chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.75
Sex: F
Vaccine: DTP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 33 month old white female in good health with no medical history and no known allergies who on 21AUG2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live. On 21AUG2001 the patient was also vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation), a dose of haemophilus B conjugate vaccine + hepatitis B vaccine recombinant yeast, a dose of Streptococcus pneumonia vaccine (Prevnar) and a dose of diptheria toxoid + pertussis vaccine + tetanus toxoid (DTaP CONN). There were no other concomitant medications. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The patient's mother reported that on 22APR2003 (previously reported as approximately 15JUL2003) the patient developed breakthrough chicken pox with less than 50 lesions after exposure to community chickenpox. The patient developed the first lesions following exposure to a cousin who had chicken pox.The patient did not have a fever at first, but developed a mild fever 2 days after the first lesions. There were a total of about 20 vesicles on the arms, legs and trunk. No diagnostic studies were performed On 22JUL2003 the pediatrician saw the patient's mother and reported that the child was at home with chickenpox. This could be described as a mild case. On 22JUL2003 there were only 4 lesions remaining. Unspecified medical attention was sought and no treatment was necessary. The physician "indicated" that there were other cases in her practice, but she could not now recall the patients. It was reported that the chicken pox lasted 3-5days and subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a patient with no relevant medical history who in 2001 at 12 months of age was vaccinated with a dose of varicella virus vaccine live. It was noted that the patient had "recently" developed a breakthrough rash. Unspecified medical attention was sought. It was unknown if the patient had recovered. There was no product quality complaint involved. At the time of this report the child was 36 months of age. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old female who was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The reporter indicated that as a result the patient developed a rash on the face and trunk and a high fever. It was also noted that the patient "developed lymph nodes around the groin area." Unspecified medical attention was sought. The patient subsequently recovered. A product complaint was not involved. Additional information has been requested.
Age: 1.8
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 22 month old female patient with an allergy to amoxicillin + clavulanate potassium (AUGMENTIN), who on 09JUL2003 was vaccinated SC in the right arm with 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On 21JUL2003, reported as 12 days later, the patient developed macular, papular, 1x7cm diameter scabbed lesions at the injection site. The registered nurse reported the patient did not have a fever or generalized rash, and she did not require treatment. The registered nurse reported the symptoms are now resolved, and the patient has recovered. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old Caucasian female with no known allergies who on 14JUL2003 (also reported as 13JUL2003) at 9:00 AM was vaccinated SC in the left thigh with a 0.5ml first dose of varicella virus vaccine live. Concomitant vaccination on the same day at 9:00 AM included a fourth dose IM in the right thigh of Streptococcus peneumoniae vaccine (PREVNAR). Other concomitant medication started on 14JUL2003 included ferrous sulfate (Fer-in-sol) (previously reported as there was no other concomitant medication). On 21JUL2003 at 14:15, the mother called the doctor's office to report that  her child developed 4 to 5 vesicles on the trunk and extremities which were "non-itchy, "had a temperature of "99 axillary" and crankiness. The reporter also indicated that the patient had been seen at the office on 25JUN2003 for "atypical varicella." The patient was not hospitalized. Unspecified medical attention was sought and no prescription drug treatment was required. There were no laboratory results or diagnostic tests. It was noted that the patient and her siblings had no known adverse events following prior vaccination.  A product quality complaint was not involved.  Follow up information was received from the registered nurse which indicated that on 24JUL2003 the mother reported that all the vesicles scabbed expect for one on the lower leg. The mother will monitor for signs and symptoms of increased inflammation and pain and follow up as needed. Additional follow up information that the patient had recovered. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old male patient with no allergies who on 11JUL2003 was vaccinated in the lower right thigh with a doe of varicella virus vaccine live. Concomitant vaccinations included a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) in the left thigh and a dose of Haemophilus B conjugate vaccine (ACTHIB). There was no other concomitant medication. By 20JUL2003, the patient had developed a 102 degree fever and spots on his back and belly. Unspecified medical attention was sought, but no other studies were performed. At the time of the report, the patient no longer had a fever and was "recovering with sequelea" from the spots on his back and belly. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a woman at a physician's office concerning a 12 month old female with no allergies and no medical history who on 11JUL2003 at 13:15 was vaccinated subcutaneously with a first dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 18JUL2003, while on vacation one week after vaccination, the physician's office received a call from the mother of the patient. She reported that the patient had "broke out with varicella and went through the stages" on the left arm, left hand, left leg and the face. She also reported that a rash had developed around the injection site on the left arm, left hand, the left side of the face and the left leg. The patient was not seen in the medical facility. Unspecified medical attention was sought. No diagnostic tests were performed. The patient's mother treated her with calamine lotion and colloidal oatmeal baths (AVEENO) as needed. Subsequently, the patient's symptoms resolved and the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash erythematous, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old male child with no history of chickenpox who was vaccinated with a dose of varicella virus vaccine live 0.5ml. There was no recent exposure to chickenpox or herpes zoster. On 24JUL2003, it was reported that the patient "now has shingles", described as a "scabbed erythematous patch" about 50 cent sized on the right buttocks.There were no other systemic symptoms and a maximum temperature was reported as none. The degree of pain was unknown. Specimens for PCR and direct fluorescent antibody were not collected. A photo was not taken. It was noted that the child was vaccinated at another facility. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pain, Pruritus, Viral infection
Clinical narrative: Information has been received from the mother of a 6 year old male child with a history of atopic dermatitis who on 14SEP1997 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 21JUL2003 the child devloped in excess of 20 lesions on his upper left arm. Pain and itching were associated with the lesions. Unspecified medical attention was sought and on 22JUL2003 the child was diagnosed with shingles and was given cream to treat the lesions. On 25JUL2003 the patient began to recover (also reported as recovering with sequalea). No product quality complaint was involved. On 28JUL2003 a nurse from the physician's office reported that she had not spoken to the mother of the child in a week. She planned to phone the patient's mother. It was also reported that the nurse did not think it was likely that a specimen would be available at this date on this patient. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a lab technician in a physician's office concerning a 4 year old female who in May 2000 was vaccinated with a doe of varicella virus vaccine live. The reporter indicated that in approximately March 2003 to April 2003 the pt developed a mild case of breakthrough varicella. It was noted that the pt recovered. Follow up information indicated that the pt had a "light case"; no problem or fever were noted. The reporter also indicated that the pt's sibling had a similar experience after vaccination with a dose of varicella virus vaccine live (WAES # 0307USA01574).  No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced "a breakthrough". Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the nurse indicated that they were unable to acertain which child had the reaction that was reported by the dad at a clinic visit. They are unable to provide any additional information. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning her 4 year old son with no known drug allergies who was born at 3 weeks gestation and has a history of herpes simplex type 1 requiring ventilator assistance at 4 weeks of age who on 27APR1999 was vaccinated SC with first dose of varicella virus vaccine live. There was no concomitant medication. In April 2001, the patient developed shingles for the first time and for the second time in April or May 2002. On 29JUL2003 the patient's mother reported that her son was currently having an outbreak. She reported that his rash is always on his upper back on the right side and this was the third time he developed shingles since receiving varicella vaccine live. It was reported that the patient was recovering with sequelae. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a LPN concerning a 7 year old male who on 08/02/01 was vaccinated with a dose of varicella virus vaccine live (Lot # 638811/0498L). It was reported that the pt has had chickenpox twice since then, in March 2002 and in May 2003. Both cases were relatively mild. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from the mother (who is also a registered pharmacist) of a female pt with no medical history who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Seven days post-vaccination, the pt developed a mild case of the chickenpox. Unspecified medical attention was sought and it was unknown what treatment was provided. No diagnostic lab tests were performed. It was unknown if the pt had recovered. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a consumer regarding a "4 to 6 year old" child who may have been vaccinated with a dose of varicella virus vaccine live. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two to three weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved.  The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live (WAES # 0306USA01223, WAES # 0306USA01369, WAES # 0306USA01383, WAES # 0306USA01535 AND WAES # 0306USA01834).  He also indicated that the cases were mild, however he didn't know that two of the cases were not mild. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a  pharmacist concerning an adult hospital employee who was vaccinated SC with 0.5mL first dose of varicella virus vaccine live. The reporter indicated that the pt experienced a rash following vaccination. The reporter learned of the rash through a written question posed to her by the nursing staff asking if the pt should receive a second dose. The reporter did not have any description of the rash, whether it was improving, any other pt information or contact information for the employee health service. It was also noted that it was unknown if the pt was pregnant. Unspecified medical attention was sought and no treatment or prescription drug was required.  A product quality complaint was not involved. Additional information was received from the pharmacist which indicated that she did not have any follow up information but she would contact the director of employee health for further information. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Laboratory test abnormal, Unevaluable event, Unintended pregnancy
Clinical narrative: This is in follow-up report(s) previously submitted on 5/14/2004. Information has been received through the manufacturer's pregnancy registry from a physician and a 27 year old female with no medical history and no known drug allergies who on 06/24/03, and 07/24/03 was vaccinated SC in the left thigh with a first and second dose of varicella virus vaccine live (Lot # 0726M and 643120/0505M) respectively. There was no concomitant medication. There were no varicella or herpes zoster symptoms post vaccination.  The pt was not vaccinated for immigration purposes. Subsequently, the pt developed a swollen area where the shot was given. It was also reported that on 07/29/03 the pt had a positive pregnancy test. The physician believes that the pt was about 4 weeks pregnant.  On 05/9/03 the pt was tested for varicella antibodies before vaccination and the results were negative. The pt's LMP was 06/20/03 and the EDD is  03/27/04.  Unspecified medical attention was sought. Until week 8, approximately 08/17/03 the pt took venlafaxine hydrochloride. No product quality complaint was involved. On 19-May-2004 it was reported that the patient was last seen in July 2003. She had moved out of state in late August 2003 and it was recommended that she schedule an initial pregnancy visit with an obstetrician before moving. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a physician concerning a 37 month old female who on 05/30/01 was vaccinated IM with a first dose of varicella virus vaccine live (Lot # 636575/1467K, dilutent # 633772/0489L).  It was reported that the pt had varicella at the time of vaccination. On 07/26/03 the pt was seen by the physician and a clinical diagnosis of varicella was made. She had approximately 31 lesions and had experienced a "breakthrough". Subsequently, 7-10 days later, the pt recovered. No product quality complaint was involved. No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no allergies or medical history who on 07/18/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644790/0333N).  Concomitant vaccination on the same day included a dose of MMRII (Lot # 639918/0880M). There was no other concomitant medication. On 07/28/03 the pt developed a maculopapule rash primarily on the trunk and also on the neck, arms and face. Unspecified medical attention was sought. The pt was treated with Benadryl and Ibuprofen as needed. At the time of the report, the condition had not subsided. A product quality complaint was not involved.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a LPN concerning a 5 year old "F" student with no medical history and no allergies who on 04/26/96 was vaccinated SC with a first dose of varicella virus vaccine Live (Lot # 616868/1653B). There was no illness at the time of vaccination. At a recent visit to the physician's office the mother stated that in April 1998 her daughter developed a varicella-like rash. It was noted that they were not sure of all the details. The mother also reported that the child developed chickenpox following exposure to another unvaccinated sibling who had developed chickenpox after being exposed to the disease in school. The nurse noted that their office had no record of this event and could offer no further information on the matter. No medical attention was sought. No diagnostic tests were performed. Subsequently the pt recovered. No product quality complaint was involved. No further information is expected. It was also reported that the pt's sibling was vaccinated with a dose of varicella virus vaccine live and developed chickenpox (WAES # 0307USA01111).
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 19 year old black female pt with no past medical history and no allergies who on 03/24/03 and on 05/30/03 was vaccinated with varicella virus vaccine live (Lot # 643083/0572M). There was no concomitant medication. On 07/21/03 the pt had a negative titer.  The pt sought unspecified medical attention. There were no adverse symptoms noted.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning an 8 year old male who was vaccinated with varicella virus vaccine live. Subsequently, the pt had a mild breakthrough varicella. The pt sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a certified MA concerning a 4 year old white male with no known allergies or medical history and in "good health" who on 12/18/00 was vaccinated with a first dose of varicella virus vaccine live. Concomitant vaccinations on the same day included a first dose of MMRII, a third dose of HIB conj vaccine (manufacturer unknown), a first dose of Streptococcus pneumoniae vaccine (Prevnar), a third dose of DTP and a third dose of IPV.  There was no illness at the time of vaccination. The reporter indicated that the child had chickenpox two years after vaccination. On 05/16/03 the pt was seen at the practice with an unspecified number of lesions at varying stages and no fever. Varicella disease was confirmed. Supportive care was recommended. It was also noted that treatment was required. Subsequently, the pt recovered. The reporter also indicated that the vaccine was administered at another practice. It was noted that the pt was a foster child and was with different parents at the time of vaccination. A product quality complaint was not involved. No further information is expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 9 year old female with an unknown past medical history who was vaccination with a dose of varicella virus vaccine live. On 07/31/03 the pt developed 200 pox and fever of 103 degrees. No treatment was provided. It is unknown if the pt recovered. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 2.5
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN concerning a 30 month old who on 01/09/02 was vaccinated with a dose of varicella virus vaccine live (Lot # 638650/1235L).  On 07/24/03, 2 weeks after exposure to a 4 year old child who on 07/11/03 was diagnosed with shingles (also reported as a child with chickenpox and a child who had chickenpox illness in April 2000), the pt was seen at the physician's office and was found to have a mild case of chickenpox. No treatment was required. No product quality complaint was involved. It was also reported that 3 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox (WAES # 0309USA00332 to 0309USA00334).  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a CMA concerning a 5 year old black female who on 03/19/99 was vaccinated with a first dose of varicella virus vaccine live.  There was no concomitant medication. The reporter indicated that the pt developed chickenpox post vaccination. On 08/01/03 the pt reported to the office with a mild case of chickenpox "all over her body". The rash was described as non-pruritic. The reporter was unaware of any specific treatments that the pt was given by the doctor. At the time of the report the events had not abated. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Rash
Clinical narrative: Information has been received from a LPN concerning a 5 year old white female with no past medical history and no known drug allergies who on 01/04/99 was vaccinated in the right anterior thigh with a first dose of varicella virus vaccine live (Lot # 628149/1325H).  There was no illness at the time of vaccination. On 07/25/03 she developed multiple lesions all over the body. Some of the lesions were vesicles filled with fluid. The child was very itchy. The lesions erupted 24 hours prior to the office visit on 07/26/03. The outcome was reported as recovered. No further problems occurred.  The reporter also indicated that one other developed a rash after being vaccinated with a dose of varicella virus vaccine live (WAES # 0307USA02281).  No further information is expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a NP concerning a 15 month old female who was vaccinated SC with a dose of varicella virus vaccine live. Subsequently seven days post vaccination the pt presented with chickenpox. She had approximately 50-70 lesions. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug administration error, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 5 year old Hispanic/Native American male with no medical history and no known drug allergies who on 07/12/03 at 12:30 was inadvertently vaccinated SC in the right thigh with an expired first dose of varicella virus vaccine live (Lot # 640071/1317L; expired on 03/18/03).  On 07/21/03 at 12:30 the pt was also vaccinated SC in the left thigh with a second dose of MMRII (Lot # 643390/0771M), a fifth dose given IM in the right arm of DTAP (Infanrix, Lot # 572A2) and a fourth dose given SC in the left arm of IPV (Lot # T14462).  There were no other concomitant medications. There was no illness at the time of vaccination. The pt's mother stated that he had a slight fever the day of the immunizations and that she gave him Tylenol. It was also reported that the pt had no adverse side effects. Unspecified medical attention was sought. No diagnostic studies were performed. On 08/14/03 it was reported that, "at this time", the physician had not decided whether to revaccinate the pt and was awaiting more information. No product quality complaint was involved. On 08/26/03 it was reported that the physician had decided not to revaccinate. No further information is expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a LPN concerning a 13 year old female pt who on 08/04/03 was vaccinated with a second dose of varicella virus vaccine live. Subsequently on approximately 08/04/03, the pt developed an induration and swelling at the injection site. Unspecified medical attention was sought, but no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 15 month old female pt with no past medical history who on 04/17/03 was vaccinated SC with a 0.5mL first dose of varicella virus vaccine live. There was no concomitant medication. On 08/05/03, the pt developed chickenpox and presented to the medical office with approximately 12 lesions. No lab tests were performed and no treatment was required. The reporter indicated that therapy with varicella virus vaccine was discontinued and that the pt was recovering with sequelae.  A product quality complaint was not involved. Additional information has been requested.
Age: 2.7
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a 32 month old male pt in good health with no known allergies, who on 07/03/02 (also reported as 07/31/01) was vaccinated in the left thigh with a 0.5mL dose of varicella virus vaccine live (Lot # 637977/1898K).  Concomitant therapy administered on the same day 07/31/01 included a third dose of Haemophilus B conjugate vaccine (manufacturer unknown) (Lot # not available). There were no other concomitant medications. No rash occurred at the site of injection post-vaccination. On 11/14/02 the pt was seen in the physician's office with a "classic presentation" of chickenpox all over and coming in crops at all stages. The physician described it as a moderate case. It was noted the pt did not have a fever at the time of the visit, but he was itchy and Benadryl was recommended. It was reported that the physician estimated that the onset of symptoms was 3 to 4 days prior to the visit (approximately 11/10/02), and resolution took another 3-4 days (approximately 11/18/02).  The physician confirmed there was no known exposure in this case. It was reported that the pt was seen again on 08/04/03 with a history of "rash for 7 days". The rash was a varicella form with over 100 diffuse lesions. The physician reported that the rash was again in crops at all stages, appearing all over except for the muccus membranes. The pt also had a runny nose and a low grade fever (100.1 degrees F by ear thermometer) and "gorgza". It was noted that "usual chickenpox care" was recommended. The physician reported that again there had been no known exposure for this case. It was noted the adverse event abated, and no treatment was required. There was no product quality complaint reported. The physician stated that he was puzzled that the child had received the varicella virus vaccine live 2 years ago and had had two apparent breakthrough cases of chickenpox. The physician indicated the pt was a normal host and he was not aware of any immune dificiency, either primary or secondary. The physician reconfirmed that the pt had no known exposure to varicella prior to either case of breakthrough. The physician also stated, "it's possible that the rashes are something other than varicella; however, the clinical presentation looked very much like chickenpox." On 08/08/03 a scab from a lesion for VZV identification was obtained. On 08/11/03 it was sent to the lab. On 08/13/03 it arrived in the lab. The VZV DNA was not amplified and the B-globin DNA was amplified. On 08/19/03 it was reported that the PCR analysis revealed that the specimen was negative for varicella zoster virus. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed "vaccine failure" and "had more than 50 lesions".  It was noted that the doctor did not provide any additional information at the time of this report. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned a sibling that was vaccinated with varicella virus vaccine live and developed a similar experience (WAES # 0308USA00824).  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 4 year old male who in 2000 was "vaccinated at 12 months" of age with a SC dose of varicella virus vaccine live 0.5mL. On approximately 08/06/03, "a few days ago", the pt presented to the doctor's office with "50 lesions which started on the lower half of his body, but spread to other parts". Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no past medical history who on 06/26/03 was vaccinated with a dose of varicella virus vaccine live (site unknown) (0.5mL) (Lot # 641155/0793M) (SC). Concomitant therapy included MMRII and Prevnar. On 07/08/03 the pt developed "red, botchy lesions on trunk, face and scalp. The child came back 24 hours later and those lesions were crusty on his face and scalp." The total number of lesions reportedly "may have reached 50." The pt sought unspecified medical attention. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy
Clinical narrative: This is a 28-year-old male member who received his primary smallpox vaccination on 04/25/04. Initially, vaccination site/course went as described in briefing. Over the course of the last several months, intermittently since vaccination, developed a single "knot" under both arms. Since approximately late November 2003, has developed only under the left arm. Client states that the knot appears about every 6 weeks and lasts approximately 12-16 hours. He describes the knot as non-painful, "dime-size knot" that is smooth and round. It does not limit his arm motion. Denies fever, chills, fatigue, nausea and vomiting in association with the presence of the knot. He was seen at clinic and told that it was "a common thing".
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: Reported to emergency department on 4/22/2004 with itching and redness to right deltoid.  Pulse Ox 99%, temp 98.0, pulse 112, resp 22, blood pressure 119/64 at ED visit.  Follow up appt. made with M.D. on 4/26/2004.
Age: 0.36
Sex: M
Vaccine: HBHEPB, IPV, PNC
Symptoms: Dyspnoea, Myelitis transverse, Otitis media, Paralysis, Pneumonia
Clinical narrative: Child develops upper resp. infection and given antibiotic after receiving Hib and HB.  2 mos. later receives DTaP immunization.  1 week later develops upper respiratory infection and ear infection.  Administered antibiotic.  2 weeks after DTaP and 60 days after Hib & HB, develops a spinal lesion causing pneumonia, 103 fever, paralysis, breathing problems, etc.  After 5 MRIs, Xrays, blood tests/cultures (CDC), urine tests, EEG, ultrasound, nasal wash, spinal tap, genetic testing (skin biopsy) Diagnosed w/Transverse Myelitis which is listed as an adverse reaction under Central Nervous System on Comvax vaccination insert. In the last two years, has received ongoing physical/aqua therapy. He has been followed by a neurosurgeon, neurologist, pediatrician, geneticist, urologist, orthopedist, orthotist, seen by a chiropractor, massage/occupational/phsycial/speech therapist, and treatment from different alternative medicines.
Age: 0.36
Sex: M
Vaccine: HBHEPB, IPV, PNC
Symptoms: Pyrexia, Skin ulcer, Upper respiratory tract infection
Clinical narrative: Child develops upper resp. infection and given antibiotic after receiving Hib and HB.  2 mos. later receives DTaP immunization.  1 week later develops upper respiratory infection and ear infection.  Administered antibiotic.  2 weeks after DTaP and 60 days after Hib & HB, develops a spinal lesion causing pneumonia, 103 fever, paralysis, breathing problems, etc.  After 5 MRIs, Xrays, blood tests/cultures (CDC), urine tests, EEG, ultrasound, nasal wash, spinal tap, genetic testing (skin biopsy) Diagnosed w/Transverse Myelitis which is listed as an adverse reaction under Central Nervous System on Comvax vaccination insert. In the last two years, has received ongoing physical/aqua therapy. He has been followed by a neurosurgeon, neurologist, pediatrician, geneticist, urologist, orthopedist, orthotist, seen by a chiropractor, massage/occupational/phsycial/speech therapist, and treatment from different alternative medicines.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Influenza like illness, Injection site mass, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Sore throat, Feverish, Symptoms similar to Cold and flu symptoms, Occassional cough, Vaccine site has Baseball size lump with itching. No treatment given.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Pyrexia, Rhinitis
Clinical narrative: Sore throat, Feverish, Symptoms similar to Cold and flu symptoms, Occassional cough, Vaccine site has Baseball size lump with itching. No treatment given.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Contusion, Erythema, Injection site mass, Injection site swelling, Joint range of motion decreased
Clinical narrative: Place vaccine administered turned Bright Red and then Black and Blue. Member also had swelling and a lump the size of Baseball. Internally shoulder became extremely sore and could not raise arm above shoulder height. Member stated it felt like it was sore in the bone. Member did not come to work on 18 May 2004 because of soreness of arm shoulder area.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Shoulder pain
Clinical narrative: Place vaccine administered turned Bright Red and then Black and Blue. Member also had swelling and a lump the size of Baseball. Internally shoulder became extremely sore and could not raise arm above shoulder height. Member stated it felt like it was sore in the bone. Member did not come to work on 18 May 2004 because of soreness of arm shoulder area.
Age: 56.0
Sex: F
Vaccine: DT, TYP
Symptoms: Bursitis, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Myositis
Clinical narrative: In October 2003, patient called me and told me that the site where her TD shot was had remained sore and over the past few months had become more severely painful especially upon rasing her arm and the she was having occasional tingling and numbness in her left hand.  Upon review by our missionary medical consultant, she consulted a neurologist who treated her with a Medrol dosepack and Celebrex.  Diagnosis myositis, bursitis as a reaction to the Td shot.  Recovery has been slow and was unable to return to work in December as scheduled.  Doctor told her it would take months to recover.
Age: 56.0
Sex: F
Vaccine: DT, TYP
Symptoms: Paraesthesia
Clinical narrative: In October 2003, patient called me and told me that the site where her TD shot was had remained sore and over the past few months had become more severely painful especially upon rasing her arm and the she was having occasional tingling and numbness in her left hand.  Upon review by our missionary medical consultant, she consulted a neurologist who treated her with a Medrol dosepack and Celebrex.  Diagnosis myositis, bursitis as a reaction to the Td shot.  Recovery has been slow and was unable to return to work in December as scheduled.  Doctor told her it would take months to recover.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash maculo-papular
Clinical narrative: Information has been received from a physician assistant concerning a 7 year-old Caucasian male with "no allergies" who on 09-Apr-1998 was vaccinated subcutaneously with a first dose of varicella virus vaccine live 0.5 ml (Lot number 624781/0056H) and "had break thru chicken pox" which was a confirmed case of varicella on 17-June-2003. There was no concomitant medication. On 17-Jun-2003, the patient presented to the physician assistant with a "light macular/papular rash". There were no laboratory studies performed. It was noted that no treatment or hospitalization was needed. Subsequently, the patient recovered. The reporter also mentioned another patient who experienced a similar reaction with varicella virus vaccine live (Lot number 637672/1610K) (WAES #0308USA01920). No further information is expected.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Muscular weakness, Pain
Clinical narrative: From initial information received on 07/29/03 from a health care professional regarding adverse events occurring in the USA, it was reported that a 34 year old female pt received DT ADS PED USP vaccination lot # T0746AE, administered in the right deltoid on the morning of 07/09/03.  Per the reporter, the pt received TD ADS ADULT USP, however the lot number provided was for DT ADS PED USP.  The next morning the pt experienced fatigue, headache, body aches and gastrointestinal distress. On 07/12/03 the pt had a fever and body aches with headache. Extremity weakness. The pt was seen by a physician on an unspecified date. The pt recovered after 14 days.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Erythema, Infection, Pain, Pyrexia
Clinical narrative: Information has been received from a public health nurse who received a voice message from a physician concerning a 47 month old female child with no known drug allergies and a history of chickenpox at 3 months old who on 08/07/03 was vaccinated SC in the left deltoid with a first dose of varicella virus vaccine live (Lot # 645052/0204N). There was no illness at the time of vaccination. Subsequently the pt developed zoster. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that on 08/07/03 at 9PM the pt experienced right sided abdominal pain with a right sided reddened rash with early vesicular patches with front distribution from the umbilical area. She also had a fever up to 103 degrees. The reporter indicated that he believed the pt was started on Zovirax. On 08/11/03 it was noted that the rash was drying well.  It was also noted that the rash occurred within 42 days of the vaccination. The location of the herpes zoster was the right trunk. The herpes zoster was noted to be painful for the child, but the nurse was "not sure they did a scale of the pain". The pt had a history of chickenpox at 3 months of age. No recent exposure to chickenpox or herpes zoster. No direct flourescent antibody done. No specimen was collected for PCR. No photo was taken. The outcome was reported as recovered. No further information is expected.
Age: 1.58
Sex: F
Vaccine: DTAPH, HBHEPB, IPV, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 month-old female with "good health" and no known allergies who on 01-Aug-2003 at 13:00 was vaccinated in the left thigh with a first dose of varicella virus vaccien live 0.5 ml (Lot number 644569/1158M). Concomitant therapy "given on the same day",  01-Aug-2003 included a fourth dose in the right arm of diptheria toxoid/pertussis vaccine/teta (TriHIBit) (Batch # U0996DA), a fourth dose in the left arm of Streptococcus pneumoniae vaccine (Prevnar) (Batch #491/189), a third dose in the right leg of Hib conj-hepatitis B vaccine (Lot #644279/0962M) and a third dose in the right arm of polivirus vaccine (IPOL) (Batch #W0907). It was noted there were "no chronic meds". There was no illness at the time of vaccination. On 13-Aug-2003 at 8:00 a.m., The patient "developed a few chicken pox pimples (8-10)", described as vesicular lesions around the neck and body, "(very mild)". The child was seen that day at the practice". There was no fever and the child was playful and active. There were no relevant diagnostic or laboratory tests performed. No prescription or over-the counter medication was recommended. It was also noted that "per phone call to the family today", on 15-Aug-2003, the child "fine". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male patient who on 28-Aug-2003 was vaccinated in the right lower arm with a first dose of varicella virus vaccine live (lot number 644250/1153M). Concomitant therapy on 28-Aug-2003, included a third dose in the left lower arm of poliovirus vaccine inactivated (IPOL) (Batch #W0704-2). There was no illness at the time of vaccination. There were no symptoms following prior vaccinations. On 04-Sep-2003, the patient developed a disseminated rash consistent with varicella. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male pt who on 08/14/00 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Lot # 634502/0538K).  At the time of vaccination the pt had a red maculopapular rash which was diagnosed as [[name]]ola. The pt presented to the office for a physical on 09/15/03 with 50+ vesicular lesions and no other symptoms. There was treatment required. There was no product quality complaint involved. Follow up information indicated that on 09/14/03 the pt developed a rash. On 09/15/03, the pt was seen by the physician and the pt's mother reported that this rash was [[name]] today. Over 50 lesions were noted and the physician diagnosed the rash as chickenpox. No lab or diagnostic tests were performed. On 09/22/03, the pt recovered. No further information is available.
Age: 2.1
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 25 month old male with a medical history of "asthma" and "reflux" and fundoplication in May 2003 who on 07/31/02 was vaccinated in the right lower arm with a first dose of varicella virus vaccine live (Lot # 642635/0270M).  Concomitant therapy on 07/31/03, included a third dose in the left lower arm of IPV (Batch # U0426-2). Other medication included albuterol, Pulmicort. Illnesses at the time of vaccination were diarrhea and cough. On 09/14/03, in the evening, the pt developed a mild varicella rash 13 1/2 months post vaccination. There were no relevant diagnostic lab tests completed. It was noted that the pt recovered. No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Face oedema, Urticaria
Clinical narrative: Information has been received from a RN and a physician concerning a 3 year old male with no drug allergies who on 10/23/03 at 09:30 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 643596/0767M).  On 10/23/03 at 09:30 (also reported as 10 to 15 minutes post-vaccination) the pt developed hives over 50% of his body and some swelling of his lip. The hives were primarily on his face, neck and shoulders. There was no wheezing noted. The pt was treated with and responded to oral Benadryl. Within 30 minutes the hives and swelling had decreased and the pt recovered. An epinephrine pen was sent home with the child as a precaution. No product quality complaint was involved. No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Erythema, Infection, Pyrexia
Clinical narrative: Information has been received from a NP concerning a 12 month old male with no allergies or medical history who on 07/31/03 was vaccinated SC in the right thigh with a first 0.5mL dose of varicella virus vaccine live (Lot # 644794/0334N).  Concomitant vaccinations on the same day included a first dose SC in the left thigh of MMRII (Lot # 645399/0103N) and a third dose IM in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (Lot # 488204). There was no other concomitant medication. There was no illness at the time of vaccination. "About a week and a half later", on approximately 08/10/03, the pt developed a rash that resembled chickenpox. The lesions were about his trunk, cheek, and extremities. They started as red, then they became raised, formed pustules, and then appeared fluid filled. As this rash was resolving, about a week later, the child experienced another similar rash taking the same course as the last one. That rash seemed to be resolving and then on 09/20/03, the child began to develop the same type of rash again. Each time there was a low grade fever, but the parents reported that the child was teething and frequently had low grade fevers. Unspecified medical attention was sought and no treatment was required. It was noted that the adverse event abated. A product quality complaint was not involved. Follow up information was received from the nurse practitioner which indicated that since administration of the varicella virus vaccine live on 07/31/03 the pt has had three chickenpox outbreaks approximately two to three weeks apart. Only cutaneous symptoms were noted. There were no systemic symptoms. Subsequently, the pt recovered. No further information is expected.