chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 7 year old female who in approximately 2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and on approximately May-2007 was vaccinated with another dose of varicella virus vaccine live (Oka/Merck). On approximately 18-JUL-2007, the patient experienced fewer than 50 lesions after receiving the vaccine. The lesions were concentrated on the trunk and back, some were on the extremities. No lesions on the face. Unspecified medical treatment was sought. No product quality complaint. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with cold symptoms at the time of vaccination who on 15-MAY-2000 was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 631467/1682J) in the left arm. On 30-MAY-2007, the patient developed 20 lesions in various stages after exposure 1-2 weeks prior. The patient did not have any adverse events following prior vaccinations. The patient went to the doctor's office. The patient was treated with Benadryl and calamine. Subsequently, the patient recovered. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella
Clinical narrative: Information has been received from a healthcare worker and an office manager concerning a 5 year-old-patient who, in approximately December 2002 at one year of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). He broke out with shingles at age 2. It is unknown if medical attention was sought. It was also reported that approximately one year ago he had chickenpox. It was unspecified if medical attention was sought. No outcomes were reported. On 19-Mar-2007 he was given a 0.5 milliliter dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD). It is reported that there was no adverse experience following the vaccination. No product quality complaint was involved. Follow up information received on 09-Jul-2007 from a healthcare worker states that the identity of the patient is unknown and no further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from VAERS by a physician, concerning a 10-year-old female with a history of Kawaski's Disease in 1997, and a concurrent condition of asthma that does not require any chronic medications, who on 28-MAY-1997 was vaccinated in the arm with a dose of varicella virus vaccine live (Oka/Merck) (lot # 621200/0180E). There were no concomitant vaccinations on 28-MAY-1997. On 19-APR-2003, while the patient was on vacation in another country, the patient developed a red raised rash on her chest, spreading to her arms. There were over 60 lesions and lots of itching. Unspecified medical attention was sought. It is unknown if there were any diagnostic laboratory data. It is unknown if there were any other medications given. The outcome is reported as not recovered. It is unspecified if a product quality complaint was involved. No further information is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on 27-SEP-2002 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot#640556/0258M). On 13-JUL-2007, the patient experienced an unspecified adverse event. Subsequently, on 20-JUL-2007 the patient recovered. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient, "older than kindergarten", who was vaccinated with a varicella virus vaccine live (Oka/Merck), and subsequently experienced "a similar experience", of red, swollen spots, some up to the size of a fist at injection site. No lot numbers were provided. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Flank pain, Injection site erythema
Clinical narrative: Information has been received from a 25 year old female with a history of allergy to medications in the "Neomycin family" who at the age of "4" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Marketed in the US in 17-MAR-1995). In approximately July 2006, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 17-JUL-2006, the patient developed injection site swelling and redness. The patient reported she was unsure how the vaccine was administered. The patient also developed fever, diarrhea, pneumonia and enlarged spleen in the next few days. The patient visited the emergency room and various tests were performed including blood tests, x-rays and a CT Scan (results not provided). The patient was not admitted as an inpatient. The patient reported therapy however, the patient reported she currently had pain in her side. The patient hadn't visited a physician recently due to lack of insurance. The patient reported that she lost her job during the period of all of the events she experienced in 2006. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pneumonia, Pyrexia, Splenomegaly, X-ray
Clinical narrative: Information has been received from a 25 year old female with a history of allergy to medications in the "Neomycin family" who at the age of "4" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Marketed in the US in 17-MAR-1995). In approximately July 2006, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 17-JUL-2006, the patient developed injection site swelling and redness. The patient reported she was unsure how the vaccine was administered. The patient also developed fever, diarrhea, pneumonia and enlarged spleen in the next few days. The patient visited the emergency room and various tests were performed including blood tests, x-rays and a CT Scan (results not provided). The patient was not admitted as an inpatient. The patient reported therapy however, the patient reported she currently had pain in her side. The patient hadn't visited a physician recently due to lack of insurance. The patient reported that she lost her job during the period of all of the events she experienced in 2006. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Herpes zoster, Ophthalmological examination, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a healthy, white, 34-month-old female patient with no pre-existing allergies, birth defects or medical conditions, who was vaccinated on 19-Apr-2005, at the age of 12-months with an intramuscular first dose of varicella virus vaccine live (Oka/Merck) (lot# 649269/0986P). On 18-Jul-2007 the patient developed a rash, "small pimples" on her right forehead and scalp that gradually spread to her right eye lid. It was slightly itchy. The patient did not have any pain or a fever. On 22-Jul-2007 the patient was taken to a clinic and diagnosed with shingles. On the morning of 23-Jul-2007 the patient went to the doctor's office for follow-up, evaluated and sent to ophthalmology for a corneal exam. The patient was started on acyclovir. There were no diagnostic tests and laboratory data. No outcome is reported. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Follow up information has been received from a health professional concerning an 18 year old black female student, with no medical history on drug allergies, who on 05-JUL-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations administered on that same day included the first dose of hepatitis A vaccine virus (inactive) (MSD) (Lot# 656966/0018U) in the right arm, the first dose of GARDASIL vaccine (yeast) (MSD) (Lot# 657868/0523U) in the right thigh, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (AC52B005CA) in the right arm and the first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot# U2327AA) in the left thigh. There was no illness at the time of vaccination. On that same day, the patient developed a local reaction with 4.5 x 3.5 cm injection site swelling and 4.5 x 3.5 cm redness (left arm). It was also noted that the patient also developed zoster after vaccine earlier in life. It was unknown whether medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male who on 24-JUN-2002 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#640555/0974L). Concomitant therapy included a fourth dose of Prevnar (Lot#485994) given IM in the left thigh. On 20-MAY-2007, the patient developed a rash all over. The patient was seen in the office on 24-MAY-2007 and was diagnosed with chickenpox. The physician treated symptomatically and there were no complications. No further information was provided. Follow up information from the nurse indicated that on an unspecified date the patient recovered. Additional information is not expected. This is one of several reports from the same source.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Headache, Pyoderma, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with allergies to Augmentin and Keflex and a history of eczema who on 08-NOV-2006 was vaccinated SC in the left thigh with a second dose of virus vaccine live (Oka/Merck(Lot#654695/1055F). Concomitant therapy included a second dose of hepatitis A vaccine (inactive) (MSD) (Lot#655301/0741F) given IM in the left thigh. On 15-MAY-2007, the patient presented to the office with a rash and headache. The patient was diagnosed with chickenpox and pyoderma. The physician prescribed Zithromax and Bactroban. On 18-MAY-2007 the patient recovered. No further information was provided. Additional information is not expected. This is one of several reports from the same source.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old Hispanic female who on 21-MAY-1999 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#630027/0312J). Concomitant therapy included a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot#630104/0127J) given SC in the left arm. The patient was seen in the office on 17-MAY-2007 with a rash that started the previous week. She had scattered areas all over the body. She was diagnosed with chickenpox. Symptomatic treatment was prescribed. There was no fever or complications. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Exposure to communicable disease, Infection, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with Down's Syndrome, coronary disease, penicillin allergy, Zithromax allergy and atrial septal defect (closed in May 2006) who on 20-AUG-2003 and 23-MAY-2007 was vaccinated with the first and second dose of varicella virus vaccine live (Oka/Merck) (Lot # 644565/1149M and 657408/0517U) SQ in the left thigh, respectively. Concomitant vaccinations on 23-MAY-2007 included the first dose of VAQTA (Lot # 654514/0304U) IM in the left thigh and second dose of M-M-R II (Lot # 64892/1028F) SQ in the right thigh. Prior vaccination included Hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On 25-MAR-2007, the patient experienced rash all over. On 28-MAR-2007, the patient came into the office with a rash all over. The patient was diagnosed with infected chickenpox and treated with Neosporin. The patient had a positive exposure at daycare. The patient did not have fever. The patient recovered from the rash all over and the infected chickenpox. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pain, Rash pruritic, Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old Hispanic male with asthma who on 05-FEB-2007 at 17:00 was vaccinated SC in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 654753/1250F). Concomitant vaccination at the same time included a first dose of hepatitis A virus vaccine inactivated (MSD) (lot # 656497/1213F) given IM in the right arm. On 28-MAR-2007 the patient presented to the office with an itchy, painful rash on his face which started on 27-MAR-2007. The patient had no fever. The patient was diagnosed with chickenpox. The patient was treated with mupirocin ointment. At the time of the report the patient's recovery status was unknown. Additional information received from the registered nurse indicated that this was a case of vaccine failure. On an unspecified date the patient recovered. It was noted that there were no complications. Additional information was not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white female with no known allergies or pertinent medical history who on 28-NOV-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient had a fever and nasal congestion at the time of vaccination. On 28-MAY-2007 the patient developed a rash, nasal congestion, a cough and fever two days in duration. The patient was exposed to varicella and developed varicella lesions head to toe. It was unspecified if medical attention was sought. There were no lab studies performed. On 05-JUN-2007 the patient recovered. No further information is expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash macular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white male who on 15-MAY-2007 when he was 12 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In May 2007 the patient experienced breakthrough chicken pox with 2 dozen lesions on his torso and 3 dozen lesions on his head. Unspecified medical attention was sought. Unspecified medical attention was sought. He was treated with calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) baths. It was reported that his lesions healed. No diagnostic laboratory tests were undertaken. No product quality complaint was involved. This is one of several reports received from the same source. It was reported that the patient's sister WAES 0709USA03914 experienced a similar event following vaccination with varicella virus live (Oka/Merck). Additional information has been received from the registered nurse who stated that the patient's other called in office on 18-MAY-2007 and stated that the patient had red dots on abdomen and back and were spreading up to face. The spots were reported as itchy. No further information is expected.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an adult female who on 16-MAR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). It was reported that the physician was confused because they are both varicella containing vaccines. No symptoms were noted. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 05-JUN-2007 was vaccinated with a 0.5 mL of varicella virus vaccine live (Oka/Merck). It was reported that with in 36-48 hours after receiving the vaccination the patient experienced soreness and a larger than normal red area around the injection site. Unspecified medical attention was sought. No product quality complaint was involved. This is one of two reports from the same source. Additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella zoster serology negative
Clinical narrative: Information has been received from a registered nurse concerning a female with no medical history who in approximately 1992, at the age of six, was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient was found to have a negative titer for varicella. Unspecified medical attention was sought. No further information available. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12-month-old patient who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, one week after vaccination, the patient experienced a rash. No further information is available. There was no product complaint involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood thyroid stimulating hormone normal, Full blood count normal, Metabolic function test normal, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 16 1/2 year old female who "2 weeks prior to adverse event" (in December 2006), was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no medical history or concomitant medication reported. In January 2007, the patient experienced early morning tremors. The patient had no tremors during day or when seen at the office. The patient received unspecified medical attention. Laboratory evaluation was performed in February 2007 which included a normal thyroid hormone test, normal complete metabolic profile, normal complete blood count, a negative mononucleosis test, and a normal erythrocyte sedimentation rate. The patient's outcome was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 16 1/2 year old female who "2 weeks prior to adverse event" (in December 2006), was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no medical history or concomitant medication reported. In January 2007, the patient experienced early morning tremors. The patient had no tremors during day or when seen at the office. The patient received unspecified medical attention. Laboratory evaluation was performed in February 2007 which included a normal thyroid hormone test, normal complete metabolic profile, normal complete blood count, a negative mononucleosis test, and a normal erythrocyte sedimentation rate. The patient's outcome was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old black male who on 05-MAR-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 643586/0802M). On 08-MAR-2007 the patient experienced varicella. On 13-MAR-2007, the patient recovered from varicella. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a female approximately 12 to 13 years of age, who at around 12 months of age, in approximately 1995, was vaccinated with varicella virus vaccine live (Oka/Merck). On 19 MAR 2007, the patient's mother reported that the patient was experiencing a breakthrough rash from the varicella virus vaccine live (Oka/Merck), that she had received at approximately 12 months of age. It was reported that the patient's entire body was covered, including her mouth and throat. The patient was treated with Viscous of Lidocaine. The patient is expected to return for for a follow up visit in a day or two. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old male who on 05-MAR-2003 was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck) (lot # 643586/0802M). On 22-FEB-2007 the patient developed varicella, and was recovered on 28 FEB 2007. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 13 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 17-MAR-2007 the patient developed a full blown case of chicken pox. On 19-MAR-2007 the patient presented to the doctors office. The patient's mother indicated that the child was previously vaccinated with varicella virus vaccine live (Oka/Merck) on an unspecified date but there was no written documentation of the vaccination dates. The patient was treated with "acyclovir(ZOVIRAX). At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Petechiae
Clinical narrative: Information has been received from a physician concerning a 1 year old male described "as a health child" who on 28-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 08-MAR-2007, within eight days of vaccination, the patient developed "generalized petechia over his whole body." The patient's petechia persisted for two weeks. The doctor was unsure the petechia was related to therapy with varicella virus vaccine live (Oka/Merck). At the time of the report the patient was not recovered. There was not product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an unknown number of patients who were vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced breakthrough cases of "full blown" chicken pox after receiving varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. There was no product quality complaint involved.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 35-year-old male with asthma and no drug allergies who on 02-FEB-2007 was vaccinated subcutaneously with a first dose, 0.5 mL, of varicella virus vaccine live (Oka/Merck) (Lot # 655065/1142F). Concomitant therapy included Pulmicort, albuterol, Allegra, Nasonex, Zantac and Neurontin. On 09-FEB-2007, a week after vaccination, the patient experienced five rashes on his body. Medical attention was sought. On 20-Mar-2007, the patient still had two areas that were visible but healing. No treatment was required and no laboratory tests were performed. At the time of reporting no date of recovery was reported for the event of rash, as it was considered to be self limited. On 23 MAR 2007, the patient received his second dose of varicella virus vaccine live (Oka/Merck). There was no product quality complaint involved. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female who on 11-JAN-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 635604/1150K). Additional suspect vaccination included a first doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 636658/1161K). Concomitant vaccination included a dose of pneumococcal vaccine, pneumococcal 23V polysaccharide vaccine (manufacturer unknown) (lot # 472046). On 08-MAY-2007, the patient presented to the office with an itchy rash that started at school, the patient had no fever. Symptomatic treatment was administered. On 11-MAY-2007, the patient returned to the office with the rash which became infected. The patient was treated with Augmentin. The patient's status at the time of the report was unknown. No further information was provided. Additional information was obtained. The registered nurse reported that on 11-JAN-2007, the patient was also vaccinated with a dose of Prevnar (Wyeth, lot # 472046). It was reported that the patient "came to the office" on 08-MAY-2007 with a rash that started that morning "AM" (time of vaccination unknown). The patient had no fever. The patient was diagnosed with varicella vaccine breakthrough. There were no complications. On 11-MAY-2007, "became infected." The patient was treated with "amoxicillin and hydrocortisone." Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received concerning a 4-year-old female who on 03-DEC-2003 was vaccinated subcutaneously in the right thigh with her first, 0.5 mL, dose of varicella virus vaccine live (Oka/Merck) (Lot # 646137/0474N). It was noted that the patient woke up with a rash, and presented to the pediatrician's office on 01-MAR-2007, when she was diagnosed with varicella. Outcome not reported. No additional information available. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 13-year-old female with no pertinent medical history and an allergy to penicillin and amoxicillin who on 17-AUG-1998 was vaccinated subcutaneously into left arm with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot# 625047/1574E). There was no concomitant and or prior vaccines reported. There was no illness at the time of vaccination. On 17-MAR-2007 the patient developed an unknown number of varicella lesions. It was reported that the patient's father had shingles at an unknown time, and it was not known if the father had received any varicella containing vaccine. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. As of 22-Mar-2007 the patient was recovering from chicken pox. No product quality complaint was involved. The outcome was not known at the time of reporting. No additional information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a pediatrician's office concerning a 6-year-old female with no previous medical history and no illness at the time of vaccination who on 10-AUG-2000 was vaccinated subcutaneously in the right arm with her first dose of varicella virus vaccine live (Oka/Merck) (Lot 3 634502/0538K). On 10-MAR-2007, the patient experienced chickenpox evidenced by an erythematous papular rash scattered in the back, chest and arm with some areas of scabbing. There was no fever. Approximately 50 lesions were noted with excoriation. Subsequently, the patient recovered from chickenpox. No additional information to report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a mild case of shingles. Medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site mass, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a healthy, 44-year-old, female medical technologist, with a history of penicillin allergy who on 01-MAR-2007 at 10:00 am was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 654693/1052F) (also reported as "1025F"). Concomitant therapy included Lamisil. On 02-MAR-2007, 24 hours after vaccination, the patient experienced localized injection site swelling, which continued to swell and developed into a lump. Her whole upper arm eventually became swollen, red, pruritic, warm, painful and tender. Medical attention was sought. The patient self-medicated with Benadryl and ice packs. The patient recovered on 05-MAR-2007. No further information available. There was no product quality complaint involved. Follow up information indicated that on 03-Mar-2007, the patient's right tricep region swelled, was warm and itchy. It was a localized reaction. The patient recovered on 06-Mar-2007. It is unspecified if medical attention was sought. It is also reported that on an unspecified date the patient received a flu shot and experienced a localized reaction.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a healthy, 44-year-old, female medical technologist, with a history of penicillin allergy who on 01-MAR-2007 at 10:00 am was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 654693/1052F) (also reported as "1025F"). Concomitant therapy included Lamisil. On 02-MAR-2007, 24 hours after vaccination, the patient experienced localized injection site swelling, which continued to swell and developed into a lump. Her whole upper arm eventually became swollen, red, pruritic, warm, painful and tender. Medical attention was sought. The patient self-medicated with Benadryl and ice packs. The patient recovered on 05-MAR-2007. No further information available. There was no product quality complaint involved. Follow up information indicated that on 03-Mar-2007, the patient's right tricep region swelled, was warm and itchy. It was a localized reaction. The patient recovered on 06-Mar-2007. It is unspecified if medical attention was sought. It is also reported that on an unspecified date the patient received a flu shot and experienced a localized reaction.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a five year old patient who was vaccinated with varicella virus vaccine live (Oka/Merck) on an unknown date, from another physician (Information unknown). The patient developed breakthrough chickenpox. The chickenpox was severe with more than 50 lesions, and was a "full blown case." Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, Culture negative, Rash papular, Streptococcal identification test negative
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old male with right lymphadenitis at the time of vaccination with no preexisting allergies who on 24-OCT-2000 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Augmentin. On 10-MAR-2007, the patient experienced a rash described as "five papules on the face to vesicles." There was no fever. No laboratory or diagnostic tests were performed. On 16-MAR-2007, the patient recovered from papular and vesicular rash. Follow up information was received from a registered nurse, who reported that on an unspecified date a "quick test" for strep throat was performed, which was negative and the agar plate was negative at 24 and 48 hours. No other tests were done. No further information expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Neurological symptom
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a "neurological event." Unspecified medical attention was sought. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Rash, Skin warm
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on 16-MAR-2007 was vaccinated, in one arm, with varicella virus vaccine live (Oka/Merck) and hepatitis A vaccine (inactive). Concomitant therapy, that same day, included vaccination, in the other arm, with measles-mumps-rubella vaccine (M-M-R II), diphtheria toxoid (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VACCIN DTP) and poliovirus vaccine (IPV-VIRELON). Subsequently, the patient experienced warmth, redness, a knotted spot and a pin prick rash, on the arm where varicella virus vaccine live (Oka/Merck) and hepatitis A vaccine vaccine (inactive) were given. The child did not experience a fever. The mother dosed the child with Benadryl, which seemed to help initially, but subsequent doses did not evoke any response. The patient was seen at the physician's office on 20 MAR 2007. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a 64 year old female nurse with hypertension and an allergy to valdecoxib (BEXTRA) and a history of cataract operation who on 23-MAR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included ramipril (ALTACE), loteprednol etabonate (LOTEMAX), sulfacetamide sodium/sulfur (ROSAC) and aspirin. The nurse reported that she was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) instead of zoster vaccine live (Oka/Merck) (ZOSTAVAX). The patient reported that she picked up what she thought was zoster vaccine live (Oka/Merck) (ZOSTAVAX) at the pharmacy, then went to her doctor office for vaccination. Post vaccination she was given the package insert from the box. When the patient arrived home she found out that the insert was for varicella virus vaccine live (Oka/Merck). So she called the pharmacist who told her "there is no difference between varicella virus vaccine live (Oka/Merck) (VARIVAX) and zoster vaccine live (Oka/Merck) (ZOSTAVAX). Patient's outcome was unknown. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Information has been received from a health professional concerning a 7 year old white female who on 23-MAR-2007 was vaccinated intramuscularly into the leg with a booster varicella virus vaccine live (Oka/Merck) (Lot # 655071/1148F). On 23 MAR 2007 the patient experienced "local pain" which resolved in one day, 24 MAR 2007. It is unknown if medical attention was sought. There was no product quality complaint. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female patient who on 07-MAR-2007 was vaccinated subcutaneously with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy given the same day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 08-MAR-2007 32 hours after vaccination the patient experienced 8 cm round hard and hot welt rash at the injection site. Medical attention was sought. On 13-MAR-2007 redness was gone and on 16-MAR-2007 rash was down to quarter size. The patient was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female who in November 2006 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 20-MAR-2007, about 4 months later, the patient experienced rash breakthrough. An approximately 20 lesions were scattered around her body that looked like chicken pox lesions. The patient had no fever and was not even itchy. Additional information from the nurse practitioner indicated that the patient was seen months ago and she had no record of who the patient was at this time. No additional information is expected.
Age: 8.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse concerning an 8-year-old male patient who on an unspecified date was vaccinated by injection with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) or measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (reporter unsure). On 26-MAR-2007 the patient experienced a mild case of chickenpox. The outcome is reported as not recovered. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 10 year old female with juvenile arthritis who on 14-MAR-2007 was vaccinated with a second dose varicella virus vaccine live (Oka/Merck) (Lot # 656127/1314F). On 27-MAR-2007, the patient was seen in the physician's office because she developed redness at injection site and experienced soreness at injection site. The patient was treated with acetaminophen (TYLENOL) and 1 % hydrocortisone and was told to follow up with the office if there was no improvement. The patient's outcome was not reported. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash macular, Rash papular, Varicella
Clinical narrative: Information has been received from a nurse (also reported as a health professional) concerning an 8 year old male with attention deficit/hyperactivity disorder and no known allergies who on 02-MAR-2000 was vaccinated with varicella virus vaccine live (Oka/Merck) 0.5 mL SC in the left thigh (Lot # 632037/1355J). Concomitant therapy included methylphenidate HCl (CONCERTA). The nurse reported that the patient had developed chicken pox on 26-MAR-2007. The nurse reported that the patient had not improved and sought unspecified medical attention. Follow-up information was received from the physician. It was reported that the patient was an 8 year old Caucasian male experienced maculopapular rash with blistering with no other symptoms. Concomitant therapy included methylphenidate HCl (CONCERTA) daily. There was no illness at the time of vaccination. The patient recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a registered nurse concerning a 23-year-old female, with no pertinent medical history, who failed to seroconvert after getting two doses of varicella virus vaccine live (Oka/Merck). On 09-Apr-2002, she was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). On 14-May-2002, the patient received her second dose of varicella virus vaccine live (Oka/Merck). On 14-Mar-2007 her titer was 0.26. Unspecified medical attention was sought. On 03-Apr-2007, the patient received a booster dose of varicella virus vaccine live (Oka/Merck). The patient will have another titer done in June. No product quality complaint was issued. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male with no medical history and no drug allergies who on 04-OCT-2002 was vaccinated intramuscularly with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#637679/0448M). There was no concomitant medication. On 28-MAR-2007, the patient experienced a breakthrough. Subsequently, the patient was brought to the doctor's office and the patient was treated with acyclovir. No lab studies were performed. As of 02-April-2007, the patient was fully recovered. No product quality complaint was involved. Additional information has been requested. This is a consolidation of two reports concerning the same patient.
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male with asthma and no allergies who on 26-APR-2001 was vaccinated with 0.5ml intramuscular (IM) dose of varicella virus vaccine live (Oka/Merck) (lot# 636565/0922K). Concomitant therapy included albuterol. On 20-MAR-2007 the patient experienced lesions on his ear, lip, neck and trunk, 35 to 50 total lesions. The patient was treated with acyclovir 800mg four times a day for 5 days. VZVID was offered and declined. Subsequently, the patient recovered. No additional information is available at this time. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a registered nurse stated that this patient with no pre-existing allergies, birth defects or medical conditions received a first dose of varicella virus vaccine live (Oka/Merck) in the right leg on 26-APR-2001. Concomitant vaccine administered on the same day included a second intramuscular dose of PREVNAR vaccine (CRM197) (Lot #"471-171") in the left leg. Illness at the time of vaccination included allergic rhinitis. On 20-MAR-2007, the patient developed lesions on the nape of the neck, right ear, and lip. No medical attention was sought.
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old male with no allergies and no medical history who on 16-SEP-2002 was vaccinated SC in the left thigh with a 0.5 mL first dose of varicella virus vaccine live (Oka/Merck) (Lot# 640822/1153L), expiration date of 14-Feb-2003. Concomitant vaccines administered on the same day included a fourth dose of Prevnar given IM in the right thigh. The child presented to the office on 28-MAR-2007, with probable chicken pox, approximate range of 50 to 249 lesions and no fever. The mother of the child stated that the onset of the outbreak began on 26-Mar-2007 with an itchy rash on the arms, back and stomach. Treatment consisted of comfort measures. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. In follow-up received 04-JUN-2007, it was reported that the patient recovered on 04-APR-2007. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 9 year old female who approximately 11-MAR-2007 was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck), and forty eight hours later on 13-MAR-2007, the patient had a red location reaction on the injection site. Unspecified medical attention was sought. There was no treatment given to the patient, but she has already recovered. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old patient (gender unknown) who "about 4 years ago" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In approximately 2003 the patient experienced a mild case of chickenpox. Subsequently, the patient recovered from mild case of chickenpox. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. This is one of several reports received from the same source. No additional information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who at 12 months of age (in approximately 2001) was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed 250-500 lesions across the trunk and a low grade fever. Lesions were scaly and looked very similar to shingles lesions. Therapy with varicella virus vaccine live was discontinued and the patient was reported to be recovering. The patient sought unspecified medical attention. In follow-up information it was reported that, "We have not had a 7 year old male with adverse experience to varicella vaccine, no one this age was diagnosed with varicella either." No further information is available.
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 59 year old male who on 27-MAR-2007 was accidentally vaccinated with a dose of varicella virus vaccine live (Oka/Merck), instead of zoster vaccine live (Oka/Merck), (duration, dose and indication not reported). As of 27-MAR-2007, no adverse effect was reported and the wrong drug was administered by mistake. This was not a product quality complaint. This was a nursing error. Additional information has been requested.