chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a physician concerning 2 pts who were vaccinated with varicella virus vaccine live (dosage, dose series, route and lot number not provided). The physician reported that she has seen 2 pts develop "zoster" and inquired as to how common it was to observe this condition in pts who have received vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from an RN concerning a 30 year old female pt with no known allergies who on 2/12/98 was vaccinated with the 1st dose of varicella virus vaccine live. Subsequently, the pt's titer was drawn (nurse had no date), which was negative. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a Medical Technologist concerning pts who on unspecified dates were vaccinated with varicella virus vaccine live. There were no concomitant medications reported. The reporter indicated "over the last year, the clinic had seen about 3-4 cases of break through rash after (varicella virus vaccine live)". It was reported as unknown if the pts sought medical attention. No further details were available. No further information is available.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from an RN concerning her 38 year old husband with no known drug allergies and a history of chicken pox as a child who was not on any medications. On 5/30/01, 1 of the couple's sons was vaccinated with varicella virus vaccine live. The pt was subsequently exposed to the vaccine and on 7/1/01, the pt developed 5 burn-like blisters that were approx. 1" in diameter (4 on his hand and 1 on his left thigh). Unspecified medical attention was sought. All of the blisters subsequently, completely resolved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old child who on 7/9/01 was vaccinated with varicella virus vaccine live. On 7/18/01, the pt presented with a "break-through" chicken pox rash on the trunk of the body, with no fever. The health professional also reported about another pt (WAES01072005). No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Rash papular
Clinical narrative: Information has been received from a consumer concerning her daughter who on 07/07/2001 was vaccinated with varicella vaccine. On approx. 07/17/2001, the pt experienced redness and bumps around the injection site. The pt's mother also reported that her daughter developed 100 slightly raised red bumps which never blistered on her body. The rash subsequently resolved. The pt's mother reported that rash "came and went fairly quickly." Additional info is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received on 24 JUL 2001 from a female registered nurse who was vaccinated with a first and second dose of varicella virus vaccine live (site unknown), within the last 8 years. A titer was drawn a few years after the vaccinations, subsequently the patient failed to seroconvert. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning "several" patients who were vaccinated with varicella vaccine. The physician reported that the patients subsequently developed a mild case of "chicken pox breakthrough." The physician reported in follow-up that she had identified every one of which she knew at that time. Additional info is not expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a female consumer concerning her 12 year old son with no known allergies, no concomitant therapy and no medical history who on 10 JUL 2001 was vaccinated with varicella virus vaccine live. On 13 JUL 2001 he broke out with chicken pox, approximately 100-150 lesions. Medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site mass, Pyrexia
Clinical narrative: Information has been initially received from a registered nurse concerning a 1 year old grand daughter who on 07/06/2001 was vaccinated first dose in her thigh with varicella vaccine. Concomitant therapy included MMR vaccine, HIB conj-hep B vaccine. Other comcomitant therapy included Prevnar. On approx. 07/08/2001, 2-3 days post-vaccination, the pt developed a "knot" at the injection site on one of her thighs and a generalized body warmth; a fever. It was reported that the specific sites of injection for each vaccine was not known. The fever and the injection site knot on her thigh had resolved on the following day. It was noted that the child had been teething prior to her vaccination. On approx. 07/17/2001, the pt developed fine red rash-little dots on her chest which had resolved within a day. It was also reported by the registered nurse that her father who had asbestosis, emphysema, long term steroid therapy for treatment of his emphysema, and a history of being "susceptible to pneumoniae," chicken pox and shingles around his chest 'several years ago" also had experienced symptoms. On 07/16/2001, the child's grand father had developed blistering around the corner of his eye and forehead which was initially diagnosed as conjunctivitis. The blistering continued to worsen, and the pt returned to his physician who diagnosed shingles. The pt was treated for shingles with an unspecified medication. It was reported that the pt had scabbed lesions around the corner of his eye, forehead, and scalp. On follow-up, it was reported by the nurse that he was "feeling better" today. Upon review, this pt experience was considered to be a possible secondary transmission of herpes zoster. In follow-up, the registered nurse was interested in info on secondary transmission. The VZV ID Program was discussed with her. The reporting nurse stated that the pt had a number of scabs, and there were several in the pt's scalp area, which could be unroofed without risk of scarring. She stated that she would speak with her father to see if he would like to participate in the VZV ID Program. Additional info has been requested.
Age: 2.7
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Irritability
Clinical narrative: Information has been received from a physician concerning a 31 month old white female infant with no known allergies who on 13 DEC 1999 was vaccinated SQ in the left arm with a .5 mL first dose of varicella virus vaccine live (lot #631774/1034J). There were no concomitant medications or illnesses at the time of vaccination. It was noted that a rash did not occur at the site of injection or elsewhere within 42 days of vaccination. On 24 JUL 2001 the infant presented to the physician's office with herpes zoster (onset date of 17 JUL 2001) and was reported to have been fussy and uncomfortable. The lesions were distributed on the right dorsal forearm and 10-12 vesicles (in a 2.5 cm circle with one vesicle more dorsally near the wrist were present. It was noted that the infant was exposed to her mother who had a history of shingles in Nvember 2000. The infant's mother reported that the child has had the rash for approximately a 1-week duration. The infant was not treated with antivirals since the herpes zoster was of one week duration. There were nor prior adverse events following previous vaccinations. It was noted that the infant did not have a history of chickenpox and that the specimen was not obtained for PCR analysis. Follow up information has been received and indicated that infant has not been seen since the experience, and that it was unknown if she recovered. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 28 year old female w/NKDA who in 1997 was vaccinated (first dose) with varicella virus vaccine live (dosages, route and lot number not provided. Concomitant therapy included hormonal contraceptives (unspecified date in1997, the patient developed a "site reaction". It was indicated that at that time, the patient had sought medical attention. No further information is available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received form a registered nurse concerning a 16 year old female. The pt wsa vaccinated with first and second doses of varicella vaccine on 10/05/2000 and 11/02/2000, respectively. In July 2001 the pt's varicella zoster virus antibody test was negative. On 07/24/2001 the pt received an additional dose. Additional info has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a M.S. concerning now a five year old female who in September 1996 was vaccinated with one dose of varicella vaccine. On 11/23/2000 the pt experienced breakthrough varicella. Subsequently, the pt recovered from breakthrough varicella. Other patients were reported with similar symptoms. No further info is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from an M.S. concerning a 4 year old Asian male who on 17 APR 1997 was vaccinated with one dose of varicella virus vaccine live. On 21 NOV 2000 the patient experienced breakthrough varicella. On 27 NOV 2000 the patient recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella virus live (WAES01072609; 01072611-01072617; 01030289; 01072717; 01072719). No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been recived concerning a 6 year old white male who on 08/02/96 was vaccinated with varicella virus vaccine live. On 11/21/00, the patient experience breakthrough varicella. On 11/29/00, the patient recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella virus vaccine live (WAES 01072609-01072610, 01072612-01072617, 01030289, 0107217, 01072719). no further information is available.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received concerning now a five year old female who on 11/17/1996 was vaccianted with one dose of varicella vaccine. On 11/21/2000 the pt experienced breakthrough varicella. On 11/24/2000 the pt recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella vaccine. No further info is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from an M.S. concerning now a five year old male who on 07/03/1996 was vaccinated with one dose of varicella vaccine. On 11/21/2000 the pt experienced breakthrough varicella. The pt was treated with oral acyclovir. On 11/28/2000 the pt recovered from that experience. No further info is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from an M.S. concerning a 5 year old white male with asthma who on 24 JUN 1997 was vaccinated with one dose of varicella virus vaccine live (lot #622969/0423E). On 08 NOV 2000 the patient experienced varicella. On 16 NOV 2000 the patient recovered from varicella. Other patients were reeported with similar symptoms following varicella virus vaccine live (WAES01072609-01072613; 01072415-01072617; 01030289; 01072717; 01072719). No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received concerning now a 4 year old female who on 12/19/1996 was vaccinated with one dose of varicella vaccine. On 11/21/2000 the pt experienced breakthrough varicella. On 11/21/2000 the pt recovered. No further info is available.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received concerning a 4 year old male with asthma who on 07/28/97 was vaccinated with one dose of varicella virus vaccine live. On 11/22/00, the patient experienced breakthrough varicella. On 11/25/00, the patient recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella virus vaccine live (WAES 01072609-01072615, 01072617, 01030289, 01072717 01072719). No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received concerning now a 4 year old female who on 11/03/1998 was vaccinated with one dose of varicella vaccine. On 11/20/2000 the pt experienced breakthrough varicella. On 11/23/2000 the pt recovered. No further info is available.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a female (date of birth 10 JUN 1971) with no known allergies whoon a unspecified date was vaccinated with the second dose of varicella virus vaccine live (site unknown). Subsequently, the patient failed to seroconvert. The patient did not seek medical attention. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a pharmacist concerning her son now a 23 month old male with no known allergies who on 07/24/2001 was vaccinated with varicella vaccine in his left arm. On 07/25/2001, the pt experienced a hard nodule/lesion near the injection site. The mother was not sure if it was a mosquito bite or a reaction from the vaccine. Additional info has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 4 year old female who on 19 FEB 1997 was vaccinated with varicella virus vaccine live. On 23 NOV 2000 the patient experienced breakthrough varicella that lasted 3 days. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now a 4 year old female with asthma who on 06/24/1997 was vaccinated with varicella vaccine. On 11/24/2000 the pt experienced breakthrough varicella that lasted seven days. Subsequently, the pt recovered. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a state immunization offician concerning a patient who was vaccinated with two doses of varicella virus vaccine live. The patient subsequently tested seronegative for antibodies. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash vesicular, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 14 month old Caucasian female with no previous significant medical history, no known illness at the time of vaccination, no known recent varicella or herpes exposure and no previous history of chicken pox, who on 17 JUL 2001 (previously reported as 2 months ago, in approximately May 2001 and also as 07 JUL 2001 was vaccinated with the first .5 mL dose (lot #638653/1890K) of varicella virus vaccine live administered SC in the right arm (also reported as the left arm/deltoid. There was no concomitant medication. It was reported that on 30 JUL 2001, the patient was seen at the physician's office for follow up to an ear infection. That same day, she was diagnosed with herpes zoster that began on 29 JUL 2001. The physician noted that a varicella zoster or herpes zoster like presentation oh the child's nose. It was reported that the multiple, small, vesicular lesions were clustered, primarily on the left side of her nose and did not cross the midline. This was also described as multiple blisters on the end of the left nostril. It was reported on 01 AUG 2001 that the patient did not have a fever and had no other symptoms. A specimen, consisting of 2 swabs, was collected from vesicular lesions and sent for varicella zoster virus identification on 31 JUL 2001. The lab received the specimen on 01 AUG 2001. On 24 AUG 2001, notification was received from the lab that VZV DNA and B-globin DNA were not amplified and that the specimen was inadequate to process; therefore, no strain ID was made and a direct fluorescent antibody test was not performed. It was noted that the patient did not develop a rash at the injection site or elsewhere within 42 days of the vaccination. Subsequently, it was reported that the patient recovered from her experience. No further information is available.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning a 13 month old male who on 05/09/2001 at 3:45pm was vaccinated in the left thigh with a first dose of varicella vaccine. On 05/30/2001 at 9:30am the pt broke out in a mild case of chicken pox. Unspecified medical attention was sought. The pt recovered. It was reported that another pt had a similar experience after vaccination with varicella vaccine.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 30 year old female who in March 2001 and April 2001 was vaccinated with first and second dose of varicella vaccine. In June 2001, a titer was done and came out negative. The pt sought unspecified medical attention. Additional info has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 13 month old male with no past medical history record who on 03/23/2001 at 10am was vaccinated with the first dose of varicella vaccine SC in the left upper arm. There was no illness at the time of vaccination. On 05/13/2001 the pt developed lesions with watery blisters, described as itchy. It was noted that the pt or sibling did not experience an adverse event following previous vaccinations. There was no further info provided. No further info is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 5 year old male who in March 2001 was vaccinated with a dose of varicella vaccine. In July 2001, the pt did not have a titer. The pt sought unspecified medical attention. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site oedema, Injection site pain, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old white female child with no past medical history and no known allergies who on 06 JUL 2001 (also reported as 16 JUL 2001) was vaccinated with a first dose of varicella virus vaccine live in the right thigh ((lot #636580/0098L). Concomitant therapy that day included a first dose of measles vaccine (+) mumps vaccine (+) rubella vaccine live (second generation) (MSD) (lot #637837/0373L) in the left thigh. There were no illnesses at the time of vaccination. The medical assistant reported that immediately following the varicella virus vaccine injection, the patient developed a significant local injection site reaction of swelling and tenderness about the size of a half-dollar. On 27 JUL 2001, the child was again seen in the office and still had a bump at the injection site that was tender to the touch. Follow up information received from a medical assistant on 24 SEP 2001 indicated that on 06 JUL 2001 the child had an immediate (+) local hive)" at the varicella injection site. It was reported that the child was administered diflorasone diacetate (PSORCON) cream and diphenhydramine hydrochloride (BENADRYL) and was sent home. The child's mother was told to call the office if the symptoms got worse. Itw as reported that the child recovered from the hive on 07 JUL 2001 and that she recovered from her experience. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTP, VARCEL
Symptoms: Crying, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a five year old with no known allergies who on 08/01/2001 was vaccinated with varicella vaccine. Concomitant therapy included diphtheria toxoid/pertussis vaccine/teta. There was no other concomitant medication. After receiving the injections the child began to cry and developed a flat, red rash on both arms, the front and back of his neck, and behind his ears. No other symptoms were noted. The mother stated that the child develops a similar rash "whenever he cried hard." On the advice of the reporting nurse, the child was taken to a local ER, where he was examined and released with no recommended follow-up treatment. The rash resolved totally within one to two hours post vaccination. Additional info has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Ear disorder, Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning now a 7 year old male with no known allergies who on 08/04/1999 was vaccinated with the first dose of varicella vaccine in the right arm. There was no concomitant medication or illness at the time of vaccination. On 06/27/2001, the pt had tubes in ears with bilateral drainage and was followed with antibiotics. On 07/28/2001 the pt developed chicken pox with 15 pox, "reddened spots" and had no fever. The pt sought unspecified medical attention and was being treated at home. It was reported that the pt recovered. Additional info has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Eczema, Infection, Mood swings
Clinical narrative: Information has been received from a consumer concerning her 24 month old male son with a mold allergy and a history of asthma who on 06/19/2001 was vaccinated with varicella vaccine. There were no concomitant medications or current illnesses. On 06/19/2001 it was reported that the pt had erratic mood swings. A week later, on approx. 06/26/2001, the pt broke out with chicken pox around the injection site and he developed eczema. Unspecified medical attention was sought. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash macular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 4 year old Caucasian male with no known allergies and no past medical history who on 29 JUN 2001 at 10:30 AM was vaccinated with the first dose of varicella virus vaccine live (lot #638653/1890K), in the left arm. On 30 JUL 2001 at 08:00 the patient was presented with a severe case of chicken pox. It was reported that there were more than 300 lesions all over the body, including mucous membranes. The patient also had a high fever, but the temperature was unknown. It was reported that the patient had macular papular lesions with a erythematous base, pustules, and vesicles. The affected areas were reported to be the scalp, oral mucosa, face, trunk genitalia, and extremities. It was reported that the patient recovered on 10 AUG 2001. The patient sought unspecified medical attention. There was no other information provided. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 3 year old male who was vaccinated with varicella vaccine. In the last couple of months, the pt broke out in a mild case of chicken pox. Unspecified medical attention was sought. It was reported that another pt had a similar experience after vaccination with varicella vaccine. Additional info has been requested.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a physician concerning a 18 month old female with no known drug allergies and no prior medical history who on 07/07/2001 was vaccinated with varicella vaccine. On that same date, the pt was vaccinated with MMR vaccinated in the opposite leg. On 07/10/2001, the pt's mother telephoned the physician's office complaining that the varicela vaccine injection site had become red, tender, swollen and hard. The pt was treated with a cool compress. On 07/17/2001, red bumps were noted at the injection site. On 07/18/2001, the pt's mother phoned the physician's office again with the same complaints. The pt was seen in the office on 07/20/2001 at which time the area around the varicella vaccination site on the anterior thigh was noted to be indurated, erythematous with 2-3 localized zoster-like vesicles. The pt was afebrile, no other systemic symptoms were noted and no lab testing was performed. On 08/06/2001, the pt was seen by the physician who noted that the pt had 3 papular lesions with surrounding erythema, no vesicles and that the lesions had a "look of drying out varicella lesions around the injection site." The pt did not received any treatment. Subsequently, the pt recovered. Additional info is not expected.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 18 month old female with no known drug allergies and no prior medical history who on 07/07/2001 was vaccinated with varicella vaccine. On that same date, the pt was vaccinated with MMR vaccinated in the opposite leg. On 07/10/2001, the pt's mother telephoned the physician's office complaining that the varicela vaccine injection site had become red, tender, swollen and hard. The pt was treated with a cool compress. On 07/17/2001, red bumps were noted at the injection site. On 07/18/2001, the pt's mother phoned the physician's office again with the same complaints. The pt was seen in the office on 07/20/2001 at which time the area around the varicella vaccination site on the anterior thigh was noted to be indurated, erythematous with 2-3 localized zoster-like vesicles. The pt was afebrile, no other systemic symptoms were noted and no lab testing was performed. On 08/06/2001, the pt was seen by the physician who noted that the pt had 3 papular lesions with surrounding erythema, no vesicles and that the lesions had a "look of drying out varicella lesions around the injection site." The pt did not received any treatment. Subsequently, the pt recovered. Additional info is not expected.
Age: 2.1
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 25 month old white male with no known drug allergies who on 23 May 2000 was vaccinated at 16:30 with a first dose of varicella virus vaccine live, SC in the left thigh (lot #634837/1862J). Concomitant therapy on 23 MAY 2000 at 16:30 included a third dose IM in the right thigh of hib conj-hepatitis b vaccine (lot #634236/0290K), a first dose, SQ in the right thigh of MMR vaccine (lot #630385/0049K) and a first dose, IM in the right thigh of streptococcus pneumoniae vaccine (PREVNAR) (lot #471204). On 15 JUN 2001 at 16:00 the patient experienced a chicken pox breakthrough with minimal lesions of trunk and limbs. The patient was not distressed at the time of vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old child with streptococcal pharyngitis who on 03/31/2000 was vaccinated with varicella vaccine. Concomitant therapy included (therapy unspecified). On 05/10/2001, the pt experienced lesions on trunk minimal and strep phyaryngitis and went to the doctor's office. Additional info has been requested.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 28 year old male patient with no known drug allergies who in 2000 was vaccinated with a complete series of varicella virus vaccine live (site unknown). There was no concominant medication. On 07 AUG 2001 it was reported that a recent titer did not detect seroconversion. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a representative of the physician's office concerning a 19 year old female who was vaccinated twice with the varicella virus vaccine live. Subsequently the patient failed to seroconvert. Additional information has been requested.
Age: 2.2
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Laboratory test abnormal, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 26 month old Caucasian female with no past medical history and no known drug allergies who on 30 MAY 2000 was vaccinated with the first dose of varicella virus vaccine live (lot #634491/0441K) in the left arm. Concomitant vaccination that same day included the first dose of streptococcus pneumoniae vaccine (PREVNAR) in the left thigh. It was also noted that on 12 APR 2000 the patient received a dose of hepatitis B vaccine (recombinant) (Engerix-B) (Lot #2808A2). There was no other concomitant  medication or illness at the time of vaccination. On 28 JUL 2001 at approx. 10:30, the patient developed a itchy erythematous rash with vesicular lesions located on the lower lumbar area on the left side, dermatone distrubtion. The vesicular rash was cultured and found to be varicella zoster virus. The patient was afebrile, experienced pain of 3-4 on a scale of 0-10 and experienced itching. On 02 AUG 2001 herpes zoster was noted and a specimen was obtained from a vesicle to be sent for VZV testing. The patient did not have a history of chicken pox or recent exposure to chicken pox or herpes zoster. It was also reported that patient did not have any in utero exposure since the mother was not susceptable. Follow up information on 08 AUG 2001 reported that the child has crusted over at this point. It was noted that the patient has not had an adverse event following previous vaccinations. Subsequently, the patient recovered.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 6 year old Hispanic female who on 03 MAY 2001 was vaccinated with a dose of varicella virus live (site unknown) (lot #637971/1895K) (.5 ml), intramuscularly. This does not comply with the recommended dosage route. On 07 AUG 2001, it was reported that the patient was presented at the doctor's office with chicken pox last week (approx. 31 JUL 2001). The patient was "covered with rash, but only a couple of papules and had a low grade fever for one to two days. In follow up the physician reported that the patient experienced varicella like rash and fever. The patient's varicella like rash and fever persisted. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received concerning a 14 month old white female who on 06 JUL 2001 was vaccinated in the right arm with a first dose of varicella virus vaccine live (lot #638652/0233L). Additional vaccinations on 06 JUL 2001 included a first dose in the left arm of MMR vaccine (lot #638162/0597L) (MSD) and a second dose in the left thigh of streptococcus pneumoniae vaccine (PREVNAR) (lot #480904). There was no illness at the time of vaccination. On 30 JUL 2001 the patient experienced few papulovesicules lesions on her trunk and less on her arms. Subsequently, on 03 AUG 2002, the patient recovered. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old white female with no known allergies and no past medical history who was vaccinated IM in the left deltoid with a first and second dose of varicella virus vaccine live (lot #636579/0086L) on 28 JUN 2001 and 30 JUL 2001 (also reported as 20 JUL 2001), respectively. There were no concomitant medications or illnesses at the time of vaccination. On 04 AUG 2001, the patient developed a vesicular rash of greater than 12 lesions. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse which indicated that the patient recovered from her experience on 20 AUG 2001. Additional information has been received from a completed questionnaire which indicated that the patient had no history of chicken pox or recent exposure to chicken pox or herpes zoster. It was noted that the patient's lesions started at her feet and legs, and then disseminated to other areas. The same source also provided information on another person's experience with varicella vaccine live (WAES01083115). No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male who on 15 APR 1999 was vaccinated with .5 ml dose of varicella virus vaccine live (lot #626406/1841H). There were no concomitant therapies. On approximately 10 MAY 2001, the patient developed minimal lesions. It was noted that his brother had the same thing too. Subsequently, the patient recovered from the minimal lesions. The treating physician also reported the experience of several other patients who were vaccinated with varicella virus vaccine live (WAES01072424). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician and  a Pharm D. concerning a 4 year old female with no history of chicken pox or shingles. On 08/21/2001, she was vaccinated with varicella vaccine in the right arm. On 08/30/2001, the pt developed herpes zoster. A sample from the vesicular lesions was collected on that day and sent to the lab. Subsequently, the pt recovered from her experience. In follow-up, it was noted that specimen was varicella zoster virus positive and the presence of wild type VZV was identified on 08/30/2001. Additional info is not expected.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 month old male with no past medical history who on 08/20/2001 was vaccinated with a first dose of varicella vaccine SC in the left thigh. Concomitant therapy that day included a first dose of MMR vaccine SC in the right thigh, diphtheria toxoid/pertussis vaccine/tetanus IM in the right thigh and the third dose of hep B vaccine IM in the left thigh. There was no illness at the time of vaccination. On 08/26/2001, the pt presented to the office with varicella. It was reported that the pt recovered. Additional info has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Condition aggravated, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female inpatient with pneumonia and febrile who was vaccinated with pneumococcal vaccine 23 polyvalent, per hospital protocol. Subsequently the pt developed increased fever and respiratory symptoms. The outcome of the pt's increased fever and respiratory symptoms was not known. The physician reported that the pt's increased fever and respiratory symptoms prolonged the pt's hospitalization. Follow-up information received from a woman in the physician's office indicated that the office did not have any information on this patient, not even a date of birth. It was reported that the physician was probably a consulting physician on the case, and additional information would be difficult to obtain wihtout the patient's date of birth. No further information is available. Follow-up information received form the physician indicated that pneumonia occurred in the patient and she was given pneumococcal vaccine 23 polyvalent vaccine adn on 4/10/02, the pneumonia severely worsened after vaccination. He also reported that the patient had an increase in fever and an allergic reaction to the pneumococcal vaccine 23 polybalent. It was unknown if the patient recovered. The physician considered the event to be immediately life-threatening. Additional information is not expected.
Age: 0.08
Sex: M
Vaccine: MMR
Symptoms: Cognitive disorder, Ear disorder, Speech disorder
Clinical narrative: Information has been received from the father of a now 6 year old male who in 12/95 was vaccinated with the 1st dose (0.5ml) of MMRII, at less than 1 month of age. There was no concomitant medication. In approx. 12/95, the pt developed ear difficulties (details unknown). At the age of 2 (in 1997), the pt experienced difficulty in his speech. The reporter stated that the pt was not dx'd with autism but was dx'd as having pragmatic language. The pt did seek medical attention. Upon medical review, the pt's difficult speech and pragmatic language were considered "Other Important Medical Events". Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: MEA
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Initial and follow-up info has been received from a nurse practitioner concerning a "healthy," obese female pt who was vaccinated with measles virus vaccine SC on 04/08/2002. The pt had no previous past medical history of problems with vaccines, had a negative measles titer and was immunized on 04/08/2002 with measles vaccine. On 04/16/2002, the pt first noted redness on her right arm. On 04/17/2002, the pt called the office complaining of redness at the injection site and called the office again later that day, reporting that the redness was worsening. On 04/18/2002, the pt notified the office that the injection site was not improving and was assessed by the nurse practitioner that same day. The nurse practitioner described the pt's arm as red, swollen and hot and was diagnosed with a large, suspected cellulitus of the right arm. Dicloxacillin therapy was prescribed for the pt and was instructed to elevate her arm. The pt was scheduled to leave for a trip on 04/20/2002 and she was instructed to cancel her trip due to her arm condition. The pt reported to the nurse practitioner on 04/22/2002 that her erythema was decreasing and she was instructed to continue dicloxacillin therapy. On 04/23/2002, the pt visited the nurse practitioner again and her erythema was worsening. It was redder, and hotter with new areas appearing. The pt had the following lab values performed on 04/23/2002: Measles titer-pending; elevated sedementation rate, normal WBC count; elevated CRP. An HIV test was not performed because the pt had no risk factors. The pt was scheduled to leave for a trip on 04/24/2002; however, she cancelled the trip and the nurse practitioner stated that the airlines refused to refund the pt's money. The nurse practitioner also stated that the physicians are going to write a letter to get the pt reimbursd for her cancelled trip. The nurse practitioner stated that the pt's final diagnosis was  an atypical measles reaction and the dicloxacilin therapy provided no relief. The nurse practitioner also stated that the pt's cellulitis of right arm and atypical measles reaction were considered other medical events and were serious since the pt had to cancel her trip. The nurse practitioner also discussed the events of a male pt who was vaccinated with measles virus vaccine from the same lot and she was concerned about the particular lot of vaccine. The nurse practitioner also stated that her records indicate that in the past year she had given the measles vaccine a total of eight times from that lot and two fo the eight pts had had adverse reactions. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info is not expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism
Clinical narrative: Information has been received from a consumer concerning a 42 month old male who on 11/17/99 was vaccinated with MMRII. In 9/01, the pt developed behavioral problems and on an unspecified date in 2/01, was dx'd with autism. Upon internal medical review, autism was considered to be an "Other Important Medical Event". Additional information has been requested. Follow up on 01/21/04: "Additional conflicting follow up information was received from the consumer. It was reported that within the first month after the pt was vaccinated "some unusual behavior developed." The consumer reported that the pt refused to wear his pajama's to bed and didn't want to have any pictures taken. The child was diagnsed with autism in 02/02.  Upon internal medical review, autism was considered to be an other important medical event (OMIC). Additional information has been requested."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea
Clinical narrative: The pt became apneic shortly (5-10 minutes) after receiving the vaccines. The pt regained breathing spontaneously.
Age: 27.0
Sex: F
Vaccine: RUB
Symptoms: Abasia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: The pt developed tingling and numbness in hands and feet on 05/30/2001. On 06/01/2001, itching all over the body. On 06/02/2001, more tingling and numbness. on 06/03/2001, tingling in lips, tongue added. Numbness in all described plus loss of balance, weakness in knees and legs, and was unable to walk. The pt was hospitalized. On 06/07/2001, the pt became totaly paralyzed. Pt was diagnosed with Guillain-Barré syndrome. On 06/28/2001, the pt was discharged to home.
Age: 27.0
Sex: F
Vaccine: RUB
Symptoms: Pruritus
Clinical narrative: The pt developed tingling and numbness in hands and feet on 05/30/2001. On 06/01/2001, itching all over the body. On 06/02/2001, more tingling and numbness. on 06/03/2001, tingling in lips, tongue added. Numbness in all described plus loss of balance, weakness in knees and legs, and was unable to walk. The pt was hospitalized. On 06/07/2001, the pt became totaly paralyzed. Pt was diagnosed with Guillain-Barré syndrome. On 06/28/2001, the pt was discharged to home.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Flushing, Heart rate increased, Hyperaemia, Paraesthesia
Clinical narrative: The pt developed swelling in throat, tingling in tongue, flushed feeling chest and back. Pt had elevated pulse and BP. Hyperemia noted. A follow up report received on 5/30/2002 adds: Hyperemia noted on chest. Rx: IV and PO Benadryl, observed for 4 hours. Home without recurrence of problems.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: The pt developed swelling in throat, tingling in tongue, flushed feeling chest and back. Pt had elevated pulse and BP. Hyperemia noted. A follow up report received on 5/30/2002 adds: Hyperemia noted on chest. Rx: IV and PO Benadryl, observed for 4 hours. Home without recurrence of problems.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: Mom reported rash on abdomen, face, and back 2 days after getting vaccinations.
Age: 3.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site induration, Injection site pain, Urticaria
Clinical narrative: Rash began day of vaccine at site of VZV, Lasted 3 days before seeking care. Exam: urticarial rash 1 cm to site. Extending laterally with diameter 15 cm with induration and tenderness.
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Pruritus, Urticaria
Clinical narrative: Felt dizzy and weak immediately following. Later in day, developed itching and hives. Benedryl given per phone conversation.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, IPV, VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: The pt developed papular, vesicular rash in different stages more on back of neck, back, same on chest and extremities. Very itchy and few on back are crusted.
Age: 36.0
Sex: M
Vaccine: JEV
Symptoms: Hyperaesthesia, Pruritus
Clinical narrative: The pt developed hyperesthesias and pruritis fllowing JEV #3 onset within a few hours post vaccination. Symptoms have decreased but not resolved.
Age: 4.7
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: The pt developed red, swollen, warm to touch, palpate knot at injection site for 24 hrs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Left deltoid red, warm, no induration.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, RAB
Symptoms: Erythema induratum, Oedema, Pain
Clinical narrative: Hard, red, swollen, warm to touch and painful. Told him to watch hand, take Tylenol and use cold compresses
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling, itching, hot to touch, no pain, tenderness or edema. Photo taken of left arm to indicate area of redness/swelling.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema, Injection site induration, Oedema
Clinical narrative: Redness, swelling right thigh, "overlying redness, underlying induration". Nontender, afebrile, no streaks-Photo taken to indicate redness.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral, Skin ulcer
Clinical narrative: Received DTaP on Monday 5/13/02. Little red mark, size of quarter that night. Tuesday morning same, Tuesday night-parent noticed leg swollen from knee up. Looks the same today. Giving child Benadryl's (children) liquid and Benadryl cream 05/20/02-leg normal size, everything-ok.
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: 5/19/02 fever 101, Rash on legs, chest, back and face. Diagnosis chicken pox per personnel in office
Age: 1.25
Sex: M
Vaccine: DTAP, HBPV, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: " Left leg 8 cm diameter red, some induration- area of injection:" Picture was taken and is part of pt's file.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain swelling redness left deltoid
Age: 0.75
Sex: M
Vaccine: HEP, IPV
Symptoms: Blister, Crying, Dysphonia, Rash, Vomiting
Clinical narrative: 1 hr post vaccination-suden onset blistering rash on chest, emesis X 2, prolonged crying, hoarse cry. Began to self-resolve over 102 hrs; re-seen in office-only rash remained at 4 hrs.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site hypersensitivity
Clinical narrative: Cellulitis @ site of injection
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: Localized reaction at injection site - erythema and fever (101 degrees F-rectal)
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rash, Rash macular
Clinical narrative: Twenty-four hours after vaccination, infant developed a blotchy bumpy dark rash from her neck to groin. Mother denies any other changes that would promote a rash such as change in detergent, new clothing, etc.
Age: 4.6
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 24 hrs post vaccination, the pt developed edema and redness at injection site. Was instructed to apply cool compresses and to call if redness or swelling increased. Did not require antibiotics.