: 0.3
Sex: U
Vaccine: DTP
Symptoms: Crying, Injection site oedema, Injection site rash, Pyrexia, Screaming
Clinical narrative: The pt developed fever of 100-102 deg. F for about 6 days. Non-stop crying. Rash and swelling at injection site also noted.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Rash
Clinical narrative: The pt developed rash in the groin areas, abdomen, and chest. He was taken to the physician and treated with Benadryl.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Rash
Clinical narrative: The pt developed rash in the groin areas, abdomen and chest. Treated with Benadryl.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Anorexia, Asthenia, Fatigue, Pneumonia, Pyrexia
Clinical narrative: The pt developed generalized weakness, tired, low grade fever off and on (99-99.4 deg. F). These symptoms began one week later.  Pt also experienced no appetite and weight loss. On 03/24/2002 the pt was seen in ER with pneumonia and took Zithromax.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Weight decreased
Clinical narrative: The pt developed generalized weakness, tired, low grade fever off and on (99-99.4 deg. F). These symptoms began one week later.  Pt also experienced no appetite and weight loss. On 03/24/2002 the pt was seen in ER with pneumonia and took Zithromax.
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: IM injection given in right lateral thigh and SQ IPV. Infant crying very very hard. IM injection given in left lateral thigh of PCV and Comvax. Infant crying even harder.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: The pt developed shingles (herpes zoster) with lesion involving left side of body, chest, arm pit, and back wit clustered herpetic lesions.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaemia, Haemangioma
Clinical narrative: Information has been received from a physician concerning a 28 year old female pt who on 03/14/2000 was vaccinated with one dose of varicella virus vaccine live. It was noted that the pt received the vaccine on the 14th day of her cycle, which is also the day she was determined to have become pregnant. LMP 02/29/2000; EDD 12/05/2000. Follow-up info reported that the pt had 2 previous pregnancies. The number of live births was not reported. It was noted that no birth defects or miscarriages had occurred in previous pregnancies. The pt did not have any local or systemic reaction to the varicella virus vaccine live. On 07/26/2000 a routine ultrasound was done which showed normal IUP. Maternal serum alpha-fetoprotein on 07/05/2000 was normal. Parvovirus on 11/10/2000 was negative (the pt was tested due to exposure). It was reported that the pt had a positive PPD test and that a chest x-ray was negative. On 05/08/2000, the pt was started on therapy with Macrobid 1 tablet po bid for the treatment of UTI. No other complications occurred during the pregnancy. On 11/14/2000, 37 weeks from the LMP, the pt gave birth to a healthy baby weighing 5lb. 13oz. There were no congential anomalies, complications or other abnormalities. Follow-up info indicated that the baby was positive for thalassemia minor and on 03/16/2001 a hemangioma was noted on the left foot over the 4th and 5th digits. No further info is available. This report is part of the pregnancy registry.
Age: 33.0
Sex: F
Vaccine: MMR, TTOX, VARCEL
Symptoms: Premature labour
Clinical narrative: Information has been received from a physician concerning a 33 year old female who in January 2000 was vaccinated with one dose of varicella vaccine. Concomitant therapy included one dose of tetanus toxoid and one dose of MMR vaccine. It was noted that the pt received these vaccinations "just prior to conceiving." Approximate LMP 02/07/2000. On 06/26/2000, the pt was seen by a physician and an ultrasound was performed. The results indicated "a singleton fetus growing appropriately for gestational age at the 50-75th percentile. Amniotic fluid volume is normal. The placenta is anterior and unremarkable in appearance. No anomalies are identified." The reporting physician noted "would also like to see her follow-up ultrasound evaluation in 6 weeks, specifically to look at fetal limb lengths and to assess the appearance of the lens of the fetal eyes." Follow-up info received from a physician, indicated that on 08/07/2000 the pt had an ultrasound which revealed the following :weight 885 grams, gender: female, no anomalies, limbs, eyes and heart all OK. Follow-up information received from a physician revealed that on 09/23/2000, at 33 weeks, 2 days gestation,t he pt delivered a baby weighing 3lb. 15 oz. The physician's notes indicated that the baby was healthy and normal. It was also noted that the pt had a previous preterm delivery as well. No further information is available.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Guillain-Barre syndrome, Neoplasm malignant, Tachycardia
Clinical narrative: Information has been received from a woman through the Pregnancy Registry concerning her approximately 33 year old female friend who in approximately July 2000 was vaccinated with varicella vaccine. Two days after vaccination, the pt became pregnant. Medical attention was sought. Follow-up information from a physician indicated that the 33 year old female pt, with a past history of bronchitis, a 1998 spontaneous vaginal delivery of an 8 pound infant, gestational diabetes, in 200 a spontaneous abortion, a remote history of abnormal Pap smears, normal since without STD's, G3, P1, A1 at 34 6/7 weeks was given the EDC of 04/03/2001, by the LMP consistent with a 17 week scan who presented to labor and delivery for induction. Allergies to medications include penicillin, erythromycin and codeine. Current medication includes prenatal vitamins. The pregnancy was complicated with breast cancer with the left modified radical mastectomy performed on 02/01/2001, revealing poorly differentiated invasive dustal carcinoma with 3.5 cm greatest in diameter and positive lymph nodes. The pt needed chemotherapy two weeks postpartum so the decision was made for an early delivery. It was noted that the left mastectomy was healing well. The pt was GBS positive and will be given clindamycin secondary to allergy to penicillin. The pt desired an epidural for pain control. IV pain medications as needed in early induction. Her breast cancer was stable. She was to received chemotherapy two weeks postpartum. The pt was admitted to the labor and delivery. Sterile vaginal exam revealed a cervix that was fingertip, 2 long and high. A Cytotec induction was begun. Three Cytotec inductions had been placed. The pt had good contraction pattern and Pitocin was started. By mid-afternoon, sterile vaginal exam was 3 long and ballotable. Membranes were ruptured at approx. 3:30pm. The pt progressed through labor well and at 17:21 hr, delivered a 5lb. 8.8oz baby. On postpartum day one, the pt was doing well without complaints. She desired discharge to home. The baby would need to stay an additional day. The pt was discharged home on postpartum day two remaining afebrile meeting all goals. It was noted that the baby was given erythromycin 1 g at 17:25 and vitamin K 1 mg IM. Additional info has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyelonephritis
Clinical narrative: Information has been received from a physician, through the pregnancy registry, concerning a 36 year old female with no known allergies, past medical history or previous pregnancy who had her last mentrual period on 01/01/2001. On 01/25/2001 her pregnancy test was negative. On 01/31/2001 was vaccinated with one dose of varicella vaccine. There was no concurrent medicaiton. The pt did not have a local reaction, varicella symptoms or herpes zoster post-vaccination. On 02/06/2001 her pregnancy test was positive. On 02/15/2001 and 03/15/2001, the pt underwent routine ultrasounds which were normal. The pt declined an amniocentesis and alpha fetoprotein tests. In approximately September 2001, the pt experienced pyelonephritis and received treatment with Keflex for treatment until delivery. On 10/09/2001 the pt delivered a normal female baby weighing 8 lb. 5 oz. It was noted that the pt experienced cephalopelvic disproportion during labor/delivery. There was no concurrent medical condition. The infant did not have any feature of congential varicella zoster syndrome. No further info is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Rash macular, Viral infection
Clinical narrative: Information has been received from a health care professional concerning a 7 year old female who on 08/14/1996 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine. There was no illness at the time of vaccination. It was reported that the adverse event startedon 02/15/2001; however, conflicting information from the pt's father reported that the first indication of chicken pox in his daughter was the appearance of approximately 20 red spots scattered about the back and legs on 02/17/2001. These crusted over in 1-2 days and spots then appeared on her face on 02/19/2001, again crusting in 1-2 days. It was reported that on 02/2/2001 the pt was examined by the  physician and then released to return to school. Subsequently, the pt recovered. Additional info has been requested.
Age: 2.25
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a health professional concerning a 27 month old male with no known drug allergies who on 12/01/1999 was vaccinated with varicella vaccine. There was no concomitant medication. On 03/16/2001 the pt presented to the office with 20-50 vesicular lesions mostly on the chest and back. It was reported that no other symptoms were noted. Unspecified medical attention was sought. Follow-up info has been received from a health professional that reports the child was not hospitalized and there was no treatment. On an unknown date, the pt recovered. No further info is expected.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Otitis media, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 month old male with no known allergies and no past medical history who on 02/12/2001 was vaccinated with a first dose of varicella vaccine. Concomitant medication included a first dose of MMR vaccine. On 03/03/2001 the pt presented to the doctor's office with ataxia. It was noted that the child had fallen twice prior to the doctor's appointment. The child was hospitalized for a workup on 03/03/2001 and discharged on 03/04/2001 with a diagnosis of "ataxia secondary to varicella vaccine administration." During hospitalization the child had a CAT scan of the brain that was negative and was treated with ceftriaxone sodium. It was noted that on 03/03/2001 or 03/04/2001 the pt also developed a rash. On 03/06/2001 the child was seen in the doctor's office. The rash was described as approximately 10 maculopapular lesions, three of which appeared vesicular. Most of the lesions were on the torso with a few on the neck. The rest of the skin was clear. The child was not bothered by the rash and he was given "symptomatic treatment." It was reported that the ataxia resolved by 03/06/2001. Follow-up info has been received from a registered nurse who reports the child was brought into the doctor's office by his parents who were very upset and concerned about the fact that he apparently had been felling well. No seizures or tremors had been noted. He ate and drank well. There was no diarrhea, but he did have some vomiting on the way to the doctor's office. It was noted that other family members had viral upper respiratory tract infection type symptoms. It was reported that he fell three times. There was no head injury or loss of consciousness with any of the falls. At the office, the doctor put the child on the floor and he appeared to be ataxic. It did not appear to be a problem with pain, but he literally fell back and to the left on both occasions. The parents reported that this is exactly the same ways that he had fallen earlier. The doctor recommended hospitalization for observation. The physical exam at the doctor's office and at the hospital werre benign except for his tympanic membranes were both bright red. He was treated with Rocephin for otitis media. Lab work included ESR 15; a negative throat culture; ASO screen <200. His comprehensive metabolic panel was normal except a Na of 1135; Co2 of 19; ALK Phosphatase of 264; ALT 22. His hemogram and differential was normal except WBC 13; Mono 10.3; MCH 26.1; PLT 440; MPV 6.4; SEG 54; Lymph 34. According to the mother, the ataxia resolved by late Sunday 03/05/2001. By 03/06/2001, he was walking quite well without nay sings of ataxia or any other problems. The pt subsequently recovered.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male who in 1998 was vaccinated with Varicella virus vaccine live (site unknown), On 03/19/2001, the pt was presented with break through chicken pox. The pt sought unspecified medical attention. Follow-up information received from the nurse indicated that she was unable to locate the pt's record. No further information is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male with no past medial history who on 10/29/1997 was vaccinated with varicella vaccine. On 03/10/2001 the pt experienced atypical chicken pox. It was reported that the pt was seen in the doctor's office. The rash was described as "numerous tiny lesions in various stages-small vesicles-tiny scabs." The pt recovered from his chicken pox after 5 days. No other information was provided. Additional info is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a 28 year old female consumer concerning that female pt with no past medical history and no known drug allergies who on 02/09/2001 was vaccinated with a dose of varicella vaccine. She discovered she was pregnant on 03/09/2001. Her LMP was 05/28/1999, due to the fact she had been pregnant and nursing. On 03/12/2001, the pt developed vaginal bleeding for 8 hours. The pt's health care provider gave her two quantitative blood tests and confirmed that she is still pregnant. The pt is currently taking prenatal vitamins. No further info is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a company representative concerning an adult female who was vaccinated with a dose of Varicella virus vaccine. The pt received three doses of Varicella virus vaccine live, but she also has not seroconverted. Unspecificied medical attention was sought. No further available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a company representative concerning nine children who in 1995 were vaccinated with one dose of varicella vaccine. Three to four years later, the patients experienced "full blown chicken pox, not breakthrough pox." The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. Medical attention was sought. The records of testing prior to release of this lot have been checked by biological quality assurance and found to be satisfactory. The lot complies with the standards of the center for biologics evaluation and research and was released. Additional patients were reported who had adverse experiences following vaccination with varicella vaccine.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with no known drug allergies and no past medical history who on 03/02/2001 was vaccinated with the varicella vaccine. There was no concomitant medication. On approximately 03/20/2001, the pt broke out in two vesicles around the vaccination site. Follow-up info has been received from a health professional that reports on 03/17/2001 the pt developed "two spots on right thigh." No further info was provided. Additional info has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received a physician concerning a 5 year old male with no known drug allergies, who on 07/03/1996 was vaccinated with the first dose of varicella vaccine. There was no illness at the time of vaccination. On 03/20/2001, the pt presented in the physician's office with "about 15 vesicular lesion and no other symptoms." The physician reported the pt had "chickenpox mild." Subsequently on 03/20/2001, the pt recovered from the chicken pox. The physician also reported on the pt's sister who had a similar experience following vaccination with varicella vaccine. Additional info is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 7 year old American Indian female with no known drug allergies, who on 09/22/1997 was vaccinated with the first dose of Varicella virus vaccine live. Subcutaneously. on 03/09/2001, the  pt presented  with about 15 vesicular lesions and no other symptoms". In follow-up, the physician reported the patient had "mild chickenpox". The pt's Varicella Igm was negative < 1:10. Subsequently, the pt recovered from the Varicella. the physician also reported on the pt's sibling who had an experience following vaccination with Varicella virus vaccine live. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no known drug allergies, who on 06/17/1997 was vaccinated with varicella virus vaccine. On 03/20/2001, the pt presented with "chicken pox fifty plus varicella-like lesion." In follow-up, the nurse reported the pt presented with varicella 50-100 lesions. The nurse reported that the onset of the varicella was 03/18/2001. There was no relevant diagnostic tests and lab data. The nurse reported the pt may also have been given varicella immunoglobulin (VZIG) at one year of age, and that the reason was not known. The pt recovered from the varicella. No further info is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with the varicella virus vaccine live. The registered nurse reported that the patient "has a had two doses of varicella virus vaccine live and still has not seroconverted". Unspecified medical attention was sought. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: DTAP, HEP, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 17 month old female with a history of otic infection and upper respiratory infection and no known allergies who on 10/01/2000 was vaccinated with a dose of varicella vaccine. On 03/06/2001 the pt developed a varicella rash. Current therapies included MMR vaccine, hep B vaccine, amoxicillin, acetaminophen, DTaP and Prevnar. Unspecified medical attention was sought. No further info is available.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Information has been received from a registered nurse and a physician concerning a 13 month old female with no know drug allergies, who on 02/20/2001 was vaccinated with Varicella virus vaccine live. On 03/18/2001, the nurse reported the pt. developed less than 50 visible lesions and fever. In follow-up, the physician reported on 03/22/2001, the pt developed " papules vesicle rash (50) after vaccine given." The pt recovered from the rash. Unspecified medical attention was sought. Additional information had been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning 11 children who were vaccinated with Varicella virus vaccine live. The nurse reported that 13 children at a local school had chickenpox. The nurse reported that 13 children at a local school had chickenpox. Two of the children had unknown Vanccination history, but 11 of them were vaccinated with Varicella virus vaccine live, and all 11 had developed break thru chickenpox. No further details were provided. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a pt who was vaccinated with Varicella virus vaccine live more than a year ago, approximately in 1997.  The nurse practitioner reported that the pt developed shingles. She stated that the  injection site was the arm and the herpes zoster has developed on the left side of the body, not the arm and does not cross midline". Unspecified medical attention was sought. Additional information has been sought.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 9-tear-old white female with asthma and NKDA who on 02/25/1997 was vaccinated with a first dose of Varicella virus vaccine live SC in the right arm. There was no illness at the time of vaccination. On approximately 03/05/2001, the pt experienced chicken pox that included "15 maculopapular vesicular lesions and no other symptoms" Unspecified medical attention was sought. In follow-up, the registered nurse learned on 03/26/02, that the pt was seen by the school nurse. The pt had 15 lesions but "was already better". No further information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 7-year-old male who on 09/11/1997 was vaccinated in the left arm with a first dose of Varicella virus vaccine live. On 03/26/2001, the pt's mother reported that the child was experiencing "red mosquito like bumps". The report indicated that there were seven "bumps" total and that one was fluid filled and one the child scratched open. The child was afebrile and no treatment was ordered. Unspecified medical attention were sought The health care provider reported that two other children in the practice had Varicella after vaccination.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a fourth grade 10-year-old male who on 01/12/1996 was vaccinated with Varicella virus vaccine live. On 03/01/2001, the pt experienced Varicella. Unspecified medical attention was sought.  Follow up information has been received from a registered nurse who states the mother called the office then the physician saw the child to confirm the diagnosis of  "breakthrough case of chickenpox". The child has recovered.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a health professional concerning a 3-year-old female with NKDA and no past medical history who on 03/19/2001 was vaccinated with Varicella virus vaccine live. There was nonconcomitant medication. On 03/25/2001, the child's grandmother reported that the child experienced a generalized red rash throughout her body. She was afebrile and no treatment was ordered. Unspecified medical attention  was sought. FOLLOW-UP information has been received from a registered nurse to clarify information in this report It was reported that the pt's sister received Varicella virus vaccine live after being exposed to the chicken pox in school. A few days later, she developed  chicken pox. it was noted that the patient and her mother  broke out in the chicken pox after the sister's rash. Additonal information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health care facility concerning a 10 year old female pt who on 08/11/1995 was vaccinated with a dose of Varicella virus vaccine live. On 03/25/2001, the pt developed chicken pox with more than 70 lesions and fever. The pt sought unspecified medical attention. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from concerning a 9 year old male who on  09/07/1992 was vaccinated. On 03/24/2001, the pt developed chicken  pox and a fever with more than 70 lesions. The pt sought unspecified medical attention. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 39-year-old female pt who on 03/15/2001 was vaccinated SC with a 0.5 ml dose of Varicella virus vaccine live. Comcomitant therapy included cold medication (unspecified). On 03/29/2001, the pt developed less than 15 lesions and injection site sensitivity to touch. Unspecified medial attention was sought. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old male consumer who in August 1995, was vaccinated with varicella virus vaccine live. In March 2001, the pt developed chicken pox. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician who reported he had four doses of varicella virus vaccine live, but did not seroconvert. On 03/29/2001, the pt was vaccinate with fifth dose varicella vaccine that expired on 03/29/2001. Unspecified medical attention was sought. Additional info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a her 7 year old son who in January 1997 was vaccianted with varicella virus vaccine. In approximately January 2001, the pt developed moderate to severe chicken pox, hundreds of pox all over including the throat. The reporter was concerned about the effectiveness of the vaccine. The reporter's youngest son, did not develop the chicken pox. The reporter noted that one of her son's required acyclovir during the outbreak to minimize it as much as possible. The mother also reported that her oldest son also developed the chicken pox. Additional info has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician's assistant concerning a 13 month old male with no known allergies, who on 03/15/2001 was vaccinated with varicella virus vaccine. On 03/22/2001, the pt developed a fever of 102 deg F and vomiting which resolved. On 04/31/2001, the pt developed a fever of 105 deg F and vomiting x1. Unspecified medical attention was sought. Upon internal review fever of 105 deg F was determined to be an other medical event. Additional info has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug effect decreased
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old female who was vaccinated with the first and second dose of Varicella virus vaccine live in February 1999, and March 1999, respectively. Recently, the patient was found to have low for Varicella titers. Unspecified medical attention was sought No information is expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a  33 year old Asian female with no past medical history who on 02/09/2001 at 10:45 was vaccinated with a first dose of Varicella virus vaccine live, There was no concomitant medication or illness at the time of vaccination. On 02/21/2001, the patient was seen by a physician who noted Varicella lesions at the injection site with appeared as a red rash. The patient's experience was considered to be disabling by the reporter as the patient was unable to work from 02/21/2001- until 02/27/2001 since she is a registered nurse and was not allowed to have patient contact. On 02/27/2002, the patient recovered. No further information is expected.
Age: 4.0
Sex: M
Vaccine: MMR, OPV, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from two registered nurses concerning a 4 year old male with no known drug allergies or past medical history, who on 03/02/1998 was vaccinated with the first dose of Varicella virus vaccine live which the patient received subcutaneously in the right arm, and the third dose of oral poliovirus vaccine. Originally the one nurse reported that on 03/21/2001, the patient experienced 50 or more lesions over all his body Unspecified medical attention was sought No treatment had been ordered. In follow-up, another nurse reported that the patient had approximately 50 lesions on his abdomen and back on 04/01/2001. This nurse reported that the patient recovered.  The registered nurse also reported on the patient's sibling who had an experience following vaccination with Varicella virus vaccine live, Additional information is not expected
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 31 year old male with no known allergies or significant past medical history. On 10/13/2000, the pt had serum varicella zoster vaccine antibody test of 0.23 negative. The pt was vaccinated with the first and second dose of varicella virus vaccine on 11/03/2000, and 12/13/2000 SQ in the left arm, respectively. Subsequently, the nurse reported that the pt had no detectable titer after vaccine series was given. On 01/17/2001, the pt had another varicella virus antibody test which was negative, no detectable antibody. Unspecified medical attention was sought. Additional info has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 24 year old female with a tetracycline allergy and an erythromycin allergy who on 08/11/2000 and 09/15/2000 was vaccinated with a first and second dose respectively of 0.5 ml of varicella vaccine. There was no concomitant medication. In March 2001, the pt had undetectable titers. Unspecified medical attention was sought.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with varicella vaccine. Subsequently the pt experienced varicella lesions. Unspecified medical attention was sought. It was noted that the physician was notified by the Pediatrics Immunization Dept and is requesting an analysis of PCR to determine if the rash is associated with the vaccine or not. Additional info has been requested.