chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Skin lesion
Clinical narrative: Information has been received from a nurse concerning a 4 year old male with no drug allergies and no pertinent medical history who on 04-MAY-2009 during kindergarten physical was vaccinated subcutaneously into left thigh with a 0.5mL dose of VARIVAX (Merck) (LOT# 662188/1401X). Concomitant therapy included montelukast sodium(MSD) and PULMICORT. After vaccination, the patient experienced a local reaction. On 06-MAY-2009 the patient experienced a red lesion 1cm x 2cm on his left thigh. No lab diagnostics were performed. The patient was seen in the office. On 07-MAY-2009, the patient's mother called to report that the patient was doing better. Follow-up information has been received from the nurse concerning the 4 year old male who on 04-MAY-2009 at 10:00 AM was vaccinated subcutaneously into left thigh with the second 0.5mL dose of VARIVAX (Merck) (LOT# 662188/1401X). On 06-MAY-2009 the patient experienced local reaction--a 1cm x 2cm red lesion on his left thigh. He had recovered on 07-MAY-2009. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning her currently 15 year old daughter who in approximately 1995 (about 14 years ago) was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). There was no concomitant medication. In approximately 1995 (about 14 years ago) the patient developed shingles. The lesions were around her ribs. Unspecified medical attention was sought. No lab diagnostics studies was performed. No treatment was given. On an unspecified date about 14 years ago the patient was completely recovered. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male with no pertinent medical history nor allergy who on 16-JUN-2009 was vaccinated subcutaneously with 0.5ml dose of VARIVAX in the left thigh (lot #657720/0358Y). There was no concomitant medication. The patient developed a red bump on his left thigh after vaccination. On 24-JUN-2009 the patient's mother contacted the physician's office and on 25-JUN-2009 the patient was seen in the office. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was unknown. Follow up information has been received from the licensed practical nurse concerning the 12 month old male patient who on 16-JUN-2009, at 10:00 a.m., was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX into the left thigh (lot # 657720/0358Y). There was no illness at time of vaccination. On 23-JUN-2009 the patient developed red area on his left thigh which was measuring 1cm x 1.5cm. It was not hot or tenderness. At the time of this report, the patient's outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from an office worker concerning a 16 year old male patient with an unspecified medical history, drug reactions or allergies, who on 08-JAN-2010 was vaccinated with a dose of VARIVAX (Merck) (route unknown, lot # 665184/1009Y). Concomitant medication was unspecified. On 09-JAN-2010 the patient experienced lump on his arm after receiving VARIVAX (Merck) which was circular, red and itchy. Lab diagnostic studies performed were unspecified. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 13 months old male who on 24-JUL-2009 was vaccinated with VARIVAX (Merck, LOT # was not provided). On 06-AUG-2009 (13 days after vaccination) the patient experienced a varicella injection site reaction. The outcome of the patient was not recovered. It was unknown that the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female patient who was inadvertently vaccinated with a dose of VARIVAX (Merck) when she should had been given ZOSTAVAX (Merck) (MSD). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an 18 year old female patient with no known drug allergies/drug reactions who on 16-JAN-1996 was vaccinated with the first dose of VARIVAX (Merck) into her left thigh.  The patient received her second dose of VARIVAX (Merck) on 05-DEC-2007 into her right arm.  Concomitant therapy included hormonal contraceptives (unspecified).  It was reported that titer drawn in August showed that the patient failed to seroconvert.  The patient sought unspecified medical attention.  The outcome of the patient was unknown at the time of the report.  No further information is available.
Age: 1.51
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning an 18 month old female with no pertinent medical history and no drug reactions/allergies who on 05-JAN-2010 was vaccinated with the first dose of VARIVAX (Merck) (0.5ml, SQ).  Secondary suspect therapy included MMR II (MSD). Concomitant therapy included PREVNAR, Hep A vaccine and Hib (manufacturers: unknown). On 15-JAN-2010 the patient presented to the office with a "rash that looks like scabies that is 24 hours old." "There is no tear drop blisters noted that is common in a chickenpox rash." The patient had lesions about 25-30 on her internal trunk, 15-20 on her back, a few on her forearms, and 3-4 behind her right. The rash was not in a linear pattern that was common in scabies, but was more scattered-like. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Impetigo, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician and a consumer (patient's mother) concerning a 7 year old female who on 09-MAY-2003, was vaccinated with first dose of VARIVAX (Merck) (route not reported, lot number 643082/0593M).  The patient's mother reported that her daughter received two doses, but the physician reported that patient only received one dose.  On 13-JUL-2009 the patient experienced chickenpox (the patient was diagnosed with chickenpox on 22-JUL-2009).  On 27-JUL-2009, the patient was seen again and she was diagnosed with impetigo.  On 02-AUG-2009, the patient was seen again and she was diagnosed with impetigo.  On 02-AUG-2009, the patient had a fever.  The patient current status was unknown.  The patient sought medical attention by contracting the pediatrician.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Immunization manager concerning a 66 year old female who on 10-AUG-2009 was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported) instead of ZOSTAVAX (Merck). No symptoms reported. No medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Seroconversion test negative
Clinical narrative: Information has been received from a healthcare worker concerning a female nurse who was vaccinated with two doses of VARIVAX (Merck) (Lot # not reported).  Subsequently the patient failed to seroconvert.  There was no adverse event reported.  The nurse sought unspecified medical attention.  A "titer" test was performed with no results provided.  At the time of the report, the outcome of the patient was unknown.  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 old male patient who on 13-JAN-2010 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot# 665417/1129Y). It was reported that the next day (on 14-JAN-2010) the patient's mother called the physician to inform him that her son had some bumps on his torso. When the physician finally saw the patient on 19-JAN-2010, he diagnosed it as chickenpox. The patient also mentioned that he got the vaccine from a fellow physician and transported it from one floor to another and was not sure on the storage of the vaccine at a previous location. At the time of reporting, the patient did not recover from these events. The patient's brother's information has been captured in WAES# 1001USA02540. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a female who on unknown date was vaccinated with VARIVAX (Merck) (LOT # was not provided) and then experienced a chicken pox outbreak. The patient was given a second dose of VARIVAX (Merck) because the physician's office did not have proper patient history until after the dose was given. The outcome of the patient was unknown. It was also unknown if the patient sought medical attention. Follow-up information has been received that there was not an adverse reaction. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status. This is an amended report. Upon review of the file, the code of "inappropriate schedule of drug administration" was deleted. Follow-up information has been received from the nurse that there was no patient involved and that she was just calling for clarification. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Information has been received from a healthcare worker concerning a 5 year old female with no medical history or drugs allergies, who on 06-DEC-2004 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck), subcutaneously. On 09-APR-2009 the patient received a second dose of VARIVAX (lot # 661659/1136X).  Secondary suspect vaccination given on the same date included a dose of Hep A into the left deltoid.  On 09-APR-2009 the patient developed a large, itchy hive at the injection site of the left upper arm 5-6 hours after receiving her second dose of VARIVAX (Merck).  The injection site reaction resolved in 1 day without requiring treatment.  No laboratories studies performed.  The patient sought unspecified medical attention.  Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male patient who on an unknown date was vaccinated with the second dose of VARIVAX (Merck) (lot# 665417/1129Y). On an unknown date, the patient came down with chicken pox. The patient also mentioned that he got the vaccine from a fellow physician and transported it from one floor to another and was not sure on the storage of the vaccine at a previous location. It was unknown if the patient sought medical attention. At the time of reporting, the patient's status was unknown. The patient's brother also experienced chickenpox after vaccination with the same lot# 665417/1129Y. The patient's brother's information has been captured in WAES# 1001USA01876. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a company representative concerning her 13 month old daughter with no pertinent medical history and no drug allergy who on 06-AUG-2009 was vaccinated with a 0.5mL dose of VARIVAX (Merck) (LOT# not reported). Secondary suspect vaccinations included a dose of MMR II (MSD) on 06-AUG-2009. Concomitant vaccination included a dose of PREVNAR (manufacturer unspecified) on the same day. No other concomitant medications were reported. On 10-AUG-2009 the patient experienced a "chickenpox-like rash on her trunk" after receiving VARIVAX (Merck). No lab diagnostics was performed. The patient sought unspecified medical attention and she was recovering. No other information was available at the time of this report. Follow-up information has been received from the company representative concerning her 13 month old daughter who on 06-AUG-2009 at 03:30 PM was vaccinated subcutaneously into right thigh with a dose of VARIVAX (Merck). On 12-AUG-2009 the patient experienced rash. She had recovered on an unspecified date. This is one of the two reports from the same source. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a Registered Pharmacist/mother concerning an approximated 5 year old female with a mild allergy to egg and peanuts, who in June 2004, was vaccinated with one dose of VARIVAX (Merck). The patient took ZYRTEC as needed. In April 2007, the patient developed a mild case of chicken pox with 30 or less lesions. The patient did not receive a booster dose of VARIVAX (Merck) since she has developed chicken pox in April, 2007. On 12-DEC-2009 her sister was vaccinated with the first dose of VARIVAX (Merck). On 25-DEC-2009 the now 7 year old patient developed a fever and broke out with 3 spots "chicken pox". The patient was evaluated at urgent care at a hospital and diagnosis of chicken pox was confirmed. The sister did not develop any adverse effects. The pharmacist/mother mentioned that she felt that the vaccine virus was transmitted from sister to sister. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash papular, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female with asthma and no siblings, who on 24-APR-2006 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 650233/0912R, site of administration not reported) and on the same she was also vaccinated intramuscularly with the fifth dose of PREVNAR (Wyeth, lot# B08638H). On 04-AUG-2009 the patient developed rash on leg for 2 days, papular-vesicular in crops on upper back, abdomen and it was itchy. On 11-AUG-2009 the patient recovered. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 78 year old male patient who on 20-JAN-2010 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (Lot # 663305/1718X) inadvertently instead of ZOSTAVAX (Merck) due to a human error. No adverse affect was reported. The patient did not seek medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Secondary transmission, Skin lesion, Varicella
Clinical narrative: Information has been received from a Registered Pharmacist/mother concerning a 24 month old patient, one of 2 cousins (the AE report for another included in the WAES # 1001USA03038) who on an unspecified date was vaccinated with one dose of VARIVAX (Merck). On 01-JAN-2010, two sisters, one of which was vaccinated with a dose of VARIVAX (Merck) on 12-DEC-2009 and one who developed chickenpox on 25-DEC-2009 (WAES 1001USA02546), were visiting family. 10-14 days after the family gathering 2 cousins, the patient, one of 2 cousins developed chicken pox with 50-100 lesions. The patient had not reached to age to receive their second dose. At the time of the report the patient's outcome was unknown. It was unknown 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: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 18 year old female with allergy induced asthma and allergic to sulpha who on 12-AUG-2009 was vaccinated with second dose of VARIVAX (Merck) (booster) (lot # not reported) intramuscularly. On the same day on 12-AUG-2009 she received third dose of GARDASIL (MSD) (lot #, route and site not reported). Concomitant therapy included meningococcal vaccine (unspecified) administered on 12-AUG-2009. After getting the vaccine she experienced an injection site reaction. The arm swelled up and became warm and red. The patient did not seek medical attention. At the time on the report on 12-AUG-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow-up information was received from a physician, who reported that the female student with allergies to sulfa and AUGMENTIN received the second dose of VARIVAX (Merck) subcutaneously into right deltoid. On 12-AUG-2009, the patient developed swollen, red, 1/2 dollar size reaction and itchy. Subsequently the patient recovered. No further information is available.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a Registered Pharmacist/mother concerning a 5 year old patient, one of 2 cousins (the AE report for another cousin included in the WAES # 1001USA03037) who on an unspecified date was vaccinated with one dose of VARIVAX (Merck).  On 01-JAN-2010, two sisters, one of which was vaccinated with a dose of VARIVAX (Merck) on 12-DEC-2009 and one who developed chickenpox on 25-DEC-2009 (WAES 1001USA02546), were visiting family.  10-14 days after the family gathering 2 cousins, the patient, one of 2 cousins, developed chicken pox with 50-100 lesions.  The patient had not reached to age to receive their second dose.  At the time of the report the patient's outcome was unknown.  It was unknown if the patient sought medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 75 year old female patient who on 20-JAN-2010 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (Lot # 663305/1781x) inadvertently instead of ZOSTAVAX (Merck) (MSD) due to a human error. No adverse effect was reported. The patient did not seek medical attention. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified dates in the past was vaccinated with two doses of VARIVAX (Merck). Subsequently, the patient developed varicella. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician and a nurse concerning an 8 year old male patient who in 2002, "sometime in 2002" was vaccinated with the first dose of VARIVAX (Merck) and the second dose of VARIVAX (Merck) (lot # 661659/1136X) in October, 2008.  On 12-AUG-2009 the patient developed a painful rash located on the left side of the front torso, on the knee, arms and legs.  The physician and nurse reported that the patient came into the office on 13-AUG-2009 and was prescribed acyclovir (manufacturer unknown) for the rash.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G normal, No therapeutic response, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning a female patient with allergies and no known drug reactions/allergies who on 10-APR-2006 was vaccinated with a first SQ dose of VARIVAX (Merck) (Lot # 646671/0628R). On 26-MAY-2006 the patient was vaccinated with a second SQ dose of VARIVAX (Merck) (Lot # 646671/0628R). Concomitant therapy included ORTHO TRI-CYCLEN LO, ZYRTEC and NASONEX. It was reported that the patient had not seroconverted. No breakthrough disease was noted. The patient sought medical attention by an office visit. On November 2009 a Varicella Zoster antibody IgG level test was performed and the result was non-reactive. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old male patient with no known drug allergies/reactions and no pertinent medical history who on 28-DEC-2009 was vaccinated subcutaneously with his first 0.5 ml dose of VARIVAX (Merck) into his right deltoid and on 28-JAN-2010 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 665026/0993Y). There was no concomitant medication. It was reported that on 28-JAN-2010, almost immediately after getting virus vaccine live (Merck) the patient had tingling that affected the pinky and ring finger of the right and while the patient was at the pharmacy. At the time of the report the patient had not recovered. No diagnostic tests were performed. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who on 29-JAN-2010 was vaccinated with the third dose of VARIVAX due to a computer records error. It was stated that the patient reported feeling dizzy. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site abscess, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 10-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  Concomitant therapy included DTAP. On 13-AUG-2009 the patient experienced soreness around the injection site in addition to an abscess that was 3 inches in diameter and warm to the touch.  Unspecified medical attention was sought.  At the time of reporting the patient's outcome was unknown.  No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Hypersensitivity
Clinical narrative: Information  has been received from a physician concerning a pediatric patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). Subsequently the patient experienced an unspecified allergic reaction after the vaccination. The patient sought unspecified medical attention. At the time of the report, the patient status was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with a first and a second dose of VARIVAX (Merck) (lot # not specified). It was reported than on an unspecified date the patient developed chicken pox after receiving VARIVAX (Merck). At the time of reporting the patient's outcome was unknown. The patient was seen by her physician. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning an adult female employee of the practice who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported). Subsequently, she was diagnosed with chickenpox. At the time of this report, the employee had recovered. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 9 year old female with egg allergy and no pertinent medical history who on 05-OCT-2000 was vaccinated with the first dose of VARIVAX (Merck). On 14-AUG-2009 the patient was vaccinated subcutaneously with the second dose 0.5 mL of VARIVAX (Merck) (Lot # 664702/0727Y). There was no concomitant medication. On 14-AUG-2009 the patient's mother called the office that the patient's left deltoid was red, swollen and hot to touch where the injection was administered. No treatment required and no lab diagnostic studies were performed. At the time of the report, the events persisted. The patients sought unspecified medical attention. Caller would not be sending the form to Merck. No further information is available.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning an approximately 39 year old male employee of the hospital with no medical history and no drug reactions/allergies who "years ago" was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. Recently the patient had been determined to have negative antibody titers to varicella. The patient sought unspecified medical attention. At the time the report, the patient had not recovered. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 2 year old male with asthma, eczema and no known drug allergies who on an unspecified date was vaccinated with VARIVAX (Merck) (lot# not reported). There was no concomitant medication. One week after the vaccination, in 2001 the patient developed varicella rash. The patient was fussy the day before the rash developed. The rash started as small itchy bumps on his legs, chest and arms. The nurse practitioner stated the patient was "not all that sick". No medical attention was sought and no laboratory performed. On an unspecified date the patient recovered. No further information is available.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 12 year old male who on 10-AUG-2009 was vaccinated with the second 0.5ml dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  On 10-AUG-2009 the patient developed swelling and redness at the injection site after the second vaccination.  On 12-AUG-2009 the patient also developed a low-grade fever in addition to the injection site reaction.  Unspecified medical attention was sought.  It was unspecified if laboratory studies were performed.  At the time of reporting, the patient had not recovered.  No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Culture urine, Nasopharyngitis, Pyrexia, Rash papular
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 5 year old female patient with asthma, Asperger's disorder, attention deficit disorder, migraine and reactive airways disease, with no allergies and with a history of remotion of tonsils and adenoids, who on 28-DEC-2005 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot number not reported). On 18-JAN-2010, the patient received subcutaneously a second dose of VARIVAX (Merck) (lot # 665007/1088Y). Concomitant therapy included montelukast sodium and VENTOLIN INHALER. On 26-JAN-2010, the patient was seen for a cold. The patient was given amoxicillin (unspecified), and cough medicine (unspecified). The patient was seen again on 30-JAN-2010, and the cough medicine was switched to MUCINEX cough syrup for pediatrics. On 10-FEB-2010, the patient developed a chickenpox rash. The patient was seen by a Nurse Practitioner on 11-FEB-2010. Lesions were noted on patient's anterior stomach, left arm, left flank and legs and were described as "moderate" in amount. At the time of the report, the patient was recovering from chickenpox rash and cold. An urine culture and an urinalysis were performed on 11-FEB-2010. The results were pending at the time of the report. Patient sought medical attention through an office visit. Follow-up information has been received from the Registered Nurse, concerning the 5 year old female patient, with recurrent urinary tract infections, who on 08-JAN-2010 at 4:00 PM, received subcutaneously in the right arm the second dose of VARIVAX (Merck). In the morning of 10-FEB-2010, the patient developed chickenpox rash, described as pruritic papules starting on abdomen, going to arms, neck and upper legs. Patient also experienced stomach ache and low grade temperature. On 17-FEB-2010, the patient recovered from the chickenpox rash. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Skin lesion, Urine analysis, Varicella post vaccine
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 5 year old female patient with asthma, Asperger's disorder, attention deficit disorder, migraine and reactive airways disease, with no allergies and with a history of remotion of tonsils and adenoids, who on 28-DEC-2005 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot number not reported). On 18-JAN-2010, the patient received subcutaneously a second dose of VARIVAX (Merck) (lot # 665007/1088Y). Concomitant therapy included montelukast sodium and VENTOLIN INHALER. On 26-JAN-2010, the patient was seen for a cold. The patient was given amoxicillin (unspecified), and cough medicine (unspecified). The patient was seen again on 30-JAN-2010, and the cough medicine was switched to MUCINEX cough syrup for pediatrics. On 10-FEB-2010, the patient developed a chickenpox rash. The patient was seen by a Nurse Practitioner on 11-FEB-2010. Lesions were noted on patient's anterior stomach, left arm, left flank and legs and were described as "moderate" in amount. At the time of the report, the patient was recovering from chickenpox rash and cold. An urine culture and an urinalysis were performed on 11-FEB-2010. The results were pending at the time of the report. Patient sought medical attention through an office visit. Follow-up information has been received from the Registered Nurse, concerning the 5 year old female patient, with recurrent urinary tract infections, who on 08-JAN-2010 at 4:00 PM, received subcutaneously in the right arm the second dose of VARIVAX (Merck). In the morning of 10-FEB-2010, the patient developed chickenpox rash, described as pruritic papules starting on abdomen, going to arms, neck and upper legs. Patient also experienced stomach ache and low grade temperature. On 17-FEB-2010, the patient recovered from the chickenpox rash. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 year old female who on 14-AUG-2009 was subcutaneously vaccinated with a dose of VARIVAX (Merck) (lot number 664698/0723Y) instead of ZOSTAVAX (Merck). It was reported this was human error and not a product quality complaint. No adverse effect reported. The patient did not seek any medical attention. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an adult patient who on 16-FEB-2010 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error.  There were no adverse effects reported.  Follow-up information has been received from the medical assistant indicated that 61 year old patient was administered with the VARIVAX (Merck) (Lot #665111/1293Y) vaccine on 16-FEB-2010.  When the physician told the medical assistant to administer the shingles vaccine she grabbed the wrong vial.  The medical assistant reported that after 28 days the patient would receive the ZOSTAVAX (Merck) dose.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Hypersomnia, Injection site erythema, Injection site movement impairment, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female with no known drug reaction/allergies or pertinent medical history who on 12-AUG-2009 was subcutaneously vaccinated in the right upper arm with her second dose of VARIVAX (Merck) (lot# 664450/0692Y) and had an adverse reaction. The patient was also vaccinated with her second dose of GARDASIL on the same day. The patient did not have any reaction after the first dose of GARDASIL. Post vaccination the patient went home and became dizzy, and light headed, slept for 4 hours. The patient woke up and went to sleep again. The patient's mother took a pen and circled the injection site since it was red, stiff and warm to the touch. Since then the redness had increased outside of the pen mark at the injection site. At the time of the reporter, the patient's events persisted. The patient was being seen by the doctor for followup. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female with no known drug reaction/allergies or pertinent medical history who on 12-AUG-2009 was subcutaneously vaccinated in the right upper arm with her second dose of VARIVAX (Merck) (lot# 664450/0692Y) and had an adverse reaction. The patient was also vaccinated with her second dose of GARDASIL on the same day. The patient did not have any reaction after the first dose of GARDASIL. Post vaccination the patient went home and became dizzy, and light headed, slept for 4 hours. The patient woke up and went to sleep again. The patient's mother took a pen and circled the injection site since it was red, stiff and warm to the touch. Since then the redness had increased outside of the pen mark at the injection site. At the time of the reporter, the patient's events persisted. The patient was being seen by the doctor for followup. 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 18-FEB-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No adverse effect was reported. At the time of the report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a unknown number of patients who on an unknown date were vaccinated with the first dose of VARIVAX. Subsequently, an unknown number of patient's developed chickenpox after received their first dose of VARIVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to contact the reporter have been unsuccessful. The health Care Professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, recovery status, healthcare provider name and contact information. No further information is available at this time.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with no pertinent medical history who on 23-MAY-1996 was vaccinated subcutaneously with the first dose of VARIVAX. On 15-FEB-2010 the patient was vaccinated subcutaneously with the second dose of VARIVAX (lot # 665644/1205Y). There was no concomitant medication. Subsequently the patient developed red itchy areas at the injection site. The patient sought medical attention via phone call. No laboratory diagnostics studies were performed. At the time of the report, the patient had not recovered from these events. This is one of several reports received from the same source. The office request a lot check. A lot check had been initiated. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a female patient between the age of 8-12 years old who on unspecified dates was vaccinated with two doses of VARIVAX (Merck) (lot#s not reported). On an unspecified date in 2004 the patient came down with full blown chickenpox. Unspecified medical attention was sought. At the time of this report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Attention deficit/hyperactivity disorder, Eczema, Febrile convulsion
Clinical narrative: Information has been received from a consumer concerning her brother who on an unknown date was vaccinated with a dose of MMR II (Lot # not reported) when he was a young child. The patient experienced febrile seizures after receiving MMR II. It was reported that the patient also has ADHD and eczema. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Upon internal review febrile convulsion was considered to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Attention deficit/hyperactivity disorder, Eczema, Febrile convulsion, Motor dysfunction
Clinical narrative: Information has been received from a consumer concerning her male nephew (at the time of reporting was 18 years old) who on an unknown date was vaccinated with a dose of MMR II when he was a young child. The patient experienced febrile seizures after receiving MMR II (Lot # not reported). It was reported that the patient also has ADHD and eczema. The patient has his fine motor skills affected and requires routine medications. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Upon internal review febrile convulsion was considered to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Attention deficit/hyperactivity disorder, Eczema, Febrile convulsion, Motor dysfunction
Clinical narrative: Information has been received from a consumer concerning her male nephew (at the time of reporting was 20 years old) who on an unknown date was vaccinated with a dose of MMR II when he was a young child. The patient experienced febrile seizures after receiving MMR II (Lot # not reported). It was reported that the patient also has ADHD and eczema. The patient had his fine motor skills affected and requires routine medications. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Upon internal review febrile convulsion was considered to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician assistant concerning a currently 22 year old female who "when was still a child" was vaccinated with a dose of MMR II. It was reported that the patient experienced Guillain Barre syndrome after getting MMR II when she was a child. The patient was hospitalized (length and place unspecified) at the time and recovered on an unspecified date. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Deafness
Clinical narrative: Information has been received from a physician concerning a male patient that "15 years ago had a wild type measles" who on an unspecified date after  that illness, was vaccinated with a dose of MMR II. Physician stated that 24 hours after received the MMR II the patient became deaf. It was unspecified if lab tests were performed. The patient's outcome was unspecified. Deaf was considered to be disabling. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Convulsion, Idiopathic thrombocytopenic purpura, Nervous system disorder
Clinical narrative: Information has been received from a case in litigation from a consumer concerning her son who on 07-MAY-2004 was vaccinated with a dose of MMR II (dose, route and lot number not provided). Concomitant vaccinations received on the same day included VARIVAX and PEDVAXHIB (manufacturer unknown). The patient's mother reported that her son developed idiopathic thrombocytopenia purpura and seizure disorder and unspecified neurological injuries after vaccination. The patient's mother felt that the vaccines caused her son's idiopathic thrombocytopenia purpura, seizure disorder and unspecified neurological injuries. Upon internal review, idiopathic thrombocytopenia purpura and seizure disorder were determined to be other important medical events. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Antiacetylcholine receptor antibody, Nuclear magnetic resonance imaging brain, VIth nerve paralysis
Clinical narrative: It was reported in a published article, that a 31 month old male patient who was vaccinated with a dose of VARIVAX (manufacturer unknown) on an unspecified date, 2.5 weeks prior to evaluation (PTE). The patient was diagnosed with a recurrence of benign cranial sixth nerve palsy (left) (date unspecified). The patient had a history of benign cranial sixth nerve palsy (left) after vaccination with HIB (OMPC) (manufacturer unknown, WAES#0905USA02200). Lab test included magnetic resonance imaging (MRI) and Acetylcholine Receptor Antibody (AchRab). The results were not provided. The patient was recovering but incomplete while on the last follow up visit. Various etiologies proposed as possible mechanisms responsible for benign sixth nerve palsy, including variant ophthalmologic migraine, atypical myasthenia gravis, inflammation secondary to viral infection or an idiosyncratic vaccine response. The cause of case with recurrence is unclear. For a child presenting with new onset sixth nerve palsy, the author recommended a thorough history and physical examination to evaluate for any other neurological symptoms or signs followed by magnetic resonance imaging (MRI) of the brain with and without contrast. The decision to perform a lumbar puncture as well as serum myasthenia gravis testing, Lyme testing and anti-Gq1b testing should be made on a case-by-case basis. Parents should be instructed that the majority of cases of benign sixth nerve palsy do not recur. However, the minority of instances that recur are still benign. Additional information had been requested.
Age: 1.49
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Irritability, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old female who on 22-JUL-2009 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck) (lot # 660665/0491Y), subcutaneously into the left arm.  The mother called the physician office on 18-AUG-2009 stating that her daughter started fever on 12-AUG-2009 that lasted 2 or 3 days, and on 18-AUG-2009 the patient had chickenpox on her stomach.  The patient was treated with oral BENADRYL.  No laboratories studies performed.  The patient was recovering.  Follow up information received on 16-SEP-2009 from registered nurse indicated that the patient had a medical history of murmur apical, umbilical hernia and food allergies.  The patient did not have any illness at the time of vaccination.  On 22-JUL-2009 at 11:40 the patient was vaccinated with a first dose of VARIVAX (Merck) (lot # 66435/0642Y, previously reported as (660665/0491Y), subcutaneously into the left deltoid.  It was also reported by the patient's father that on 12-AUG-2009 his daughter started with 2 or 3 days of fever-she was very crabby during the fever- they took her to a walk in clinic yesterday to have her ears checked but she did not have the rash yet and nothing was found wrong.  According to the father, she had chickenpox all over her abdomen, several bumps are vesicles and she was starting to itch-this happened all within the last hour- they were starting to itch-she was actually acting a little happier today.  Advised BENADRYL 3/4 tsp every 4-6 hours as needed.  The patient did not require an office visit, and no follow up needed unless concerning symptoms.  The patient recovered on 20-AUG-2009.  No further information is available.
Age: 1.49
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old female who on 22-JUL-2009 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck) (lot # 660665/0491Y), subcutaneously into the left arm.  The mother called the physician office on 18-AUG-2009 stating that her daughter started fever on 12-AUG-2009 that lasted 2 or 3 days, and on 18-AUG-2009 the patient had chickenpox on her stomach.  The patient was treated with oral BENADRYL.  No laboratories studies performed.  The patient was recovering.  Follow up information received on 16-SEP-2009 from registered nurse indicated that the patient had a medical history of murmur apical, umbilical hernia and food allergies.  The patient did not have any illness at the time of vaccination.  On 22-JUL-2009 at 11:40 the patient was vaccinated with a first dose of VARIVAX (Merck) (lot # 66435/0642Y, previously reported as (660665/0491Y), subcutaneously into the left deltoid.  It was also reported by the patient's father that on 12-AUG-2009 his daughter started with 2 or 3 days of fever-she was very crabby during the fever- they took her to a walk in clinic yesterday to have her ears checked but she did not have the rash yet and nothing was found wrong.  According to the father, she had chickenpox all over her abdomen, several bumps are vesicles and she was starting to itch-this happened all within the last hour- they were starting to itch-she was actually acting a little happier today.  Advised BENADRYL 3/4 tsp every 4-6 hours as needed.  The patient did not require an office visit, and no follow up needed unless concerning symptoms.  The patient recovered on 20-AUG-2009.  No further information is available.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 4 year old female with no medical history or allergies who on 13-MAY-2006 was vaccinated SC with the first and only dose ("1 vial" dose) of VARIVAX (Merck) (lot# not reported). On 01-MAY-2009 the patient developed chickenpox. The lesions spread from her face to arm. Subsequently, the patient recovered from chickenpox. No lab diagnostics studies were performed. The patient was seen by the physician. Additional information has been requested.