chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a RN concerning a 12 month old white female with no known allergies or medical conditions who on 14-APR-2003 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot number 644031/1058M). Concomitant therapy included a first dose SC in the left thigh of MMRII (lot number 644708/1125M). There was no illness at the time of vaccination. On 24-APR-2003 the reporter stated that there were "more spots last night, low grade fever, four to five small papules, chickenpox." Unspecified medical attention was sought. It was noted that there were no diagnostic tests or laboratory results. There were no adverse events following prior vaccination. Additional information from the RN indicated that in the pm of 23-APR-2003 there were four to five small papules on the first day, then a generalized rash with fever and one episode of emesis for four days. The pt subsequently recovered. No further information is expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old female with an unknown medical history who on 04FEB1997 was vaccinated with a dose of varicella virus vaccine live. It was unknown if the patient was on concomitant medication. ON 02APR2003 the patient was seen in the office with a "very mild case of chicken pox". No lab or diagnostic studies were performed It was also reported that there had been a serious outbreak of chicken pox in local schools. Unspecified medical attention was sought. It was also noted that three other patients, two of whom are siblings of the above mentioned patient, were vaccinated with a dose of varicella virus vaccine live and developed chicken pox.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 24 month old male patient with no past medical history who on 26MAR2002 was vaccinated subcutaneously in the right leg with a 0.5ml dose of varicella vaccine live. There was no concomitant medication or vaccinations. On 01APR2003, the patient developed vesicular lesions on a red base on the right anterior hip and thigh int he L2 distribution, spreading  to the groin and penis. Unspecified medical attention was sought, but no therapy was required.  On approximately 17APR2003, the patient was seen by the physician and the lesions had dried out. The patient was sent to the dermatologist, but there had been no report and it was unknown if the lesions were scraped. The reporter indicated that the adverse experience required no treatment, the adverse experience abated and the patient recovered. The reporter also mentioned two other patients that had adverse experiences following vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 30 year old female who in 1998 was vaccinated at another medical facility with a first and second dose of varicella virus vaccine live. On 24APR2003, it was reported that "a few weeks ago" antibody testing was performed and the results were negative. The physician questioned if the patient needed to be revaccinated.  Unspecified medical attention was sought. Additonal information has been requested.
Age: 3.25
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 19 month old white male with no past medical history and no known drug allergies who on 29DEC2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. The child had bilateral otitis media serous at the time of vaccination. ON approx. 25MAR2003 the patient broke out with lesions of chickenpox. The patient was seen and treated on 28MAR2003. The reporter indicated that the patient recovered. No diagnostic tests or laboratory data were reported No further information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with asthma that does not require any chronic medications and a history of Kawasaki's disease in 1997 who on 28MAY1997 was vaccinated in the arm with a dose of varicella virus vaccine live. There were no concomitant vaccinations on that day. On 19APR2003 while on vacation in Cancun, the patient developed a red raised rash on her chest, spreading to her arms. There were over 60 lesions and lots of itching. On 22APR2003, the patient was seen by the physician and was treated with oral Benadryl. At the time of the report, the physician expects the rash will still be there. The reporter also mentioned two other patients had adverse experience following vaccination with varicella virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a child patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chickenpox. The reporter also mentioned two other patients that had adverse experiences following vaccinations with varicella virus vaccine live. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular, Rash pustular
Clinical narrative: Information has been received from a RN concerning an 8 y/o white female child with no past medical history and no known drug allergies who in September 1995 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. It is unknown if there were adverse events following prior vaccinations of the patient or her siblings. On 16Apr2003 the pt developed multiple macules and pustales and some scabs on her trunk, face, and extremities. The pt was treated with acyclovir (ZOVIRAX) x 5 days. The reporter indicated that the pt recovered. No diagnostic tests or laboratory data were reported. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a vaccine technician concerning an adult female who in approximately April 1999, 4 years ago, was vaccinated with a 2 dose series of varicella virus vaccine live. The reporter indicated that "ELISA test titer negative". No additional information is available at this time. Unspecified medical attention was sought. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 21 y/o female pt with no relevant medical history who on 28Jan1999 and 11Mar1999 received a first and second dose of varicella virus vaccine live (lot number unk), respectively. There was no illness at the time of vaccination. There was not concomitant medication. On 21Apr2003, a titer for varicella was completed and results were negative (results previously reported as "no immunity". It was also noted that there were no "problems" with the vaccine and no side effects. Unspecified medical attention was sought. No further information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 y/o white male with minimal reactive airway disease who on 30Sep1996 was vaccinated IM in the left thigh with a dose of varicella virus vaccine live. There was no listed illness at the time of vaccination. The reporter indicated that on 24Apr2003 the pt broke out with chickenpox. It was noted that the pt had greater than 50 lesions. Unspecified medical attention was sought. Follow up information has been received from the licensed practical nurse which indicated that on 25Apr2003 the pt came to the dr's office with a rash which started "yesterday". A physician diagnosed the rash as "probable varicella." The reporter also noted that there was no note in the chart that stated which route of administration was used. It was indicated that the patient recovered. There were no diagnostic tests or laboratory results. There were no adverse events following prior vaccination. No further information is expected. The reporter also noted that she has been seeing many cases of chickenpox in children who where previously vaccinated with a dose of varicella virus vaccine live.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 month old female who on 25MAR2003 was vaccinated with a dose of varicella virus vaccine live (lot #643593/0868M). On 18APR2003 the patient's mother noted a rash on one foot and hand. On 25APR2003 the patient presented to their office with a rash on the left side as well and it was diagnosed as shingles. Unspecified medical attention was sought. It was unknown if treatment was required for the shingles.
Age: 4.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male patient with a history of contact dermatitis at 18 months of agae who on 28APR2000 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot no. 632724/0087K). concomitant vaccination in the left leg included a third doe of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (Lot 1317K). There was no illness at the time of vaccination. On 27APR2003, the patient developed "typical" chickenpox. The patient presented to the doctor's office with approximately 20 widely disseminated vesicular lesions, but no treatment was required. Subsequently, the patient recovered. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old Caucasian female patient who on 30NOV1998 was vaccinated with a first dose of varicella virus vaccine live (Lot no. 626768/0669H). On 25-APR-2003, the patient developed chickenpox. On 28APR2003, the patient presented to the doctor's office with a few "typical" lesions on her face and chest. The lesions were dry. The patient did not have a fever. It was noted that the patient had been around a girl who had chickenpox. Subsequently, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a female registered nurse with no known drug allergies and no past medical history who on 24APR2003 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the day following the vaccination, the patient developed a "fine maculopapular rash" on her "trunk and extremities" and fever of 101 deg F. The patient was reported as "recovering with sequalea". Unspecified medical attention was sought. Follow up information indicated that the patient developed a maculopapular rash on 28APR2003. No pustules were noted. The rash was described as a fine, itchy, maculopapular rash over her chest, trunk, abdomen, and upper extremities. The rash improved with diphenhydramine hydrochloride (BENADRYL) after two days. The outcome was reported as recovered. No further information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 7 y/o white male student with no medical history and no allergies who on 07Oct1996 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. On 10Mar2003 the pt was "seen here" and it was reported that had "broken out" with chickenpox which was complicated by impetigo. Medical attention was sought and the pt was treated with amoxicillin trihydrate (AUGMENTIN) and mupirocin (BACTROBAN) "(sister + strep)". There were no diagnostic or laboratory tests performed. Subsequently, the pt recovered. No further information is expected.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Gastroenteritis, Medication error, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician and the pt's mother concerning a 19 month old female who had no medical history who on 11Apr2003, at 1000, was vaccinated in the left vastus lateralis with the second dose of varicella virus vaccine live (second dose given due to clinical error in recording first dose given on 20Sep2002). There was no concomitant therapy. On 28Apr2003, the pt presented to the physician's office with diarrhea and vomiting. A diagnosis of gastroenteritis was made. The pt's mother also reported that in April 2003, for over a week, her daughter also developed a fever and a few spots on her skin. As of 02Jun2003, the pt was without complaints. It was also noted that the pt did not have any problems after her first dose. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 4 year old female who on 01Sep2000, was vaccinated with a dose of varicella virus vaccine live. The LPN reported that in April 2003 the pt presented to the physician's office with a rash. The pt had approx. 25-50 lesions on her turso and buttocks. A diagnosis of chickenpox was made. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Otitis media, Rash macular, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a 5 y/o white female with an allergy to amoxicillin noted on 13Feb1999 who on 04Mar1999 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 04Mar1999 the pt was also vaccinated IM in the left arm with a third dose of hepatitis B vaccine recombinant (ENGERIX B). There was no other concomitant medication. The pt had serious otitis media at the time of vaccination. There were no adverse events following prior vaccinations. On 22Apr2003 the pt developed multiple vesicles and macules and draining vesicles on his face, trunk, and extremities. Medical attention was sought and he was treated with acyclovir (ZOVIRAX) x 5 days and topical relief. No diagnostic or laboratory tests were performed. Subsequently, the pt recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a health professional concerning a pt who on 04Feb1997 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 02Apr2003 the pt experienced breakthrough chickenpox which was described as a small fluid filled rash all over the body with itching. The reporter indicated that 2 other patients were vaccinated with a dose of varicella virus vaccine live and developed breakthrough chickenpox on 02Apr2003. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a certified medical assistant concerning an 8 y/o white female pt who on 24Aug2000 was vaccinated SC in the Left arm with a first dose of varicella virus vaccine live. 0.5mL. On 28Apr2003, the pt developed chickenpox. She had no fever. She was seen in the office on 29Apr2003, with about 40 lesions on the thighs, trunk, and back. Medical attention was sought and no treatment was required. Subsequently, the pt recovered. No further information is expected. This is a consolidation of two reports concerning the same pt.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old female pt with no relevant medical history and no known drug allergies who on 13Oct2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. An illness at the time of vaccination was urinary frequency with a negative culture. There was no concomitant medication. On 22Apr2003 the pt developed a fever of 104 degrees and chickenpox described as a mild rash that began on the forehead and spread to the neck, back and abdomen with 20 lesions, papules and vesicles. It was noted that there were no other symptoms. There was no relevant laboratory data. Unspecified medical attention was sought. She was treated with acetaminophen (Tylenol) and diphenhydramine HC1 (Benadryl). Subsequently, the pt recovered. No other information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a pt who on 21Jul1998 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 02Apr2003 the pt experienced breakthrough chickenpox which was described as a small, fluid filled rash all over the body with itching. The reporter indicated that 2 other pt's were vaccinated with a dose of varicella virus vaccine live and developed breakthrough chickenpox on 02Apr2003. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Concomitant medications included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation ) (MSD). There were no other concomitant medications. On 02Apr2003 the pt experienced breakthrough chickenpox which was described as a small, fluid filled rash all over the body with itching. It was noted that the pt had over 100 seen. The reporter indicated that 2 other pt's were vaccinated with a dose of varicella virus vaccine live and developed breakthrough chickenpox on 02Apr2003. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning a 26 month old white male with a history of a sacral dimple (normal MRI) who on 11Apr2002 was vaccinated SC in the right thigh with a first 0.5mL dose of varicella virus vaccine live. The pt had a small hematoma on his right toe at the time of vaccination. Concomitant therapy that day included a first dose in the right leg of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD), a fourth dose in the left leg of Streptococcus pneumoniae vaccine (PREVNAR), and a fourth dose in the left leg of HIB conjugate vaccine (HIBTITER). There were no other concomitant medications. On 28Apr2003 the child presented to the office with a rash on his right thigh. A dermatology consult stated that the rash was herpes zoster. The rash was described as "maculopapular and disseminated in crops over the entire right thigh". No other symptoms were noted. The physician indicated that upon follow up with the child's mother, the rash had almost completely cleared. Follow up information received from a physician indicated that on 28Apr2003, one year after receiving the varicella virus vaccine live injection, the child developed a herpetic rash in the same location as the injection. The physician indicated that the rash is resolving. There was no rash at the site of the injection or elsewhere within 42 days of the the vaccination. It was also noted that the child did have a fever 2 weeks prior to the rash, but was afebrile at the time of the herpes zoster onset. It was noted the child's pain was quantified as 0 to a 1 (10 being the most), indication that it was just a little itchy. There were no other systemic symptoms. There was no history of chickenpox or recent exposure to chickenpox or herpes zoster. No direct flourescent antibody was done. No specimen was collected for PCR. No photo was taken. It was also noted that when the child was 22 months old he was vaccinated with a fourth dose of diphtheria toxoid (+) pertussis vaccine and developed a swollen right arm at the injection site. There were no adverse events following prior vaccinations for the pt's siblings. Relevant diagnostic tests and laboratory data are located in the lab's section of the report. As per the consultation report, the clinical impression and diagnosis was: 1) well developed 24 month old boy at 90% and 98% for height and weight. 2) Immunization up to date. 3) S/p Herpes Zoster lesions (shingles). 4) Normal CBC and differential. 5) Normal Lymphocyte Subpopulations. 6) Normal Immunoglobulins,G, A, M, E, and IgG subclasses. 7)Protective Pneumococcal, Tetanus, Diphtheria, and H Influenzae B titers. 8) Normal Complement. The pt was recommended to have at hand acyclovir (ZOVIRAX) ointment to apply using a finger cot or rubberglove QID for 7 days (if a similiar lesion reappears), and to follow up as needed. No further information is expected.
Age: 1.58
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a RN reporting on behalf of an MD concerning a 19 month old male pt who on 03Apr2003 was vaccinated in the right arm with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 17Apr2003 in the AM, a follow up visit indicated that the pt had 2 red papules at the site of injection. There was no relevant diagnostic data. It was also noted that the pt was otherwise unremarkable. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician assistant who is a female pt that was vaccinated with four doses of varicella virus vaccine live and "did not seroconvert", "{per commercially available aviable tests}". It was noted that she was exposed to chickenpox "yesterday" on 29Apr2003 and that she was not pregnant. The pt received Globulin, Immune, VZIG (Human), (VZIG) on 30Apr2003. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, HEP, VARCEL
Symptoms: Acne, Drug ineffective, Infection, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old hispanic male who on 14Apr2003 was vaccinated in the left thigh SQ with the first dose of varicella virus vaccine live, 0.5mL. (Lot #0549B not valid) Concomitant vaccinations on that same day included the third dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (MSD) (Lot #645024/1169M) in the right leg and the third dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacterer unknown). On 26Apr2003, the pt's vaccine injection site area became red, slightly swollen and a lump also noted. On that same day, the pt developed pimple-like areas on his left breast, his upper lip and left ear. The pt was noted to be afebrile (96.2), irritable and was not sleeping well. A diagnosis of mild varicella was made. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, HEP, VARCEL
Symptoms: Injection site swelling, Insomnia, Irritability, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old hispanic male who on 14Apr2003 was vaccinated in the left thigh SQ with the first dose of varicella virus vaccine live, 0.5mL. (Lot #0549B not valid) Concomitant vaccinations on that same day included the third dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (MSD) (Lot #645024/1169M) in the right leg and the third dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacterer unknown). On 26Apr2003, the pt's vaccine injection site area became red, slightly swollen and a lump also noted. On that same day, the pt developed pimple-like areas on his left breast, his upper lip and left ear. The pt was noted to be afebrile (96.2), irritable and was not sleeping well. A diagnosis of mild varicella was made. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning an adult female who was vaccinated with a first dose of varicella virus vaccine live. The reporter indicated that the pt developed a mild chickenpox rash after the initial dose. Unspecified medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received concerning a 6 year old female pt who on 02Jul1997 was vaccinated with a dose of varicella virus vaccine live. The pt developed a moderate case of chickenpox. It was noted that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint reported. It was also reported that three other pt's developed a similar reaction. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 44 year old male pt who on approximately 18Apr2003, was vaccinated with a dose of varicella virus vaccine live. On 02May2003, the pt presented to the office with 7 disseminated vesicular lesions on the trunk and face. Unspecified medical attention was sought. There was no product quality complaint reported. MD provided no further information.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a female pharmacist who in March 1998, was vaccinated with a dose of varicella virus vaccine live. On approximately 25Apr2003, a titer was drawn and was negative. The pt noted that it was important because she wants to become pregnant soon. Unspecified medical attention was sought. It was noted that a product quality complaint was not involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning a male pt who on 06Aug2002 was vaccinated with a dose of varicella virus vaccine live. On 23Apr2003 the pt developed break-through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other pt's were vaccinated with a dose of varicella virus vaccine live and developed break-through chickenpox. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer concerning her 10 year old son who seven years ago, in approximately 1996, was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child "broke out with chickenpox this week and has 52 pox on his body." It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information was received from a woman in a physician's office which indicated that she was not able to "locate" the pt involved in this case. Therefore, no further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with varicella virus vaccine live. The RN reported that on 12Apr2003 the pt's 7 month old younger brother who had not been vaccinated because of his age came down with chickenpox. Subsequently two weeks later, reported as 26Apr2003, the pt, who had been vaccinated, "broke out with a moderate case of chicken pox". Unspecified medical attention was sought. The reporter mentioned that two other siblings also "broke out with a moderate case of chicken pox" following vaccination with varicella virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Infection transmission via personal contact
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated (date unknown) with varicella virus vaccine live. It was noted that 12-Apr-2003 the patient's 7 month-old younger brother who had not been vaccinated because of his age came down with the chicken pox. Subsequently two weeks later, reported as 26-Apr-2003, the patient who had been vaccinated, "broke out with a moderate case of chicken pox". Unspecified medical attention was sought. The reporter mentioned that two other siblings also "broke out with moderate cases of chicken pox" following vaccination with varicella virus vaccine live (WAES #0304USA01423), (WAES#0305USA00437). Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received concerning a 7 year-old patient who on 26-Aug-1996 was vaccinated with a dose of varicella virus vaccine live (lot number 617075/1663B). The patient developed a moderate case of chickenpox. It was noted that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint reported. It was also reported that three other patients developed a similar reaction (WAES#0305USA00312), (WAES #0304USA535) and (WAES #0305USA00536). Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received concerning an 8 year old male patient who was vaccinated with a dose of varicella virus vaccine live (the patient's mother stated that the child was immunized but "could not produce and immunization record"). The patient developed a severe case of chickenpox. It was also note that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsquently, the patient recovered. There was no product quality complaint reported. It was also reported that three patients experienced a similar reaction (WAES #0305USA0313), (WAES #0305USA00534) and (WAES #0305USA00536). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received concerning a 3 year-old female patient who was vaccinated with a dose of varicella virus vaccine live (it was noted that there was no immunization record however, the patient's mother stated the child was immunized). The patient developed a moderate case of chickenpox. It was also noted that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint reported. It was also reported that three other patients experienced similar reactions (WAES #0305USA00312), (WAES #0304USA00534) and (WAES# 0305USA00535). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 09-Jun-1999 was vaccinated with a dose of varicella virus vaccine live. On 23-Apr-2003 the patient developed break-through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break-through chickenpox (WAES #0305USA00356 and 0304USA00585 through 0305USA00595). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old female who on 30-May-2000 was vaccinated with a dose of varicella virus vaccine live. On 17-Mar-2003 the patient developed break-through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break-through chickenpox (WAES #0305USA00356, 0304USA00584, 0305USA00586 through 0305USA00595). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male on 09SEP1999 was vaccinated with a dose of varicella virus vaccine live. On 11APR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 15 week old female patient who on 03SEP2002 was vaccinated with a dose of varicella virus vaccine live On 03APR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old female who on 09-FEB2002 was vaccinated with a dose of varicella virus vaccine live. On 24FEB2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old patient who on 21MAY2001 was vaccinated with a dose of varicella virus vaccine live. On 03MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients received a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 3.75
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 45 month old female who on 12JUN2002 was vaccinated with a dose of varicella virus vaccine live. On 24MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with  a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old patient who on 31JAN2000 was vaccinated with a dose of varicella virus vaccine live. On 24MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old male who on 29Jan1998 was vaccinated with a dose of varicella virus vaccine live. On 12MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine and developed break through chicken pox. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old male who on 16MAY1998 was vaccinated with a dose of varicela virus vaccine live. On 10FEB2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine and developed break through chickenpox. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 28SEP1998 was vaccinated with a dose of varicella virus vaccne live. On 21FEB2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old female who on 02FEB1999 was vaccinated with a dose of varicella virus vaccine live. On 04 FEB 2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Age: 1.7
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional and a physician concerning an approximately 18 month old female child with no allergies an no history of chickenpox or recent chickenpox exposure who on 11JUL202 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot 642632/0324M). There was no concomitant medication. It was also noted that no rash occurred at the site of injection post-vaccination. In December 2002 a "first episode" of "manylesions" occurred. The patient subsequently recovered. On 19APR2003 the child developed a rash with two coalescent lesions on the right heel. A specimen form the rash was sent for a direct fluorescent antibody test and a culture and both were negative. The reporter noted that se did not know what type of rash the child had. Additionally, it was noted that on 19APR2003 the patient developed herpes zoster. A specimen was obtained on 22APR2003 from a papule lesion for varicella zoster virus (VZV) analysis at Columbia University. Information was received from the VZV Identification Program at Columbia University which indicated that the specimen was insufficient to properly analyze, no VZV DNA was amplified and was "negative for b-globin, no strain ID". It was noted that the patient recovered. Additional information was received from a woman in the physician's office who stated that "this was the second occurrence of these lesions/rash on the same site, the right heel." The reporter did not have a definitive diagnosis related to the rash and did not think herpes zoster was the definitive diagnosis. She also stated that the direct fluorescent antibody was negative but there were too few cells to interpret the data, therefore it was more likely to be an inadequate specimen. No  further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with varicella virus vaccine live. It was reported the patient later developed chicken pox and required treatment with acyclovir. It was noted no other information was provided. Additional information has been requestsed.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information form the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 10 year old patient (Grade 03:5St) who on 11SEP1996 was vaccinated with a dose of varicella virus vaccine live. On 03DEC2002, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Furuncle, Infection, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician, consumer and nurse concerning a 12 month old white female with no allergies or medical history who on 22APR2003 at 2:45PM was vaccinated IM in the left thigh with a dose of varicella virus vaccine live (lot 643532/0601M). There was no illness at the time of vaccination. The reporter indicated that the patient developed cellulitis at the site of injection. In the AM of 6MAY2003, two weeks after injection, the patient developed a poc at the site which became infected. It was indicated that the patient was also on ibuprofen. It was noted that the patient was well at the time of the visit to the office and had developed a hot and swollen area at the injection site that was treated with ibuprofen and amoxicillin. It was noted that the patient recovered. A product quality complaint was not involved.
Age: 7.0
Sex: F
Vaccine: DTP, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from an office manager concerning a 7 year old hispanic female patient with no relevant medical history and no known allergies who on 21FEB1997 was vaccinated with a first dose of varicella virus vaccine live 0.5ml.On 21FEB1997, concomitant medication included a fourth dose of diptheria toxoid+pertussis vaccine+tetanus toxoid. On 06MAY2003 at 07:00, the patient was diagnosed with a moderate case of chickenpox also described as a moderate varicella rash. Medical attention was sought. The patient was given phenergen for itch/pain. ON 12MAY2003, the patient recovered. No further information is expected.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Arthralgia, Pruritus
Clinical narrative: 2 MONTHS AFTER THE 4TH VACCINATION AN ITCHY PIMPLE RAISED FOR 2 DAYS THEN SUBSIDED.  5 MONTHS AFTER THIS SAME VACCINATION THE PIMPLE RETURNED THIS TIME IT WAS 5x THE SIZE OF THE FIRST AND EXTREMELY ITCHY.  ALSO JOINT PAIN IN LEFT ELBOW AND LEFT KNEE WAS PRESENT AND STILL HAS NOT SUBSIDED (AT TIME OF SUBMITTAL OF THIS REPORT)
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: RASH, SWELLING, FEVER X 3 DAYS
Age: 5.0
Sex: F
Vaccine: DT, IPV, MMR
Symptoms: Erythema, Pruritus, Rash, Rash macular
Clinical narrative: Parent reports pt. scratching neck and red blotches and some rash 5/6.  By 5/7, entire neck, upper chest red like "sunburn, slight rash".  Child itching, seen by Dr. 5/7, tx prednisone 5 mg. 2xday.  P.A. states "doesn't think it's from serum; suspects mfg. process".
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Abnormal behaviour, Aggression, Cellulitis, Injection site mass, Rash
Clinical narrative: Within 2 days child developed a rash and induration on his left thigh.  This gradually resolved over 3 days.  Around this time child's behavior changed: mother says he became very aggressive, would not be quitened down, would hit people, growl at parents.  She says this behavior is new and is convinced that it is related to the vaccine, possible MMR. Nurse follow up on 06/02/04 states: ADD: cellulitis (L) thigh.  Nurse follow up on 06/16/04 states: "No new information."
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Abnormal behaviour, Fall, Memory impairment, Oedema peripheral, Rash
Clinical narrative: Within 2 days child developed a rash and induration on his left thigh.  This gradually resolved over 3 days.  Around this time child's behavior changed: mother says he became very aggressive, would not be quitened down, would hit people, growl at parents.  She says this behavior is new and is convinced that it is related to the vaccine, possible MMR. Nurse follow up on 06/02/04 states: ADD: cellulitis (L) thigh.  Nurse follow up on 06/16/04 states: "No new information."
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Speech disorder
Clinical narrative: Within 2 days child developed a rash and induration on his left thigh.  This gradually resolved over 3 days.  Around this time child's behavior changed: mother says he became very aggressive, would not be quitened down, would hit people, growl at parents.  She says this behavior is new and is convinced that it is related to the vaccine, possible MMR. Nurse follow up on 06/02/04 states: ADD: cellulitis (L) thigh.  Nurse follow up on 06/16/04 states: "No new information."
Age: 0.19
Sex: M
Vaccine: DTAPH, HEP, IPV, PPV
Symptoms: Apnoea, Hypokinesia, Pallor, Somnolence, Staring
Clinical narrative: Wasn't breathing the next morning.  Kept turning white when he would sleep.  He has been having staring spells and sleeping much more than normal. He has also been less responsive than he was prior to the shots.  He was put on an event monitor and admitted to the hospital the evening after his shots to be checked for sleep apnea.  He has been given an EEG and will have a CT scan today to check for seizures. I do not know the manufactures of the shots or where they were administered exactly... only that they were given in his legs.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Skin ulcer
Clinical narrative: Pt. was given MMR at 12 month well child visit on 5/3/04. Mother reports fever 5 days  post-vaccination and a rash on 5/16/04.  Rash was non-puritic in nature over pt's. entire body.  Lesions were 0.2 cm to 1 cm diameter, macular, and erythematous.  Pt. given Des Owen lotion 0.05% to apply bid for 7 days.  Mother informed this treatment is not necessary, but may help if rash is related to a different cause.
Age: 4.0
Sex: M
Vaccine: DT
Symptoms: Injection site reaction
Clinical narrative: 2 days following immunization patient developed a large local reaction which lasted for 5 days. no treatment - reassurance to patient