chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning an adult male scientist who was vaccinated with the first dose of Varivax. Illness at the time of vaccination included a rash. The NP reported that, a few days after being vaccinated, the patient developed varicella-like rash. Unspecified medical attention was sought. It was subsequently determined that the patient's rash was not varicella. The patient's rash subsequently resolved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning himself, in 1995 he was vaccinated with two doses of Varivax. In approximately July 2006, he broke out with a mild form of herpes zoster virus. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Folliculitis
Clinical narrative: Information has been received from a physician concerning a 17-month-old white male who on 01-MAR-2007 at 16:25 pm was vaccinated subcutaneously in the left arm with a first dose of Varivax (lot# 652081/0942R). In July 2006, the patient experienced 2 weeks of lesions. the patient was initially diagnosed with varicella, but was subsequently seen by a dermatologist and diagnosed with folliculitis. The patient had a full recovery. Further information was available at the time of this report. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Medication error
Clinical narrative: Information has been received from a consumer concerning her almost 3-year-old son with no pertinent medical history or allergies, who at about 18 months of age, in approximately February 2005, was vaccinated with a dose of Varivax. Concomitant therapy included an "antiviral" (unspecified). The patient showed signs of a rash on the back of the thighs and back medial attention was sought and he was diagnosed with shingles on 01-AUG-2006. The pediatric office then noted that the vaccination given to the patient "may have been outside the recommended storage ranges and may not have been viable". At the time of the report the patient had not recovered from the shingles. No further information was available regarding the temperature excursion. No product quality complaint was involved.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15-month-old male with no pertinent medical history or allergies, who on 05-JUL-2006 was vaccinated subcutaneously one time with a 0.5 ml dose of Varivax (lot# 654330/0492F). Concomitant therapy included TYLENOL given prior to the vaccination for the prevention of pain and fever and a vaccination with a dose of MMR. On 30-JUL-2006 the patient started breaking out with what looked like large pimples that were red and raised that blistered then broke and scabbed over within 24 hours. The patient's mother treated him with DIMETAPP (new formula). More breakouts occurred over more areas. The areas with the breakouts were itchy. The nurse mentioned that the child ran a fever before the breakouts occurred. As of 02-AUG-2006 the patient was still having breakouts. As of 09-AUG-2006 the patient was recovered. This was considered to be a non-serious report. No product quality complaint was involved. The nurse indicated in follow-up that the event did not require intervention to prevent serious criteria. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15-month-old male with no pertinent medical history or allergies, who on 05-JUL-2006 was vaccinated subcutaneously one time with a 0.5 ml dose of Varivax (lot# 654330/0492F). Concomitant therapy included TYLENOL given prior to the vaccination for the prevention of pain and fever and a vaccination with a dose of MMR. On 30-JUL-2006 the patient started breaking out with what looked like large pimples that were red and raised that blistered then broke and scabbed over within 24 hours. The patient's mother treated him with DIMETAPP (new formula). More breakouts occurred over more areas. The areas with the breakouts were itchy. The nurse mentioned that the child ran a fever before the breakouts occurred. As of 02-AUG-2006 the patient was still having breakouts. As of 09-AUG-2006 the patient was recovered. This was considered to be a non-serious report. No product quality complaint was involved. The nurse indicated in follow-up that the event did not require intervention to prevent serious criteria. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a female with no known allergies or past medical history who was 22 years old at the time of the report, and was vaccinated with a first and second dose of Varivax in July 1998 and August 1998 respectively. Subsequently, a titer from an unspecified date showed no immunity to varicella. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Pyrexia, Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician and licensed practical nurse concerning an 11 year old white female with no known allergies or past medical history who on 22-SEP1998 was vaccinated in the right arm with a 0.5 ml dose of Varivax (lot # "08404"). There was no concomitant medication or illness at the time of vaccination. On 27-JUL-2006, two weeks after her unvaccinated sibling had a case of shingles, the patient developed a breakthrough case of chickenpox, with between 50 and 100 lesions, "she was covered in bumps". The patient also had fevers and back pain. Medical attention was sought, a varicella zoster DNA PCR was performed and varicella zoster was detected. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 20-year old Caucasian male with no pertinent medical history or allergies, who on 11-JUL-1997 was vaccinated subcutaneously with a first 0.5 ml dose of Varivax (lot# 617355/0567D). There was no concomitant medication. On 24-MAY-2006 a titer for varicella was drawn and came back with a negative value of 0.15 Elfa units. Unspecified medical attention was sought. It was reported that the patient did not have any symptoms. No outcome was reported. No product quality complaint was involved. The patient was re-vaccinated with two doses of Varivax on 21-JUL-2006 and 21-AUG-2006 (both with lot# 649269/0986P). The patient's vaccination records included the following vaccinations: diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) given on 24-JAN-1986, 26-MAR01986, 27-MAY-1986, 17-JUN-1987 and 12-APR-1991; poliovirus vaccine inactivated (unspecified) (manufacturer unspecified) given on 24-JAN01986, 26-MAR-1986, 17-JUN-1987 and 12-APR-1991; MMR (manufacturer unspecified) given on 16-MAR-1987 and 12-APR-1991; Hib conj vaccine (manufacturer unspecified) given on 16-MAR-1987 and 12-APR-1991; Hib conj vaccine (manufacturer unspecified) given on 11-DEC-1987; hepatitis B virus vaccine given on 29-JUN-1994 (lot# 610862/0594A), 31-AUG-1994 (lot# 611797/0444A) and 20-FEB-1995 (lot# 612921/1152A) and MENOMUNE-A/C/Y/W-135 (lot# UE157AA) given on 08-JUN-2004. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a health professional concerning a male with no past medical history and no allergies who in March 2006 was vaccinated with a dose of Varivax. Concomitant therapy included acyclovir. Subsequently, on 05-AUG-2006, the patient developed varicella zoster. A PCR for wild vs vaccine type was obtained from the patient's left buttock on 05-AUG-2006. Follow up information indicated that the specimen showed wild type virus. Follow up information indicated that on 05-AUG-2006 the patient developed a rash with lesions on the left perineal S2-S3. He was diagnosed with varicella zoster. A specimen (a vesicle type lesion) was obtained on 05-AUG-2006 from the patient's left buttock. VZV DNA was amplified. The interpretation showed adequate specimen, wild type strain. The outcome was reported as recovered. There was no recent exposure to chickenpox or shingles. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8-year-old white female who on 09-JUL-1999 at 11:40AM was vaccinated in the left arm with a first dose of Varivax (Lot # 628697/1838H). On 28-JUL-2006 the patient broke out with chickenpox. Subsequently, the patient recovered. No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning his adult daughter who in 1995 was vaccinated with two doses of Varivax. In approximately July 2006, she broke out with a mild form of herpes zoster virus. It is unknown if medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated "a few years ago" with Varivax. Subsequently the patient developed a "mild, wild-type rash". The physician also reported that "thee were only a few lesions, it was very mild." Unspecified medical attention was sought. Subsequently, the patient recovered from the "mild, wild-type rash". No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male child with no known allergies or past medical history who on 29-JUN-2001 was vaccinated SC with a first dose of Varivax (lot# 638652/0233L). Concomitant vaccination included a first dose of MMR (lot # 638702/0253L) given SC. On 08-AUG-2006 (also reported as 07-AUG-2006), the patient presented with 35-40 itchy, "insect bite like lesions" on his chest, back and legs. No other symptoms were noted. The patient was treated with BENADRYL. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Petechiae, Rash
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter, who is a twin, with asthma and no drug reactions/allergies who on 31-JUL-2006 at 15:30 was vaccinated with a dose of Varivax. Concomitant vaccination the same day included a dose of MMR, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. Other concomitant therapy included FLOVENT. On 31-JUL-2006 by 19:00, the patient developed petechiae and a red rash on her face around the eyes and mouth areas, ears and neck. On 01-AUG-2006 the patient was seen by the doctor who did not treat the rash and told the patient's mother it should go away on its own. As of 10-AUG-2006 the patient was recovering. The rash had diminished but the mother "can see that it has turned brown". No lab Diagnostic tests were performed. There was no product quality complaint involved. The patient's twin brother (0608USA02605) had a similar experience following vaccination with Varivax. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 6 year old daughter who on 20-DEC-1999 was vaccinated SQ with a 0.5 mL dose of Varivax. Five years ago, in August 2001, the patient developed a case of the shingles. On 09-AUG-2006, a second outbreak of the shingles appeared in the same spot. The consumer's daughter did not have an outbreak of chicken pox. The patient's outcome was not reported. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning an approximately 3-year-old female who in approximately August 2004, at one year of age, was vaccinated with the first dose of Varivax. The physician reported that in approximately 2006, the patient developed chickenpox characterized by 50 lesions. The physician noted that three lesions were on the patient's chest, some were on her legs and some were on other parts of her body. Unspecified medical attention was sought. Subsequently, the patient recovered from the chickenpox. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Oral disorder, Pruritus, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 7 year old male, with no medical history and no allergies, who on 10-AUG-2000 was vaccinated with a 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 632724/0087K). There was no concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that the child presented with 20-35 itchy, insect bite like lesions on his face, gums, buttocks, and legs, that began on 10-AUG-2006. No other symptoms were noted. The patient was treated with over the counter diphenhydramine hydrochloride (BENADRYL). It was reported that on 18-AUG-2006 the patient was vaccinated with a first dose of measles-mumps-rubella vaccine (MSD) (Lot# 635283/0406K) and a first intramuscular dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot# 471653). There were no laboratory or diagnostic tests performed. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient recovered. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Culture, Rash papular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 month old male with atopy who on 08-AUG-2006 was vaccinated with a dose of Varivax. Concomitant vaccination included an unspecified hepatitis vaccine. On 10-AUG-2006, "two days after vaccination" the patient developed lesions on his face and left foot. There were three lesions on the face and multiple lesions on the foot. Some lesions were papular vesicles and some were crusting. It was reported that the patient was not having any pain. It was reported that a "culture" was done. At the time of the report the patient had not recovered. Unspecified medical attention was sought, there was no product quality complaint involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old male described as a health male with no reported medical history (allergies unknown) who on 10-JUL-2006 was vaccinated with a dose of Varivax (lot # 652868/0267F). On 24-JUL-2006 the patient developed a generalized rash over trunk and face. He also had itching of the rash. Medical attention was sought. On 29-JUL-2006, the patient recovered. It was reported that the office was deciding whether to give the patient a second dose. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Petechiae, Rash
Clinical narrative: Information has been received from a consumer concerning her 4 year old twin son with asthma and no drug reactions/allergies who on 31-JUL-2006 at 3:30PM was vaccinated with a dose of Varivax. Concomitant therapy that day at 3:30PM included a dose of MMR, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine live oral, ZYRTEC, NASONEX, SINGULAIR and FLOVENT. On 31-JUL-2006 at 7:00PM< the patient developed petechiae and a red rash on his face (specifically around the eyes and mouth areas), ears, and neck. The mother took the child to the physician the next day. The physician did not treat the rash, and told her that it should go away on its own. As of 10-AUG-2006, the rash diminished but the mother "can see that it turned brown". The outcome was recovering. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 12-year-old female with no medical history or allergies, who on 26-JUL-2006 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (lot# 652630/0247F). There was no concomitant medication. On 07-AUG-2006 the patient began the first day of symptoms of breakthrough chickenpox. At the time of the report the patient's symptoms had worsened and the patient had about 26 lesions. Unspecified medical attention was sought and oral diphenhydramine hydrochloride (BENADRYL) was administered. The patient had not recovered. No product quality complaint was involved. The reporter considered the patient's breakthrough chickenpox to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on approximately 26-JUL-2006 was vaccinated SQ with a 0.5 ml second dose of Varivax (lot# 652725/0249F). Concomitant vaccination included BOOSTRIX. On 26-JUL-2006 the patient developed erythema at the injection site. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9-year-old female who was vaccinated SC with a second 0.5mL dose of Varivax (Lot # 652725/0249F). There were no concomitant medication. On 27-JUL-2006 the patient developed erythema and a fever. The outcome is recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 36-month-old white male (31 lb., 38 in.) with no pre-existing allergies, birth defects or medical conditions, who on 27-OCT-2004 was vaccinates subcutaneously in the arm with a first dose of Varivax (lot# 648757/0594P). Concomitant vaccination included a first dose of MMR (lot# 648144/0042P) given subcutaneously in the arm on 27-OCT-2004 and a first dose of FLUZONE (lot# U1442AA) given intramuscularly in the arm on 23-OCT-2004. There was no illness at the time of vaccination. There was no rash at the injection site or elsewhere within 42 days of the vaccination. On 05-AUG-2006 the patient developed a cluster of blisters on his left shoulder with a sharp border medially. He was seen by a physician and diagnosed with shingles. It was reported that there was no history of chickenpox or exposure to chickenpox or herpes zoster. No laboratory or diagnostic tests were performed. It was reported that the patient had no pain and was treated with acyclovir for five days. At the time of this report the patient recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a certified medical assistant (C.M.A.) concerning an older adult woman in her 80's who during the week of 07-AUG-2006 was vaccinated with a dose of Varivax. It was reported that varicella-zoster virus vaccine live was ordered from the distributor but varicella virus vaccine live was delivered. The C.M.A. thought that the vaccine was to be used as the shingles vaccine. Unspecified medical attention was sought. The patient did not experience any adverse symptoms. The reporter also said that this was not a product confusion case. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male with no known medical history or allergies who on 24-JAN-2003 was vaccinated SC in the left arm with 0.5 mL first dose of Varivax (lot # 643594/0808M). Concomitant vaccination administered that day included a SC first dose in the right arm of MMR. There was no illness at the time of vaccination. On 02-AUG-2006 the patient broke out in a rash. It was reported that the patient developed chickenpox with 50 papules scattered on the body. BENADRYL and AVEENO BATH were used as treatment. Medical attention was not sought. No laboratory diagnostic tests were performed. There were no adverse events following prior vaccination. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician's assistant (P.A.) concerning a 13-year-old male with no pertinent medical history or allergies, who on 22-JUL-1999 was vaccinated with a first dose of Varivax. there was no concomitant medication. On 07-AUG-2006 the patient had a titer taken and had a "failure to convert". The titer was less than 0.91 for IgG and the IgM was less than 0.90. Unspecified medical attention was sought. At the time of this report, the patient had not recovered and there was no further information. No product quality complaint was involved. The patient's brother also experienced "failure to convert" (WAES# 0608USA03682). Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician's assistant concerning a 9 year old black male with no known allergies or pertinent medical history who on 03-SEP-1999 was vaccinated with a dose of Varivax (lot# 630675/0424J). There was no concomitant medication. On 07-AUG-2006 a titer was 0.98 for IgG and IgM was less than 0.90, the patient failed to convert. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. The patient's brother (WAES # 0608USA03595) also experienced a failure to convert. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Varivax (lot number not available). Subsequently the patient developed a minor rash on the arm. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint. No additional information is expected.
Age: 1.1
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old black female with no allergies or medical history who on 12-JUN-2006 in the a.m. was vaccinated SC in the left arm with a first dose of Varivax (lot # 652798/0429F). Concomitant vaccination at the same time included a SC first dose in the right arm of MMR (lot # 650105/0829R), an IM first dose in the left thigh of VAQTA (lot # 651877/0706R), and an IM fifth dose of PEDVAXHIB (lot # 651986/0527R). There was no concomitant medication. There was no illness at the time of vaccination. On approximately 14-AUG-2006, two to three days prior to seeing a physician on 17-AUG-2006, the patient had broken out into a chickenpox-like rash. The patient had no fever and was exhibiting normal activity. There was a total of 10 or more lesions that were at variable stages of development. Noted on the patient's chart were three lesions on the face and four lesions on the legs. The lesions on the legs were crusting. There were one to two new red vesicular bumps on the patient's arm. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the nurse who reported that the patient's adverse event onset was 15-AUG-2006. The patient was examined on the second or third day of illness/rash. No fever was noted. The patient was positive for varicella lesions. The patient recovered on an unspecified date.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female patient, under 6 years of age, who was vaccinated with Varivax at 12 months of age. Subsequently, the patient's mother reported that her child developed chickenpox despite vaccination. It is unknown how long after the vaccination the child developed chickenpox and the office does not have any documentation to support this claim, nor any details. It was noted that medical attention was sought and that the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her son who was vaccinated with a dose of Varivax on an unspecified date. Subsequently, the patient experienced a bad case of chickenpox. It was unspecified if medical attention was sought. No outcome information was reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with an allergy to AMOXIL who on 09-AUG-2006 was vaccinated SC in the left arm with a first dose of Varivax (lot # 652725/0249R). Concomitant therapy included an over-the-counter allergy medication (unspecified). On 10-AUG-2006, within 24 hours of vaccination, the patient developed redness and swelling of about two centimeters. No medical attention was sought and the patient recovered from these events on 16-AUG-2006. It was also noted that the patient received an unspecified concomitant booster with 3.5 inches of redness for that injection and had more pain with the booster. The patient recovered from these events on an unspecified date. No further information is available. The patient's sibling had a similar experience after therapy with Varivax (WAES # 0608USA05445).
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning a 9 year old male who on 26-JAN-1998 was vaccinated with a dose of Varivax. On 27-JUL-2006 the patient developed a chickenpox rash. On 29-JUL-2006 the patient was triaged by the office. No information on the number of lesions or related symptoms were available. Subsequently, the patient recovered. The patient's siblings (WAES # 0608USA04853 and 0608USA04854) also had adverse experiences after vaccination. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning a 7 year old male who on 28-FEB-2000 was vaccinated with a dose of Varivax. On 13-JUL-2006 the patient developed a chickenpox rash. The patient was triaged by the office. Subsequently, the patient recovered. No further information was available. The patient's siblings (WAES # 0608USA04849 and 0608USA04854) also had adverse experiences after vaccination. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a consumer concerning a 7 year old female who on 28-FEB-2000 was vaccinated with a dose of Varivax. On approximately 30-JUN-2006, the patient experienced a rash over her trunk and genitals. On 01-JUL-2006 the patient was triaged by the office, started on the chickenpox protocol and BENADRYL dosing. On 06-JUL-2006 the patient was triaged by the office and the rash had almost resolved, with two pox not scabbing over on leg and buttock. On 10-JUL-2006 the patient was triaged with pox not scabbing on buttock, between fingers and between toes. It was reported that there were greater than 100 pox throughout the course. Subsequently the patient recovered. The patient's siblings (WAES # 0608USA04849 and 0608USA04853) also had adverse experiences after vaccination. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced an injection site reaction which was reported to be an "extreme local reaction". However no specifics of the reaction were known. Unspecified medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a woman at a pediatric office concerning a 17-year-old female who on 11-AUG-2006 was vaccinated in the right arm with a second dose of Varivax (lot# 652725/0249F). There was no illness at the time of vaccination. On the morning of 12-AUG-2006 the patient experienced swelling, redness at the injection site and hot to touch. It was reported that the patient recovered as of 16-AUG-2006. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye burns, Medication error, Ocular hyperaemia
Clinical narrative: Information has been received from a 38 year old female medical assistant with allergies to sulfonamide, iodine contrast, and nitrofurantoin (MACRODANTIN) and a medical history of chickenpox and shingles who on 22-AUG-2006, at approximately 14:00, was splashed in the right eye when she popped the top from a syringe of a dose of Varivax (lot # 652871/0430F). She stated that she tried to flush her right eye with water. After two hours, her right eye still burned. She had a minimal amount of erythema in the right sclera. There was no edema or discharge. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received which indicated that the event completely resolved and lasted one week to 10 days. It was note that the patient had a "right eye burn - NOS." No further information is expected.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from an employee in a physician's office concerning a 4 year old white male who on 07-OCT-2003 at 11:53 a.m. was vaccinated in the left arm with a first dose of Varivax (lot # 644571/1160M). On 10-AUG-2006, the patient developed chickenpox. Subsequently, the patient recovered on an unspecified date. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 11-NOV-1999 was vaccinated with a dose of Varivax. On 13-MAY-2006 the patient developed breakthrough, there was no lesion count. Medical attention was not sought, the breakthrough was reported to the physician's office by a parent, and the patient received no treatment. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 11-APR-1997 was vaccinated with a dose of Varivax. On 10-MAY-2006 the patient developed breakthrough, there was no lesion count. The patient received no treatment and was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 20-NOV-2001 was vaccinated with a dose of Varivax. On 01-MAY-2006 the patient developed breakthrough, thee was no lesion count. The patient received no treatment and she was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old patient who was vaccinated with a second dose of Varivax. On an unspecified date, the patient developed redness and swelling of a 4.5 cm area and pain. No further information is available.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Headache, Herpes zoster, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse and physician concerning a 7-year-old male with no known allergies or past medical history who on 29-JUN-2000 was vaccinated in the right thigh with a 0.5 first dose of Varivax (lot# 632718/1856J). Concomitant vaccination included a first dose of MMR II (lot # 632456/0173K) given in the left thigh. No rash occurred at the injection site or elsewhere within 42 days of vaccination. On 19-AUG-2006 the patient experienced left arm pain. On 20-AUG-2006, the patient developed a "herpes zoster rash" on his left arm. On 22-AUG-2006, the patient was seen at the physician's office having a "shingles-like rash" from his left shoulder to the radial side of his wrist. He was diagnosed with shingles. The patient also had a temperature of 101.7, a headache and a sore throat. The patient rated his pain 1 on a scale of 0 (least) to 10 (most). It was reported that the patient does not have a history of chickenpox, and that it was unknown if the patient has a recent exposure to chickenpox or herpes zoster. There was no specimen collected for PCR and a direct fluorescent antibody was not done, no other diagnostic test or labs were performed. The boy was treated with BENADRYL and acyclovir. On 01-SEP-2006 the patient recovered. The reporter considered the shingles to be an other important medical event. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse and physician concerning a 7-year-old male with no known allergies or past medical history who on 29-JUN-2000 was vaccinated in the right thigh with a 0.5 first dose of Varivax (lot# 632718/1856J). Concomitant vaccination included a first dose of MMR II (lot # 632456/0173K) given in the left thigh. No rash occurred at the injection site or elsewhere within 42 days of vaccination. On 19-AUG-2006 the patient experienced left arm pain. On 20-AUG-2006, the patient developed a "herpes zoster rash" on his left arm. On 22-AUG-2006, the patient was seen at the physician's office having a "shingles-like rash" from his left shoulder to the radial side of his wrist. He was diagnosed with shingles. The patient also had a temperature of 101.7, a headache and a sore throat. The patient rated his pain 1 on a scale of 0 (least) to 10 (most). It was reported that the patient does not have a history of chickenpox, and that it was unknown if the patient has a recent exposure to chickenpox or herpes zoster. There was no specimen collected for PCR and a direct fluorescent antibody was not done, no other diagnostic test or labs were performed. The boy was treated with BENADRYL and acyclovir. On 01-SEP-2006 the patient recovered. The reporter considered the shingles to be an other important medical event. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 13-JUL-1999 was vaccinated with a dose of Varivax. On 05-MAY-2006 the patient developed a breakthrough case of varicella. It was reported that the patient had 50+ lesions on his trunk. The patient received no treatment and he was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested. The patient's siblings (WAES # 0608USA06084 and 0608USA06085) had similar experiences following vaccination with Varivax.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 13-JUL-1999 was vaccinated with a dose of Varivax. On 05-MAY-2006 the patient developed a breakthrough case of varicella. It was reported that the patient had less than 50 lesions on his trunk. The patient received no treatment and he was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested. The patient's siblings (WAES # 0608USA06083 and 0608USA06085) had similar experiences following vaccination with Varivax.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female who on 13-JUL-1999 was vaccinated with a dose of Varivax. On 05-MAY-2006 the patient developed a breakthrough case of varicella. It was reported that the patient had less than 50 lesions on her trunk. The patient received no treatment and she was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested. The patient's siblings (WAES # 0608USA06083 and 0608USA06084) had similar experiences following vaccination with Varivax.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no known allergies or pertinent medical history who was vaccinated SC with 0.5 ml first and second doses of Varivax on 30-JAN-2006 (lot# 650234/0913R and 10-MAR-2006 (lot#648936/0114R) respectively. There was no concomitant medication. Subsequently the patient had negative titers. No symptoms have been reported. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Eyelid oedema
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old male with a history of a rash from PROZAC who in July 2006, was vaccinated with a first dose of Varivax. The following day, in July 2006, he experienced mild unilateral eyelid swelling. Unspecified medical attention was sought and the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced an unspecified adverse reaction. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Varicella
Clinical narrative: Information has been received from a physician's office concerning a 7 year old white male who on 25-JUL-2000 was vaccinated SC in the right thigh with a first dose of Varivax (lot # 635205/0073K). Six years after vaccination, on 24-JUL-2006 the patient developed chickenpox disease. It was reported that the patient had moderate disease with cellulitis. Subsequently the patient recovered. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 16-month-old female with no pertinent medical history or allergies, who was vaccinated with a dose of Varivax. There was no concomitant medication. on 17-AUG-2006 the patient presented with varicella zoster. Unspecified medical attention was sought. It was reported that the rash was about 60 vesicular lesions that followed the L-4 dermatome. It was reported that she was treated with "Burrows Solution". The physician did not request PCR testing. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning an 8 year old male who on 12-MAR-1999 was vaccinated with a first 0.5 ml dose in the right arm of Varivax (Lot# 627337/1057H). There was no concomitant medication. On 11-AUG-2006 the patient experienced rash on his back with less than 50 lesions. The patient had no fever and recovered completely by 14-AUG-2006. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 10 year old patient who was vaccinated with a first dose of Varivax. "In the past few years", beginning in approximately 2004, the patient experienced "shingles many times". Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 24 month old male who was vaccinated with one dose of Varivax. "Within the last month", in August 2006, the patient experienced breakthrough. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a 26 month old female, with no medical history and no allergies, who on 14-JUN-2005 was vaccinated with 0.5 ml subcutaneous dose of Varivax (Lot# 648948/0895P). There was no concomitant medications. On 26-AUG-2006 the patient experienced a scattered rash her body with between 50-249 maculopapular lesions, with yellow vesicles with erythema. The patient was itchy and had no fever. The patient was seen in the office on 28-AUG-2006 and was diagnosed with breakthrough varicella. The patient was treated with AVEENO BATH, calamine lotion and BENADRYL. The patient's mother called the physician's office on 31-AUG-2006 and stated that the child was doing better, and that most of the rash was scabbed over with less itching. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Additional information has been requested. 05/16/2008 Follow-up information was received by the health professional indicating that the child was vaccinated with a 0.5 ml subcutaneous dose of VARIVAX (Oka/Merck) in the left thigh. On 06-AUG-2007, (previously reported as 26-Aug-2007) rash developed on arm, 20-30 1 cm red papules, some vesicular. Patient was afebrile. Treated symptoms with "BENADRYL" for itching and oatmeal baths. No further information expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Scab, Skin discolouration, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 26 month old female, with no medical history and no allergies, who on 14-JUN-2005 was vaccinated with 0.5 ml subcutaneous dose of Varivax (Lot# 648948/0895P). There was no concomitant medications. On 26-AUG-2006 the patient experienced a scattered rash her body with between 50-249 maculopapular lesions, with yellow vesicles with erythema. The patient was itchy and had no fever. The patient was seen in the office on 28-AUG-2006 and was diagnosed with breakthrough varicella. The patient was treated with AVEENO BATH, calamine lotion and BENADRYL. The patient's mother called the physician's office on 31-AUG-2006 and stated that the child was doing better, and that most of the rash was scabbed over with less itching. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Additional information has been requested. 05/16/2008 Follow-up information was received by the health professional indicating that the child was vaccinated with a 0.5 ml subcutaneous dose of VARIVAX (Oka/Merck) in the left thigh. On 06-AUG-2007, (previously reported as 26-Aug-2007) rash developed on arm, 20-30 1 cm red papules, some vesicular. Patient was afebrile. Treated symptoms with "BENADRYL" for itching and oatmeal baths. No further information expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 12 year old female, with no medical history and no allergies, who, "10 years ago", in approximately 1996, was vaccinated with a dose of Varivax. On 17-AUG-2006 the patient developed shingles on her right arm. The rash presented as hundreds of vesicular lesions following a dermatomal distribution. The patient also reported pain. The patient was treated with VALTREX, 1000mg, TID, for 7 days. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a 30 year old female, with allergies to penicillin and aspirin, who was vaccinated with a first and second 0.5 ml dose of Varivax (Lot# 649993/0896R) on 23-FEB-2006 and 06-APR-2006, respectively. Concomitant therapies included hormonal contraceptives (unspecified) and ZOLOFT. On 31-AUG-2006 a titer was done and came back negative. It was noted that the patient had no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 07-NOV-1996 was vaccinated with a dose of Varivax. Subsequently, 24-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 01-MAY-1998 was vaccinated with a dose of Varivax. Subsequently, on 16-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.