chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: ANTH, BCG
Symptoms: Blister, Rash
Clinical narrative: Rash developed on wrists and upper shoulders on 04/12/2003.  Visited doctor for initial evaluation that night.  Rash spread by 04/13/2003 to face, neck, and back.  Small blisters and pimples characterized outbreak, symptoms spread to arms and legs by 04/15/2003.  Began to taper off by 04/17/2003.  Most visible symptoms gone by following week.  Was given Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left thigh swollen and red
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red, swollen left leg.  Larger than 50 cent piece.  Child brought to office.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Rash macular
Clinical narrative: blotchy skin near injection site of DTaP.  Fever next day.  Started day after fever.  Children's Motrin and Tylenol given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site warmth, Urticaria
Clinical narrative: 04/04/2003:  Right shoulder upper 1/2 of arm swollen and hot to touch x 2 days. 05/02/2003:  Hives palm size moving around trunk x 2 days.  Decreasing prednisone treatment x 4 days.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Myalgia, Neck pain
Clinical narrative: On 05/21/2003 muscle of left arm was hot and sore and hurt really bad. Also hurt to move shoulder the next am after injection. Neck hurt 05/28/2003 p/c stated arm was much better- no pain now.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Approximately 24 hours after injection, pt developed a quarter sized area of induration and erythema at site (left anterior thigh). Increase in size over 24 hours. Then increase rapidly to about 5-6cm area next day. Not particular tender and ambulated well. No Dx given P O diphenhydramine and P O steroid x 4 days.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Oedema
Clinical narrative: Severe swelling, erythema of leg
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: DTaP#4 received (LA)- <24 hours after injection , arm from left shoulder to approximately 2 in above elbow very swollen and red.
Age: 1.2
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varivax administered to right arm SQ on 05/16/2003, on evening of 05/29/2003, parent reported rash, on 05/30/2003 less than 10 vesicular lesions, some unbilicated some ruptured, localized at neck. chest, abdomen, none seen on scalp or face
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 31 year old female with asthma and an allergy to codeine and beta blockers, currently on therapy with Ortho-Novum, and Nidrin and a history of migraines who was vaccinated with MMR II "as an infant." On 4/22/02 the pt had a measles titer drawn and subsequently, the measles titer was negative. The pt sought unspecified medical attention. The outcome of the pt's negative measles titer was unknown. Follow-up info has been received from a licensed practical nurse. The nurse reported that the pt received MMR II, and "had no problems with it." The nurse also reported that the pt needed documentation of the vaccine to continue nursing school. No further info is available.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a male who in approximately 1987, at approximately age 14, was vaccinated with MMR II. The pt received this vaccine in a foreign country. Subsequently, the pt told the nurse practitioner that he experienced a severe anaphylactic reaction. The pt did seek medical attention. Follow up info revealed that since the pt received the vaccination in a foreign country approximately 15 years ago there was no additional info available.
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal, Viral infection
Clinical narrative: Information has been received from a female pt who as a child was vaccinated with MMR II. Subsequently, she developed measles and mumps. The reported indicated that the titer for rubella had been negative. Unspecified medical attention was sought. Additional info has been requested. The pt also indicated a similar experience with MMR II (WAES0304USA02938).
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a Pharm. D. concerning a female who in the 1950's was vaccinated with MMR. In approximately 1950 the pt had an anaphylactic reaction. Additional info has been received from the Pharm. D. The Pharm. D. reported that the pt was an employee who had reported to employee health dept that she had an anaphylactic reaction after she had received the MMR II in the 1950's (vaccine was not available until 1978). The Pharm. D. reported t hat she was unsure what vaccine the pt had received and did not have any further info on this case. Upon internal review, anaphylactic reaction was considered to be an other important medical event (OMIC). Additional info is not expected.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old male with no past medical history who on 1/16/01 and 7/9/01 was vaccinated with the first and second dose (638450/0030L) (IM in the left deltoid) of hep A virus vaccine inactivated. There was no illness at the time of vaccination. This does not comply with the recommended dosage schedule. On 3/26/02 the pt's serology testing came back negative. It was noted that the pt will receive two additional doses. The pt sought unspecified medical attention. It was noted on 4/3/01 the pt began another vaccine series of hep A vaccine (Havrix). No further info is expected.
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received on 4/17/02 from a physician who "two or three years ago" was vaccinated with two doses of hep A virus vaccine inactivated. On 4/17/02 it was reported that the physician tested negative for antibodies against hep A. It was noted that the physician did not know what antibody test was used. The physician sought unspecified medical attention. Additional info has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Liver function test abnormal
Clinical narrative: Information has been received from a Pharm. D. concerning a female who was vaccinated with hep A virus vaccine inactivated. Subsequently the pt developed elevated liver function tests. The outcome of the elevated liver function tests was unknown. The pt sought unspecified medical attention. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: DTP, HEPA, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Information has been received from a physician concerning a 5 year old female with seasonal allergies who on 5/6/02 was vaccinated in the right deltoid with the first dose of hep A virus vaccine inactivated (641164/1504L). Concomitant vaccination the same day included MMR in the right arm (640560/1092L) and diphtheria toxoid/pertussis vaccine/teta in the left arm. Other concomitant therapy included Claritin and Patanol. On 5/7/02, the pt complained to the mother of the discomfort at the injection site. The whole deltoid area was hot, swollen and erythematous. The pt was seen in the office on 5/8/02 with all the same symptoms as well as pain/tenderness. There were no systemic symptoms at any time. Additional info has been requested.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a health professional concerning a 6 year old male pt who on 4/29/02 was vaccinated with a dose of hep A virus vaccine inactivated. On 5/2/02 the pt presented with a mild rash on his face and an injection site rash. Unspecified medical attention was sought. Additional info  has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old male with no past medical history who on 5/13/02 at 14:00 was vaccinated with the first dose of hep A vaccine inactivated (641153/0072M) RA, IM. Concomitant therapy that date and time included a second of MMR II (640318/1085L) LA, SC, the fourth dose of poliovirus vaccine (U0344) LA, IM, and a fourth Mantoux test (c0942AB) LA, dermal. There was no illness at the time of vaccination. On 5/14/02 at 14:00 the pt developed redness and swelling at the injection site. The pt was given bydrocortisone cream for the rash and given warm compresses for the injection site. Follow-up reported that the pt had a red right swollen arm, that was reported to be "warm to touch," and a rash along the neck and lower lobe of ears. There were no relevant diagnostic tests or laboratory data performed. The pt had sought medical attention. It was also noted that the pt did not have any adverse events following previous vaccinations. It was reported that the pt recovered on 5/21/02. It was also reported that another pt was vaccinated from the same lot and had a similar reaction (WAES0205USA02296). No further info is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old male with no past medical history who on 5/13/02 at 14:00 was vaccinated with the second dose of hep A virus vaccine inactivated (641163/0072M). Concomitant therapy that date and time included the fourth dose of poliovirus vaccine (U0425) LA, IM and the fifth dose of DTaP (542A2) LA, IM. There were no other reported concomitant medications. On 5/15/02 at 14:00 the pt developed redness and swelling at the injection site. The pt was given hydrocortisone cream to apply for rash and warm compresses for the injection site. Follow-up reported that the pt also had a red swollen right arm, described as "warm to touch," and a rash along neck and back of ears. There were no relevant diagnostic tests or lab data performed. It was also noted that the pt did not have any adverse events following previous vaccinations. It was reported that the pt recovered on 5/21/02. It was also reported that another pt was vaccinated from the same lot and had a similar reaction (WAES0205USA01866). No further info is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old male with no past medical history who on 5/13/02 at 14:00 was vaccinated with the second dose of hep A virus vaccine inactivated (641163/0072M). Concomitant therapy that date and time included the fourth dose of poliovirus vaccine (U0425) LA, IM and the fifth dose of DTaP (542A2) LA, IM. There were no other reported concomitant medications. On 5/15/02 at 14:00 the pt developed redness and swelling at the injection site. The pt was given hydrocortisone cream to apply for rash and warm compresses for the injection site. Follow-up reported that the pt also had a red swollen right arm, described as "warm to touch," and a rash along neck and back of ears. There were no relevant diagnostic tests or lab data performed. It was also noted that the pt did not have any adverse events following previous vaccinations. It was reported that the pt recovered on 5/21/02. It was also reported that another pt was vaccinated from the same lot and had a similar reaction (WAES0205USA01866). No further info is expected.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Face oedema, Injection site erythema
Clinical narrative: Information has been received from a health professional concerning an approximately 15 year old female who in 2000 was vaccinated with a dose of hep a virus vaccine inactivated. She then experienced a swollen face and redness at the injection site. Subsequently, the pt's condition resolved. Unspecified medical attention was sought. No further info was available. Additional info has been requested.
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a 67 year old male surgeon with asthma and hypertension who on 12/4/98 was vaccinated in the deltoid with the first dose of hep A virus vaccine inactivated (626422/0603M). On 7/11/99 the surgeon was vaccinated in the deltoid with the second dose of hep A virus vaccine inactivated (627357/0888H). There were no illnesses at the time of the vaccinations. On 9/25/01 a hep A IgM antibody test yielded negative results. On that same day, high lab values were also yielded for cholesterol 312 and triglycerides 1191. The surgeon reported that he had no apparent immunity and no hep A antibodies. Subsequently, the surgeon recovered. The pt also experienced a similar event after vaccination with hep B vaccine (WAES0204USA02495) and also reported that other members of his family also had no measurable antibodies after vaccination with hep A virus vaccine (WAES0207USA01064). This is a consolidation of two reports concerning the same pt. No further info is available.
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Chills, Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a male doctor of medical dentistry with rheumatoid arthritis and unknown allergies, who on 6/21/02 was vaccinated with a hep a vaccine, but does not know if he received hep A virus vaccine inactivated or hep A vaccine (Havrix). Concomitant therapy included Enbrel and Remicade. On an unknown date in 2002 the pt developed diarrhea, chills, fever and weakness. Unspecified medical attention was sought. Additional info has been requested.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a Pharm. D. concerning a male with a history of cholangitis sclerosing and liver function tests raised (asymptomatic) (6 months) who on 6/27/02 was vaccinated with hep A virus vaccine inactivated (642919/0214M). The Pharm. D. reported that the pt experienced an IgM response, making it appear like the pt developed active disease from the vaccine. It was reported that there was no possibility of exposure. Additional info has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Palpitations
Clinical narrative: Information has been received from a female consumer with allergies to penicillin and sulfa and a history of palpitations when young and mitral valve prolapse who on 7/22/02 was vaccinated with a dose of hep A virus vaccine inactivated. Concomitant therapy included Tranxene and Aciphex. On 7/23/02 in the evening, the pt developed heart palpitations that lasted for 45 minutes and diarrhea. Additional info has been received from the physician. The physician reported that he did not know of any reaction as reported by the pt. No additional info is expected.
Age: 3.6
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test abnormal, Viral infection
Clinical narrative: Information has been received from a physician concerning a 43 month old female who had been vaccinated on 5/3/01 and 2/27/02 with a first (634836/0547K) and second (640711/1394K, left "lat") dose of hep A virus vaccine inactivated. On 7/5/02 the pt presented to the office with a "febrile illness-suspicion for hep A." It was also reported that the "child became sick and did not develop any antibodies." Additional info revealed that the physician who administered the second dose, "ran hep A and hep A&B totals to determined what antibody levels for child was." Results were reported as, "IgG and IgM negative, non-reactive antibodies." An epstein-Barr virus antibody test from 7/5/02 was > or =1.10 (positive antibody detected) which had the following interpretation, "suggestive of a past epstein-barr virus infection. In infants, a similar pattern may occur as a result of a passive maternal transfer of antibody." It was further clarified that the pt did not have hep A. Follow-up info received from the physician indicated that the reason for his report on this pt was solely because of a viral illness, which prompted lab work. Those labs indicated that the pt had no immunity to hep A, "despite the administration of the appropriate series of hep A vaccine." The pt recovered from the viral illness on an unspecified date. Additional info is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician conerning a 12 year old male with no known drug allergies who on 07/09/2002 was vaccinated with a dose of hepatitis A virus vaccine inactivated.  There was no concomitant medication.  On 07/12/2002 the patient experienced diarrhea.  As of 07/29/2002, the patient's diarrhea was still present.  Unspecified medical attention was sough.  Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old male with no relevant medical history or known allergies who was vaccinated with 3 doses of hepatitis A virus vaccine inactivated (manufacturer unknown).  There was no concomitant medication.  It was reported that a "recent" hepatitis A IgM antibody test was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year old female with leukemia and an allergy to Sulfa, who on an unknown date was vaccinated with a dose of hepatitis A virus vaccine inactivated (manufacturer unknown)(Lot # not given).  Subsequently, the patient had a negative titer for Hepatitis A.  The reporter also indicated that the patient had been vaccinated at another facility and that there were no immunization records available.  It was further reported that the patient had similar experiences with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (WAES # 0206USA01324) and hepatitis B vaccine recombinant (yeast) (manufacturer unknown) (WAES # 0208USA02265).  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a Ph.D. concerning a 20 year old female who on 08/05/2002 was vaccinated with hepatitis A virus vaccine inactivated.  It was reported that the patient's titer was drawn on 08/19/2002 (no results provided).  It was reported that the client was asymptomatic but in August 2002, she developed a slight elevation in liver enzymes with a serum aspartate aminotransferase of 61.  The reporter questioned if the patient's IgM could be positive two weeks post vaccination with hepatitis A virus vaccine inactivated.  Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: HEPA
Symptoms: Abdominal distension, Anorexia, Body temperature decreased, Flushing
Clinical narrative: Information has been received from a 66 year old patient with a history of spinal stenosis who on 08/19/2002 was vaccinated with a booster dose of hepatitis A virus vaccine inactivated.  There was no concomitant medication.  The patient indicated that about "9 days after the shot", approximately 08/28/2002, she experienced a cold feeling on her tongue, loss of appetitie, bloated feeling, her body gets cold and hot "very" easily, and her temperature is kind of low.  It was unknown whether medical attention was sought.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 06/09/1999 and on 08/30/2000 was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated.  It was reported that one or both of the vaccinations was from a recalled lot.  Serology testing performed on 09/09/2002 showed her hepatitis A immunity status was determined to be "borderline."  The patient sought unspecified medical attention.  Follow-up information received on 02/20/2003 from a doctor of pharmacy reported that "they do not know who the patient is."  Lot numbers were not available.  No further information is expected.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a mother concerning her 20 year old son with no past medical history and no known drug allergies who in "May and fall of 2000" was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated.  It was reported that the patient was vaccinated from recalled lots.  On 09/05/2002 the patient donated blood and was told that his ALT was elevated at 500.  The patient was negative for hepatitis B and C, however his AST, LDH, GGT were elevated.  The lab work was repeated the week of 09/16/2002 with results pending.  The mother reported that her son had contracted hepatitis A.  The patient sought medical attention.  It was reported on 09/27/2002 that the patient started on amoxicillin "last week" and the patient was scheduled to have a liver ultrasound on 09/28/2002.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 4-year-old female patient with mild eczema who on 09/19/2002 in the PM was vaccinated with a second dose hepatitis A virus vaccine inactivated (reported lot # 728A9, not valid for this product) in her left leg.  At the same time she received a sixth dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (reported lot # 526A9) in the left leg.  On the morning of 09/20/2002, the patient developed a 6 x 8- centimeter area of induration to the left thigh at the area of vaccination, also described as "severe site of administration reaction"; and the reported event onset was 12-24 hours after vaccine administration.  The patient was taken to the emergency room because her primary care physician was not open on the weekend; the areas around the hepatitis A virus vaccine inactivated vaccination site were determined to be "cellulitic".  The reporter indicated the patient was treated with an oral steroid (name and dose not reported) and it was also noted the patient was put on a course of unnamed antibiotics.  The reporter indicated the patient had no known adverse events following prior vaccinations, and no laboratory tests were performed.  It was noted the patient saw her primary care physician on 09/23/2002 and was reported as "doing better".  She was instructed to finish the antibiotics as ordered.  It was noted the patient recovered on 09/25/2002.  The reporter mentioned that "several" patients also had an experience following vaccination with hepatitis A virus vaccine inactivated (WAES # 0301USA00760).  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with no drug allergies who on 10/15/2002 was vaccinated with hepatitis A virus vaccine inactivated.  It was reported that the vaccine had expired on 05/27/2002.  The patient did seek medical attention.  It was also reported that a 75 year old male was vaccinated with hepatitis A virus vaccine inactivated that had expired (WAES# 0301USA01140).  Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A
Clinical narrative: Information has been received from a nurse practitioner concerning a 55 year old male who on 08/16/2001 and on 04/01/2002 was vaccinated with the first (lot # 639195/0523L) and second (lot # 641256/1415L) dose of hepatitis A virus vaccine inactivated, respectively.  Subsequently, the patient "tested positive for hepatitis A."  The reporter did not know whether the test was for IgG or IgM.  It was noted that the first dose administered was from a recalled lot.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of hepatitis A virus vaccine inactivated.  Subsequently, the patient developed symptoms of Hepatitis A and had elevated liver function tests.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with a history of recent foreign travel and no known drug allergies who on 11/06/2002 was vaccinated with a dose of medication.  On 11/07/2002, the child developed jaundice and diarrhea.  On 11/18/2002 a positive diagnosis of hepatitis "A" was made based on serologic testing.  On 11/25/2002 it was reported that there was a possible vaccine failure.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Nonspecific reaction
Clinical narrative: Information has been received from the mother of a 5-week-old female patient with no relevant medical history or illnesses at time of vaccination who on 11/04/2002 was vaccinated intramuscularly in the "LT" with a dose of hepatitis A virus vaccine inactivated (lot # 644325/0922M) 0.5mL.  Follow-up information from the physician revealed that no reactions were reported from the mother of the patient up to 1 week after the inadvertantly given hepatitis A vaccine inactivated to the infant.  However, it was reported by the mother that the patient developed a slight fever.  No further information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of hepatitis A virus vaccine inactivated.  The reporter indicated that the patient received a dose that was later recalled.  The vaccine was administered again and the total number of injections was reportedly unknown.  A titer revealed an elevated IgM.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 31-year-old male patient who was vaccinated with hepatitis A virus vaccine inactivated (manufacturer unknown).  Subsequently, 10 days post vaccination, the patient presented with a severe headache.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a Pharm. D. concerning a child (age and gender not reported) who was vaccinated on unspecified dates with 2 series, a total of 4 doses, at the appropriate schedule for each with hepatitis A virus vaccine inactivated (lot # not reported).  A titer done 4 weeks later was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a 75 year old male who on 10/15/2002 was vaccinated with hepatitis A virus vaccine inactivated.  It was reported that the vaccine had expired on 05/27/2002.  The patient did seek medical attention.  It was also reported that a 72 year old female was vaccinated with hepatitis A virus vaccine inactivated that had expired (WAES # 0210USA01672).  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female patient with a penicillin allergy and a history of a negative titer who in 1995 was vaccinated with a 2 dose series of hepatitis A virus vaccine inactivated (lot # not reported).  There were no concomitant medications.  On 01/22/2003 the patient had a titer that was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a person in a doctor's office concerning a 33 year old male with no past medical history who in January 2001 and on July 2001 was vaccinated with a first (lot @ 634178/1330K) and second dose (lot @ 636384/0408L) of hepatitis A virus vaccine inactivated, respectively.  There were no concomitant medications.  On 02/11/2003 it was reported that a "titer was drawn 2 to 3 weeks ago."  The titer was negative.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Arthralgia, Arthritis, Myalgia
Clinical narrative: This report was received from the manufacturer for hepatitis A virus vaccine inactivated and was assigned manufacturer report number A0388251A.  This report concerns a patient who on 07/02/2002 was vaccinated with a dose of hepatitis A virus vaccine inactivated.  Subsequently, the patient developed arthritis with muscle pain and joint pain.  This was originally reported by a registered pharmacist.  Additional information has been requested. FOLLOW-UP information from the reporting pharmacist stated, "The incident you refer to did not involve any product manufactured by Merck." Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea
Clinical narrative: Pt presented to ER w/ hisotry of 2 short episodes of apnea < 10sec. Overnight observation revealed no abnormalities.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Dizziness, Eye irritation, Paraesthesia, Throat tightness, Tongue oedema
Clinical narrative: 05/27/2003 states after received shots, face tingled, eyes burned, and felt dizzy. States when got home tongue swelled and throat felt like it was swelling. States took a nap and it resolved. BP 05/27/2003 received at health dept and waited 20 mm   BP 124/70 and stated was felling better when left  no complaints today 05/28/2003
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: 4 month old awoke in am with generalized tonic seizure brought to ER afebrile work- up. Blood chem normal, Brain CT/MRI normal, LP normal. Received immunization 16-18 hours earlier.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Oedema
Clinical narrative: Right deltoid inflamed swollen
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Knot in upper right thigh
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash erythematous
Clinical narrative: Pt had large red raised rash on thigh. Approx. 4x4 in diameter. Instructed to use Benadryl.
Age: 5.08
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Varicella.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Large 23x26cm indurated, red patch L lower ext (thing).
Age: 39.0
Sex: F
Vaccine: PNC, TTOX
Symptoms: Erythema, Feeling hot, Injection site pain, Joint range of motion decreased, Oedema
Clinical narrative: ABOUT SIX HRS AFTER HAVING THE SHOT MY ARM BECAME VERY SORE ABOUT THE SITE. LATER THAT EVENING MY ARM WAS SO SORE THAT I COULDN'T LIFT IT OR USE IT.  THE UNDERSIDE OF MY ARM BECAME VERY RED, SWOLLEN, HOT AND EXCRUCIATINGLY PAINFUL TO THE TOUCH.  IT LOOKED LIKE CELLULITIS.  TODAY, 4 DAYS AFTER THE SHOT, THE REDNESS AND SORENESS IS SUBSIDING.
Age: 39.0
Sex: F
Vaccine: PNC, TTOX
Symptoms: Pain
Clinical narrative: ABOUT SIX HRS AFTER HAVING THE SHOT MY ARM BECAME VERY SORE ABOUT THE SITE. LATER THAT EVENING MY ARM WAS SO SORE THAT I COULDN'T LIFT IT OR USE IT.  THE UNDERSIDE OF MY ARM BECAME VERY RED, SWOLLEN, HOT AND EXCRUCIATINGLY PAINFUL TO THE TOUCH.  IT LOOKED LIKE CELLULITIS.  TODAY, 4 DAYS AFTER THE SHOT, THE REDNESS AND SORENESS IS SUBSIDING.
Age: 57.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Pyrexia, Upper respiratory tract infection
Clinical narrative: 57 yo male with history of cardiomyopathy of unknown etiology received the smallpox vaccine on 3/13/03.  Experienced pruritis at the vaccination site and low-grade fever one week after vaccination which lasted 2 days.  Was called on 5/23 by health department representative for active surveillance follow-up.  At that time vaccinee reported that on 5/14/2003, in the setting of a febrile URI, he had been seen for follow-up at the heart failure clinic.  He reported no changes in cardiac symptomatology (no DOE, SOB, increased fatigue).  No new c/o at the time other than the URI. Cardiologist heard rales on auscultation of the lungs.  Performed an echocardiogram which revealed an ejection fraction of 30% (decreased from prior EF of 60% (by echo) done 2-3 years ago).  He was brought back to clinic on 5/19 for a MUGA scan which revealed an EF of 48%.  The patient is currently doing well, functioning at baseline, and back to work.  Will follow-up again with cardiologist next week.  We are awaiting medical records from the above described work-up.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Rt arm red and tender to touch.  warm to touch.  moves arm. swollen deltoid area.  5/30/03 phone call to mothershe stated child seen by a doctor on 5/29/03.  Dx'd with local reaction tX cold compresses and prn and cortaid ointment.  5/30/03 mother stated site looks better
Age: 23.0
Sex: M
Vaccine: HEPA, TD, TYP, YF
Symptoms: Erythema, Rash
Clinical narrative: Above client received yellow fever vaccine on 05/13/2003.  Nine days later called to report a generalized reddened rash.  Denies itching or fever.  Stated he took Benadryl 50mg.  After discussing his situation with the pharmacist.  Also states he repeated the Benadryl 50mg dose 4-5 hours later and today 05/03/2003 his rash is gone.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blister, Erythema, Injection site pustule, Injection site ulcer, Rash macular
Clinical narrative: Erythematous macular patch over trunk, flanks, thighs.  Pruritic with scale, blister, pustule, ulcerator. Lasted 5-7 days.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash pruritic
Clinical narrative: Erythematous macular patch over trunk, flanks, thighs.  Pruritic with scale, blister, pustule, ulcerator. Lasted 5-7 days.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash macular, Rash papular, Rash pruritic
Clinical narrative: Transient maculopapular, pruritic eruption on chest, back neck, face both arms-12 days after SPV & 13d after Anthrax #2.  Also with large local prescription after Anthrax dose 1-2.  Also presisten tremulousness after Anthrax #2 & SPV #1.  Rash resolved.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Erythema multiforme-Truncal distribution with macular papular patter-pruritic
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Migraine
Clinical narrative: Migraine headache right sided 8 days after SPV; Persisting about 1 week.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Anxiety, Condition aggravated, Nightmare
Clinical narrative: Anxiety attack, nightmares 2 hours after SPV. Aggravated by epinephrine. Vital signs, exam: no suggestion of anaphylaxis.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Rash papular
Clinical narrative: Patient presented with multiple red papules on the arm, legs, neck and back.  At the present lesions are not pruritic.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Patient was administered smallpox vaccine, 17 days later she broke out in multiple red papules that were very pruritic.  The papules are on the back, arms, legs, neck.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Reinoculation site 2 cm from initial innoculation along area of derifitis from tape reaction.
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Urticaria
Clinical narrative: small evacent urticaria 10 days post vaccination.
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Inoculated tape abrasion so 3 mm crust just like vacc crust beside vaccine.
Age: 0.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: ~55 yo female had progression of vaccination site thru all stages, but somewhat slow.  Scab did not form until 3 weeks post-vax and persisted until weeks 4-5.  Site healed completely.  At ~ 7 weeks post-vax, she developed 1.5-2 cm area of erythema and induration at vax site.  No fluctuance, no lymphadenopathy, no fever.  Patient with h/o breast CA, not currently on immunosuppressive drugs (only tamoxifen).
Age: 0.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: ~55 yo female had progression of vaccination site thru all stages, but somewhat slow.  Scab did not form until 3 weeks post-vax and persisted until weeks 4-5.  Site healed completely.  At ~ 7 weeks post-vax, she developed 1.5-2 cm area of erythema and induration at vax site.  No fluctuance, no lymphadenopathy, no fever.  Patient with h/o breast CA, not currently on immunosuppressive drugs (only tamoxifen).
Age: 0.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash vesicular
Clinical narrative: ~55 yo female had progression of vaccination site thru all stages, but somewhat slow.  Scab did not form until 3 weeks post-vax and persisted until weeks 4-5.  Site healed completely.  At ~ 7 weeks post-vax, she developed 1.5-2 cm area of erythema and induration at vax site.  No fluctuance, no lymphadenopathy, no fever.  Patient with h/o breast CA, not currently on immunosuppressive drugs (only tamoxifen).
Age: 3.0
Sex: M
Vaccine: DTAPH, HEP, HEPA, IPV, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: LEFT THIGH 3 X 2.5 CM RED AND WARM TO TOUCH.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Blood bilirubin increased, Chromaturia, Eye disorder, Hepatomegaly, Jaundice
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with mild reactive airway disease who on 1/25/02 was vaccinated in the right thigh with a second dose of MMR II (637983/0152L). Concomitant vaccination the same day included a first dose of Havrix (706A2), a fifth dose of Infanrix (524A2), a fourth dose of IPOL (t1464) given in the left deltoid and his first Tubersol (C0619AA) skin test given intradermally. Within 24 hrs, the pt developed a fever and experienced malaise and he was treated with Motrin. On 1/27/02, two days post vaccination, the pt had one episode of vomiting. His mother reported that his skin color and the "whites of his eyes" were yellow. The pt told his mother that his urine was "black." On 1/28/02, the pt was seen by a physician who noted that his liver was "slightly enlarged" and he had jaundice. Lab tests revealed an increase in bilirubin, but his liver function tests were within normal limits. The pt returned to the physician on 2/20/02 and his lab tests came back "OK." The physician told the pt's mother that the jaundice would resolve in a "couple of weeks." All other events resolved within one to four days of their onset. Follow-up info from the physician indicated that the child was well at the time of his vaccinations. It was reported that he received his first dose of MMR II at another practice on an unspecified date. The physician reported that the pt presented to his office on 1/28/02 and had a slightly enlarged liver and had some lab work done. The pt's liver enzymes were "slightly elevated, but not very much and certainly not as high as what you would expect with active disease. The child also had positive antibodies to hep A." The physician reported that he "is associating the adverse events with the hep A vaccine that the child received." Since that time it was reported that the pt has complained of stomachaches and the mother reported that the "child is not eating well." The pt has a doctor's visit on 2/19/02 and weighed 41 lbs. At another visit on 4/2/02, he weighed 40 lbs. It was reported that the pt has recovered from all of his adverse experiences. The pt's stomachaches and "not eating well" were considered to be incidental findings. Additional follow up info from the physician indicated that the pt's total serum bilirubin test, direct plasma bilirubin test, serum aspartate aminotransferase test, serum alanine aminotransferase test were reported as 3.7, 0.4, 110, 34, respectively. The pt's serum hep A antibody test on 1/28/02 was positive. No further info is available.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Liver function test abnormal, Malaise, Pyrexia, Vomiting, Yellow skin
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with mild reactive airway disease who on 1/25/02 was vaccinated in the right thigh with a second dose of MMR II (637983/0152L). Concomitant vaccination the same day included a first dose of Havrix (706A2), a fifth dose of Infanrix (524A2), a fourth dose of IPOL (t1464) given in the left deltoid and his first Tubersol (C0619AA) skin test given intradermally. Within 24 hrs, the pt developed a fever and experienced malaise and he was treated with Motrin. On 1/27/02, two days post vaccination, the pt had one episode of vomiting. His mother reported that his skin color and the "whites of his eyes" were yellow. The pt told his mother that his urine was "black." On 1/28/02, the pt was seen by a physician who noted that his liver was "slightly enlarged" and he had jaundice. Lab tests revealed an increase in bilirubin, but his liver function tests were within normal limits. The pt returned to the physician on 2/20/02 and his lab tests came back "OK." The physician told the pt's mother that the jaundice would resolve in a "couple of weeks." All other events resolved within one to four days of their onset. Follow-up info from the physician indicated that the child was well at the time of his vaccinations. It was reported that he received his first dose of MMR II at another practice on an unspecified date. The physician reported that the pt presented to his office on 1/28/02 and had a slightly enlarged liver and had some lab work done. The pt's liver enzymes were "slightly elevated, but not very much and certainly not as high as what you would expect with active disease. The child also had positive antibodies to hep A." The physician reported that he "is associating the adverse events with the hep A vaccine that the child received." Since that time it was reported that the pt has complained of stomachaches and the mother reported that the "child is not eating well." The pt has a doctor's visit on 2/19/02 and weighed 41 lbs. At another visit on 4/2/02, he weighed 40 lbs. It was reported that the pt has recovered from all of his adverse experiences. The pt's stomachaches and "not eating well" were considered to be incidental findings. Additional follow up info from the physician indicated that the pt's total serum bilirubin test, direct plasma bilirubin test, serum aspartate aminotransferase test, serum alanine aminotransferase test were reported as 3.7, 0.4, 110, 34, respectively. The pt's serum hep A antibody test on 1/28/02 was positive. No further info is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Flushing, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male pt with a history of transposition of the great artery (TGA), ventricular septal defect (VSD), subpulmonic stenosis, an atrial septostomy and a Rastelli procedure (September 1997) who on 3/7/02 at 11:30 was vaccinated SC in the right arm with the second dose (638515/0376L) of MMR II. There was no concomitant medication. A half-hour after vaccination, at 12:00, the pt developed a diffuse rash, flushing and urticaria over the torso and extremities. The pt's mother administered Benadryl 25mg and they returned to the physician's office. The pt then received dexamethasone 50mg IM, another Benadryl 25mg and Orapred 15mg/5cc, 1.5cc given. The symptoms subsided and the pt recovered. It was noted that an appointment was made with an allergist to investigate a possible latex allergy. No further info is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema multiforme, Gait disturbance, Joint swelling, Laboratory test abnormal, Rash
Clinical narrative: Initial and follow-up info has been received from a physician and a registered nurse concerning a 5 year old white male, with a history of urticaria lesions (treated with Zyrtec) and allergy to (Cefzil), who at 10 on 4/3/02, "at his kindergarten physical" was vaccinated with the second dose of MMR II (639914/0023M), administered SC, in the left thigh. Concomitant therapy, that same day and time, included the fifth dose of Infanrix (537A2), administered IM, in the right thigh and the first dose of "injectable" IPOL (U0614), administered SC, in the right thigh. It was noted that the pt had received oral poliovirus vaccine, previously. There was no additional concomitant medication and no illness at the time of vaccination. On the evening of 4/6/02 the pt developed joint swelling and erythema multiforme lesions. It was reported that he was unable to bear weight. The rash was present on his skin, only. There were no lesions in the eyes, mouth, or anal area. Unspecified medical attention was sought. Lab testing was performed. "Rapid strep" was positive. Rheumatoid factor, CBC, ESR, urinalysis, and CRP were negative. On approximately 4/10/02, the pt recovered. No further info is available
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash macular, Rash papular
Clinical narrative: Information has been received from a mother concerning her 14 month old daughter with no known allergies with an ear infection (frequent otitis media) and sinusitis who on 04/09/2002 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 640964/1096L) in the right arm subcutaneously.  Concomitant therapy that day included a dose of varicella virus vaccine live (site unknown).  Other concomitant therapy that day included antibiotics.  There were no other reported concomitant medications.  On 04/16/2002 the patient developed a fever and a runny nose.  On 04/17/2002 the patient developed a rash across her trunk which was reportedly "gone within a couple of days."  The patient sought unspecified medical attention.  Follow-up information from the patient's physician reported that on 04/17/2002 the patient developed a fever and an "erythematous maculo-papular rash on trunk".  The symptoms lasted for two days.  It was reported that the patient recovered on 04/19/2002.  It was noted that the patient and the patient's sibling did not have any adverse events following previous vaccinations.  On 05/21/2002 the patient had a complete blood count.  The absolute monocytes count was reported to be 1139 Cells/mcL (reference range 200-1000 mcL).  No further information is expected.