chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning 9 patients who were vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX due to a human error. There were no adverse effects reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a office worker concerning her 12 year old female child who on an unspecified date, was vaccinated with the second dose of VARIVAX (Merck) (lot number not reported). The office worker stated that "2 weeks previous to 3/14/2011" (on approximately 28-FEB-2011), her child contracted shingles after receiving the second dose of VARIVAX (Merck). It was reported that the patient received prednisone (also reported as prednozone) and an anti viral for the treatment of the event. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Local reaction
Clinical narrative: Information has been received from a Nurse practitioner concerning a female patient who "two weeks ago" (on approximately 28-FEB-2011), was vaccinated with a dose of VARIVAX (Merck) (lot number not reported) and experienced a localized reaction which was a "purple-redness" on her skin where the injection was administered. The patient sought unspecified medical attention. The patient did not receive treatment for the event. At the time of the report the patient was recovering. 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 patient who on 12-JUL-2001, was vaccinated with the first dose of VARIVAX (Merck) (dose and lot number not reported). It was noted that the patient never received a second dose of VARIVAX (Merck). The patient was diagnosed this past Saturday, on 12-MAR-2011 with chickenpox. It was reported that the patient received treatment but the reporter was not exactly "sure of the details". At the time of the report the outcome of the patient was not provided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 months old male who on 07-MAR-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot #668544/1321Z expiration date: 07-OCT-2012). Concomitant medications include a vaccination with a dose of VAQTA in the opposite leg that VARIVAX (Merck) on a same date that previous vaccine at the "same office visit". On 14-MAR-2011, the patient's mother noted a "red raised area on the right thigh at the VARIVAX (Merck) injection site". On 15-MAR-2011, the office saw the patient and reported "the rash was 3/4 inch by 2 inches and no was not painful or itchy". No problem was noted in the opposite leg. Warm compresses to the area were the treatment given for the rash. No lab diagnostics studies were performed. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a 53 year old female registered nurse with no allergies or pertinent medical history who in 1997 or 1998 was subcutaneously vaccinated with two 0.5 mL doses of VARIVAX (Merck) (lot number not reported). There was no concomitant medication. Registered nurse reported that she had titers drawn in 2007 and they came back negative for immunity to the varicella virus (consumer reported that she had none further laboratories performed). The registered nurse did not seek medical attention. No treatment was given for this adverse event. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 5 year old male who on 19-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # 665967/0224Z, 0.5ml, SC). On 20-JUL-2010 the patient experienced redness, swelling, fever and discomfort on his right leg. The patient received unspecified medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Erythema
Clinical narrative: Information has been received from a registered nurse concerning an "11 year old" male patient who on 22-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot # 666863/0467Z). On 23-JUL-2010 the patient returned to the office with discomfort and redness (unspecified where). At the time of the reporting, the patient's status was unknown. This is one of two reports from the same source. The patient's brother's experience has been captured in WAES 1008USA03167. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse at the physician's office concerning a 4 year old female who on 07-JUN-2010 was vaccinated with VARIVAX (Merck), injection. On 08-JUN-2010 ("the next day"), the patient returned to the office with a fever of 101.5 degrees (taken orally), she was also vomiting however did not have any pain or diarrhea. At the time of the report, the outcome was unknown. Therapy with VARIVAX (Merck) was not reintroduced. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 28-JUL-1998 was vaccinated with the first dose of VARIVAX (Merck), SC, 0.5 ml. On 05-MAY-2010, was vaccinated with the second dose of VARIVAX (Merck) (Lot# 666695/1706Y), SC, 0.5 ml. On 07-MAY-2010 the patient was diagnosed with cellulitis in her left arm after receiving her second dose of VARIVAX (Merck). She was given KEFLEX (manufacturer unspecified) 500 mg for treatment. The patient had sought unspecified medical attention. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 14 year old female patient who on 09-AUG-2010 was vaccinated SC with her second 0.5 ml dose of VARIVAX (Merck) (lot number 665967/0224Z) on the right arm. The date of her first dose of VARIVAX (Merck) was not provided. After receiving the second dose of VARIVAX (Merck), the patient experienced warmth, swelling and a knot at the injection site on her right arm on 11-AUG-2010. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a patient who on 11-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (lot#666855/0162Z). Subsequently, the patient developed classic chicken pox lesion within 4 to 7 days after receiving the VARIVAX (Merck). At the time of this report, the patient's outcome was unknown. Follow up information was received from a physician who was requesting a lot check on the above VARIVAX (Merck) (lot#666855/0162Z). This is one of several reports from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a consumer concerning her daughter who in approximately 2001, "9 years ago" was vaccinated with one dose of VARIVAX (Merck) (Lot#: not reported). The consumer stated that her daughter had negative varicella antibody titers 2 weeks ago, on approximately on 28-JUL-2010. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received from a physician who indicated that there was no reaction. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a patient who on 14-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (lot#666855/0162Z). Subsequently, the patient developed classic chicken pox lesion within 4 to 7 days after receiving the VARIVAX (Merck). At the time of this report, the patient's outcome was unknown. Follow up information was received from a physician who was requesting a lot check on the above VARIVAX (Merck) (lot#666855/0162Z). This is one of several reports from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning her child who on an unspecified date, was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced injection site reactions of rash, redness and swelling. At the time of this report, the patient was recovering. It was unknown if the patient sought medical attention. Follow-up information has been received from the nurse in the physician's office who reported that they cannot give patient names due to The Health Insurance Portability and Accountability Act (HIPAA). This is the first of four reports received from the same source. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date, at the age of twelve months, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). A few years later, the patient developed shingles. The physician decided not to give her a second dose. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Injection site warmth, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 8 year old son with a history of severe anaemia as an infant and no drug allergies who on 02-AUG-2010, received a dose of DTaP. On 10-AUG-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot #666368/0227Z). The first dose of VARIVAX (Merck) was administered a few years ago (lot # 666368/0227Z) with no reaction. On 16-AUG-2010, the patient experienced an injection site reaction at the VARIVAX (Merck) site 5 inches in diameter with red welts and very hot. The patient saw a doctor on 16-AUG-2010 and was started on KEFLEX capsules for possible cellulitis at the injection site. On 18-AUG-2010, "two days later", he experienced about 9 penny sized red circles with white centers, on both palms of his hands. The circles were puffy, no fluid in circles, with itching and burning. He saw the doctor again and the KEFLEX was discontinued and started on BENADRYL but there was no effect and it made him sleepy. He saw a doctor each day. He also saw a dermatologist on 19-AUG-2010, and was treated with an unnamed cream. Both doctors were unsure if it was related to the VARIVAX (Merck), but feel it might be since it started at the injection site. The patient had never had a reaction from any vaccination. He was scheduled for unnamed blood tests on 20-AUG-2010. At the time of reporting, the patient was not recovered. Follow-up information has been received from a person in the physician's office who reported that the male patient with no illness at time of vaccination on 12-AUG-2010 (previous reported as 10-AUG-2010) at 01:00 PM was vaccinated at left arm with the second dose of VARIVAX (Merck) (lot #666368/0227Z). On an unspecified date, the patient experienced redness around the vaccination site (7 x 7 cm) was lasting 3 to 5 days and then generalized hives were lasting 4 to 5 days. The patient treated with prednisone and ZYRTEC and in 23-AUG-2010 to 25-AUG-2010 the patient recovered. No further information is available.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Expired drug administered, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient who on 05-AUG-2010 was vaccinated with a dose VARIVAX (Merck) (Lot # 666367/0248Z; expiration date 04-FEB-2010). Secondary suspect vaccine given on the same day included a dose of MMR II (MSD) (Lot # 666295Y/1776Y; expiration date 16-DEC-2010). Concomitant vaccine given on the same day included a dose of KINRIX. It was reported that the parent called office on 10-AUG-2010 stating child had injection site reaction. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was not reported. The office requested a lot check. A lot check has been initiated. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 666367/0248Z was satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who on 28-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 665991/0338Z; expiration date 05-MAR-2012). Secondary suspect vaccine given on the same day included a dose of MMR II (MSD) (Lot # 667190/0406Z; expiration date 18-MAR-2012). Concomitant vaccine given on the same date included a dose of HAVRIX. It was reported that on 07-AUG-2010, the patient experienced a rash at the injection site for VARIVAX (Merck) or MMR II (MSD). It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was not reported. The office requested a lot check for lot# 665991/0338Z. Upon internal review, a lot check was requested for MMR II (MSD) lot number 667190/0406Z. A lot check has been initiated. This is one of several reports from the same source. Follow up information has been received via telephone call from a registered nurse concerning a patient who experienced the reaction after the second dose of VARIVAX (Merck). Information on the other vaccinations was not available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (Lot# 665991/0338Z and lot# 667190/0406Z) in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who on 03-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# 665804/1300Y; expiration date 09-SEP-2011). Secondary suspect vaccine given on the same day included a dose of MMR II (Lot# 665426/1118Y; expiration date 13-AUG-2011). Concomitant vaccine given on the same day included a dose of KINRIX. It was reported that the patient experienced injection site swelling. On 05-MAY-2010, the parent called office stating that the child had injection site reaction. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was not reported. The office requested a lot check for lot# 665804/1300Y. A lot check has been initiated. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665804/1300Y was satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Injection site erythema, Injection site nodule, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old male patient with overweight and asthma who on 12-AUG-2005 was vaccinated with a first dose of VARIVAX (Merck) (Lot# unknown). Second dose of VARIVAX (Merck) (Lot# 666368/0227Z) was given on 17-AUG-2010. The nurse reported that about 16 days after patient's first vaccination with VARIVAX (Merck) in approximately 28-AUG-2005, he developed "possible chickenpox vs. VARIVAX (Merck) reaction" and had an asthma attack. His mother called it "full blown chickenpox". On 19-AUG-2010, after his second vaccination the patient developed a "golf ball size knot" and redness at the injection site which was being treated with BENADRYL, MOTRIN and ice. The patient's outcome regarding possible chickenpox vs VARIVAX (Merck) reaction and asthma attack was not reported. At the time of the report, the patient had not recovered from golf ball size knot and redness at the injection site. The patient sought medical attention. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old patient who within the last two weeks (in August 2010) was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided). The nurse reported that the patient experienced normal redness around the injection area (in August 2010). The nurse reported that BENADRYL took care of the redness. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a Registered Nurse concerning a female adult patient who on an unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). Subsequently the patient developed a small breakthrough case of chickenpox after vaccination. Vaccination with VARIVAX (Merck) was discontinued. At the time of reporting, the outcome of the event was not reported. It was unspecified if the patient sought medical attention. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Ataxia
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (route and lot number not reported). On an unknown date, the patient developed ataxia after VARIVAX (Merck). The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Erythema
Clinical narrative: Information has been received from a registered nurse concerning an "11 year old" male patient who on 22-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot # 666863/0467Z). On 23-JUL-2010 the patient returned to the office with discomfort and redness (unspecified where). At the time of the reporting, the patient's status was unknown. This is one of two reports from the same source. The patient's sibling's experience has been captured in WAES1008USA01911. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old male patient with no pertinent medical history and no drug reactions/allergies who on 20-AUG-2010 was vaccinated subcutaneously with first dose of VARIVAX (Merck) (lot # 668078/0718Z, expired on 14-MAY-2012). There was no concomitant medication. On 21-AUG-2010, the patient developed local injection site reaction. The redness has increased to "soft ball" size but without any swelling. The patient had sought unspecified medical attention. No laboratory diagnostic study was performed. At the time of the report, the patient was recovering. Follow-up information has been received from the medical assistant concerning this male patient who on 20-AUG-2010 was vaccinated subcutaneously in left arm with the second dose (previously reported as the first dose) of VARIVAX (Merck) (lot # 668078/0718Z). There was no illness at time of vaccination. It was reported that the patient developed soft ball size redness swollen on 23-AUG-2010. The patient did not require emergency room/doctor visit. Ice, ibuprofen and BENADRYL were given. At the time of the report, the patient had recovered. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 9 year old male who was vaccinated with 2 doses of VARIVAX (Merck) on separate, unspecified occasions, contacted chickenpox on an unspecified date in the last 30 days. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Ultrasound antenatal screen normal, Urine human chorionic gonadotropin positive, Vaginal haemorrhage
Clinical narrative: Information has been received from a nurse practitioner, for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 15 year old female with no pertinent medical history and no drug reactions/allergies who on 23-DEC-2009 and 06-JUL-2010 was vaccinated subcutaneously with the first and second 0.5 mL dose of VARIVAX (Merck) (second dose LOT# 665880/1299Y). There was no concomitant medication. Subsequently the patient was determined to be pregnant. On 31-JUL-2010 the patient was evaluated in a local emergency room due to experience vaginal spotting. The patient was seen in the office on 06-AUG-2010. A urine pregnancy test was positive and prenatal ultrasound was normal on that date. The LMP is 11-JUN-2010; the EDD is 18-MAR-2011. The nurse practitioner didn't report the outcome of vaginal spotting at this time. Follow-up information has been received from the nurse practitioner who reported that the patient was in clinic to her pediatrician on 06-JUL-2010. She received intramuscularly (formerly reported as subcutaneously) with the second dose of VARIVAX (Merck). She received her first prenatal care appointed on 06-AUG-2010. Review indicated presently 33.1 weeks gestation. She received vaccine when pregnancy. She was being monitored regularly. No obvious problems encountered to date. The patient "now" had different insurance. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a company representative concerning a 6 year old male who in 2005 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). Then, the patient contracted chicken pox on an unspecified date in the last four weeks. The patient sought medical attention via visited to urgent care clinic. No further information is available.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site reaction, Local reaction, Pruritus
Clinical narrative: Information received from the nurse concerning a 12 year old female patient on 11-AUG-2010 was vaccinated with her second dose of VARIVAX (Merck) (lot#667820/0757Z). On 11-AUG-2010 the patient had redness, pruritus and local site reactions. The patients sought medical attention and were treated with ice pack and comfort measures. The patient recovered from redness, pruritus and local site reactions on an unspecified date. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse who reported that many years ago she was doing auditing and she saw that one boy came in to the nurses' office. It was reported that there was on boy that was unrelated, not in the same classes or lunch, with different physicians. The boy on unspecified dates, had received two doses of VARIVAX (Merck) and had a mild chicken pox outbreak on neck. The registered nurse contacted during telephone follow-up could not supply the following information: patient's name, dates of birth, dates of vaccination, lot numbers, dates of the events, recovery status, health care provider name and contact information. The registered nurse contacted during telephone follow-up could not supply the following information: patient's name, dates of birth, dates of vaccination, lot numbers, dates of events, recovery status, health care provider name and contact information. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a boy who on an unspecified date was vaccinated with VARIVAX (Merck) (lot # not reported). After several year of vaccination, the patient got a case of chickenpox. The patient received unspecified medical attention. At the time of the reporting, the patient's outcome was unknown. Follow up information received from a physician indicating that the information leading to us sending the letter resulted from our representative's misunderstanding. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Exposure to communicable disease, Rash, Varicella virus test
Clinical narrative: Information has been received from a nurse concerning one or two healthcare workers who on an unspecified date had been vaccinated with VARIVAX (Merck) (lot #, expire date and route not reported). The patients might have developed a rash on an unspecified date following vaccination, possibly after being exposed to varicella, long after initial vaccination with one dose of VARIVAX (Merck). She could not refer to their charts, or to provide any details of the cases. The patients sought unspecified medical attention. Follow-up information received via telephone call from a nurse concerning a male healthcare worker who on an unspecified date had been vaccinated with a dose of VARIVAX (Merck) (lot #, expire date and route not reported). Nurse stated that only one healthcare worker developed a blistered rash. Nurse stated that the situation had occurred in the past five years, and that a serum varicella zoster virus antibody test was done at the time to see if the patient had had chickenpox in the past (results not provided). Nurse stated that the patient source of the exposure was not disclosed to have chicken pox until some time after he had it. Nurse added that the physician overseeing the exposure issue gave instructions that workers should not be given a first dose of VARIVAX (Merck) during the incubation period or to give a second dose to those who had only one VARIVAX (Merck) dose before. The feeling was that the physician did not want to introduce the possibility that the rash was caused by VARIVAX (Merck), and therefore it could clearly be determined to have been caused by exposure to varicella. At the time of the report, patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient who on 03-JAN-2011 was inadvertently vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. It was unknown if the patient sought a medical attention. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a male patient who on 04-JAN-2011 was intended to receive ZOSTAVAX (Merck) and was inadvertently vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # not reported) SQ. No adverse symptoms were reported. No further information is available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscle spasms, Pain, Vomiting
Clinical narrative: Information was received from the mother of a 16 year-old female patient who was vaccinated with a second dose of VARIVAX in approximately 2009. The date of the first dose of VARIVAX was not reported. The patient complained of bad cramps that started two weeks after the second dose and have continued for a year and one-half. The cramps were described as lasting a few hours and sometimes up to a day. "The cramps cause a lot of pain and occasionally cause the daughter to throw-up." The patient sought medical attention from a physician, and she has not recovered. This is one of two reports received from the same source. No additional information is expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Dysmenorrhoea, Loss of consciousness
Clinical narrative: Information has been received from the mother of a 13 year old female who was vaccinated with a second dose of VARIVAX (Merck) in approximately July 2009. The dates of the first vaccine were not reported. The mother reported that her daughter passed out after severe menstrual cramps following a second dose of VARIVAX (Merck). It was reported she passed out less than a year after receiving the second dose of the vaccine. It was reported that medical attention was sought, and the patient was seen in the doctor's office. This is one of two reports from the same source. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Angioedema, Blood immunoglobulin E increased, Blood test, Full blood count, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no known allergies and no medical history who in 1995 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) and on 07-JAN-2011 was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). Suspect therapy included on 07-JAN-2011 she was also vaccinated with a third dose of GARDASIL (Lot # not reported) on the same day. Concomitant therapy included minocycline. The physician reported that on 07-JAN-2011 the patient experienced angioneurotic edema after receiving a second dose of VARIVAX (Merck). The patient's arm at the injection site of VARIVAX (Merck) on later the same day felt warm, swollen, and painful. The next day on 08-JAN-2011 her arm was swollen down to her elbow and felt heavy. She was instructed by another physician to take BENADRYL. On 09-JAN-2011 the patient was examined by the other physician and the patient's hands, arms, and face were swollen, she had hives and felt as if she had a lump in her throat. On unspecified date she was taken to the emergency room but was not admitted. On unspecified date she was treated with BENADRYL and a tapering dose of prednisone. The physician stated that the patient on unspecified date had discontinued using BENADRYL because it causes drowsiness. It was also reported that the patient was currently taking ZYRTEC, complete blood cell count (dates and no results reported), other blood tests (not results reported) and serum immunoglobulin E test (IGE) (high). At the time of the report the patient's outcome was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral, Sensation of foreign body, Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no known allergies and no medical history who in 1995 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) and on 07-JAN-2011 was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). Suspect therapy included on 07-JAN-2011 she was also vaccinated with a third dose of GARDASIL (Lot # not reported) on the same day. Concomitant therapy included minocycline. The physician reported that on 07-JAN-2011 the patient experienced angioneurotic edema after receiving a second dose of VARIVAX (Merck). The patient's arm at the injection site of VARIVAX (Merck) on later the same day felt warm, swollen, and painful. The next day on 08-JAN-2011 her arm was swollen down to her elbow and felt heavy. She was instructed by another physician to take BENADRYL. On 09-JAN-2011 the patient was examined by the other physician and the patient's hands, arms, and face were swollen, she had hives and felt as if she had a lump in her throat. On unspecified date she was taken to the emergency room but was not admitted. On unspecified date she was treated with BENADRYL and a tapering dose of prednisone. The physician stated that the patient on unspecified date had discontinued using BENADRYL because it causes drowsiness. It was also reported that the patient was currently taking ZYRTEC, complete blood cell count (dates and no results reported), other blood tests (not results reported) and serum immunoglobulin E test (IGE) (high). At the time of the report the patient's outcome was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Somnolence
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no known allergies and no medical history who in 1995 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) and on 07-JAN-2011 was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). Suspect therapy included on 07-JAN-2011 she was also vaccinated with a third dose of GARDASIL (Lot # not reported) on the same day. Concomitant therapy included minocycline. The physician reported that on 07-JAN-2011 the patient experienced angioneurotic edema after receiving a second dose of VARIVAX (Merck). The patient's arm at the injection site of VARIVAX (Merck) on later the same day felt warm, swollen, and painful. The next day on 08-JAN-2011 her arm was swollen down to her elbow and felt heavy. She was instructed by another physician to take BENADRYL. On 09-JAN-2011 the patient was examined by the other physician and the patient's hands, arms, and face were swollen, she had hives and felt as if she had a lump in her throat. On unspecified date she was taken to the emergency room but was not admitted. On unspecified date she was treated with BENADRYL and a tapering dose of prednisone. The physician stated that the patient on unspecified date had discontinued using BENADRYL because it causes drowsiness. It was also reported that the patient was currently taking ZYRTEC, complete blood cell count (dates and no results reported), other blood tests (not results reported) and serum immunoglobulin E test (IGE) (high). At the time of the report the patient's outcome was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Information has been received from a female consumer concerning her 16 year old female who in June or July (specific date unspecified, year unspecified) was vaccinated with VARIVAX (Merck) at the age of 16 years old (route, dose not reported). Two weeks later the patient got her period and very bad cramps. It was unspecified it the patient had sought medical attention. At the time of the report, the outcome was unknown. Follow up information has been received from a medical assistant who stated that it was a certain patient who got her period after getting VARIVAX (Merck) and had very bad cramps. Follow up information has been received from a physician who reported that on 18-JUL-2001 the patient was vaccinated with her first dose of VARIVAX (Merck) (route, dose and lot# unspecified). On 26-AUG-2009 the patient was vaccinated with her second dose of VARIVAX (Merck) (route, dose and lot# unspecified). The patient had experienced intermittent abdominal cramping and vomiting since receiving her second dose of VARIVAX (Merck). At the time of the report, the outcome was unknown. The physician did not think this was related to receiving VARIVAX (Merck). Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old male patient who on unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported). The physician stated that on unspecified date the patient developed varicella after VARIVAX (Merck) administration. It was unknown if the patient was administered with one or two doses of VARIVAX (Merck). At the time of the report the patient had recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 month male patient who on 28-SEP-2009 was vaccinated with a first dose of VARIVAX (Merck) (dose, route and lot# not report). The physician stated that on 11-NOV-2010 the patient was diagnosed with varicella. At the time of the report the patient had recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with a history of drug reaction/allergy while on prior therapy with GARDASIL (WAES # 1101USA02692 who in August 2003, was vaccinated with a first 0.5 ml dose of VARIVAX (Merck) (Lot# not reported) SQ, and on 01-JUL-2009 was vaccinated with a second 0.5ml dose of VARIVAX (Merck) (Lot# 664021/0502Y, Exp date 09-APR-2011), SQ. On an unspecified date, the patient went to the office for a routine physical and said that she had rash on her leg. The physician stated that on approximately 27-DEC-2010, 1 week prior to January 3rd, diagnosed her with shingles. The physician thought it was too late to provide treatment for the shingles. Patient had treated the lesion herself with CALADRYL, ELIDEL and NEOSPORIN for the lesion. There were no laboratories diagnostics performed. The physician reported that on unspecified date the patient had recovered. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Rash generalised, Vaccination complication
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 12 year old male patient who on 29-JUL-2010 was vaccinated with his second dose of VARIVAX (Merck) (Lot# unknown). Concomitant therapy included ADACEL, VAQTA (MSD) and MENACTRA. The nurse reported that on 29-JUL-2010, the patient had an atypical VARIVAX (Merck) reaction. The patient had an impressive rash everywhere that looked horrible. On an unspecified date, the patient went to the hospital but was not admitted. The patient went to a dermatologist on 30-JUL-2010 and the dermatologist believed the rash was due to VARIVAX (Merck). The rash had not changed. Patient was placed on VALTREX and XYZAL. At the time of the report, the patient had not recovered. Follow-up information has been received from a Licensed Practical Nurse concerning the male patient with no illness at time of vaccination who on 29-JUL-2010 (also reported as 28-JUL-2010) was vaccinated intramuscularly with his second dose of VARIVAX (Merck) (Lot# 666872/0473Z). Concomitant therapy administered intramuscularly included a first dose of ADACEL (lot number 3382AA) and MENACTRA (lot number 43068A7). Suspect therapy given included a first dose of VAQTA (MSD) (lot number 668349/0795Z). On 30-JUL-2010 (previously reported as 29-JUL-2010) the patient had a rash which was diagnosed as atypical VARIVAX (Merck) reaction. On an unspecified date, the patient recovered from rash. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer who stated that a pediatrician informed that children in her area who on unspecified dates were vaccinated with two doses of VARIVAX (Merck) (Lot # unknown) were getting chickenpox despite the two doses of the vaccine. At the time of the report, the patients' outcomes were unknown. This is one of several reports obtained from the source. It was unknown if the patients sought medical attention.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Medical Assistant concerning a patient who on 28-JUL-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Medical Assistant concerning a patient who on 07-JUN-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No symptoms were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash vesicular, Streptococcus test, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse, concerning a 5 year old female patient with no known drug reactions or allergies, who on 14-JUN-2006, was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot number not provided). On 19-MAY-2010, after receiving the dose of VARIVAX (Merck), the patient was diagnosed with varicella. The patient also had fever of 101F and a cough. On 19-MAY-2010, the patient went to the emergency room and was released the same day. A rapid strep test was performed and the result was negative. The physician at the emergency room stated it was the worse case of varicella he had ever seen. At the time of reporting the patient's outcome was unknown. Follow up information has been received from a registered nurse. The patient with not known allergies, on 14-JUN-2006 received a first dose of VARIVAX (Merck) (Lot # 649734/0789R), in the right arm. Concomitant vaccinations included a first dose of MMR II (Lot # 649805/0465R) in the left arm, a fourth dose of DAPTACEL (Lot # C240AA) in the left arm, and ACTHIB (Lot # VE709AA) in the right arm, all of them given on the same day at prior primary care physician office. On 20-MAY-2010 the patient was diagnosed with chickenpox. The patient presented to ER with fever of 101 degrees, cough, and pox type rash. At ER the patient had performed a rapid strept test which was negative per mother via phone call. On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urine analysis
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old male with no pertinent medical history and no drug allergies who on 25-FEB-2003 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 643082/0593M, expiration date unknown) (SC). On 16-JUN-2010, the patient received the second 0.5ml dose of VARIVAX (Merck) (lot# 665034/0994Y, expiration date 13-JUL-2011) (SC). Concomitant therapy included DETROL. On 17-JUN-2010 the patient experienced red and swollen at the injection site of the upper left arm. The patient visited an office. Urine analysis was performed and result was unknown. At the time of the report, the patient had not recovered. Follow up information has been received from the medical assistant and the physician concerning an 11 year old male patient with no illness at time of vaccination and no pre-existing allergies, birth defects, medical conditions who on 16-JUN-2010 was subcutaneously vaccinated with the second dose of VARIVAX (Merck) (665034/0994Y) in his left arm. On 16-JUN-2010 (previously reported as 17-JUN-2010), the patient experienced redness, swelling, pain at injection site of his left upper arm which worsen for 3 days after injection was given. There were no relevant diagnostic tests and laboratory data. On 22-JUN-2010, the patient recovered. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning a patient who in 1996 was vaccinated with a dose of VARIVAX (Merck). Several weeks ago in approximately June 2010 the patient did the titer test and resulted in negative titer. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Back pain, Herpes zoster, Rash
Clinical narrative: Information has been received from a current 56 year old female nurse, who in June 2006, when she was 52 year old was vaccinated SC with "1" dose of VARIVAX (Merck) (Lot # not reported). The consumer reported, that 21 days after receiving VARIVAX (Merck) in approximately June 2006 she developed zoster. She began to develop pain in the back of her right knee that radiated to her back. She also reported that "few days later" she developed a rash. The rash had resolved and the consumer had persistant pain for two month afterwards. On an unspecified date, the consumer was recovered. It was unknown if the patient sought medical attention. No further information is available.