chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Blood test, Drug exposure before pregnancy, Pregnancy test, Vaccination failure
Clinical narrative: Information has been received from a 34 year old female consumer with no pertinent medical history and no known drug reactions/allergies for VARIVAX (Merck), a Pregnancy Registry Product, who in 2006 was vaccinated with the two dose series of VARIVAX (Merck), one month apart. Concomitant therapy included "pre-natal" (no further specified). In 2006, about four months after receiving the first dose of VARIVAX (Merck), the consumer found out that she was pregnant. The consumer stated that the pregnancy was fine and received full pre-natal care. She also stated that she was hospitalized only for the delivery. On an unknown date pregnancy test, "blood work" and prenatal testing were performed but no results were provided. In 2009, at age 37, due to a lack of immune response, the patient received another two doses of VARIVAX (Merck) one month apart. At the time of the report, at 38 years old, the consumer stated that she felt that she had no immunity still. The patient sought medical attention with a physician. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning an adult patient who in 2004 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported). In 2005 the patient received second dose of VARIVAX (Merck) (lot # not reported). "A recent" varicella titer was "not adequate". It was unknown if the patient sought medical attention. At the time on the report on 28-APR-2010 the patient had not recovered from varicella titer "not adequate". Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a health professional concerning a 12 month old patient who in approximately January 2010, "early 2010", was vaccinated with a dose of VARIVAX (Merck). Suspect secondary vaccination administered on the same day included a dose of MMR II. Two weeks later the patient presented with rash all over the body. The patient called the physician's office. On an unknown date the patient recovered from rash all over the body. Follow-up information was received which reported that there was no patient involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a "16-17" year old female patient with no pertinent medical history and no known drug reactions/allergies who in April 1994, was vaccinated with VARIVAX (Merck). The physician believed that the date was incorrect since the vaccine was not released until May 1995 and mentioned that the patient may not had received the vaccine since the date was incorrect. There was no concomitant medication. On approximately 29-MAR-2010, "two weeks ago", the patient developed chickenpox with a fair amount on her arms and hands. The patient sought medical attention by an office visit. At the time of the report, the patient was recovering. No laboratory or diagnostic studies were performed. Follow up information has been received from a physician who indicated that he was questioning the date reported by a parent that her daughter had received VARIVAX (Merck) in 1994. The physician stated that he really questioned the patient actually got the vaccine but that the parent had merely given a fictitious date; possibly no vaccine was ever given. The physician also mentioned that the patient contracted chicken pox in March 2010. The case was full blown with a significant number of vesicles that scabbed in the classic manner. It was also reported that the patient's sister experienced chicken pox after receiving VARIVAX (Merck) (WAES# 1007USA01141). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on 09-APR-2010 was vaccinated with a dose of VARIVAX (Merck) instead of a dose of ZOSTAVAX (Merck) (MSD). The patient was not experiencing any known symptoms. Additional information has been received from a registered pharmacist who received the original report from a registered nurse indicated that the patient received VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD) due to a medication error. Additional information has been received from a registered pharmacist indicated that the VARIVAX (Merck) Lot# was 665880/1299Y. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a physician concerning a "9 to 10" year old patient who was vaccinated with a dose of VARIVAX (Merck). It was reported that "the patient experienced nerve pain and then shingles" in "the week of 05-APR-2010". The patient received unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Neuralgia, Rash vesicular
Clinical narrative: Information has been received from a consumer concerning her granddaughter who is in college now. When the patient was in junior high was vaccinated with a 0.5 ml dose of VARIVAX (Merck). "Last week", on approximately 06-APR-2010, the patient developed shingles like rash on her lower back and nerve pain. The patient had not been diagnosed. At the time of the report the patient had not recovered. The patient did not seek medical attention. No further information is available.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 13 year old patient who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (Lot number unspecified). The physician reported that the patient broke out with the chicken pox within the last few weeks (as recent as 12-APR-2010). 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 has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old male patient who on 15-OCT-2004 and 12-NOV-2007 was vaccinated with the first dose (lot# 648032/1157N) and second dose (lot# 658408/1177U) of VARIVAX (Merck). On 09-MAR-2010 the patient was diagnosed with the chickenpox and was given ZOVIRAX (manufacturer unspecified). The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered from chickenpox on an unspecified date. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 6 year old male who on 05-DEC-2001 was vaccinated with the first dose of VARIVAX (Merck) (lot number unspecified). On 12-JAN-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 654526/1141F). After vaccination of the second dose (date unspecified, approximately in 2007) the patient developed chickenpox and was given BENADRYL and CALADRYL for treatment. The symptoms improved on therapy. On an unspecified date, the patient had recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old female patient who on 03-MAR-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 665587/1203Y). The physician reported that the patient received all 4 years old vaccines. On an unspecified date, the patient experienced chickenpox and the patient was given BENADRYL and CALADRYL. At the time of this report, the patient's outcome was unspecified. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Fatigue, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Information has been received from a consumer concerning her 13 year old son who in August 2000, was vaccinated with a dose of "chickenpox vaccine" (manufacturer unspecified) and developed chickenpox. The patient felt sick on 10-APR-2010 and on 11-APR-2010, with a sore throat and nausea and he felt tired. On 12-APR-2010 the patient went to school and came home with "a blister on his collar bone". On the morning of 14-APR-2010 he had a blister on his inner thigh and his calf and had a sore throat. It was unknown if medical attention was sought. The outcome of the patient was not reported. Follow up information has been received which reported that on 30-AUG-2000 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). He had a few red pustular lesions on his leg, arm and neck. He went to see the physician and the physician's impression was questionable chickenpox, but could not diagnose today. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the physician concerning the 13 year old male patient with no allergies and no other medical history. The physician reported that the patient's sister developed wild type chickenpox one week after the brother given vaccine at different clinic. There was no illness at the time of vaccination. Typing was done in our lab. This is one of several reports from the same source. Additional infection is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 13 year old son who in August 2000, was vaccinated with a dose of "chickenpox vaccine" (manufacturer unspecified) and developed chickenpox. The patient felt sick on 10-APR-2010 and on 11-APR-2010, with a sore throat and nausea and he felt tired. On 12-APR-2010 the patient went to school and came home with "a blister on his collar bone". On the morning of 14-APR-2010 he had a blister on his inner thigh and his calf and had a sore throat. It was unknown if medical attention was sought. The outcome of the patient was not reported. Follow up information has been received which reported that on 30-AUG-2000 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). He had a few red pustular lesions on his leg, arm and neck. He went to see the physician and the physician's impression was questionable chickenpox, but could not diagnose today. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the physician concerning the 13 year old male patient with no allergies and no other medical history. The physician reported that the patient's sister developed wild type chickenpox one week after the brother given vaccine at different clinic. There was no illness at the time of vaccination. Typing was done in our lab. This is one of several reports from the same source. Additional infection is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Secondary transmission, Varicella
Clinical narrative: Information has been received from a consumer whose son on 17-MAR-2010 was vaccinated with VARIVAX (Merck) (lot number 665586/1227Y) concerning her 11 year old daughter with a history of chickenpox when she was one year old who on 14-APR-2010 developed chickenpox. Her son did indeed receive VARIVAX (Merck) as well as VAQTA (MSD) (lot number 66030/1397Y) and "MCV4 meningitis vaccine " (other manufacturer). Her son did not develop any rash. The patient had chickenpox again and on the morning of 14-APR-2010, she had blisters on her stomach, back, arms and scalp. The patient felt fine otherwise. It was unknown if medical attention was sought. The outcome was not reported. Follow up information has been received which reported that on 30-AUG-2000 the patient was vaccinated with a dose of VARIVAX (Merck) at another office. She had red small pustular lesions on her limbs and trunk, no vesicles were noted. She went to see the physician and the physician's impression was questionable chickenpox, but could not diagnose today. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the physician who reported that the patient did not receive our vaccine and had wild type chickenpox. This is one of several reports from the same source. Additional infection is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an adolescent female who was vaccinated with a dose of VARIVAX (Merck) as a young child on an unspecified date. The patient was showing breakthrough chickenpox on 14-APR-2010. At the time of the report, the outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician and a registered nurse concerning a boy who on unspecified dates was vaccinated with his second doses of VARIVAX (Merck) (lot number not reported). On an unspecified date the patient broke out in hives around the injection site. No medical attention was sought. "After a few days", on an unspecified date, the patients recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a consumer and a nurse concerning an approximately 12 month old male who on 05-MAR-2010 was vaccinated with a dose of VARIVAX (Merck). On 17-MAR-2010, the patient did have a rash on his side. On 12-APR-2010, the rash had likely healed. Additional information is not expected. A 15 year old female who babysat the patient experienced secondary transmission and chickenpox. The events has been captured in WAES 1004USA00190.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from an office manager concerning her 12 month old daughter who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). Subsequently, the patient got a mild breakthrough case of chicken pox. The patient did not seek medical attention. At the time of the report the patient had recovered. No further information is available.
Age: 26.0
Sex: F
Vaccine: TTOX, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a 26 year old female consumer with no known drug reactions/allergies and no pertinent medical history who on 28-APR-2010, was vaccinated with a dose of VARIVAX (Merck) (manufacturer unspecified). Secondary suspect vaccination included "a tetanus shot in the same arm during the same visit". On 29-APR-2010, the patient's arm, where she got the vaccine was large, red and swollen. The patient did not know if this was her first or second dose of VARIVAX (Merck) (manufacturer unspecified), she stated she might have gotten a varicella vaccine when she was a baby but her mother did not remember. No diagnostic tests were performed. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a female patient with no pertinent medical history and erythromycin allergy who "17 years ago", in approximately April 1993, at 11 years of age was vaccinated with a dose of VARIVAX (Merck) (route and lot # unknown). Concomitant therapy included prenatal vitamins. The Licensed Practical Nurse reported that currently the patient had negative varicella titers. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old male patient with no known drug allergies or pertinent medical history who on 12-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot # 666044/1428Y). Secondary suspect vaccination included hepatitis A vaccine  (inactivate) (MSD). Subsequently, on approximately 12-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 26-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Face injury, Hyperhidrosis, Lip haemorrhage, Lip injury, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse, concerning a 11 year old male patient, with no medical history or medicines and no allergies, who on 23-JUL-2004, was vaccinated subcutaneously with 0.5 mL dose of VARIVAX (Merck) (lot number not reported). On 20-APR-2010, the patient received intramuscularly the second 0.5 mL dose of VARIVAX (Merck) (lot number 665882/1409Y). Other vaccines administered the same day included ADACEL and MENACTRA. On 20-APR-2010, before leaving the exam room, the patient fainted. The patient recovered right away and with no apparent injury. The patient sought unspecified medical attention. This is one of several reports concerning siblings received from the same source (MSD, WAES# 1004USA04407). Follow-up information has been received from a registered nurse, who reported that on 20-APR-2010, at 09:00 am, the patient received in the right deltoid the second dose of VARIVAX (Merck). The nurse reported that the patient received on the same date a dose of ADACEL as part of his well-child examination. The patient tolerated the injection process and was waiting for his younger brother's immunization to be completed. When the patient stood to leave, his mother reported that he took several steps forward and leaned over. The mother thought that the patient was tying his shoe when he collapsed, striking his nose on the edge of the examination table footrest. The mother called for help and when the nurse arrived, she found the patient laying face down on the floor of the examination room. The patient was pale and diaphoretic. His pulse was normal but he was unconscious. The nurse rolled the patient onto his side in recover position and monitored him for approximately 45-60 seconds when the patient began to regain consciousness and respond to his name. The patient remained pale but his vital signs were stable. At that moment, the nurse was joined by a licensed practical nurse, who assisted in monitoring the patient. Temperature was 98.3, pulse (apical) was 88 and blood pressure was 100/60. The patient was responsive to questioning. The patient had no recollection of the event. Ice was applied to the contusion/abrasion on his nose. It was noted that he bit the inside of his lower lip which was bleeding slightly. Bleeding was controlled and he remained in the recovery position for approximately 15 minutes with continuous observation until the patient felt well enough to stand. The patient ambulated from the room on his own with an escort. No further information is available.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse, concerning a 11 year old male patient, with no medical history or medicines and no allergies, who on 23-JUL-2004, was vaccinated subcutaneously with 0.5 mL dose of VARIVAX (Merck) (lot number not reported). On 20-APR-2010, the patient received intramuscularly the second 0.5 mL dose of VARIVAX (Merck) (lot number 665882/1409Y). Other vaccines administered the same day included ADACEL and MENACTRA. On 20-APR-2010, before leaving the exam room, the patient fainted. The patient recovered right away and with no apparent injury. The patient sought unspecified medical attention. This is one of several reports concerning siblings received from the same source (MSD, WAES# 1004USA04407). Follow-up information has been received from a registered nurse, who reported that on 20-APR-2010, at 09:00 am, the patient received in the right deltoid the second dose of VARIVAX (Merck). The nurse reported that the patient received on the same date a dose of ADACEL as part of his well-child examination. The patient tolerated the injection process and was waiting for his younger brother's immunization to be completed. When the patient stood to leave, his mother reported that he took several steps forward and leaned over. The mother thought that the patient was tying his shoe when he collapsed, striking his nose on the edge of the examination table footrest. The mother called for help and when the nurse arrived, she found the patient laying face down on the floor of the examination room. The patient was pale and diaphoretic. His pulse was normal but he was unconscious. The nurse rolled the patient onto his side in recover position and monitored him for approximately 45-60 seconds when the patient began to regain consciousness and respond to his name. The patient remained pale but his vital signs were stable. At that moment, the nurse was joined by a licensed practical nurse, who assisted in monitoring the patient. Temperature was 98.3, pulse (apical) was 88 and blood pressure was 100/60. The patient was responsive to questioning. The patient had no recollection of the event. Ice was applied to the contusion/abrasion on his nose. It was noted that he bit the inside of his lower lip which was bleeding slightly. Bleeding was controlled and he remained in the recovery position for approximately 15 minutes with continuous observation until the patient felt well enough to stand. The patient ambulated from the room on his own with an escort. No further information is available.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (Lot number unspecified). The physician reported that the patient broke out with the chicken pox within the last few weeks (as recent as 12-APR-2010). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 18 year old patient who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (Lot number unspecified). The physician reported that the patient broke out with the chicken pox within the last few weeks (as recent as 12-APR-2010). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who was vaccinated with a second dose of VARIVAX (Merck) (dose, route and lot number not reported). Physician reported that the patient received the second dose and still experienced chickenpox (20 or less vesicles). This physician was not the one that administered the vaccine, he only diagnosed the chickenpox in the patient. Patient sought for unspecified medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old female patient with no pertinent medical history and no known drug reactions/allergies who in 2001 was vaccinated with a first dose of VARIVAX (Merck) (lot# 632719/1241K). On 30-APR-2010 the patient was vaccinated SC with a second 0.5 ml second dose of VARIVAX (Merck) (lot# 665887/1591Y) in her left arm. Concomitant vaccination administered in the patient's right arm included GARDASIL and VAQTA. Subsequently, the patient was back in the office for cellulitis. On 02-MAY-2010 the patient was seen at an after hours pediatric acute care for a left swollen arm. The patient was being treated with KEFLEX and BENADRYL. At the time of the report, the patient was recovering. No laboratory or diagnostic studies were performed. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye pruritus
Clinical narrative: Information has been received from a 56 year old female consumer who is also a Registered Nurse, with no pertinent medical history and no known drug allergies who reported that on 21-APR-2010, some of a dose of VARIVAX (Merck) splashed in her right eye during administration of vaccine to a patient. There was no concomitant medication. The registered nurse stated that she rinsed her eye twice and her eye was slightly itchy before second rinse but at the time of the report it was fine. The patient did not seek medical attention. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 03-MAY-2010, was vaccinated inadvertently with a 0.5 ml SC dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). The Medical Assistant stated that this was staff error and not product confusion. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received which reported that there was no adverse event to report. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse, concerning an adult female patient with no pertinent medical history, who on unknown dates was vaccinated with the first and second doses of VARIVAX (Merck) (routes and lot numbers not provided). On an unknown date, a varicella antibody titer test was performed, and the result was negative. The patient's outcome was unknown at the time of reporting. The patient sought medical attention via office visit. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: Information has been received from a field employee and a nurse concerning a two patients who were vaccinated with a dose of VARIVAX (Merck) (date, dose route and lot number not reported). The field employee stated that the nurse discovered that two patients who were given at least one dose of VARIVAX (Merck) had a chicken pox outbreak. The nurse clarified that the two patients involved were administered two doses of VARIVAX (Merck) and were subsequently diagnosed with herpes zoster (date unspecified). Both patients' zoster had a distribution of the right neck. At the time of the report the outcome of the patients were unknown. It was unspecified if the patients sought medical attention. Follow-up information has been received from the 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 the same 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. This is a consolidation of two reports concerning the same patients. This is one of several reports received from the same source. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 79 year old female patient who on 26-APR-2010 was vaccinated with a SC dose of VARIVAX (Merck) (dose not reported, lot number 665690/1215Y) instead of ZOSTAVAX (Merck). It was a human error not PQC. No adverse effects were reported. Patient did not seek 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 licensed visiting nurse concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot # not reported) instead of ZOSTAVAX (Merck) by accident. No adverse effect was reported. Follow up information has been received from a licensed visiting nurse who reported no adverse reactions on follow-up diagnostic studies were experienced by patient. No further information is available.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter a female who was vaccinated with a dose of VARIVAX (Merck) (date, route, lot number and dose not reported). Suspect vaccine included MMR II (date, route, lot number and dose not reported). The consumer reported that the patient received the two vaccines on the same day. It was reported that the following day the patient experienced hives (date unspecified). At the time of the report the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature decreased, Confusional state, Feeling abnormal, Hyperhidrosis, Incorrect route of drug administration
Clinical narrative: Information has been received from a registered nurse, concerning a 7 year old male patient, with no medical history or medicines and no allergies, who on 23-JUL-2004, was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot number not reported). On 20-APR-2010, the patient received intramuscularly the second 0.5 mL of VARIVAX (Merck) (lot number 665882/1409Y). No other vaccines administered the same day. On 20-APR-2010, before leaving the exam room, the patient fainted. The patient recovered right away and with no apparent injury. No labs or diagnostics studies were performed. The patient sought unspecified medical attention. This is one of several reports concerning siblings received from the same source (MSD, WAES# 1004USA03467). Follow-up information has been received from the nurse practitioner, who reported that the patient was in office for his well child examination on 20-APR-2010 and for immunization update of second varicella, which received at 9:00 am in the left deltoid. The nurse reported that the patient was in good health and had no complaints, physical examination completed, the patient was given his varicella immunization without incident. After observing that his brother had a syncopal episode following immunization, the patient was instructed to rest in a chair. The patient verbalized no concerns until he was "thirsty". The patient was instructed not to drink the water from the tap due to its taste and he continued to sit in the chair but repeated he was thirsty and then said "I don't feel good". The patient slumped back into the chair and then drew his extremities inward. His mother and a licensed practical nurse, lowered him to the floor and placed him in recovery position. The patient remained unconscious for approximately 20 seconds and then abruptly opened his eyes. The patient stated "I feel asleep and now I am on the floor". The patient was instructed to remain quiet, vital signs were stable at tympanic temperature of 96.9. 108 apical pulse 108 and blood pressure 96/60. His color returned to normal. The patient was mildly diaphoretic. He continued to improve under observation, was given a small cup of spring water he drank. The patient returned to sitting in the chair, looked mildly confused but answered questions appropriately. Upon standing to leave, the patient became more ashen, stated that he had a "tickle in the throat" and then projectile vomited water twice. The patient returned to the chair and regained his color. The patient then stated "I feel fine now". He was allowed to rest for several additional minutes and then ambulated from the waiting room to the car with escort. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Loss of consciousness, Pallor, Posture abnormal, Skin discolouration, Syncope
Clinical narrative: Information has been received from a registered nurse, concerning a 7 year old male patient, with no medical history or medicines and no allergies, who on 23-JUL-2004, was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot number not reported). On 20-APR-2010, the patient received intramuscularly the second 0.5 mL of VARIVAX (Merck) (lot number 665882/1409Y). No other vaccines administered the same day. On 20-APR-2010, before leaving the exam room, the patient fainted. The patient recovered right away and with no apparent injury. No labs or diagnostics studies were performed. The patient sought unspecified medical attention. This is one of several reports concerning siblings received from the same source (MSD, WAES# 1004USA03467). Follow-up information has been received from the nurse practitioner, who reported that the patient was in office for his well child examination on 20-APR-2010 and for immunization update of second varicella, which received at 9:00 am in the left deltoid. The nurse reported that the patient was in good health and had no complaints, physical examination completed, the patient was given his varicella immunization without incident. After observing that his brother had a syncopal episode following immunization, the patient was instructed to rest in a chair. The patient verbalized no concerns until he was "thirsty". The patient was instructed not to drink the water from the tap due to its taste and he continued to sit in the chair but repeated he was thirsty and then said "I don't feel good". The patient slumped back into the chair and then drew his extremities inward. His mother and a licensed practical nurse, lowered him to the floor and placed him in recovery position. The patient remained unconscious for approximately 20 seconds and then abruptly opened his eyes. The patient stated "I feel asleep and now I am on the floor". The patient was instructed to remain quiet, vital signs were stable at tympanic temperature of 96.9. 108 apical pulse 108 and blood pressure 96/60. His color returned to normal. The patient was mildly diaphoretic. He continued to improve under observation, was given a small cup of spring water he drank. The patient returned to sitting in the chair, looked mildly confused but answered questions appropriately. Upon standing to leave, the patient became more ashen, stated that he had a "tickle in the throat" and then projectile vomited water twice. The patient returned to the chair and regained his color. The patient then stated "I feel fine now". He was allowed to rest for several additional minutes and then ambulated from the waiting room to the car with escort. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Thirst, Throat irritation, Vomiting projectile
Clinical narrative: Information has been received from a registered nurse, concerning a 7 year old male patient, with no medical history or medicines and no allergies, who on 23-JUL-2004, was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot number not reported). On 20-APR-2010, the patient received intramuscularly the second 0.5 mL of VARIVAX (Merck) (lot number 665882/1409Y). No other vaccines administered the same day. On 20-APR-2010, before leaving the exam room, the patient fainted. The patient recovered right away and with no apparent injury. No labs or diagnostics studies were performed. The patient sought unspecified medical attention. This is one of several reports concerning siblings received from the same source (MSD, WAES# 1004USA03467). Follow-up information has been received from the nurse practitioner, who reported that the patient was in office for his well child examination on 20-APR-2010 and for immunization update of second varicella, which received at 9:00 am in the left deltoid. The nurse reported that the patient was in good health and had no complaints, physical examination completed, the patient was given his varicella immunization without incident. After observing that his brother had a syncopal episode following immunization, the patient was instructed to rest in a chair. The patient verbalized no concerns until he was "thirsty". The patient was instructed not to drink the water from the tap due to its taste and he continued to sit in the chair but repeated he was thirsty and then said "I don't feel good". The patient slumped back into the chair and then drew his extremities inward. His mother and a licensed practical nurse, lowered him to the floor and placed him in recovery position. The patient remained unconscious for approximately 20 seconds and then abruptly opened his eyes. The patient stated "I feel asleep and now I am on the floor". The patient was instructed to remain quiet, vital signs were stable at tympanic temperature of 96.9. 108 apical pulse 108 and blood pressure 96/60. His color returned to normal. The patient was mildly diaphoretic. He continued to improve under observation, was given a small cup of spring water he drank. The patient returned to sitting in the chair, looked mildly confused but answered questions appropriately. Upon standing to leave, the patient became more ashen, stated that he had a "tickle in the throat" and then projectile vomited water twice. The patient returned to the chair and regained his color. The patient then stated "I feel fine now". He was allowed to rest for several additional minutes and then ambulated from the waiting room to the car with escort. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Therapeutic response decreased
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 2008 was vaccinated with two doses of VARIVAX (Merck) three months apart. VARIVAX (Merck) titers were checked in 2010 and the patient had detectable antibodies but not considered to be in protective range. At the time of the report, the outcome of the patient was not reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Information has been received from a consumer concerning her "7 1/2 year old" son with asthma, allergy diary, egg allergy and allergy to anything with soy, who on 28-APR-2010 was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown). There was no concomitant medication. It was reported that on 04-MAY-2010 the patient developed a low grade fever and blotchiness all over his skin. There were no laboratory diagnostic tests performed. The patient did not seek medical attention. The vaccine was not reintroduced. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who was vaccinated with a second dose of VARIVAX (Merck) (dose, route and lot number not reported). Physician reported that the patient received the second dose and still experienced chickenpox (20 or less vesicles). This physician was not the one that administered the vaccine, he only diagnosed the chickenpox in the patient. Patient sought for unspecified medical attention. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TTOX, VARCEL
Symptoms: Injection site erythema, Injection site pain, Local reaction, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 39 year old female who on 05-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # 665396/1170Y). Concomitant therapy included tetanus toxoid. Later that day the patient developed redness and pain at the VARIVAX (Merck) injection site. On 06-MAY-2010 the patient returned to the physician with a fever of 100.2 F and extreme tenderness at the injection site. The area was described by the physician as "very red and almost looked like an abscess". At the time of the report, the patient had not recovered. Follow up information was received from the physician concerning a 31 year old (also reported as 39 year old) female with no known drug allergies who on 04-MAY-2010 (previously reported as 05-MAY-2010) was subcutaneously vaccinated with the first dose of VARIVAX (Merck) (lot # 665396/1170Y) in her right arm. In the afternoon of 05-MAY-2010, the patient experienced local reaction: tenderness, erythema and fever. At the time of the report, the patient had recovered on unspecified dates. No further information is available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Malaise, Oropharyngeal pain, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 24-SEP-2007 was subcutaneously vaccinated with the first dose of VARIVAX (Merck). On 30-JUL-2008, the patient was subcutaneously vaccinated with the second dose of VARIVAX (Merck). On 05-MAR-2010 the patient was feeling sick with sore throat and minute cough. On 07-MAY-2010, the patient came in and had about 10 lesions and the physician diagnosed the patient with chickenpox. There were no lab diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an office manager ( also reported as health care student) for VARIVAX (Merck) and GARDASIL, two Pregnancy Registry products, concerning a female baby whose 18 year old mother with "high blood pressure kidney" was vaccinated with a second dose of VARIVAX (Merck) (lot number not reported) and a first dose of GARDASIL (Lot number not reported), on 17-FEB-2010. It was noted that the LMP was not documented (per the chart the patient was 7 months pregnant on 29-APR-2010), and the actual delivery date was reported as 03-AUG-2010. The office manager reported that the baby girl was brought into the office on 11-DEC-2010 for her routine check-up by the grandmother. The reporter stated that "The baby received her shots, her weight was improving (formula issue at birth), growth was ok, and the baby was sleeping well". The baby was scheduled to be seen in February 2011, but was a "no show". The mother's experience has been captured in WAES 1005USA00866. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male patient with no known drug allergies or pertinent medical history who on 14-APR-2010, was subcutaneously vaccinated in the left upper arm with 0.5 mL dose of VARIVAX (Merck) (lot # 666044/1428Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PENTACEL. Subsequently, on approximately 14-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 26-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown of the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Age: 1.05
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male patient with no known drug allergies or pertinent medical history who on 20-APR-2010, was subcutaneously vaccinated with the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 666044/1428Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subsequently, on approximately 20-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 30-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one several cases reported by the same source.
Age: 1.04
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old female patient with no known drug allergies or pertinent medical history who on 20-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 666044/1428Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subsequently, on approximately 20-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 30-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old female patient with no known drug allergies or pertinent medical history who on 15-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 666044/1428Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subsequently, on approximately 15-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. The office was contacted by phone, on 30-APR-2010. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.