chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning his "about 6 year old" nephew who on an unspecified date was vaccinated with a dose of Varivax. "Around last week", in October 2006, the patient "experienced a serious break out of chickenpox". The patient visited the ER though he was not hospitalized. At the time of the report the patient was recovering, it was reported that the patient improved, however it was not known if the patient was on or off therapy. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning her 13-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 09-OCT-2006 at 17:00 was vaccinated SC with the second dose of Varivax (lot # 654030/0913F). Concomitant vaccination included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 11-OCT-2006, 24 hours post vaccination, the patient experienced pain, swelling, redness (1.5 inch circle around the site), and itching at the injection site. Unspecified medical attention was sought. There were no lab diagnostic studies obtained. Additional information indicated that on 10-OCT-2006 at 15:00 the patient developed a large red wheal approximately 3" at the injection site with pain and redness and that was warm to touch and itchy. Subsequently the patient recovered. There was no product quality complaint. It was reported that at 5 years old the patient had a local reaction following the fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. No additional information is expected.
Age: 13.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site warmth, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a registered nurse concerning her 13-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 09-OCT-2006 at 17:00 was vaccinated SC with the second dose of Varivax (lot # 654030/0913F). Concomitant vaccination included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 11-OCT-2006, 24 hours post vaccination, the patient experienced pain, swelling, redness (1.5 inch circle around the site), and itching at the injection site. Unspecified medical attention was sought. There were no lab diagnostic studies obtained. Additional information indicated that on 10-OCT-2006 at 15:00 the patient developed a large red wheal approximately 3" at the injection site with pain and redness and that was warm to touch and itchy. Subsequently the patient recovered. There was no product quality complaint. It was reported that at 5 years old the patient had a local reaction following the fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 4-year-old female who on 11-OCT-2006 was vaccinated with a second 0.5 ml, dose of Varivax. Subsequently, the patient experienced shingles on three of her dermatomes. Unspecified medical attention was sought. No additional information provided. There was no product quality complaint. The outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 33 month old white female with no known allergies or medical history, who on 14-JAN-2005 was vaccinated in the right thigh with a dose of Varivax (lot # 648317/0439P). Concomitant vaccination included a first dose of MMR (lot # 647282/0345P) given in the left thigh. There were no other concomitant medications. There was no illness at the time of vaccination. On 07-OCT-2006 the patient presented to the physician's office with shingles that appeared below her left breast on the chest, also reported as herpes zoster on the left chest wall, T7 and T8 dermatomes. It was reported that it did not seem to be painful. At the time of the report the patient had not recovered. It was reported that the patient has not had adverse events following prior vaccinations. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 30 month old white son with no known allergies or medical history, who on 01-APR-2006 was vaccinated in the left thigh with a first dose of Varivax (lot # 648310/0278P), there was no illness at the time of vaccination and no bad reaction was noted. On approximately 11-OCT-2006 the patient developed a mild case of chickenpox. Unspecified medical attention was sought. On 15-OCT-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 month old white male who on 07-DEC-2005 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 649739/0121R). Concomitant vaccination on the same day included a SC first dose in the right thigh of MMR (lot # "653153/0996R"-invalid for this product). There was no illness at the time of vaccination. On 10-OCT-2006, the patient developed chickenpox which was confirmed in the physician's office on 11-OCT-2006. It was described as pink, itchy pox mostly on the patient's stomach. The patient's outcome was unknown. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white female with no known allergies who on 02-OCT-1997 was vaccinated in the right thigh with a first dose of Varivax (lot # 622973/0541E). Concomitant vaccination on the same day included a second dose in the left thigh of MMR (lot # 623503/0741E) and a fourth dose in the left thigh of HIBTITER (lot # M265RF). There was no illness at the time of vaccination. On 12-OCT-2006, at 11:00 a.m., the patient developed two to three red areas with a yellow center. The breast and chest had scattered areas of red spots on the center with fluid. The patient was seen in the physician's office on 13-OCT-2006. At the time of the report, the patient was still recovering. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 30-OCT-2000 was vaccinated SC with a first dose of Varivax (lot # 634514/0539K). Concomitant vaccination on the same day included a dose of hepatitis B virus vaccine (lot # "635587/1092K"-invalid for this product). On 09-SEP-2006, the patient developed chickenpox. The patient recovered on an unspecified date. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Varicella
Clinical narrative: Information has been received from a woman in a physician's office concerning a 5 year old male who on 30-OCT-2000 was vaccinated SC with a first dose of Varivax (lot # 634514/0539K). On 10-SEP-2006, the patient developed chickenpox. The patient recovered from chickenpox on an unspecified date. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning an 11 year old male who on 30-OCT-2000 was vaccinated with a first subcutaneous dose of Varivax (Lot# 634514/0539K). On 10-SEP-2006 the patient experienced chickenpox. Subsequently, the patient recovered. Medical attention was not sought. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 62-year-old male who on 26-JUL-2006 was vaccinated with a dose of Varivax. However, it was noted that Zostavax was ordered. The reporter indicated "med sound alike error". Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 69-year-old male who on 26-JUL-2006 was vaccinated with a dose of Varivax. It was reported that Zostavax was ordered but Varivax was given. Subsequently, the patient did not experience any adverse events. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 5 year old white female with a peanut allergy who on 01-APR-2003 was vaccinated in the right lower arm with a first dose of Varivax (lot # 641787/0758M) (diluent lot # 638153/0886M). There was no illness at the time of vaccination. On 10-OCT-2006 the patient presented to the office with an outbreak of chickenpox, the actual onset date was not reported. At the time of the report the patient's recovery status was unknown. No further information was available. Additional information has been requested. The patient's brother (WAES # 0610USA10411) had a similar experience after vaccination.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 39 month old white male with a peach allergy who on 10-AUG-2004 was vaccinated in the left upper arm with a first dose of Varivax (lot # 645575/0436N) (diluent (lot # 646509/0516N). There was no illness at the time of vaccination. On 10-OCT-2006 the patient presented to the physician's office with an outbreak of chickenpox, actual onset date not reported. At the time of the report the patient's recovery status was unknown. No further information was available. Additional information has been requested. The patient's sister (WAES # 0610USA10406) had a similar experience following vaccination.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 12-year-old female with no pertinent medical history or allergies who on 17-MAR-1999 was vaccinated subcutaneously with one dose of Varivax (lot# 628694/1663H). There was no concomitant medication. On 10-OCT-2006 the patient broke out in a chickenpox-like rash. She was seen in the physician's office on 12-OCT-2006 and it was noted that she had scattered vesicular lesions on her face, neck, ear, trunk and extremities and also had 2 lesions in her throat. No laboratory or diagnostic tests were performed. The patient was recommended baths and oral BENADRYL. 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: Body temperature increased, Erythema, Scab, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with no medical history or allergies who on 08-FEB-1999 was vaccinated with an SC first dose of Varivax (lot # 628246/1655H). There was no concomitant medication. There was no illness at the time of vaccination. Subsequently on 15-OCT-2006 the patient developed chickenpox and a temperature of 100.9 degrees. The patient was seen in the office on 16-OCT-2006 and had approximately 100 lesions on his trunk and face. The lesions on his face were red and flat, whereas the lesions on his trunk were red and raised. He was treated with CALAMINE LOTION. On 23-OCT-2006 the patient was much improved and the remaining areas were scabbed over. Subsequently the patient recovered. No laboratory tests were performed. There was no product quality complaint involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no allergies or medical history who in 1997 was vaccinated IM with a first dose of Varivax. There was no concomitant medication. On 16-OCT-2006, the patient developed shingles. Unspecified medical attention was sought. 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 requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test positive, Varicella
Clinical narrative: Information has been received from a physician concerning a healthy 35 year old female who on 22-SEP-2006 was vaccinated with Varivax following negative VZV serology for her "green card". On approximately 02-OCT-2006, 10-14 days after vaccination, the patient developed varicella. The lesions were all papules and there would not be a specimen for further testing. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Scab
Clinical narrative: Information has been received from a health professional concerning a health professional concerning a 14 year old male who on 21-JUL-2002 was vaccinated SC in the right arm with a first dose of Varivax (lot # 639778/0981L). On 29-SEP-2006, the patient developed 20 scattered scabbed papules on mostly the anterior and posterior trunk. There were very few on the upper extremities. No medical attention was sought. The patient's outcome was not reported. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 6 year old white female with no medical history or allergies who on 17-OCT-2006 at 14:00 was vaccinated with a second dose of Varivax (lot # 654528/1044F). There was no concomitant medication. There was no illness at the time of vaccination. On 18-OCT-2006 the patient developed redness and swelling at injection site radiating to elbow. Unspecified medical attention was sought. No laboratory tests were performed. Subsequently, the patient recovered. The patient did not experience any adverse events following prior vaccination. There was no product quality complaint involved. No further information is available.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 31 month old male who on 16-JUN-2005 was vaccinated IM with a dose 0.5 mL dose of Varivax (lot # 648935/0829P). On 03-OCT-2006, the patient was seen by a health department for a rash. On 04-OCT-2006, he was seen in reporter's office with a rash with blisters and no fever with breakthrough chickenpox. He was treated with AVEENO bath. No diagnostic laboratory tests were performed. The patient's mother called days later to report that the child was fine. The outcome was recovered. A product quality complaint was not involved. No additional information is expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female who had a negative varicella titer in 2004 (0.32) and no history of previous Varivax vaccinations who in 2004 was vaccinated with two doses of Varivax. On 18-OCT-2006, the patient tested negative for seroconversion (0.61). The patient had not contacted the disease and had not had any problems due to lack of seroconversion. 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: Rash, Varicella
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 4-year-old male who on 25-AUG-2003 was vaccinated intramuscularly with a 0.5 ml dose of Varivax (lot# 643768/1063M). On 17-OCT-2006 the patient developed a rash and was seen by a physician on 18-OCT-2006. He was diagnosed with chickenpox and treated with an AVEENO bath. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 3-year-old female who on 20-AUG2004 was vaccinated intramuscularly with a 0.5 ml dose of Varivax. On approximately 07-OCT-2006 the patient developed breakthrough chickenpox and was seen by a physician on 09-OCT-2006. It was reported that on 11-OCT-2006 the patient was better. At the time of this report she was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female who on 23-FEB-1999 was vaccinated IM with a 0.5 mL dose of Varivax (lot # 629140/1835H). It was reported that the patient developed a rash a few days prior to being seen in the office on 17-OCT-2006 with breakthrough chickenpox. On exam the patient's lesions were drying. The patient returned to school. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Candidiasis, Full blood count abnormal, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 17-month-old male with no pre-existing allergies, birth defects, or medical conditions who on 28-APR-2006 was vaccinated SC in the left arm with a first dose of Varivax (Lot # 652803/0262F). There was no illness at the time of vaccination. On 06-OCT-2006 the patient was seen with a fever of 101.8 and a rash. It was noted that the patient had croup on 04-OCT-2006. There was no known exposure to chickenpox. The patient had 2 skin papules on her back, and one on each of the following places: her left flank, right abdomen, right cheek, back of right knee, and forehead. Her diagnosis were: thrush (treated with DIFLUCAN); chickenpox (plan was to treat symptoms): and fever (CBC was noted to be viral). The outcome was recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 17-month-old male with no pre-existing allergies, birth defects, or medical conditions who on 28-APR-2006 was vaccinated SC in the left arm with a first dose of Varivax (Lot # 652803/0262F). There was no illness at the time of vaccination. On 06-OCT-2006 the patient was seen with a fever of 101.8 and a rash. It was noted that the patient had croup on 04-OCT-2006. There was no known exposure to chickenpox. The patient had 2 skin papules on her back, and one on each of the following places: her left flank, right abdomen, right cheek, back of right knee, and forehead. Her diagnosis were: thrush (treated with DIFLUCAN); chickenpox (plan was to treat symptoms): and fever (CBC was noted to be viral). The outcome was recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a physician concerning a 4-year-old white male who on 30-MAY-2003 was vaccinated SC in the left arm with a first dose of Varivax (Lot # 644248/1145M). On 12-OCT-2006 the patient developed a rash consistent with a mild case of varicella (<25 lesions). Subsequently, the patient recovered. No complications were noted. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified nurse assistant concerning a 68 year old male who was vaccinated with a dose of Varivax instead of a dose of Zostavax. There was no adverse event. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8-year-old white female who on 15-JAN-1999 was vaccinated with a dose of Varivax. The physician reported that on 16-OCT-2006, the patient developed varicella characterized by five lesions on her chest and abdomen. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated during routine immigration exams with a dose of Varivax. Subsequently the patient developed a mild to moderate chicken pox-like rash. The lesions were noted to be papules. The patient's outcome was not reported. Further information is not expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female with migraine headaches and a KEFLEX allergy who "in college" on an unspecified dates one month apart was vaccinated with first and second doses of Varivax. Subsequently the patient's titers were checked by her obstetrician/gynecologist and the results show that the patient is "not immune", the patient remains seronegative,. No adverse experience was related to this event and the patient was not on any medication at the time of the report. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 02-OCT-2006 was vaccinated with a SC first dose of Varivax (lot # 654083/0917F). There was no illness at the time of vaccination. On 15-OCT-2006 the patient developed "break through pox and cellulitis at site". Unspecified medical attention was sought. Subsequently, the patient recovered from break through cellulitis. There was no product quality complaint involved. The patient's vaccination history included a 0.5 mL first, second, third and four dose of INANFRIX on 20-SEP-2005 (AC14A006BA), 22-NOV-2005 (AC14A06CA), 10-JAN-2006 (AC14A007AA) and 10-AUG-2006 (AC14B033AA); a 0.5 mL first, second and third dose of ENGERIX-B on 22-AUG-2001, 25-JAN-2005 (AHBVA070AA), and 27-MAY-2005; a 0.5 mL first dose of Hib conj vaccine (651250/0186R); a 0.5 mL first, second and third dose of IPOL on 13-OCT-2005 (Y0324), 08-DEC-2005 (Y0576 and 09-FEB-2006 (Y0576); a first dose of MMR (654545/0701F). Additional information is not expected.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash pustular
Clinical narrative: Information has been received from a physician concerning a 32 year old male, with hypertension, obesity, and possible diabetes, who on 02-OCT-2006, at 2:16 pm, was vaccinated with a 0.5 ml subcutaneous dose in the left of Varivax (Lot# 652806/0265F). Concomitant therapy included LOTENSIN. On 16-OCT-2006 the patient developed a pustule and a rash on his face and chest. It was noted that the reporter did not consider the event to be a breakthrough of varicella but a rash. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that on 16-OCT-2006 the patient developed a fever and a varicella-like eruption on the face and chest. The reporter considered the patient's fever and varicella-like eruption to be disabling. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Laboratory test, Rash
Clinical narrative: Information has been received from a registered nurse concerning her 43 month old grandson with no pertinent medical history, who in 2004, at 1 year of age, was vaccinated with with a dose of Varivax. There was no concomitant medication. On 28-SEP-2006, the patient awoke with "one spot on his face". By 30-SEP-2006 the rash had spread over the entire left side of the patient's face and inside his throat. The patient's scalp and neck were not involved. The patient had blisters on his left eyelid. The patient was originally seen in a clinic and diagnosed with Herpes Simplex but the diagnosis was later changed to Herpes Zoster. The patient was given an unspecified antibiotic and antiviral. The patient had an allergic reaction to the antibiotic. Both of the medications were discontinued. A second opinion was sought and the diagnosis of Herpes Zoster was confirmed. The patient was also seen by a dermatologist and an ophthalmologist. The patient did not have any ocular involvement. The dermatologist sent a sample of the blister to a lab but the results were inconclusive. Subsequently, on an unspecified date the patient recovered. 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: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no known allergies or pertinent medical history who on 19-AUG-1999 was vaccinated with a 0.5 ml first dose of Varivax (lot # 629257/1851H). There was no concomitant medication. On 23-AUG-2006 the patient developed a "chickenpox like rash with over 50 lesions". The patient had no other symptoms. Medical attention was sought and the patient was treated with an unspecified antihistamine and calamine. No labs were performed. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning an 8 year old patient who on 04-JAN-1999 was vaccinated with a 0.5 ml dose of Varivax (Lot# 627333/1244H). On 13-OCT-2006 the patient experienced breakthrough chickenpox. It was reported that skin lesions were cultured, varicella zoster was isolated and was identified by immuno-fluorescence. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a receptionist concerning a patient who on an unspecified date was vaccinated with one dose of Varivax. Subsequently the patient "came down with a mild case of shingles, herpes zoster". Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning his 13-year-old son who at age 10 in approximately 2003 was vaccinated with a dose of Varivax. "Approximately 10 months ago," in approximately January 2006, the patient experienced a mild case of chicken pox. No medical attention was sought. Subsequently, the patient recovered "after the third day of having the chickenpox". No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 73-year-old patient who, "one week ago", on 19-OCT-2006 was vaccinated subcutaneously one time with a 0.5 ml dose of Varivax. The administration of Varivax was an error, patient was suppose to receive Zostavax. It was unspecified if medical attention was sought. It was reported that the patient did not experience any known symptoms. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 3-year-old female with a penicillin allergy who in 2004 was vaccinated with her first dose of Varivax. On 23-OCT-2006 the patient received her second dose of Varivax. Following vaccination, the patient experienced redness and swelling at the injection site. The patient was seen in the ER and treated with TYLENOL and ADVIL. At the time of this report, the patient had not recovered. No product quality complaint was involved. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning an adult female in her mid 20's who on unspecified dates as an adult was vaccinated with first and second doses of Varivax. Subsequently, a varicella titer was done and the patient remains seronegative for varicella. No further information was available. There was no product complaint involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test, Varicella
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history, who in 1998 was vaccinated SC with a first, one time 0.5 ml dose of Varivax. There was no concomitant medication. ON approximately 20-OCT-2006 the patient developed chickenpox and on 25-OCT-2006 the patient presented to the office "covered head to toe with chickenpox". Unspecified medical attention was sought and "blood work" was performed (results not reported). At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Varicella
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15-year-old white male with no pre-existing allergies, birth defects or medical conditions, who on 29-AUG-2005 was vaccinated with a dose of Varivax (lot# 648943/0893P). There was no concomitant medication and no illness at the time of vaccination. On 10-OCT-2006 the patient experienced exact same itchy rash as his sister who had a confirmed case of varicella. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered as of 22-OCT-2006. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Varicella
Clinical narrative: Information has been received from a woman in a physician's office concerning a 12 month old white female who on 19-FEB-2002 was vaccinated IM in the right leg with a first dose of Varivax (lot # 640153/0823L). On 13-OCT-2006, the patient started to develop chickenpox lesions. No medical attention as sought. The disease was noted to be in progress and the patient had not yet recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an office manager in a physician's office concerning a patient who was vaccinated with a single subcutaneous dose of Varivax in error instead of Zostavax. No product quality complaint was involved. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Mumps antibody test negative, Rash, Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old black male employee with no known drug allergies and hypertension controlled with unspecified medications who on 02-OCT-2006 at 09:00 AM was vaccinated SC in the right arm above the elbow with a first 0.5 mL dose of Varivax (lot # 653311/0441F). Concomitant vaccination on 02-OCT-2006 at 09:05 AM included a first dose in the left deltoid of hepatitis B virus vaccine (lot # 652882/0038F). There was no illness at the time of vaccination. On 24-OCT-2006, the patient developed six spots or bumps. He was noted to be afebrile and had been working with no work time missed. Unspecified medical attention was sought. 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 registered nurse who reported that hiring labwork for the employee reflected non-immunity to varicella. As part of their policy, anyone with questionable immunity and direct patient contact is immunized upon employment. He received a Varivax and a hepatitis B virus vaccine that first day. A doctor visit was required only related to patient contact and the ability to work. A varicella titer following the patient's outbreak, on 17-NOV_2006, was positive at 93.2 EU/ML. On 27-OCT-2006 the staff was informed and no other persons became ill. He recovered on an unspecified date. Additionally, medical records detailed the patient was seen by a physician on 27-OCT-2006. It was noted that he complained of blister-like" bumps on the face, forearm, and abdomen. He had recent Varivax. Spots looked like varicella rash. He was afebrile with no respiratory problems. The physician stated that it was possible that he was breaking out secondary to the vaccine. The likelihood of him transmitting it to others was very low. The physician recommended that he go home from work that day and return for a follow-up visit in the AM of 30-OCT-2006 before going back to work. They would likely check his varicella titer in a few weeks and hold the second vaccination. It was noted that to other associates who had been working closely with the patient were check for varicella immunity. Both were found to be immune. On 13-DEC-2006, he was seen again for a follow-up visit. He had no problems and no other occurrences of varicella.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received concerning an 11 year old white male with no known allergies or past medical history on on 16-OCT-2006 at 18:00 was vaccinated SC in the right arm with a second dose of Varivax (lot # 654528/1044F). Concomitant vaccination included a first dose of Boostrix (lot # AC52b011BA) given IM in the left arm. There was no illness at the time of vaccination. On 18-OCT-2006 at 09"00 the patient developed redness and swelling at the site (actual site not specified), also reported as a localized allergic reaction. Unspecified medical attention was sought. No diagnostic tests or labs were performed. It was reported that the patient had not had any adverse events following prior vaccination. The patient recovered on 22-OCT-2006. Additional information is not expected.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 7 year old patient who in approximately 1999, at one year of age, was vaccinated with a dose of Varivax. Subsequently, on 3 different occasions, the patient experienced reoccurrences of shingles at different locations. It was unknown if medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Laboratory test abnormal, Ultrasound scan normal
Clinical narrative: Information has been received from a licensed practical nurse through the Merck Pregnancy Registry concerning a 17-year-old Hispanic female with no history of previous pregnancies who on 23-JUN-2006 was vaccinated with Varivax (Lot # 652454/1017R). Two-and-a-half-weeks after vaccination (last menstrual period on 05-JUL-2006) the patient was found to be pregnant. A screening ultrasound was performed on 27-OCT-2006, results were normal. On 25-OCT-2006, MSAP testing was performed and results were reported as abnormal. No maternal adverse events such as local reaction at vaccine site, varicella or shingles after vaccination occurred. No additional information provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who was vaccinated with the second dose of Varivax one week after the first dose. The nurse did not report that the patient had any adverse reactions to this dosing. The reporter also noted that the patient had a blood test performed for seropositivity which was negative. A product quality complaint was not involved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old male who on unspecified dates was vaccinated with first and second doses of Varivax. Subsequently, "1.5 years ago", in approximately April 2006, the patient developed a case of shingles. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Information has been received from a pediatrician concerning an 11 year old male with Shwachman-Diamond syndrome including variable hypogammaglobinemia and inconsistent white blood cell status and no history of varicella who in mid August, 2006 was vaccinated with a dose of Varivax. The patient has had at least three outbreaks of varicella described as papules, no vesicles. He has been admitted to the hospital three times since September 2006 and responded to intravenous acyclovir twice. He also received intravenous immune globulin but it made no difference. There have not been any T-cell studies. The patient went home on oral acyclovir but it was not effective. He continued to have an atypical varicella and is currently hospitalized although discharge is pending. It was noted that the patient's younger sister was vaccinated with Varivax at the same time and also has Shwachman-Diamond syndrome and has not had any adverse reaction to date. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological sample to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the  Merck vaccine VZV strain. The pediatrician noted that she can also do PCR analysis at her hospital and was not sure if she would be sending specimens. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Rash papular
Clinical narrative: Information has been received from a physician concerning a 15 month old white female with no medical history or allergies who on 20-OCT-2006 was vaccinated SC in the right thigh with a 0.5 mL first dose of Varivax (lot # 654525/1041F). There was no illness at the time of vaccination. Ten days after vaccination the patient experienced redness and tenderness at the injection site. She also developed three papules that were not varicella like. One was on her torso and two in the diaper area. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the physician described the patient's experience as on 30-OCT-2006 her right thigh was slightly erythematous without tenderness, and slightly firm with a central papule at the site of injection, the patient's diaper area had two papules that were not varicella appearing. The patient's right cheek had one papule that was not varicella appearing. The patient recovered in November 2006. No laboratory diagnostic tests were performed. The patient did not experience any adverse events following prior vaccination. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information was received from a physician concerning a male, about 6 years old, who was vaccinated with vericella virus vaccine live (Oka/Merck). On 01-November-2006 he "broke out in zoster". The patient's present status was unknown at the time of this report. There was no concomitant medication. Unspecified medical treatment was sought. This is in follow-up to report(s) previously submitted on 5/16/2007. Information was received from a physician concerning a male about 6 years old who was vaccinated with VARIVAX (Merck). On 01-November-2006 he "broke out in zoster". The patient's present status was unknown at the time of this report. There was no concomitant medication. Unspecified medical treatment was sought. There was no product quality complaint. No additional information expected.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 16-year-old patient who was vaccinated with the first and second doses, respectively, of varicella virus vaccine live (Oka/Merck). The NP reported that the patient subsequently developed a breakthrough case of shingles. It was unknown if the medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 26 month old male (also reported as female) with a history of otitis media who on 27-MAR-2003 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 641983/0291M). On 20-OCT-2003 the patient was diagnosed with shingles. It was reported that the patient never had chickenpox before. Unspecified medical attention was sought. Subsequently, on an unspecified date, the patient recovered. It was reported that the patient had not had any adverse events following prior vaccination. No additional information was reported. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an elderly patient who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of varicell-zoster virus vaccine live (Oka/Merck) (MSD) for Herpes Zoster prevention. Unspecified medical attention was sought. There were no reported problems with the vaccination. There was no product quality complaint involved. It was reported that this was a case of misinterpretation which occurred "on all levels." Additional information received confirmed that no adverse effects or problems were incurred. No further information was provided. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Malaise, Pain, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 year old female with no known allergies or pertinent medical history, who on 22-JAN-1999 was vaccinated with a dose of varicella virus live (Oka/Merck). There was no illness at the time of vaccination. On 29-OCT-2006 (also reported as 30-OCT-2006) the patient developed a questionable case of varicella. The patient's symptoms included a headache, achiness and 2-3 itchy maculopapular lesions on her abdomen, back and left arm (with no vesicles), the patient was also reported to be feeling sick. On 03-NOV-2006 medical attention was sought and the lesions were small, scabby and itchy at that time. There were no labs performed. On 06-NOV-2006 the patient recovered, No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 year old female with no known allergies or pertinent medical history, who on 22-JAN-1999 was vaccinated with a dose of varicella virus live (Oka/Merck). There was no illness at the time of vaccination. On 29-OCT-2006 (also reported as 30-OCT-2006) the patient developed a questionable case of varicella. The patient's symptoms included a headache, achiness and 2-3 itchy maculopapular lesions on her abdomen, back and left arm (with no vesicles), the patient was also reported to be feeling sick. On 03-NOV-2006 medical attention was sought and the lesions were small, scabby and itchy at that time. There were no labs performed. On 06-NOV-2006 the patient recovered, No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: PNC, UNK, VARCEL
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 9 week old health white male with no known allergies who on 03-NOV-2006 was inadvertently vaccinated SC in the left upper arm with a 0.5 mL dose of Varivax instead of Prevnar. Concomitant vaccination included "all the other typical 2 month pediatric vaccinations." There was no known illness at the time of vaccination. Unspecified medical attention was sought. The physician confirmed that this was not product confusion, just staff error. The baby experienced a 102 degree fever 1 day post vaccination which resolved that day or next. No other labs or diagnostic tests were performed. The baby has been symptom free since then. There was no product quality complaint involved. It was reported that the patient and his siblings have not had adverse events following prior vaccination. No further information was provided. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with an unspecified thyroid condition, osteoporosis and high blood pressure who on 03-NOV-2006 was vaccinated SC with on 0.5 mL dose of varicella virus vaccine live (Ork/Merck) instead of varicella-zoster virus vaccine live (Oka/Merck) (MSD). Concomitant therapy included lisinopril (MSD), levothroxine Na (SYNTHROID) and ibandronate sodium (BONIVA). It was reported that there were no adverse events in the patient. Medical attention was not sought. No further information was available. There was no product quality compliant involved. Additional information from the registered nurse indicated that the reason for the error was that the packaging looks "a little similar" and the "VAX" in both product names made it similar also. Since this incident the practice has labeled the top of the freezer with product names and indications. The nurse felt this should help avoid confusion in the future. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning his 26 year old daughter  with no known allergies and no pertinent medical history, who on 15-JUL-1996 and 20-AUG-1996 was vaccinated SC with first (lot # "03893") and second (lot # 612222/0241D) doses of varicella virus live vaccine live (Oka/Merck) respectively. There was no concomitant medication. Routine lab work was done by the patient's OB/GYN physician in January 2005 in which it was found that she had no immunity. It was reported that the patient has not gotten the chickenpox since receiving the two doses of varicella virus vaccine live (Oka/Merck). the patient suffered no ill effect. No further information was available. There was no product quality complaint involved. Additional information is not expected.