chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 39 month old white male with no pre-existing medical conditions or allergies, who on 15-Oct-2001 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot #639432/0787L). Concomitant vaccine therapy administered IM in the left arm on 15-Oct-2001 included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot #481548). It was reported the patient was not ill at the time of vaccination and the patient did not have any adverse events following prior vaccinations. On 12-Jan-2004 the patient developed an itchy rash described as "papules on face, head, trunk, legs". The registered nurse reported that the patient visited the physician, who treated the patient with diphenhydramine hydrochloride (Benadryl). There were no laboratory or diagnostic tests performed. The patient recovered. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning her daughter who in January 2000, was vaccinated with a 0.5 mL dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that her daughter subsequently developed full blown breakthrough varicella. It was unknown if medical attention was sought, but no prescription drug treatment was required. Subsequently, the physician's daughter recovered. The physician also reported that two of her other children developed mild breakthrough varicella after being vaccinated with varicella virus vaccine live. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 8 year old white female twin who on 09-Jul-1996 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot number 616867/0243D). Illness at the time of vaccination were: on 14-Jun-1996 treatment for otitis media and bronchitis, on 24-Jun-1996, the patient was treated for viral syndrome and fluid in the right ear and was finishing clarithromycin (Biaxin). On approximately 02-Jan-2004, at the age of 7 years old, the patient had several days of sporadic vomiting, "then fevers" and developed chickenpox described as a breakout of lesions with "areas of cellulitis" and was prescribed cefadroxil (Duricef). The patient was seen on 15-Jan-2004 with less than 50 lesions on the face, trunk and extremities. The outcome was recovered, date of recovery was unknown. The reporter considered chickenpox, cellulitis, vomiting and fevers to be other important medical events. No further information is expected. (OMIC)
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 8 year old white female twin who on 09-Jul-1996 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot number 616867/0243D). Illness at the time of vaccination were: on 14-Jun-1996 treatment for otitis media and bronchitis, on 24-Jun-1996, the patient was treated for viral syndrome and fluid in the right ear and was finishing clarithromycin (Biaxin). On approximately 02-Jan-2004, at the age of 7 years old, the patient had several days of sporadic vomiting, "then fevers" and developed chickenpox described as a breakout of lesions with "areas of cellulitis" and was prescribed cefadroxil (Duricef). The patient was seen on 15-Jan-2004 with less than 50 lesions on the face, trunk and extremities. The outcome was recovered, date of recovery was unknown. The reporter considered chickenpox, cellulitis, vomiting and fevers to be other important medical events. No further information is expected. (OMIC)
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 12-month old daughter who on 09-Jan-2002 was vaccinated with a dose of varicella virus vaccine live (lot #638244/0466L). Suspect vaccination on the same day included a third dose of HIB conj. vaccine (lot #639437/0929L) and a third dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 641449/1230L). The patient's vaccination history was noted to include a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (IPOL), and an "RV shot" on 27-Feb-2001, a first and second dose of HIB conj vaccine on 27-Feb-2001 (lot #638138/1548K (also reported as 1548K0")) and 01-May-2001 (lot #639437/0929L) respectively, a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) on 14-Aug-2001 (lot #640323/0753L) and 19-Nov-2001 (lot #640323?0753L) respectively, and a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live  on 01-Apr-2002 (lot #638706/0745L (also reported as "0745L0"). The mother reported that each time the patient "had a shot (any shot)" she experienced a rash around the diaper area and a fever (Hib conj vaccine (WAES #0401USA01373), hepatitis B virus vaccine rHBsAg (yeast) (WAES #0401USA01516) and measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES #0401USA01517). The mother was told to "just wait through the fevers." A product quality complaint was not involved. Additional information was received from a physician which indicated that there was no administration of varicella virus vaccine live to the patient at his facility. No further information is expected. The mother reported that the patient developed a severe urinary infection after therapy with Hib conj vaccine (WAES #0401USA01373).
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning an adult female who was vaccinated with a dose of varicella virus vaccine live (Lot #636580/0098L). Subsequently the patient "did not show seroconversion when titered post vaccination". No other information was available. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that one other patient "did not show seroconversion" (WAES #0312USA02727). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a moderate case of chickenpox. No other information was available at the time of this report. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that at the time of this report the patient was 8 years old. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a male who on 05-Aug-2002 was vaccinated with a dose of varicella virus vaccine live (lot #639432/0787L). In July 2003, the patient presented with chickenpox and recovered without treatment. In January 2004, the patient experienced zoster and was treated with acyclovir. It was noted that the zoster was localized to his right trunk. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product complaint involved. The reporter also indicated that the patient's sister (WAES #0402USA01326) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from an occupational health registered nurse concerning a 21 year old black female patient care assistant with no allergies, no history of chicken pox and no medical history on 07JAN2004 was vaccinated subcutaneously in the left arm with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On the night of 20JAN2004 the patient stated her temp was as high as 104F. On 21JAN2004 the patient was seen in the office with a fever of 101.2F and a sore, swollen, hard and slightly red, 2-3 diameter area (silver dollar size) around the injection site. There were no lesions at the time of report. The patient was advised to take acetaminophen (Tylenol) for an elevated temperature and discomfort, apply warm compresses to her left upper arm for discomfort and was then sent home. She was instructed not to return to work until she was afebrile. No diagnostic lab tests were performed. On 22JAN2004 the patient reported to the occupational health clinic prior to work. She was afebrile, there was no rash or redness and there was a "little" soreness. It was reported that the patient had recovered. No product quality complaint was involved. No further information is expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Information has been received from an occupational health registered nurse concerning a 21 year old black female patient care assistant with no allergies, no history of chicken pox and no medical history on 07JAN2004 was vaccinated subcutaneously in the left arm with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On the night of 20JAN2004 the patient stated her temp was as high as 104F. On 21JAN2004 the patient was seen in the office with a fever of 101.2F and a sore, swollen, hard and slightly red, 2-3 diameter area (silver dollar size) around the injection site. There were no lesions at the time of report. The patient was advised to take acetaminophen (Tylenol) for an elevated temperature and discomfort, apply warm compresses to her left upper arm for discomfort and was then sent home. She was instructed not to return to work until she was afebrile. No diagnostic lab tests were performed. On 22JAN2004 the patient reported to the occupational health clinic prior to work. She was afebrile, there was no rash or redness and there was a "little" soreness. It was reported that the patient had recovered. No product quality complaint was involved. No further information is expected.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old black female who on 09SEP2003 at 5:25AM, on 22OCT2003 at 3:15Am, and on 31DEC2003 at 2:50Am was vaccinated with a first, second and third dose of varicella virus vaccine live subcutaneously in the left deltoid, respectively. There was no illness at the time of vaccination. Subsequently, the patient "did not seroconvert after two doses of vaccine." Follow up information reported that the patient "did not seroconvert after three doses of vaccine." On 19FEB2004 the patient tested negative for VZV antibody. There was no product quality complaint involved. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Information has been received form a licensed practical nurse concerning a 12 month old male with upper gastroesophageal reflux and no known drug allergies who on 22JAN2004 at 11:30am was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant therapy included ranitidine HCl. There was no illness at the time of vaccination. The nurse reported that a few minutes after administration, the pt developed a flat are of redness at the injection site. Inside of the redness was a raised white rash described as hives. There was no itching and the reaction was localized. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Follow up information was received from a registered nurse who indicated that on 23JAN2004 at 11:30am the patient had an immediate reaction to the vaccination. It was described as a localized wheal and flare that occurred before the needle was out of the thigh. There were no other signs and symptoms. It was also noted that there were no adverse events following prior vaccination. No further information is expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old white female probation officer who on 01DEC2003 at 15:00 was vaccinated subcutaneously in the right arm with a second dose of varicella virus vaccine live at 15:00; SQ in right arm. Prior to receiving the first dose, on approximately 10OCT2003, the patient had a VZV IgG antibody test result of 0.22 (< or = 0.90 is negative with no VZV antibody detected; >= 1.10 is positive with VZV antibody detected). After the receiving the second dose, on 12JAN2004, the pt had a VZV IgG antibody test result of 0.72. The reporter noted that a titer did not show seroconversion. Unspecified medial attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved. Additional information is not expected.
Age: 3.5
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse RN concerning a 42 month old female with no allergies or pertinent medical history who on 20JUL2001 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 22JAN2004 the patient developed break through chickenpox characterized by 8-10 chickenpox "blobs" with two on her face. It was noted that the patient was afebrile. Unspecified medical attention was sought,but no laboratory/diagnostic tests were performed. At the time of this report, the patient's chickenpox persisted. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male who on 27MAY1999 was vaccinated with varicella virus vaccine live. On 23JAN2004 the patient developed 20-100 vesicular lesions. There was no fever. The patient sought medical attention. The pt was prescribed acetaminophen (Tylenol) and diphenhydramine HCl (Benadryl) for treatment. There was no product quality complaint involved Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 11 year old Caucasian son with no known medical history who on 25AUG1995 was vaccinated in the deltoid with a first 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. During the first week of January 2004 the patient developed a full blown case of chickenpox. Unspecified medical attention was sought. There was no treatment required for the adverse event. Subsequently the pt recovered. There was no product quality complaint involved. Follow up information form the physician indicated that the patient was not seen since 05OCT2002. It was reported that the pt has a history of congenital bilateral hydronephrosis and vesicostomy. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a female with no relevant medial history and no known drug allergies who on 25MAY1995 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient's mother reported that the patient developed multiple vesicles and papules on the trunk, back and scalp. It was noted the vaccine was administered at another practice and that the patient's sibling had chickenpox 11 days prior and was evaluated on 26DEC2003. Medical attention was not sought. It was noted that the patient recovered. No further information is requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Decreased appetite, Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female student who has a twin sister and a history of having been treated for reactive airway disease in the past who on 7/9/96 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 616867/0243D). There was no illness at the time of vaccination. On 1/2/04 the patient broke out with lesions of chicken pox, had vomited one time, had a decreased appetite, and on and off fevers. The patient was seen in the office with 20-30 lesions with areas of cellulitis. The patient was prescribed cefadroxil. Subsequently, the patient recovered. Chicken pox, vomited one time, decreased appetite, and cellulitis were considered to be other important medical events (OMIC). No further information is expected. It was also reported that the patient's twin sister was vaccinated with a first dose of varicella virus vaccine live (lot # 616867/0243D) and also developed chicken pox, vomiting and cellulitis.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female student who has a twin sister and a history of having been treated for reactive airway disease in the past who on 7/9/96 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 616867/0243D). There was no illness at the time of vaccination. On 1/2/04 the patient broke out with lesions of chicken pox, had vomited one time, had a decreased appetite, and on and off fevers. The patient was seen in the office with 20-30 lesions with areas of cellulitis. The patient was prescribed cefadroxil. Subsequently, the patient recovered. Chicken pox, vomited one time, decreased appetite, and cellulitis were considered to be other important medical events (OMIC). No further information is expected. It was also reported that the patient's twin sister was vaccinated with a first dose of varicella virus vaccine live (lot # 616867/0243D) and also developed chicken pox, vomiting and cellulitis.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who between 1998-2003 was vaccinated with a dose of varicella virus vaccine live. The nurse noted that the child had been vaccinated and then came down with shingles. The child was in the first grade and has been kept out of school. No other information was given. Unspecified medical attention was sought. There was no product quality complaint. The reporter also identified 14 other patients. Additional information has been requested.
Age: 3.6
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Eye swelling, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 43 month old female with a multicystic dysplastic right kidney and recurrent otitis media, and with no known drug allergies who on 30JUN2001 (reported as 31JUN2001) was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was also reported that the pt was also vaccinated IM in the right arm with a third dose of hepatitis b virus vaccine rHBsAg+ Hib conj vaccine on 28JUN2001. On 23JAN2004 the pt presented with chickenpox. At the time of the report, the child had not yet been seen by the physician but the diagnosis was made from information received over the phone. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 16JAN2004, the pt developed varicella pox after an "unvaccinated" sibling had varicella. the pt's pox spots rapidly spread to the entire body, including the inside of the mouth to the eyelids. Her eyelids were swollen shut. The pt also had a fever of 101-102 degrees. The pt continued to have a pox breakout that spread through 23JAN2004. The pox finally began to scab on 29JAN2004. The pt was treated with diphenhydramine hydrochloride, acetaminophen and oatmeal baths. the outcome was reported as recovered on 29JAN2004. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccination of the patient. The reporter also indicated that 2 of the patient's siblings developed mild varicella after vaccination with varicella virus vaccine live. This patient's case was worse than her siblings. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Pruritus, Rash, Viral infection
Clinical narrative: Information has been received form a registered nurse concerning a 6 year old male with attention deficit disorder who on 09SeP1999 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 20JAN2004 the pt presented to the drs office with chickenpox. The child had an itchy rash with blisters and bumps, head to toe, for 3 days. The child was afebrile. Treatment was over the counter medication as needed. Subsequently, the pt recovered from chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 year old male who was vaccinated with a dose of varicella virus vaccine live. On 1/25/04 the patient developed breakthrough chicken pox, with the rash onset was 1/25/04. The physician reported that he had a patient report to the office with a chicken pox like rash on 1/27/04. The rash had scabs on his back, stomach, and shoulders. The lesions were crusted over. The quantity was not recorded. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no known allergies and a history of otitis and no other pertinent medical history who on 2/1/99 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 628248/1659H). On 1/27/04 the patient developed breakthrough chicken pox. She presented to the clinic with fever and 300 chicken pox. It was noted that the chicken pox were on both legs and torso. Treatment was recommended with calamine (+) camphor (+) pramoxine hydrochloride, diphenhydramine hydrochloride, and calamine lotion. It was reported that the patient had not yet recovered from the chicken pox. There was no product quality complaint involved. Additional information has been requested.    Follow up information indicated that on Jan 26 2004, the patient developed a fever and vesicles all over her body. On 01/27/2004, the patient was diagnosed with varicella and over 100 lesions were noted throughout. The patient was treated with calamine (-) camphor (+) pramoxine hydrochloride (Aveeno), diphenhydramine hydrochloride (Benadryl) and calamine lotion. No ASA and Isolate. There were no lab test performed. On 02/03/2004 the patient recovered. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 year old male who was vaccinated with a dose of varicella virus vaccine live. The NP reported that the patient subsequently developed shingles along his waist/midline area. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a nurse concerning a male patient who in 1999 was vaccinated with a dose of varicella virus vaccine live (lot # 625387/0313H). On 1/30/04 the patient came to the office with about 10 chicken pox lesions. It was noted that there was another boy in the patient's class who had chicken pox. No lab diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 15 month old male who on 1/13/04 was vaccinated with the left thigh with a second dose of varicella virus vaccine live (lot # 646312/0829N). The patient's mother reported to the practice that on 1/25/04 the child developed about 20 vesicular lesions and no other symptoms. No product quality complaint was involved. Unspecified medical attention was sought. No other information was available. Follow up information indicated that the child developed a mild, scattered vesicular rash on 1/30/04. No labs or diagnostic tests were done and the patient recovered. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: DTP, OPV, VARCEL
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old black male with no known medical history who on 4/21/98 was vaccinated in the right arm with the first dose of varicella virus vaccine live. Concomitant vaccination on that same day included the fourth dose in the left arm of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # 7L81673) and the fourth dose PO of poliovirus vaccine inactivated (lot #776A1). There was no illness at the time of vaccination except for a slight fever. The NP reported that on 8/28/03, the subject developed a vesicular rash on the right temporal area, laterally around the right eye and upper lid. It was noted that the vesicular rash did not cross the mid-line. A diagnosis of shingles was made. Unspecified medical attention was sought and the patient was treated on an outpatient basis with acyclovir. Within a couple of days, the vesicles crusted over and the patient's shingles subsequently resolved. The NP also reported that another patient developed shingles after being vaccinated with varicella virus vaccine live. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Asthma, Bronchitis, Bronchospasm, Dysgeusia
Clinical narrative: My son received the Flumist vaccine. He became very nauseated immediately with complains of bad taste in mouth. He was weak that day. The next morning, he awoke vomiting, with a fever of 103.3, complains of severe headache, bronchitis, and extreme fatigue. I called the MD office where he received the vaccine, and they told me to watch him, and he should be better in "a couple of days." On the 3rd day he was better. However, he began experiencing exercise induced asthma attacks in January 2003. He was diagnosed with bronchospasm 5/2004. He had not had any reactive airway prior to the vaccine. He also has had return of chronic otitis media since vaccine- has history of OM when he was younger.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Nausea, Otitis media, Pyrexia
Clinical narrative: My son received the Flumist vaccine. He became very nauseated immediately with complains of bad taste in mouth. He was weak that day. The next morning, he awoke vomiting, with a fever of 103.3, complains of severe headache, bronchitis, and extreme fatigue. I called the MD office where he received the vaccine, and they told me to watch him, and he should be better in "a couple of days." On the 3rd day he was better. However, he began experiencing exercise induced asthma attacks in January 2003. He was diagnosed with bronchospasm 5/2004. He had not had any reactive airway prior to the vaccine. He also has had return of chronic otitis media since vaccine- has history of OM when he was younger.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: My son received the Flumist vaccine. He became very nauseated immediately with complains of bad taste in mouth. He was weak that day. The next morning, he awoke vomiting, with a fever of 103.3, complains of severe headache, bronchitis, and extreme fatigue. I called the MD office where he received the vaccine, and they told me to watch him, and he should be better in "a couple of days." On the 3rd day he was better. However, he began experiencing exercise induced asthma attacks in January 2003. He was diagnosed with bronchospasm 5/2004. He had not had any reactive airway prior to the vaccine. He also has had return of chronic otitis media since vaccine- has history of OM when he was younger.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old male who in 1998 was vaccinated SC with a dose of varicella virus vaccine live (lot # 627332/1243H). On 1/17/04 the patient developed breakthrough chicken pox. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's sister developed chicken pox after vaccination. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old female who on 1/16/04 was vaccinated SC with a first dose of varicella virus vaccine life (lot # 643597/0895M) 0.5ml. On 1/30/04, the patient presented to the doctors office with a left arm 4 by 4 cm lump described as red and hard, with a small spot underneath. There was no fever, no rash, no treatment provided and no prescription required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 14 month old male without any known immunosuppression who on 1/23/04 was vaccinated with a dose of varicella virus vaccine live. On 1/29/04, the patient developed full blown chicken pox described as a generalized chicken pox like rash. The parents of the child reported that over the weekend, the rash was getting worse with over 200 vesicles. The physician reported that the patient was otherwise healthy with the exception of low grade cold symptoms. It was noted that the child was without any known exposure to wild type virus. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 5 year old female who in 1999 was vaccinated SC with a dose of varicella virus vaccine live (lot # 631305/0728J). On 12/29/03 the patient developed breakthrough chicken pox. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's brother developed chicken pox after vaccination. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a person in a physician's office concerning an 8 year old white female who on 7/2/96 was vaccinated in the right arm with a first dose of varicella virus vaccine live (lot # 608318/0403B). On 1/30/04, the patient developed a mild case of chicken pox. Follow up information from the physician's office indicated that the patient fully recovered in one week. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HBHEPB, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 32 month old white male with no know drug allergies and a past medical history of Haemophilus B (examined by hemologist - no treatment) who on 6/7/02 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a first dose of MMR, a third dose of poliovirus vaccine inactivated, and a third dose of hepatitis B virus vaccine (+) HIB conjugate vaccine. There were no other concomitant medications. On 1/29/04 the patient developed a rash around the neck that spread to his trunk area and limbs, increasing in quantity. The patient was afebrile. The outcome was reported as unknown. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a licensed practical nurse indicated that there was no change in the patient's condition and no new data to provide. Additional information is expected.
Age: 2.0
Sex: M
Vaccine: FLU3, HBHEPB, MMR, VARCEL
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 25 month old white apparently healthy male with no known allergies and no medical history who on 1/6/03 was vaccinated SC in the right arm with a 0.5ml first dose of varicella virus vaccine live (lot # 638367/0198M). Concomitant vaccinations on 1/6/03 included a first dose SQ in the left arm of MMR (lot # 644234/0925M), a third dose IM in the left leg of hepatitis B virus vaccine  (+) HIB conjugate vaccine (lot # 643037/0652M) and a first dose IM in the right leg of influenza virus split virion 3v vaccine inactivated (lot U0941AA). There was no illness at the time of vaccination. On 2/5/04 the patient presented with shingles on his right arm near the injection site. It was reported that PCR testing was requested. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information fro the physician indicated that on 2/5/04 the patient developed shingles. The rash was described as shingles vesicle. The number of lesions were too numerous to count and they were distributed on the inner right arm, right palm. T1 and T2 dermatomes. The herpes zoster was described as coalescent vesicular patches scattered throughout T1 and T2 dermatone and right arm and chest. His maximum temperature was 98.6 and no other systemic symptoms were noted. It was reported that the patient did not have a history of chicken pox and no recent exposure to chicken pox was noted. The physician reported that a rash did not occur at the site of injection or elsewhere within 42 days of vaccination. The patient was started on cephalexin for infection on 2/10/04. A specimen was obtained from a vesicle and sent for PCR analysis on 2/10/04. The duration of the herpes was reported as 6 days and the patient recovered, however the patient's recovery status was also reported as evolving, remains anill. Follow up information indicated that the shingles began on 2/4/04, not 2/5/04 as previously reported. It was reported that the shingles was in the right arm, dermatoid in T1 and T2 distribution. There was no history of previous chicken pox thus presumably the zoster is from the vaccine strain. Samples have been sent for testing. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a physician concerning a 6 year old white female who on 12/11/98 was vaccinated in the right arm with a first dose of varicella virus vaccine live. On 2/3/04, in the PM, the patient developed vesicles on the trunk, legs, and arms. It was noted that the patient was afebrile. There was no laboratory diagnostic tests performed. Follow up information indicated that on 2/3/04 in the PM the patient developed vesicles on her trunk, legs, and arms. The vesicles began to disappear on the fourth day. The outcome was reported was recovered on 2/8/04. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with varicella virus vaccine live. Subsequently the patient developed chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No additional information available at this time. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a public health nurse concerning an 8 year old female who on 9/3/96 was vaccinated with a dose of varicella virus vaccine live (lot # MV87800). The reporter noted that the number on the bottle was MV87800, but the lot number was unknown. The reporter indicated that a school nurse told her that a vaccinated patient had chicken pox breakthrough. The mother of the patient called the school nurse on 2/5/04, stating that her daughter had been diagnosed with chicken pox by her primary physician. The patient had a high fever and chicken pox all over her body. Unspecified medical attention was sought and it was unknown if treatment was required. A product quality was not involved. Additional information was received from the public health nurse which indicated that a school nurse reported to the county health department that a third grade student was diagnosed by their primary doctor with chicken pox in January 2004. The patient had been previously vaccinated in 1996 with varicella virus vaccine live. The patient had a fever of 103 and according to the mother, was covered with chicken pox. No hospitalization was reported. Additional information has been requested.  Additional information was received from the school nurse which indicated that the patients mother called her at school to report that the patient had a high fever 104 and a rash on 2/05/2004. On 2/6/2004 the mother took the patient to the doctor and chickenpox was verified. Subsequently, the patient recovered. Additional information was received from a physician who indicated the patient missed school due to chickenpox. No further information is expected.
Age: 1.01
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Drug ineffective, Herpes zoster, Laboratory test abnormal, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male patient with no medical history who on 1/5/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644722/0072N). Concomitant vaccine therapy administered on 1/5/04 at the same appointment included a dose of MMR and hepatitis B virus vaccine (+) HIB conjugate vaccine. On 1/26/04 the patient developed 50+ lesions all over his body, fever, and malaise. The physician prescribed diphenhydramine hydrochloride, calamine lotion and acetaminophen as treatment. It is unknown whether laboratory studies were performed. There was no product quality complaint reported. Additional information has been requested.  As per follow up report: the additional information included lab study results for varicella zoster virus antibody ICM which was reported high at 6.35 ISR, varicella zoster virus antibody IGG which was reported positive with a result of 1.72 EIA, and blood culture results which showed no growth after five days. It was noted that the patient recovered. There was no product quality complaint reported. No additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male patient with no medical history who on 1/5/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644722/0072N). Concomitant vaccine therapy administered on 1/5/04 at the same appointment included a dose of MMR and hepatitis B virus vaccine (+) HIB conjugate vaccine. On 1/26/04 the patient developed 50+ lesions all over his body, fever, and malaise. The physician prescribed diphenhydramine hydrochloride, calamine lotion and acetaminophen as treatment. It is unknown whether laboratory studies were performed. There was no product quality complaint reported. Additional information has been requested.  As per follow up report: the additional information included lab study results for varicella zoster virus antibody ICM which was reported high at 6.35 ISR, varicella zoster virus antibody IGG which was reported positive with a result of 1.72 EIA, and blood culture results which showed no growth after five days. It was noted that the patient recovered. There was no product quality complaint reported. No additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DTP, OPV, VARCEL
Symptoms: Blister, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old white male with no medical history who on 2/27/98 was vaccinated SQ in the right arm with the first dose of varicella virus vaccine live (lot # 62443/1106E). Concomitant vaccinations on that same day included the fourth dose of IM diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid in the left arm (lot # 7091715) and the third dose of PO poliovirus vaccine inactivated (lot # 0907380). There was no illness at the time of vaccination. The physician reported that, on the morning of 2/6/04, the patient was diagnosed with chicken pox characterized by approximately 20 lesions (vesicles with a red base) mainly on his trunk and extremities. The patient was noted to be afebrile and had no cough, itching, or any other symptoms at that time. Unspecified medical attention was sought, but no prescription drug was required for treatment. In February 2004, the patient's chicken pox resolved. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Cold sweat, Drug ineffective, Fatigue, Infection
Clinical narrative: Information has been received from the mother of a 7 year old female who in March 1997 was vaccinated with a dose of varicella virus vaccine live. On the morning of 2/6/04, the patient developed a stomach ache, and she complained of being tired. There was no fever. The stomach ache later resolved. Upon waking up the next morning on 2/7/04, the patient's skin was clammy and she developed a mild case of chicken pox. It consisted of 4-5 pox across her forehead, 1 on each cheek, 1 on her chin, 6-8 on each arm and 3-4 on each leg with the majority of the breakout occurring on her chest, stomach, and back .The blisters were different sizes. Although she did not complain if itchiness, she did experience a stinging sensation when a few of the blisters popped. On 2/7/04 at 11:30, the patient was seen by her family doctor. At that time, her temperature was normal and a diagnosis of chicken pox was confirmed. Acyclovir 200mg/5ml, 2 teaspoon 4 times a day for 5 days was prescribed. At the time of report the patient had not yet recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 6/1/99 was vaccinated IM with a dose of varicella virus vaccine live. On 2/6/04 the patient developed a rash all over her body and a low grade fever. On 2/9/04, the patient was seen by the physician who diagnosed the patient with varicella. It was reported that the physician did not consider the breakthrough as serious. There were no lab tests performed. As of 2/9/04, no treatment was necessary and the patient had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of varicella virus vaccine live and had " a reaction ".  Unspecified medical attention was sought. No product quality complaint was involved. No additional information was provided. Follow up information from a pharmacist indicated that the event was reported to VAERS.  No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pyrexia
Clinical narrative: Information has been received from a physician concerning an adult female with a concurrent condition of asthma and no known drug allergies who on 01/23/04 was vaccinated with a dose of varicella virus vaccine live (Lot # 642685/0328M) that had expired. The pt "has now", on approximately 02/12/04, "developed papular vesicular rash with lesions on the trunk and arms, with left eye conjunctivitis".  The pt was "non febrile".  Unspecified medical attention was sought. There was no product quality complaint involved.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 30 year old female with no known allergies and a history of migraines who on 03/17/03 and 04/16/03 was vaccinated with the first and second doses of varicella virus vaccine live (Lot # 643533/0768M); 2nd dose (Lot # 643824/0870M). Concomitant medication included Zomig. It was also reported that the pt received an injection of Depoprovera on 03/17/03.  On 02/04/04, the pt had a negative titer. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.   Follow up information received from a registered nurse indicated that the patient had a failure to seroconvert to immune status. Lab tests for varicella zoster obtained on 01/08/2003 and 02/04/2004 showed that the patient was non immune. No further information is expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Nausea, Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning an adolescent male pt who on 06/06/95 was vaccinated with a dose of varicella virus vaccine live (Lot # 608580/0408B).  There was no concomitant medication. "Over the past week", on approximately 02/13/04, the pt developed chickenpox. He developed about 300 lesions with nausea and a low grade fever. He was treated with Benadryl over the counter orally and topically. Unspecified medical attention was sought. No product quality complaint was involved. The pt's sister (WAES # 0402USA01853) had a similar experience after vaccination with varicella virus vaccine live (Lot # 608580/0408B). Additional information has been requested. Follow up information indicated that approximately 9 years after given varicella virus vaccine live, on Jan 30 2004, the child developed chickenpox. It was reported at 9:00 am that he had over 300 lesions. The patient recovered on Feb 4 2004. There were no lab or diagnostic test done. It was also reported that the mother was concerned that he developed chicken pox after receiving the vaccine. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning an adolescent male pt who on 06/06/95 was vaccinated with a dose of varicella virus vaccine live (Lot # 608580/0408B).  There was no concomitant medication. "Over the past week", on approximately 02/13/04, the pt developed chickenpox. He developed about 300 lesions with nausea and a low grade fever. He was treated with Benadryl over the counter orally and topically. Unspecified medical attention was sought. No product quality complaint was involved. The pt's sister (WAES # 0402USA01853) had a similar experience after vaccination with varicella virus vaccine live (Lot # 608580/0408B). Additional information has been requested. Follow up information indicated that approximately 9 years after given varicella virus vaccine live, on Jan 30 2004, the child developed chickenpox. It was reported at 9:00 am that he had over 300 lesions. The patient recovered on Feb 4 2004. There were no lab or diagnostic test done. It was also reported that the mother was concerned that he developed chicken pox after receiving the vaccine. Additional information is not expected.