chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Ran a fever, starting 3rd day post immunization. Increased irritability, covered head to toe in red spots for 2-3 days.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Blister
Clinical narrative: Vesicular eruption quickly progressing (few days) to shallow ulcerations, rapidly healing located in 2-3cm area of right mid-forehead. No other lesions or periorbital/ocular findings. No fever. Examined by the physician on day 4 of course.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Localized-firm, red, warm, mildly swollen left upper arm. Amoxicillin 250 mg TID x 10d + cool compresses.
Age: 4.08
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus, Pyrexia
Clinical narrative: Swelling, erythema, itching, fever over left deltoid. Resolved in 2 days.
Age: 5.2
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Per parent's report (both=MD's) hive-like/circular rash at LUE ( approx 1-1 1/2 weeks post vaccination) followed by mibarin type rash at neck, chest, upper back. Treated with Zyrtec only.
Sex: M
Vaccine: DTAP
Symptoms: Drug administration error
Clinical narrative: DPT was given instead of DT. No side effects. No fever. No adverse event. Advised to take Tylenol if fever occurred but not needed.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Red rash all over body > chest/abdomen pronouciated fever.
Age: 4.5
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Site of DTaP with redness 3cm x 4cm, T 102 deg F, edema, warmth and tenderness, persisting at least 4 days post immunization.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Eye pain, Headache, Myalgia, Neck pain, Pyrexia
Clinical narrative: High fever ~ 3 hours post vaccine administration with assoc. myalgias (generalized) head ache, neck pain, eye soreness. Document temp 103 deg F in MD office following day.
Age: 4.9
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site pain, Pruritus, Rash macular
Clinical narrative: Slight induration, minimal tender and blotchy, itchy.
Age: 3.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration
Clinical narrative: Immunization reaction left deltoid 3x4cm induration, cool compresses Tylenol prn Keflex.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster
Clinical narrative: Pt developed a mild case of chicken pox 4 years after receiving varicella vaccine
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Redness at site 3x4cm and serpiginous pattern of hives/wheals on forearm, distal to site approx. 20cm in length. Left arm involvement only. Expected to recover.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: 12-14 days after vaccination broke out with chicken pox lesions on trunk, face, neck lasted over 1 week
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Immediate swelling, itching and redness.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a child who on an unspecified date was vaccinated with Varivax. It was reported that approximately 20 days following the vaccination the child developed a generalized rash. Unspecified medical attention was sought. At the time of this report, the outcome of the rash was unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 22 week old male pt with asthma, gastroesophageal reflux disease and no known drug allergies and a history of prematurity at 15 weeks who was exposed to his vaccinated sister (WAES0201USA00366) who developed chicken pox on 01/04/2002. This pt had not been vaccinated with varicella vaccine virus live. The pt was taking Zantac and Xopenex. On 01/19/2002, the pt developed a secondary transmission when he broke out in chickenpox lesions and a low-grade fever. On 01/21/2002, the pt was seen in the office with lesions on his face and torso and was afebrile at the time. He was treated with Tylenol and Aveeno baths prn. It was reportedthat the pt was breast-feeding and his mother had a positive history for varicella. On 01/23/2002 it was reported that the pt was covered with varicella lesions, he has them in his eyes and on his head. A swab specimen was obtained from a vesicular lesion and sent for PCR analysis. On 02/01/2002, the PCR results were received and it was reported that the specimen was positive for wild type VZV. On 02/06/2002, the registered nurse reported that the pt was treated with Benadryl and Aveeno baths and was recovering (he just had dried lesions). Additional info has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female who on 08/30/2001 and 10/05/2001 was vaccinated with a first and second dose respectively of varicella virus vaccine live. It was noted that after the two doses the pt did not seroconvert. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 09/27/1996 was vaccinated SC with the first dose of varicella virus vaccine live. On 01/07/2002 the child experienced a headache which lasted for three days. On an unspecified date the child developed a fever less than 101 deg F and developed "many lesions that were mostly on the face and head area." The child received baking soda baths, calomine lotion and Benadryl. It was reported that the events lasted for one week and by 01/10/2002 the child was noted to have subsequently recovered from the events. Additional info has been requested.
Age: 2.9
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Initial and follow-up info has been received from a registered nurse concerning a 6 year old female pt with no known allergies and cold symptoms at the time of vaccination who on 12/08/1998 was vaccinated with the first dose of varicella virus vaccine live SC in the left arm. On 01/17/2002, the pt developed chickenpox. On 01/21/2002, the pt presented to the physician's office with a fever and approximately 125 pox all over her body. The pt subsequently recovered and returned to school on 01/24/2002. No further info is available.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female pt who in approximately 1996 was vaccinated with varicella vaccine. The pt received two doses about one month apart. Subsequently, the pt's serology results indicated that she failed to seroconvert. The specifics of the serology test used were not known. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.3
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 31 month old male pt with no past medical history and no known drug allergies who on 09/26/2000 was vaccinated with the first dose of varicella virus vaccine live SC in his leg. On 09/26/2000 the pt was also vaccinated with the second dose of Prevnar IM in his leg and his third dose of IPOL SC in his leg. There were no other concomitant therapies or illnesses at the time of vaccination. On 01/17/2002 after a trip overseas, the pt developed mild varicella with 20 lesions and a slight fever. The child was seen in the physician's office on 01/21/2002 with 6 lesions. No treatment was needed at that time. Additional info has been received from a registered nurse. The nurse reported that the varicella virus vacicne live failed to protect fully as the pt developed 6 vesicles 15 months post vaccination on 01/22/2002 (also reported as 01/17/2002). She reported that the pt was not very ill and that he recovered in January 2002. No further info is available.
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Laboratory test abnormal, Nausea, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with varicella virus vaccine live. Subsequently the pt developed a fever, nausea, vomiting, diarrhea, rash and lesions (10-15 lesions) 7-14 days after receiving therapy. The pt had a titer drawn about 23 days post vaccination that was negative. Additional info received from the registered nurse indicated that she did not feel that the pt's symptoms were an adverse experience. She felt that the pt's experience was a common side effect. No additional info is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with varicella virus vaccine live. Subsequently the pt developed a fever, nausea, vomiting, diarrhea, rash and lesions (10-15 lesions) 7-14 days after receiving therapy. The pt had a titer drawn about 23 days post vaccination that was negative. Additional info received from the registered nurse indicated that she did not feel that the pt's symptoms were an adverse experience. She felt that the pt's experience was a common side effect. No additional info is expected.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 29 year old male who on 01/10/2002 was vaccinated with a dose of varicella virus vaccine live. On 01/11/2002 the pt experienced a mild fever, slightly swollen glands and muscle aches. On 01/14/2002 the pt developed 4-5 red spots on his face and chest. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a female pt who was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced a rash that was diagnosed to be varicella. No further info was available. Additional info has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a company representative and health care facility concerning a 7 year old female who on 04/12/1996 was vaccinated with a dose of varicella virus vaccine live. On 01/19/2002, the pt presented to the physician's office with chickenpox. She broke out in a rash all over her body and this was not a mild, but serious case of varicella. However, there was no documentation in the pt's chart as to the number of lesions she had. Subsequently, she recovered. It was reported that another pt (WAES0203USA00269) had a similar experience following exposure to varicella virus vaccine live. Additional info has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: Information has been received from a medical technologist concerning a 12 month old male with no known drug allergies who on 01/17/2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. It was reported that within a week of being vaccinated the child developed chickenpox with 90 + vesicular lesions over his entire body and a low grade fever. The pt sought unspecified medical attention. Additional info has been requested.
Age: 3.7
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 10 year old female with asthma, egg allergy since 1992 and peanut allergy and a history of tachycardia who on 08/10/1995 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included Serevent and Pulmicort for her asthma. On approximately 01/21/2002 the pt experienced a fever and "spots." The pt was seen in the office on 01/24/2002 with 150 itchy vesicles. The pt was treated with calamine lotion, aveeno and Tylenol prn. Additional info has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 7 year old pt who on 07/26/1996 was vaccinated with a dose of varicella virus vaccine live. On 01/23/2002 the pt was examined at the physician's office and diagnosed with shingles. He was not in any discomfort, but was diagnosed with shingles because of the vesicular lesions formed in a single band from his mid chest around to his back. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with no past medical history who on 01/11/2002 was vaccinated with the first dose of varicella virus vaccine live SC in the left thigh. Concomitant therapy that same day included the third dose of Prevanr IM in the right thigh. There was no illness at the time of vaccination. On 01/24/2002 (previously reported as ten days post-vaccination), the pt developed a rash on right thigh  at site of injection which was noted to be 3 small vesicles filled with fluid. It was noted that the pt's mother called the physician's office on 01/25/2002 and reported that the pt had 2 fluid filled "pimple" on the left thigh at insertion site of vaircella. It was noted that they crusted over. The pt was afebrile and did not have any signs or symptoms of illness. The pt recovered 01/28/2002 or 01/29/2002. The pt sought unspecified medical attention. Additional info has been requested.
Age: 2.5
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female who on 04/27/1998 was vaccinated with varicella virus vaccine live. On 12/19/2001 the child presented to her physician who confirmed chickenpox. At the time of this report, the outcome of the event was unknown. Additional info has been requested. The nurse also reported that a 5 year old male developed chickenpox following vaccination with varicella virus vaccine live (WAES0112USA02311).
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a woman in a physician's office and a physician concerning a 6 year old female with no past medical history or allergies who on 09/10/1996 was vaccinated with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 01/25/2002 the pt developed 20 pox lesions which were scattered all over the body, including the genital area. The pt was seen at a physician's office. Additional info has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received on 01/25/2002 from a registered nurse concerning a female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt failed to seroconvert. The pt sought unspecified medical attention. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old healthy male child who on 08/29/1997 was vaccinated with varicella virus vaccine live. On 01/06/2002 the child broke out with a rash, and on 01/07/2002 the child presented to his physician and was diagnosed with varicella. No treatment was ordered, and the child received comfort measures only. At the time of this report, the outcome of the event was unknown. No further info is expected. The nurse also reported that a 6 year old female and a 7 year old male developed varicella following vaccination with varicella virus vaccine live (WAES0201USA01195 and 0201USA02891).
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old healthy male child who on 08/25/1995 was vaccinated with varicella virus vaccine live. On 01/06/2002 the child presented to his physician with a mild varicella rash. No treatment was ordered, and the child received comfort measure only. At the time of this report, the outcome of the event was unknown. No further info is expected. The nurse also reported that a 6 year old female and a 5 year old male developed varicella following vaccination with varicella virus vaccine live (WAES0201USA01185 and 0201USA02589).
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a female pt whose younger sister was vaccinated with varicella virus vaccine live. The pt in this report was never vaccinated with varicella virus vaccine live. The pt was receiving unspecified chemotherapy. In November 2001, the pt develped shingles at the same time her five year old sister developed chickenpox. Unspecified medical attention was sought. The pt's younger sister developed chickenpox post-vaccination with varicella virus vaccine live (WAES01120544). No further info is available.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a female who on 01/05/1999 was vaccinated with varicella vaccine live. In January 2002, the pt developed chickenpox. It was reported that the child developed five lesions. Medical attention was sought. At the time of this report, the outcome of the event was unknown. No further info was available. The nurse also reported that the sibling of this child developed varicella following vaccination with varicella virus vaccine live (WAES0201USA01950).
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old female child who on 04/30/1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 01/09/2002 the child developed a rash which was classified as chickenpox. On an unspecified date the child recovered. It was noted that the child was exposed to her sibling (WAES0201USA02950) who developed chickenpox 12 days earlier. Another sibling (WAES0201USA02951) also developed chickenpox following exposure to varicella virus vaccine live. No further info is available.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Infection, Rash
Clinical narrative: Information has been received from a health professional concerning a 6 year old female child with no past medical history who on 03/12/1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 12/25/2001 the child experienced rash and headache. She was seen in the physician's office and diagnosed with a mild case of chickenpox. Subsequently, the child recovered. The child's two sisters (WAES0201USA02949 and 0201USA02951) also developed chickenpox following exposure to their sister and varicella virus vaccine live. No further info is available.
Age: 4.2
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old female child who on 06/07/1996 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. On 01/08/2002 the child developed a rash which was classified as chickenpox. The outcome of the chickenpox was not reported. It was noted that the child was exposed to her sibling (WAES0201USA02950) who developed chickenpox 12 days earlier. Another sibling (WAS0201USA02949) also developed chickenpox following exposure to varicella virus vaccine live. No further info is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a health professional concerning a male pt who in 04/17/2000 was vaccinated with a dose of varicella virus vaccine. On 01/21/2002 the pt developed chickenpox with about 15 lesions that were itchy. No other symptoms were reported. Unspecified medical attention was sought. Additional info has been requested.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning an approximately 31 year old male pt who was vaccinated with a two dose series of varicella virus vaccine live according to the recommended schedule. In approximately 2002, the pt was tesed for seroconversion using the herpes zoster ABS serology test. The pt's test was negative (did not show seroconversion). The registered nurse was not sure if the serology test was appropriate to show seroconversion for varicella virus vaccine live. Unspecified medical attention was sought. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a male pt who on 12/24/2001 was vaccinated with one dose of varicella virus vaccine live. On 12/31/2001, one week post-vaccination, the pt developed lesions and temperature, as reported by his parents. The pt sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before." The records of testing prior to release of this lot have been checked by CMP Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released. Follow-up info on 03/07/2002, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever," was because she has been in practice for a number of years, and always gave pt/parents standard info on the benefits/risks of the vaccine before its administration, and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in January 2002, including this pt and other pts who were vaccinated and experienced similar events (WAES0202USA00428, 0202USA00429, 0202USA00430, 0202USA00431, and 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in calls was just n the month of January 2002. They did not experience any unusual volume of calls in February or thus far in March 2002. Additional info has been requested.
Age: 4.75
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old child with no known allergies who on 12/05/2000 was vaccinated with a dose of varicella virus vaccine live. On 01/28/2002 the pt broke out in chickenpox, 4 spots were noted on the right side of trunk and four spots on their back. No fever was noted. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 01/09/1998 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. On 01/17/2002 the pt experienced chickenpox all over the body. Unspecified medical attention was sought. It was reported that the pt recovered on 01/17/2002. Additional info has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning his 16 month old daughter with no past medical history and no known allergies who on 01/28/2002 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 01/28/2002, 3-4 hrs post vaccination, the pt experienced fever of 102, vomiting and diarrhea. Unspecified medical attention was sought. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 5 yea rold female who in May 1997 was vaccinated in the arm with one dose of varicella virus vaccine live. There were no concurrent medications. It was noted that a rash did not occur at the site of injection post-vacicnation. On 12/13/2001, the child developed a rash consisting of papules and vesicles. There were approximately 50 lesions. There was not recent exposure to chickenpox or shingles. She presented to the physician who diagnosed her with herpes zoster alogn the right L2 dermatome. On 12/13/2001, the physician obtained a specimen from one of the lesions. A Tzanck test showed multinucleated giant cells. The physician prepared a slide from the specimen, which will be submitted for PCR analysis. The pt subsequently recovered. Additional info has been requested.  Follow up information indicated that the interpretation of PCR analysis was "VZV positive, non-typable". Additional follow up information was received on 30OCT2002. The vesicular rash specimen was positive for VZV and PCR analysis of reamplified specimen identified the presence of WT VZV. No further informationn is available.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning an approximately 7 year old female with no past medical history and no allergies who on 08/05/1996 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 01/24/2002 the pt presented to the physician's office with a case of chickenpox. It was reported that there were a fair amount of lesions with typical chickenpox presentation. The pt was prescribed Benadryl. Additional info has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 23 year old female with no known drug allergies who on 09/08/1999 was vaccinated with a second dose of varicella virus vaccine live. The first dose was given on 08/02/1996. On 01/21/2002 the pt had a titer done and it did not show seroconversion. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 13 month old male with numerous "chronic neurologic and pulmonary conditions" and multiple congenital anomalies who on 01/03/2002 was vaccinated with a dose of varicella virus vaccine live. The reporter stated that, to his knowledge, the pt was not immunosupressed. It was noted that the child is currently hospitalized and on a ventilator and that the reporter was not sure if the child was hospitalized at the time of vaccination or afterward. It was also reported that the pt was hospitalized due to his pre-existing chronic medical condition and it was, in no way, related to vaccination with varicella virus vaccine live. On 01/28/2002 the pt began to develop a rash. He had approximately 12 lesions described as very large juicy vesicles. It was also described as "typical varicella." It was noted that there were 150 vesicular lesions on his trunk, face and extremities that occurred 27 days post vacicnation. His max temp was 101 deg. It was noted that the child had no chickenpox until now and that he had no known exposure to varicella. However, three weeks ago, there was a pt in the hospital who had a case of chickenpox. To the reporter's knowledge there was no contact between that case and this pt. The physician collected a swab specimen from a vesicular lesion on 01/10/2002 the physician and it was sent for PCR analysis. It was reported that the pt recovered. Another pt (WAES0201USA03220) experienced herpes zoster following vaccination with varicella virus vaccine live. Follow-up info indicated that preliminary results showed the specimen was VZV + and that the specimen would be typed in the next week or so. Additional follow-up reported that the swab from the vesicular lesion was VZV+ and that the PCR analysis identified the presence of Oka/Vaccine strain. The pt is at home and has recovered. It was reported that, to the doctor's knowledge, the pt was not on steroids for his other underlying conditions and he was "surprised that the child's rash looked like classic chickenpox." He reported that the child was treated with acyclovir and recovered. It was also reported that the child did expose several other children in the hospital, but no other cases have been reported. One of the children exposed got prophylactic IVIG. Upon internal review varicella was considered an other important medical event. Additional info has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male with no known allergies who on 07/26/1996 was vaccinated with a dose of varicella virus vaccine live. On 01/31/2002 the pt presented to the doctor's office with varicella. The pt had chicken pox on the face, chest, shoulders, and had a low grade fever. The pt sought unspecified medical attention. Additional info has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with no past medical history and no allergies who on 04/28/1998 was vaccinated with the first dose of varicella virus vaccine in the left arm SC. There was no concomitant medication or illness at the time of vaccination. On 01/11/2002, the pt developed a mild case of chickenpox. The pt was prescribed Benadryl for the itch. Follow-up info reported no other adverse events. No further info is available.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 27 year old female pt with asthma, hypertension and anticonvulsant therapy, no known allergies and a history of migraines who was taking montelukast sodium, atenolol and Neurontin. In approximately January 2001, the pt presented to the physician's office with typical chickenpox lesions (red blotches with white vesicular centers) on her trunk, back and face. At that point in time there were 35-50 lesions. The pt's mother stated that the pt never had chickenpox, but the pt thought she had chickenpox as a child. It was reported that the pt baby-sat for 2 children who received varicella vaccine "last week" (approx. January 2002). One of the children developed a rash which was thought to be roseola when seen at te pediatrician's office (WAES0203USA01915). The pt was prescribed acyclovir and instructed to use Benadryl as needed. The physician declined to sending isolates for an analysis. Additional info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 7 year old male who on 03/09/1996 was vaccinated with a dose of varicella virus vaccine live. On 02/04/2002 it was reported that the pt "now" has chicken pox. The pt sought unspecified medical attention. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dermatitis bullous
Clinical narrative: Information has been received from a registered technician concerning her grandson who "during the last week" of January 2002 was vaccinated with a dose of varicella virus vaccine live. On 02/02/2002 the pt developed a vesicular rash over his entire body and a mild cough. There was no other info provided. Additional info has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a female PH.D whose daughter was vaccinated with Varivax. The Ph.d reported that after her daughter developed chicken pox (see WAES0112USA01686), the Ph.D also developed a fever and malaise. After her daughter became sick, the Ph. D developed a chicken pox like reaction in her mouth and on her tongue. The Ph.D stated that she "normally" experienced  neuraligia, and not a rash. She indicated that her physician "couldn't figure anything out". No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with one dose of Varivax. (Site unknown) On 01/10/01, the physician's office received a telephone call that the patient had a temperature for three days approximately 01/10/02. The patient sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before". The records of testing prior to release of this lot have been checked and found to be satisfactory. This lot complies with the standard and was released. FOLLOW- UP information on 03/07/02, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician started that the reason she used the phrase "more cells than ever", was  because she has been in practice for a number of years, and always gave patient/parent standard information on the benefits/risks of a vaccine before its administration, and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in 01/02, including this patient and other patients who were vaccinated and experienced similar events (WAES0201UDSA03018, 0202USA00428, 0202USA00430, 0202USA431, 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in calls was just in the month of 01/02. They did not experience any unusual volume of cells in 02/02 or  thus far in 03/ 02. Additioanl information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient (gender not specified) who was vaccinated with one dose of Varivax (site unknown). Concomitant therapy included on dose of MMRI. Subsequently, the patient developed a generalized rash over body. The patient sought unspecified medical attention. The physician requested a lot check on the lots because there were "more phone calls than ever before". For Varivax and MMRII, it was found that, "The records of testing prior to release of this lot have been checked and found to be satisfactory. This lot complies with the standard  and was released. FOLLOW-UP information on 03/07/02, from a physician noted there were no more adverse events  to report other than those that were previously reported. the physician stated that the reason she used the phrase "more calls than ever" was because she has been in practice for a number of years and always gave patient/parents standard information on the benefit/risks of a vaccine before its administration and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in all her years of practice, it has been her experience that parents rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in 01/02. including this patient and other patients who were vaccinated and experienced similar events  (WAES0201USA03018,0202USA00428, 0202USA00429, 0202USA00431 and 0202USA00432). The physician also  thought it was unusual that several of the adverse event seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in cells was just in the month of 01/02. They did not experience any unusual volume of calls in 02/02 or thus far in  03/02
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health profesional concerning a 10 year old male who on 09/26/96 was vaccinated with one dose of Varivax. On 02/05/2002, the patient presented to the physician's office with 100 vesicular lesions and low grade fever. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin reaction, Skin ulcer
Clinical narrative: Information has been received from the mother of a 6 year old male who was vaccinated "several years ago" with Varivax. The child's mother reported that "recently " the child broke out with a mild case of chicken pox. The mother reported that the child "had some spots, but it was not all over his body". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 32 year old male who on 05/18/01 was vaccinated with the first and second dose of Varivax. The nurse practitioner reported that the patient has failed to seroconvert. Unspecified medical attention was sought. Additional information has been sought.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash vesicular
Clinical narrative: Information as been received from a health professional concerning a 3 year old male who on 06/07/99 was vaccinated SC in the right arm with the first dose of Varivax. On 01/27/02, the patient's mother called the physician's office to notify them that chicken pox lesions were developing. It is unknown whether the patient was seen in the physician's office. The outcome of the experience was not reported. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 34 year old male who was vaccinated with a first and second dose of Varivax in 01/01 and 06/01, respectively. Subsequently the titer drawn after vaccination was negative. The patient was then vaccinated with a third and fourth dose of Varivax on 08/28/01
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a company representative concerning a 6 year old female with no known drug allergies who on  09/06/1996 was vaccinated with a dose of Varivax . On approximately 02/01/02, the patient presented to a physician's office with chicken pox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 4 doses of Varivax over 18 months and has failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 10/24/97 was vaccinated with Varivax. On 02/10/02, the patient developed a chicken pox rash (approximately ten pox) scattered on the torso and buttocks with no sequelae.  It was noted that the patient did not have any adverse events following previous vaccinations.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 7 year old male who on 01/18/96 was vaccinated with the second dose of Varivax (site unknown). On 02/11/02, the patient developed a chicken pox rash all over his body (about 50 spots), and was afebrile. It was reported on 02/11/02 that the child was "exposed to chicken pox 6 weeks ago. The patient sought unspecified medical attention. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 48 year old female who in approximately 2000 was vaccinated with two doses of varicella virus vaccine live. In approximately February 2002, the pt was found to have negative titer for IgG antibodies to varicella zoster virus. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rhinorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no known allergies who on 05/28/1998 was vaccinated with varicella virus vaccine live. On 02/08/2002 the child developed a mild varicella rash and a runny nose. The child did not have a fever. It was reported that the child's father had shingles 14 days prior. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional info has been requested.
Age: 4.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female with no past medical history who on 05/28/1997 was vaccinated with the first dose of varicella virus vacicne ive. SC. There was no illness at the time of vaccination. On 01/17/2002 the pt developed chickenpox. The pt's mother stated that her daughter had "about 25 lesions mostly on the buttocks, one on face and several under each arm." It was reported that the pt recovered on 01/21/2002. It was noted that the pt did not have any adverse events following previous vaccinations. No further info is expected.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 5 year old female with no past medical history and no known allergies who on 11/04/1997 was vaccinated with a second dose of varicella virus vaccine live. There was no concomitant medication. On 02/11/2002 the pt developed 19 pox scattered all over her body but mostly on her chest and back. The pt's oral temperature was 98.3 deg F and she had no respiratory involvement. The pt was treated with Beandryl prn. It was reported that the pt recovered. It was also noted that the pt had no known adverse events following previous vaccinations. No further info is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a female pt who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, within a few days of vaccination, the pt experienced a varicella rash over the entire body. It was described as a disseminated rash with several lesions, some vesicular in nature. No prescription drug treatment was needed for the experience and there was no hospitalization. The pt recovered. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received on 02/14/2002 from a grade school principle concerning a student who "in the past" was vaccinated with a dose of varicella virus vaccine live. On 02/14/2002, it was reported that the pt "recently" developed chicken pox. It was unknown if the pt sought medical attention. Additional info has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female who on 12/03/1997 was vaccinated with a dose of varicella virus vaccine live. On 02/14/2002 it was reported that the pt "now has chicken pox (100-150 lesions). The pt sought unspecified medical attention. Additional info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a woman concerning a her 7 year old son with no past medical history and no allergies who in 1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 02/14/2002 it was reported that recently in 2001 the pt "had caught the virus from a classmate." It was noted that the pt did not develop a fever but had about 100 lesions. The pt sought unspecified medical attention. Additional info has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a female who on 07/06/2000 was vaccinated with a dose of varicella virus vaccine live. On 02/14/2002, the pt developed chicken pox. It was noted that unspecified medical attention was sought; however, on 02/14/2002, the nurse reported that she had not seen the pt yet. Additional info has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old pt who was vacicnated with varicella virus vaccine live. Subsequently the pt developed a breakthrough varicella rash. The pt did not seek medical attention. Additional info has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a family member concerning a 6 year old female family member with no known allergies and asthma associated with colds who in 1996 was vaccinated with varicella virus vaccine live. On 02/14/1996 the pt developed 40-50 lesions. The pt did seek medical attention. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site oedema, Pyrexia
Clinical narrative: Increase tempeture, redness and swelling at injection site within 24 hours of immuniztion.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Crying, Insomnia, Irritability
Clinical narrative: Difficulty sleeping, irritable and crying
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Convulsion
Clinical narrative: Mother states that the child has a seizure lasting approximately 5-10 seconds long.  This occured twice.  Seen by the doctor on Nov 5, 2001.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Crying, Dyskinesia, Irritability, Screaming
Clinical narrative: Baby cried for 5 days- very fussy.  Had jerky-spastic type movements that started on Sat. am
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Dysarthria, Dysphagia, Hypoaesthesia, Hypokinesia, Laboratory test abnormal
Clinical narrative: vacc on 5-17.  On evening of 6-10, pt has sudden onset of dysarthia, left arm numbness, loss of right side fine motor skills, severe difficulty swallowing by 6-11, admitted to Hospital ICU on 6-11.  Afebrile.  MRI find "bilateral white matter disease" and CSF shows elevated protein of 70; other prelim tests normal
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Neck pain, Neurological symptom
Clinical narrative: Joint pain in several locations=back, foot, neck and shoulder. Numbness in arm. Neurological symptoms.
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Pain in extremity
Clinical narrative: Joint pain in several locations=back, foot, neck and shoulder. Numbness in arm. Neurological symptoms.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Apnoea, Convulsion, Pyrexia
Clinical narrative: Had seizure and stopped breathing. Temperature went over 105 deg F.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Had seizure and stopped breathing. Temperature went over 105 deg F.