chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old white female patient with no known allergies who on 24-Mar-2003 at 11 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live (Lot #644032/1059M). Concomitant vaccination included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There was no other concomitant medication. Two to three days post vaccination on approximately 26-Mar-2003, the patient developed "break through chickenpox" with a low grade fever and a small pox-like rash at the injection site. The patient sought medical attention and was treated with prescription diphenhydramine and acetaminophen (APAP). Follow-up information indicated that the patient developed a diffuse red rash with a low grade fever on 03-Apr-2003 at 15:15, ten days after the vaccine. It was noted that the patient was anxious. The reporter stated that this "also may be due to [measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)]". The reporter stated that there was no "clinically significant adverse event" and it was cleared in a few days. It was noted that the patient recovered from the diffuse red rash with a low grade fever. The reporter also mentioned a second patient that developed break through chickenpox post vaccination with a dose of varicella virus vaccine live (Lot #644032/1059M) (WAES #0304USA01917). Additional information is not expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 13-month old female with Marfan's syndrome, arthrogryposis and respiratory distress who on 28-Feb-2003, was vaccinated in the thigh with a dose of varicella virus vaccine live. Concomitant therapy included prednisolone (Prelone). The physician reported that on 04-Apr-2003, the patient develped a vesiculo-pustular chickenpox rash characterized by approximately 12-15 lesions on her trunk and back. It was noted that the patient had no recent exposure to shingles. On 07-Apr-2003, a scab specimen was obtained and was sent for laboratory testing on 08-Apr-2003. At the time of this report, the patient was being treated with acyclovir for the chickenpox rash and the outcome was unknown. Results of the PCR analysis revealed that the scab specimen contained the manufacturer vaccine-strain virus. No further information is available.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from an X-ray technician concerning a 33-year old adult female who was vaccinated with the first and second doses of varicella virus vaccine live. On 05-Apr-2003 a titer was drawn and the patient failed to seroconvert. Unspecified medical attention was sought. No other information was available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse (RN) concerning a child who on 24-Mar-1999, was vaccinated with a dose of varicella virus vaccine live (Lot 31842-invalid). The RN reported that 07-Apr-2003, the patient visited a physician's office due to a chickenpox rash characterized by about 20 chickenpox lesions. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 45-month old white male male with "EES" who on 16-Jun-2000, also reported as 06-Jun-2000, was vaccinated with a first dose in the right arm of varicella virus vaccine live (Lot #635205/0073K). It is unknow if the child was ill at the time of vaccination. Concomitant therapy that day included a first dose in the left arm of measles virus vaccine live (+) mumps virus live (+) rubella virus vaccine live (second generation) (MSD) (Lot # 634039/1714J) and a first dose in the left arm of tuberculin purified protein derivative (PPD Tine test). On 03-Apr-2003 the patient developed chickenpox, which was described as a maculopapular rash which started to develop on his left shoulder and left arm. It was also noted that the rash was pruritic and that the patient had a fever. The reporter indicated that the patient was treated with aceteaminophen (APAP). diphenhydramine, and calamine lotion. Unspecified medical attention was sought. Follow-up information indicated that on 04-Apr-2003 the patient developed a rash on his shoulders and arms that was described as red, itchy, and containing approximately 25 to 40 lesions. No fever was noted. It was noted the patient recovered. No further information is expected.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 45-month old white male male with "EES" who on 16-Jun-2000, also reported as 06-Jun-2000, was vaccinated with a first dose in the right arm of varicella virus vaccine live (Lot #635205/0073K). It is unknow if the child was ill at the time of vaccination. Concomitant therapy that day included a first dose in the left arm of measles virus vaccine live (+) mumps virus live (+) rubella virus vaccine live (second generation) (MSD) (Lot # 634039/1714J) and a first dose in the left arm of tuberculin purified protein derivative (PPD Tine test). On 03-Apr-2003 the patient developed chickenpox, which was described as a maculopapular rash which started to develop on his left shoulder and left arm. It was also noted that the rash was pruritic and that the patient had a fever. The reporter indicated that the patient was treated with aceteaminophen (APAP). diphenhydramine, and calamine lotion. Unspecified medical attention was sought. Follow-up information indicated that on 04-Apr-2003 the patient developed a rash on his shoulders and arms that was described as red, itchy, and containing approximately 25 to 40 lesions. No fever was noted. It was noted the patient recovered. No further information is expected.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old male with no known drug allergies and no past medical history who on 19Mar2003 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 04Apr2003 the patient developed a rash on his face that spread to his chest, back and groin area on 05Apr2003. The reporter indicated that "there were about 15 lesions." It was also noted that the patient had a "negative titer". Unspecified medical attention was sought. Follow up information received from a registered nurse indicated that on 04Apr 2003, 16 days after vaccination, the patient developed a rash on his face, abdomen, and groin which was described as a "diffuse varicella-like rash". The patient was reported as recovered. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations of the patient or his siblings. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient with no preexisiting medical conditions, who on 24Mar2003 was vaccinated with a dose varicella virus vaccine live. The physician reported that the next morning, 25Mar2003, the patient presented to the physician's office at 08:00AM with vesicular chicken pox, about "8-10 lesions" on his abdomen and a few under each arm (physician also reported as developed full blown chicken pox greater than 25 lesions in approximately 15 hours). The physician reported there was no known exposure to another case. It was noted the patient recovered. The reporter noted the patient did not have a fever. It was also noted the patient was not ill at the time of vaccination, and there were no laboratory tests performed. No further information is expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Face oedema, Herpes zoster, Infection
Clinical narrative: Information has been received from an infectious disease physician and a nurse concerning a 31 month old male with "no unusual medical history" and who was believed to be immunocompetent who in approximately 06/01, at one year of age, was vaccinated with a dose of varicella virus vaccine live. The physician indicated that the pt experienced two episodes of shingles. The first episode of shingles (also reported as herpes zoster type rash) occurred in 01/03 (also reported as occurring one year and four months after vaccination). It was described as a moderate case on the left face and left scalp with left eye swelling.  This episode required hospitalization. It resolved in five days without medication. The second episode of shingles (also reported as herpes zoster type rash) started "five days ago" on 04/03/03 and was described as mild and involved the shoulders and left chest. The pt had a culture at this point which was negative. A lymphocyte test was negative on 04/08/03 and IgA, IgM, and IgE were normal.  Unspecified medical attention was sought. It was noted that nothing was prescribed.  The child subsequently recovered from this episode. The nurse indicated that the pt's mother had reported another episode starting on 06/10/03 where the pt had the same type of rash on his back. It was also reported that this was a "shingles outbreak." The child did not have a vesicular lesions with these rashes. The reporter indicated that she would check with the pt's mother to see if a dried lesion sample could be obtained.  Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a physician concerning a 15 month old female patient who was vaccinated with a dose of varicella virus vaccine live. In approximately February, 2003, "a couple of months ago", the patient developed "zoster in the arm post vaccination" and a "culture was taken". The patient was taken to the ER and was hospitalized. The outcome was unknown additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 9 year old (previously reported as 4 years old) male student with no medical history and no allergies who on 04Feb1998 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was unknown if the patient was on concomitant therapy. On 05Apr2003 the patient developed full blown chicken pox with about 100 lesions. It was described as moderate to severe, not mild. Unspecified medical attention was sought. No diagnostic lab tests were performed. Subsequently, the patient recovered completely from his varicella illness, "but it took over a week". No further information is expected.
Age: 1.67
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Hypersensitivity, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 20 month old white female pt with an ear infection and no past medical history and no known drug allergies who on 15Jul2002 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 09Apr2003 the patient developed general malaise. On 10Apr2003 the patient developed chicken pox, also described as a "full blown chickenpox-like rash" and had a fever. Unspecified medical attention was sought. Follow up information indicated that the patient's two older sisters had chickenpox starting on 24Mar2004 and 31Mar2003, respectively. The patient broke out with a rash on 10Apr2003, and the mother was worried that she had the chickenpox also. However the rash was later determined to be an allergic reaction to amoxicillin, which the patient started on 01Apr2003 for an ear infection. The outcome was reported as recovered. Information was received which pertained to events which occurred approximately 10 months after vaccination with varicella virus vaccine live. This information contained the following adverse experiences: allergic reaction to amoxicillin. (10Apr2003). The nurse also reported that two other siblings developed a mild case of chickenpox and developed a mild case of chickenpox and strep throat. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 30 year old female who, about 4 weeks ago, on approximately 10Mar2003, was vaccinated with a first dose of varicella virus vaccine live. Subsequently the patient developed about 30 varicella-like lesions and a fever. Unspecified medical attention was sought. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Blister, Cerebral palsy, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male student with cerebral palsy who on 18Nov1999, was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant medications included a second dose of influenza virus vaccine (FLUZONE). There was no known illness at the time of vaccination. There were no known adverse events following prior vaccinations. On 29Mar2003, the patient developed itchy blisters. There were approximately 50-80 erythematous lesions with blisters mainly on the patient's trunk, face and legs. Upon clinical observation at an office visit on 30Mar2003, a diagnosis of varicella was made with a total of 100-200 lesions. On 14Apr2003 the child was scabbed over and able to return to school and was reported as recovered. No further information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash, Rash papular
Clinical narrative: Information has been received concerning an 8 year old male with no known allergies who on 19Nov1997 was vaccinated SC in the arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that on 03Apr2003 the patient developed a wide spread itchy rash and multiple papular and vesicular lesions. It was reported that the patient's temperature was 97.8. The patient had three contacts with varicella at school. Symptomatic treatment was provided. There were no diagnostic tests or laboratory results. It was noted that the patient recovered. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DPP, VARCEL
Symptoms: Drug ineffective, Infection, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no past medical history and no known drug allergies who on 13Dec1999 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant therapy that day included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. In approximately March, 2003, "over the last month or so", the patient developed a mild case of chickenpox. Unspecified medical attention was sought. Follow up information indicated that on 31Mar2003 the patient broke out in a papilovesicular rash on her chest, arms, back, and face. The reporter indicated that her older sister had a similar breakout 1 week prior that was determined to be chickenpox. The outcome was reported as recovered. The nurse also reported that two other siblings developed an allergic reaction to amoxicillin and an ear infection, previously reported as chickenpox and general malaise and developed a mild case of chickenpox and "strep throat". No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pharyngitis
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white female patient who on 13Dec1999 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The patient was seen in the clinic on 23Mar2003 with a mild case of chickenpox and strep throat. The child was noted to be fully recovered on 10Apr2003. Unspecified medical attention was sought. Follow up information indicated that on 24Mar2003 the patient complained of a "rash" and a sore throat. It was noted that she had scattered papulvesicular lesions on her face, trunk, arms, and back. Some of the lesions had crusted. She also was noted to have a positive strep throat culture. The physician "thought rash most likely chickenpox". The outcome was reported as recovered. The nurse reported that two other siblings developed an allergic reaction to amoxicillin and an ear infection, previously reported as chickenpox and general malaise and developed a mild case of chickenpox. No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 7 year old female who on 10May1999 was vaccinated with a dose of varicella virus vaccine live. On  11Apr2003 the pt present to the dr's office with chickenpox. The reporter indicated that the patient had less than 50 vesicular lesions and no other symptoms. No prescription drugs were required. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning an adolescent male patient who was vaccinated with a dose of varicella virus vaccine live. Several years later, the pt presented to the medical office with a mild case of chickenpox. No other symptoms were reported. Prescription drug therapy was not required. The reporter mentioned that the pt's sibling and about a dozen other pt's also developed a mild case of chickenpox post vaccination with varicella virus vaccine live.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Hypersensitivity, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning a 30 year old female who is a teacher and a college student with allergies to acetaminophen (TYLENOL), pseudosphedrine hydrochloride (SUDAFED), and "sulfa" who on 21Mar2003 was vaccinated SC with a first 0.5mL dose of varicella virus vaccine live. P2: 09May2003. There was "currently" no concomitant medication. On 09Apr2003 the pt presented to the clinic with a varicella like rash. The rash was decribed as being itchy and maculopapular, and it consisted of about 12 lesions on her chest, neck, back, arms, and legs. No fever was noted. Unspecified medical attention was sought. Follow up information indicated that on 09Apr2003 the patient broke out in a itchy rash that resembled chickenpox. On 11Apr2003 the patient was seen in the clinic. A varicella like rash on her chest, neck, legs, and one on her temple was verified. The pt only took diphenhydramine hydrochloride (Benadryl) and no other medications. The rash lasted one week and was "quarantined" for a few days since she was supposed to be around teenagers for a tournament. The pt reported to the clinic physician, who advised that she wait closer to 8 weeks for the second dose. The second dose of varicella virus vaccine live was administered on 09May2003 without further rash or problem. No further information is expected.
Age: 55.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 55 year old female with a reliable history of natural chickenpox who on 30Jul2002 was vaccinated with one dose SC of varicella virus vaccine live. Concomitant therapy that day included a first adult dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD). It was noted that on 22Jul2002, prevaccination, the pt has a chickenpox titer of 0.81. On 08Apr2003 the pt had a titer of 0.79. It was also noted that there were no untoward effects at any time. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a RN concerning a house wife who in approx. MArch 2003, was vaccinated SC in the arm with a first dose of varicella virus vaccine live. On 07Apr2003, the pt developed a rash on her forehead and body. Unspecified medical attention was sought. Subsequently the pt recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a certified Medical assistant concerning a 29 month old female, previously reported as adolescent, with no known drug allergies and no past medical history who on 25Oct2001 was vaccinated in the leg with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10Apr2003 the pt presented to dr's office with a moderate case of chickenpox. Unspecified medical information was sought. Follow up information indicated that on 10Apr2003 the pt was seen in the office and was diagnosed with varicella. Itchy pustules were found on her chest and legs. The reporter indicated that the pt's sister was vaccinated with a dose of varicella virus vaccine live and developed a moderate case of chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated (date unknown) with varicella virus vaccine live.  It was noted 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 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. No additional information is expected.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Information has been received from a RN concerning a 38 year old female RN with asthma who on 28Mar2003 at 10:45AM was vaccinated SC in the left upper arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 04Apr2003, 7 days later, the pt developed redness at the injection site (left upper arm) and a facial rash. Unspecified medical attention was sought. Follow up information received from a RN indicated that on 04Apr2003 at 10:45AM the pt developed redness and itchiness at the site of the injection. She also developed an elevated area over her body with itchiness, which was on her back, sides, and neck. On 11Apr2003 the pt was evaluated and recovered 2 weeks after breakout. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations of the pt or her siblings. No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a consumer concerning her 7 year old daughter with no known medical history who on 7/17/96 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 4/12/03 the patient developed chicken pox described as 60 lesions that were all over her body by yesterday. Medical attention was not sought. Follow up information from a registered nurse indicated that the patient's records were transferred from this office on 7/23/99 and the office had not seen the patient since 12/11/98. They have no information on this adverse experience. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male student with no medical history and no allergies who on 4/25/97 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 620614/1106D). On 4/25/97 the patient was also vaccinated SC in the left arm with a first dose of MMR (lot # 619133/1250D) and IM in the right arm with a fourth dose of Haemophilus B conjugate vaccine (lot M035PE). There was no concomitant medication. There was no illness at the time of vaccination. In the fall of 2002, the patient developed chicken pox with many vesicles. The patient was never seen in the office. Subsequently, the patient recovered. It was also noted that the patient's 10 year old sister was vaccinated with a first dose of varicella virus vaccine and developed varicella, a cough, and pneumonia. No further information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Drug ineffective, Infection, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white female student with no medical history and no allergies who on 7/10/95 was vaccinated with a first dose of varicella virus vaccine live. It was unknown if the patient was on concomitant medications. It was unknown if the patient was ill at the time of vaccination because the vaccine had been given in another physician's office. The patient had no adverse events following prior vaccinations. On 4/1/03 the patient was seen in the office with chicken pox with multiple raised papules on various body areas. The patient also had a fever and a cough. The patient was treated symptomatically. On 4/7/03 the patient was in the office again for a re-check. At that time, the child had extensive pustules along with high fevers. A chest x-ray was done which revealed pneumonia. Medical attention was sought and the patient was treated with acyclovir for the chicken pox and amoxicillin trihydrate for the pneumonia. Subsequently, the patient recovered from the chicken pox and pneumonia. It was also noted that the patient's six year old brother developed chicken pox after being vaccinated with a first dose of varicella virus vaccine live. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old white female, also reported as an adolescent, with no past medical history and no known drug allergies who on 11/1/99 was vaccinated in the leg with a first dose of varicella virus vaccine live (lot C7165). There was no illness at the time of vaccination. On 4/10/03 the patient presented to the doctor's office with a moderate case of chicken pox. Unspecified medical attention was sought. Follow up information that on 4/10/03 the patient was seen in the office with complaints of itching on her arms, legs, and stomach with small pustules. The child was recently exposed to another child with varicella. The child was diagnosed with varicella. The outcome was reported as recovered. The reporter indicated that the patient's sister was vaccinated with a dose of varicella virus vaccine live and developed a moderate case of chickenpox. No further information is expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer concerning her 9 year old daughter who has no pre-existing medical history, and who on 5/26/95 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 608581/0409B). There was no concomitant medication. It was reported that as of 4/11/03 the patient has been diagnosed with active chicken pox. It was reported that the patient had 25 pox on her face and neck, 9 on her back, 21 on her stomach and chest, and 15 on her legs for a total of 70. It was noted that the patient's mother feels this is a mild case because the pox are small in diameter, and her daughter isn't scratching or too bothered. Follow up information received from a nurse practitioner indicated that the chicken pox event onset date was 4/10/03 and the diagnosis of active chicken pox was on 4/11/03. The nurse practitioner reported she had seen the patient for her chicken pox and noted, the event was not a reaction to vaccine, vaccine given years before event. It was reported there were no laboratory tests performed. It was also reported the patient was not ill at the time of vaccination, and she has not had an adverse event following prior vaccination. Subsequently, the patient recovered.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient developed a varicella rash after being vaccinated a few weeks prior. The rash consisted of about 10 lesions. The reporter noted that the patient's day care requested a note from him regarding the child's contagiousness. Unspecified medical attention was sought. Follow up information was received from the physician indicating that he did not have the patient's name. The reporter also noted that he did not place this as adverse reaction, i.e. rash. No further information is expected.
Age: 8.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with no medical history who on 11/29/95, was vaccinated in the right arm SQ with the first dose of varicella virus vaccine live (lot # 609298/0438B). Concomitant vaccinations included the fifth dose of HIB conjugate vaccine in the left lower thigh and the first dose of MMR vaccine (Lot # 613559/0879B) in the left arm SQ. There was no other concomitant therapy. There was no illness at the time of vaccination. The RN reported that on 3/17/03, the patient had a chickenpox outbreak. No laboratory tests were performed. Subsequently, the patient recovered from chicken pox outbreak. It was also reported that four other patients in the same school also developed chicken pox after being vaccinated with varicella virus vaccine live. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from an RN concerning a 9 year old white female with no medical history who on 3/8/99, was vaccinated in the left arm SQ with the first dose of varicella virus vaccine live (lot # 626405/1840H). There was no concomitant therapy. There was no illness at the time of vaccination. The RN reported that on 3/10/03, the patient had an outbreak of chicken pox. There was no laboratory test performed. At the time of this report, the outcome was unknown. It was also reported that four other patient's in the same school also developed chicken pox after being vaccinated with varicella virus vaccine live. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female who on 3/31/03 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On approximately 4/14/03, 2 weeks after vaccination, the patient developed 5 vesicular lesions on her arm and chest. No other symptoms were reported. No prescription drug was required. Unspecified medical attention was sought. Follow up information received from a registered nurse indicated that the event was not considered an adverse event with only 5 lesions. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old Causasian female student who on 8/2/97 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 621060/1363D). There was no concomitant medication. On 4/16/03 at approximately 9:00, the patient presented to the physician's office with full blown chicken pox. The patient had approximately 75-100 lesions in various stages all over her body including 50 active chicken pox lesions. The patient was treated with oral acyclovir 200 mg four times a day for five days, acetaminophen and calamine (+) camphor (+) pramoxine hydrochloride. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Skin ulcer
Clinical narrative: Information has been received from a physician's assistant concerning a 16 month old patient who in December 2002, was vaccinated with a dose of varicella virus vaccine live. On 4/14/03 the patient presented with a dermatome rash that appeared to be shingles, described as a papular rash, no intake vesicles, some crusted lesions in three groups on the right side of the back and spread to the right side of the chest. It was noted that the rash did not cross the mid line and the child was afebrile. Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 4 year old white female with no medical history and no allergies who on 4/10/00 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 632717/1727J). There was no illness at the time of vaccination. Neither the patient nor her sibling developed adverse events following prior vaccinations. On 4/15/03 the patient came into the office with itching and a chicken pox rash with over 100 lesions with at least 50 lesions on one thigh. Some of the lesions were circled with a red ring about 1/4 inch from the center making the lesions about the size of a nickel to a quarter. It was reported on 4/16/03 that this was only day 2 and the patient is currently getting more. It was noted that this was an office visit confirmation and that there were no diagnostic or laboratory tests performed. Subsequently, the patient recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed an atypical varicella breakthrough. No further information was provided. Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 4 year old male who was vaccinated with a dose of varicella virus vaccine live (date not reported). The reporter stated the patient has experienced 2 break through case of chicken pox. It was noted the cases were considered mild. It was noted that there were no details provided on the cases. Unspecified medical attention was sought. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 30 year old female healthcare worker who was vaccinated with a second dose of varicella virus vaccine live. The physician reported that the patient subsequently developed chicken pox and had a negative varicella titer two weeks after her second dose of varicella virus vaccine live. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old white male with no past medical history and no known drug allergies who on 3/11/03 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 643590/0806M). There was no illness at the time of vaccination. On 4/16/03 in the AM the patient developed a rash behind his ears and on his back, which spread to his stomach and diaper area on 4/18/03. No fever was noted. Unspecified medical attention was sought. Follow up information received from a registered nurse indicated that on 4/17/03 the patient was evaluated for upper back and arm lesions. It was noted that the patient had raised papules, several of which had clear vesicles with erythematous base. The patient was afebrile. No diagnostic tests or laboratory data were reported. Follow up information received from a registered nurse indicated that on 4/28/03 the patient recovered. Follow up information was received on 5/20/03 which pertained to events that occurred 48 days after vaccination with varicella virus vaccine live. This information contained the following adverse experiences: bilateral conjuncitivitis, URI; and borderline left otitis. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Injection site reaction, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old white female patient with no known allergies who on 3/27/03 at 9:30 AM was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 644032/1059M). There was no illness at the time of vaccination. There was no concomitant medication. On 4/3/03, the patient developed a large reaction at the site of injection, also described as a local reaction. On 4/4/03, the patient developed small spots on the groin, abdomen, and back. on 4/4/03, the patient presented to the doctor's office. It was noted that this was a case of break through chicken pox. The patient was treated with diphenhydramine hydrochloride, acetaminophen, and ibuprofen. Subsequently, the patient recovered. The reporter also mentioned a second patient that developed break through chicken pox post vaccination with varicella virus vaccine live (lot # 644032/1059M). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an adolescent female patient who was vaccinated with a dose of varicella virus vaccine live. Several years later, the patient presented to the medical office with a mild case of chicken pox. No other symptoms were reported. prescription drug therapy was not required. The reporter mentioned that the patient's sibling and about a dozen other patients also developed a mild case of chicken pox post vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received concerning a 9 year old male who was vaccinated at age 1 with a dose of varicella virus vaccine live. On approximately 4/18/03, at 9 years old, the patient experienced full blown chicken pox. Unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a male with an unknown medical history who on 2/12/02 was vaccinated with a dose of varicella virus vaccine live (lot # 640090/1147L). It was unknown if the patient was on concomitant medication. Subsequently, the patient was seen in the office covered in chicken pox with more than 50 pox all over his body. No lab or other 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 patients who are siblings were vaccinated with a dose of varicella virus vaccine live and developed chicken pox. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Herpes zoster, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 17 month old Caucasian female patient who on 9/25/02 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 642632/0324M). On 3/4/03, the patient experienced initial symptoms of pain and a severe headache. A computed axial tomography scan was normal. On 3/13/03, the patient developed a macular papular rash, no vesicular, along the right side of her face and forehead. Zoster, shingles was diagnosed. Unspecified medical attention was sought. Subsequently, the symptoms resolved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old white female with no medical history and no allergies who on 1/20/03 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot # 643530/0599M). On 1/20/03 the patient was also vaccinated IM in the right leg with a third dose of Streptococcus pneumoniae vaccine (lot 488204). There was no illness at the time of vaccination. On 2/3/03 the patient developed a mild case of chicken pox. Subsequently, the patient 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 licensed practical nurse concerning a 7 year old male who on 8/5/96 was vaccinated with a dose of varicella virus vaccine live. On 4/15/03 the patient developed full blown chicken pox. It was unknown if the chicken pox required treatment. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female nurse (also reported as a pharmacist) who on 4/22/03 reported that on approximately 4/15/03, about one week ago, was vaccinated with a dose of varicella virus vaccine live. On approximately 4/15/03 the patient developed pain, redness, and swelling at the injection site. The reporter noted that these reactions lasted 2 days, and that she is now fine. Unspecified medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Lymphadenopathy, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 6 year old male with no known drug allergies who on 12/15/97 was vaccinated at another facility with a dose of varicella virus vaccine live. On 4/14/03 the patient presented to the doctor's office with varicella with about 20-30 erythematous, macular 8-10mm vesicles and a central, 3mm vesicles, all over his body. The patient also developed posterior cervical adenopathy. He had minimal itching. Medical attention was sought and the patient was treated with acyclovir. Subsequently, the patient recovered. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white female with no medical history who on 19AUG1997 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 22APR2003 the patient was seen in the doctor's office with papule lesions on the face, chest and back. The number of lesions were unknown and they were in various stages. The reporter indicated that it was considered to be a mild case of chickenpox. No treatment was provided. Follow up information was received from a consumer which indicated that on 22APR2003 the patient had vesicles and papules consistent with varicella. It was unknown if the patient had recovered. Additional information has been requested.
Age: 2.2
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 26 month old Caucasian male patient with no known drug allergies or no known medical conditions who on 12DEC2002 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live (lot number 640090/1147L). There was no illness at the time of vaccination and no symptoms following prior vaccinations. Concomitant therapy on 12DEC2002 included a subcutaneous first dose in the right thigh of measles virus vaccine live+mumps virus vaccine live+rubella virus vaccine live+, second generation (MSD) (lot number 640910/1049L) and an intramuscular third dose in the left thigh of hepatitis B vaccine, recomb ENGERIX B, batch number 5230A2. There were no other concomitant medications. On 16APR2003 the patient developed a small, red rash that started on the neck and face and spread to the arms, leg and chest, described as yellow, cloudy, fluid filled, itchy and more than 50 spots. There were no adverse events following prior vaccinations of the patient or his siblings. Additional follow up information indicated that on 26APR2003 the patient recovered. No further information is expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 2 year old female who in June 2001, was vaccinated with a dose of varicella virus vaccine live. On 23APR2003 it was reported that the patient "now" has "chicken pox". Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse which indicated that one year post vaccination with varicella virus vaccine live the patient had a chickenpox like rash which turned out to not be chickenpox. The patient subsequently recovered. The reporter also noted that this was not a vaccine adverse experience. No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician's assistant concerning a 31 year old female who was vaccinated with two doses of varicella virus vaccine live. At some point later (unknown time frame) the patient developed "full blown chicken pox" with over 60 lesions. No other information was given. Unspecified medical attention was sought. On 16JUN2003 it was reported that "this was not an adverse reaction to taking the vaccine". No product quality complaint was involved. No further information is expected.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 42 month old white male with no medical history who on 22NOV1999 was vaccinated in the left thigh with a first 0.5ml dose of varicella virus vaccine live (lot 631077/0705J). There was no illness at the time of vaccination. On 21FEB2002 the patient developed shingles on his right medial thigh. There was no history of chickenpox or recent exposure or herpes zoster. Subsequently the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.