chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Lethargy, Otitis media, Otorrhoea
Clinical narrative: Information has been received from a registered nurse (RN) concerning, who breastfed her daughter, a 14 month old female with no pertinent medical history, drug reaction or allergies who on 16-JAN-2007 was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot#652871/0430F). On approximately 01-FEB-2007, 29 days after being vaccinated, the patient developed a low temperature of 97.1F rectally, with lethargy and clear fluid discharge from the right ear canal. On 10-FEB-2007, nine days later, the patient became febrile with an axillary temperature of 102.2F and was subsequently diagnosed with otitis media. The patient was first treated with amoxicillin, followed by augementin. At the time of the report, the otitis media was considered to be resolving. There was no concomitant therapy. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. The nurse also noted that she is currently breastfeeding her daughter, and developed a widespread red, itchy rash on 25 FEB 2007. No further information is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (RN) concerning her 7 year old daughter who, in approximately 2001, at 12 months of age was vaccinated with varicella virus vaccine live (Oka/Merck), at a military base. Subsequently the patient developed a break through. The patient has about 30 lesions on her extremities and trunk. No additional information was provided. The outcome was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass
Clinical narrative: Information has been received from nurse concerning a female who was vaccinated with her second vaccination, 0.5 ml, of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced a red big bump on the site of the reaction. It was unknown if there was any reaction to the patient's first vaccination with varicella virus vaccine live (Oka/Merck). No further information was available. unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 08-JAN-2004 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007, two days prior to being seen by his physician, the patient developed a rash on his chest and face. He had about 12 lesions in various stages of eruption, with tiny vesicles in addition to bigger scabbed over lesions. He had a few lesions on his body, his forehead, and one on his scalp. Subsequently, the patient was diagnosed with post vaccine chickenpox. The patient was recovered at the time of this report. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash pruritic, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 21-JAN-2003, after his first birthday, was vaccinated subcutaneously with varicella virus vaccine live (Oka/Merck) (Lot#643078/0471M). On 21-FEB-2007 the patient was seen by his physician for an itchy rash that looked like little water blisters that had developed that same day. The patient's father had a shingles outbreak two weeks prior. The patient had six vesicular lesions; one on his right cheek, three on this arms, and the remainder on his torso. Dried Calamine lotion was lightly present over the top of the lesions, which the patient was itching. Post vaccine varicella infection diagnosed. Supportive measures and treatment options were discussed; along with signs and symptoms that would warrant a call back. The patient was considered recovered at the time of this report. No additional information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an approximately 3 year old male who in 2003 was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck). On approximately 06-MAR-2007, "earlier in the week" the patient presented to the doctor office with a case of breakthrough chicken pox of more thatn 50 lesions. The patient is recovering. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old male, with no pertinent medical history, drug reactions or allergies; who on 17-JAN-1997 was vaccinated with 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot#620617/1105D), and subsequently on 02-MAR-2007 was diagnosed with breakthrough chickenpox. No details were provided regarding the number of lesions, present status of patient, etc.  Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 19-OCT-2002 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck). On 09-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of varicella virus vaccine live (Oka/Merck), (Lot#654756/1335F). He also was vaccinated with hepatitis A vaccine (inactive) (MSD), and influenza virus vaccine live (unspecified) that same day. The child developed a red raised area at the injection site after vaccination on 09-MAR-2007. There was no treatment. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#654756/1335F. This report is one report of five reported by the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a medical assistant concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 19-OCT-2002 was vaccinated with his first dose of VARIVAX (Merck). On 09-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of VARIVAX (Merck) (Lot # 654756/1335F). He also was vaccinated with VAQTA (inactive), and influenza virus vaccine (unspecified) that same day. The child developed a red raised area at the injection site after vaccination on 09-MAR-2007. There was no treatment. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on lot # 654756/1336F. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of Center for Biologics Evaluation and Research and was released. No further information is expected.
Age: 1.85
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 22 month old female with a medical history of behavior issues, but no drug reactions or allergies, who on 26-FEB-2007 was vaccinated subcutaneously in the left upper thigh, with her first dose of varicella virus vaccine live (Oka/Merck) (Lot#654756/1335F). She was also vaccinated with influenza virus vaccine (unspecified) that same day. On 06-MAR-2007 the patient experienced a red, raised and a little swollen area at the injection site. No lab diagnostic studies were performed. The patient's status at the time of the report was recovering. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#654756/1335F. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. The office requested a lot check on Lot # 634756/1335F. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center and was released. No further information is expected. This is in follow-up to report (s) previously submitted on 5/16/2007.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a female in her 60's with an allergy to tetracycline who on 09-MAR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). It was reported that the nurse "grabbed the wrong one because of the VAX in both names." Unspecified medical attention was sought. The patient had no adverse events. There was no product complaint involved. No further information was provided. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 15 month old male with milk allergy and asthma who on 05-MAY-1997 was vaccinated with varicella virus vaccine (Oka/Merck). On 06-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of varicella virus vaccine live (Oka/Merck), (Lot#654756/1335F), and tetanus toxoid. On 08-MAR-2007 the patient experienced a red, swollen, warm and puffy area at the injection site. No treatment was required. The patient had an unknown reaction after the first vaccination. No lab diagnostic studies were performed. The patient's status at the time of the report was considered not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#654756/1335F. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female patient (age not reported) who on 06-AUG-202 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#639488/0572L). On 20-FEB-2007 the patient developed a break through chickenpox 5 years after getting the vaccine administered to her. Patient had less than 30 lesions. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Viral rash
Clinical narrative: Information has been received from a registered nurse concerning a child who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient developed lesions starting in the hairline, face, chest and abdomen. The child was diagnosed with a viral rash, but the nurse believed that it was chickenpox. As of 05-DEC-2006 the patient had not recovered. The registered nurse also reported on other childrens' experiences with varicella virus vaccine live (Oka/Merck) (WAES#0612USA00711). No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a teenage patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On approximately 16-FEB-2007, the patient experienced a reaction at the injection site". The nurse reported that the area felt hot and had redness and swelling. There was no product quality complaint. The patient's status was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a teenage patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On Approximately 16-FEB-2007, the patient experienced a reaction at the injection site". The nurse reported that the area felt hot and had redness and swelling. There was no product quality complaint. The patient's status was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning 2 siblings who were vaccinated with Varivax. Subsequently, they developed chickenpox. It was unspecified if medical attention was sought. Additional information has been requested. It was reported that a younger female sibling developed chickenpox after varicella vaccination (WAES 0702USA00203).
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female who on 04-FEB-1997 was vaccinated SQ with 0.5 mL VARIVAX (Oka/Merck) when she was 12 months old. Concomitant therapy included ZITHROMAX. Subsequently the patient developed a mild case of chickenpox at age 10 years, in approximately 2006. No lab diagnostic studies were performed. The patient's outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a patient (age and sex not reported) who was "recently" (approximately March 2007) vaccinated subcutaneously with a second dose (0.5 ml) of Varivax. Concomitant therapy included Vaqta. Medical history was reported as unspecified. In approximately March 2007 (date unspecified), the patient experienced erythematous area of about 12 cm diameter, with induration, at injection site. No other symptoms were noted. Subsequently, the patient recovered from erythematous area of about 12 cm diameter, with induration, at injection site. The patient sought unspecified medical attention. The events involved intervention to prevent serious criteria (other important medical event). There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no medical history who on 22-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 13-MAR-2007 the patient experienced a rash on her abdominal area and back. The physician reported that it looked like a case of moderate wild chicken pox. No labs were performed. Unspecified medical attention was sought. The patient has not recovered. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old healthy female who on 10-FEB-2000 was vaccinated with Varivax. On 06-MAR-2007 the patient experienced breakthrough chickenpox and was exposed to wild type at school. The patient had 0-25 lesions and was afebrile. No treatment was ordered. Patient outcome was not reported. 2/11/10 In follow-up received 17-APR-2007, the nurse noted there were 20-25 chicken pox spots over patient's trunk and extremities that looked papular. One lesion on the lower abdomen looked vesicular. There were no relevant diagnostic testm or laboratory data. It was unknown if there was any illness at the time of the vaccination. Patient outcome was unknown. No further information is available.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no known allergies or medical history who on 07-AUG-1995 was vaccinated SC in the arm with a first dose of Varivax (lot # 608579/0407B). Concomitant vaccination included a first dose of MMR (lot # 615609/0621B) given SQ in the arm and a fourth dose of HibTiter (lot # M005LK) given IM in the thigh. There was no illness at the time of vaccination. On 10-MAR-2007 the patient developed chickenpox lesions which were reported to be papules with erythema, pustules and a few scabbed lesions on her face, chest and abdomen. It was reported that the patient had 30-40 lesions. A clinical exam was performed, no labs or diagnostic tests were performed. Subsequently, on an unspecified date the patient recovered. It was reported that there was chickenpox in the community. No further information was provided. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 11-year-old male with no medical history, who on 27-JAN-1997 was vaccinated with a first dose of Varivax. There was no concomitant medication. On 14-MAR-2007 the patient experienced a breakthrough case of chickenpox, over 200 lesions. Unspecified medical attention was sought and the patient was placed on acyclovir. It was reported that the patient's mother recently developed shingles and the patient's father developed a case of chickenpox. No outcome was reported. No product quality complaint was involved. Additional information has been requested. 05/16/2008 As of 05-APR-2007 it was reported "the patient cleared up just fine". Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin E, Blood immunoglobulin G, Cough, Drooling, Erythema
Clinical narrative: Information has been received from a physician concerning a 3 year old male who in approximately 2005 was vaccinated with Varicella at the local health department. Within five minutes, the patient experienced rhinorrhea, drooling, watery eyes, roof of his mouth was "hurting", red face and may have had slight coughing. The patient was given an oral dose diphenhydramine hydrochloride (BENADRYL), but no epinephrine. The physician thought patient was allergic to gelatin. On an unspecified date, serum IgG to porcine gelating was elevated, at 2.10 kU/L (class 2). As of 24-JAN-2007, at the age of five years old, the patient has been able to eat beef-derived gelatin for the past year, but has avoided porcine gelatin. Recently, a RAST test to porcine gelatin had fallen to 0.38 (class 1) kU/L. Egg, pork and beef have not demonstrated IgE, either by RAST testing, or by skin testing. As of 13-MAR-2007, the patient's outcome was not reported. The patient subsequently experienced sneezing, drooling, rhinorrhea and red face with red eyes after vaccination with MMR (WAES Report 0703USA05199). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Lacrimation increased, Oral pain, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a 3 year old male who in approximately 2005 was vaccinated with Varicella at the local health department. Within five minutes, the patient experienced rhinorrhea, drooling, watery eyes, roof of his mouth was "hurting", red face and may have had slight coughing. The patient was given an oral dose diphenhydramine hydrochloride (BENADRYL), but no epinephrine. The physician thought patient was allergic to gelatin. On an unspecified date, serum IgG to porcine gelating was elevated, at 2.10 kU/L (class 2). As of 24-JAN-2007, at the age of five years old, the patient has been able to eat beef-derived gelatin for the past year, but has avoided porcine gelatin. Recently, a RAST test to porcine gelatin had fallen to 0.38 (class 1) kU/L. Egg, pork and beef have not demonstrated IgE, either by RAST testing, or by skin testing. As of 13-MAR-2007, the patient's outcome was not reported. The patient subsequently experienced sneezing, drooling, rhinorrhea and red face with red eyes after vaccination with MMR (WAES Report 0703USA05199). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no drug reactions/allergies and a history of a mild case of chickenpox in the April of 1995 who on 16-JAN-1996 was vaccinated with 0.5 cc subcutaneous of Varivax (lot# 610257/0750B). There was no concomitant medication. In 2004 the patient was diagnosed with a zoster/shingles. The patient's zoster was still present 5 months after the initial diagnosis (date unspecified). The zoster was not present at an examination 8 months after the diagnosis (date unspecified). No other information was available. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated subcutaneous with a 0.5 mL dose of VARIVAX (lot# 654327/0495F) instead of instead of ZOSTAVAX. It was confirmed that it was not product confusion. The patient is not experiencing any known symptoms. There was no product quality complaint involved. No further information is available.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 13-month-old male with no previous allergies or pertinent medical history who on 23-FEB-2007 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (Lot # 654520/1152F). Concomitant therapy included MMR II. On 13-MAR-2007, the patient experienced chickenpox rash "all over the body" including near the eyes. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The outcome was not provided. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of Varivax. Subsequently the patient developed a "less severe" case of chicken pox. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 12 year old male who on 02-MAR-2007 was vaccinated with the second dose of Varivax. There was no concomitant medication. On approximately 04-MAR-2007 the patient's upper arm was red (in between his elbow and up to his shoulder). Unspecified medical attention was sought. There were no laboratory tests performed. Subsequently, the patient recovered from the redness on his upper arm. It was reported that the patient had a similar reaction the first time he was vaccinated with Varivax. Additional information has been requested. Additional information indicated that the patient was vaccinated in the right arm with a dose of VARIVAX (lot # 655066/1141F) on 09-MAR-2007 (previously reported as 02-MAR-2007). It was reported that the patient had no known medical history. No further information was provided. No additional information is available.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old patient (gender not provided) who was vaccinated with the second dose of Varivax. Subsequently within days after being give the second dose the patient experienced injection site irritation. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse at a day school, concerning a female child who, "in the past" was vaccinated with Varivax, and has subsequently been diagnosed with chickenpox. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an approximately 10 year old female who was vaccinated with Varivax, and subsequently experienced a moderate breakthrough of over 40 lesions of a varicella type rash. It is unknown if medical attention was sought. The final outcome was not reported. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a woman from a pediatric office regarding a 7 year-old female who, on 01-MAR-2001, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 12-MAR-2007, the patient's mother reported that she had developed 10-20 chickenpox spots. It was unspecified if medical attention was sought. Subsequently, the patient recovered from chickenpox. No outcome was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old female patient who on 28-MAY-2003 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. The physician reported that on 22-MAY-2006 the patient experienced mild lesions. There was no other adverse reactions except the varicella lesions, a few lesions, with no fever and no pruritis. No lab or diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint reported. Additional information is not expected.
Age: 3.5
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 42 month old female who on 14-NOV-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot#644087/0975M). There was no concomitant medication. On 22-MAY-2006 the patient experienced moderate breakthrough case of chicken pox. The patient did not undergo any lab/diagnostic tests. The only reported adverse reaction were the varicella lesions, a few lesions with no fever or puritis. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 10 year old male who on 17-JUN-1996 was vaccinated with varicella virus vaccine live (Oka/Merck). On 13-MAR-2006 the patient had an onset of chicken pox break thru. Subsequently the patient recovered. No treatment was necessary, just comfort measures as needed. The nurse also reported on two other patients who experienced adverse events being vaccinated with varicella virus vaccine live (WAES#0602USA05682 and #0703USA05016) Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 6 year old male who on 29-NOV-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 27-Mar-2006 the patient had on onset of chicken pox break thru. Subsequently the patient recovered. No treatment was necessary, just comfort measures as needed. The nurse also reported on two other patients who experienced adverse events after being vaccinated with varicella virus vaccine live (WAES#060USA05682 and #0703USA05015) Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a child who on an unspecified date a baby/toddler was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of varicella virus live (Oka/Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of VARIVAX (Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of Varivax. Subsequently the patient developed a "less severe" case of chickenpox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white female with no known allergies and an "innocent heart murmur" who on 26-AUG-1997 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot 619268/1336D).  There was no concomitant medication. On 31-MAR-2006 the patient's mother called the registered nurse and reported her daughter developed chickenpox with 200 vesicles. On 5-APR-2006, the patient recovered from chickenpox. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a white 6 year old male with no known allergies or medical history who on 24-JAN-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant mediation. On 14-MAR-2006 the patient was diagnosed with chickenpox and by 16-MAR-2006 had 10-20 vesicles. Subsequently, the patient recovered from chickenpox 10-20 vesicles. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic
Clinical narrative: Information has been received from a registered nurse (RN), currently breastfeeding her 14 month daughter who on 16-JAN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 25 FEB 2007 the mother developed a widespread red, itchy rash. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cold compress therapy, Crying, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 4-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On 6 April 2006 the subject received his 5th injection of Infanrix (lot number AC14A006BA, expiration August 2006) at a dose of 0.5 ml in the left arm. On 7 April 2006, at 1:00 in the morning, 11 hours after vaccination with Infanrix, the subject awoke with a localized reaction to the Infanrix injection, which included swelling at the injection site, injection site pain, heat at the injection site (hot to the touch) and excessive crying (crying more than usual). The symptoms were resolved at the time of reporting. The nurse advised the subject's mother to apply cold compress and to use Tylenol as treatment of the symptoms. The healthcare professional considered the events were probably related to vaccination with Infanrix. No additional information was reported regarding this event. Dates and times of previous Infanrix injections were not reported.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 4-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On 6 April 2006 the subject received his 5th injection of Infanrix (lot number AC14A006BA, expiration August 2006) at a dose of 0.5 ml in the left arm. On 7 April 2006, at 1:00 in the morning, 11 hours after vaccination with Infanrix, the subject awoke with a localized reaction to the Infanrix injection, which included swelling at the injection site, injection site pain, heat at the injection site (hot to the touch) and excessive crying (crying more than usual). The symptoms were resolved at the time of reporting. The nurse advised the subject's mother to apply cold compress and to use Tylenol as treatment of the symptoms. The healthcare professional considered the events were probably related to vaccination with Infanrix. No additional information was reported regarding this event. Dates and times of previous Infanrix injections were not reported.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix, GlaxoSmithKline).  On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The subject was seen in the emergency room. The outcome of the events was not reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and describe the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA0). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The subject was seen in the emergency room. The outcome of the events was not reported,. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lotAC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). the injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year old subject (unknown gender) who receive diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On a unspecified date in either March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The nurse considered the events to be probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experience redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The  nurse considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids an acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). the injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was no reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to sales representative and described the occurrence of the redness and swelling at the injection site in a15-18-month-old subject (unknown gender) who received diphtheria and tetanus toxoids an acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On a specified date in either March 2006 or April 2006, the subject received the 4th dose of Infanrix in an unspecified thigh (lot AC14B018AA). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by medical assistant and described the occurrence of swollen leg in a 4-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On 05 April 2006, the subject received 5th dose of Infanrix in the left thigh (lot AC14A008AA). On 05 April 2006, the subject also received inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) in the left thigh and measles, mumps and rubella virus vaccine (MMR II, Merck) in the left arm. On 06 April 2006, one day after vaccination with Infanrix, the subject experienced injection site swelling, injection site induration, injection site warmth, and an "8 by 7 cm. erythematous area" at the injection site and swelling, "from injection site to past the knee." The subject was seen at a physician's office and was treated with an unspecified antibiotic. The events resolved on an unspecified date on or after 06 April 2006 and on or before 04 May 2006. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a medical assistant and described the occurrence of swollen leg in a 5 year old male subject who was vaccinated with Infanrix for prophylaxis. On 14 April 2006, the subject received 5th dose of Infanrix in the right thigh (lot AC14A008AA). On April 2006, the subject also received inactivated Ipol in the right thigh and MMRII in the right arm. On 15 April 2006, one day after vaccination with Infanrix, the subject experienced injection site swelling, injection site induration, and swelling, "past the knee".  The subject was seen at a physician's office.  The events resolved on an unspecified date on or before 05 May 2006. The medical assistant considered the events to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a medical assistant and described the occurrence of swollen leg in a 5 year old male subject who was vaccinated with Infanrix for prophylaxis. On 10 April 2006, the subject received 5th dose of Infanrix in the right thigh (lot AC14008AA) for prophylaxis. On 10 April 2006, the subject also received inactivated Ipol in the left thigh and MMR II in the left arm. On 11 April 2006, one day after vaccination with Infanrix, the subject experienced injection site swelling, injection site induration, and swelling, "past the knee." The subject was seen at a physician's office. The injection site swelling and injection site induration resolved on 11 April 2006. The medical assistant considered the events to possibly be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of tight feeling in arm in a subject of unspecified age and gender who was vaccinated with infanrix for prophylaxis. There were no concurrent medications. On an unspecified date on or before 24 April 2006 the subject received a dose of Infranrix in an unspecified arm (dose number not provided). The nurse reported that the lot number of Infranix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in the arm," injection site redness and swelling injection site. The subject was seen at a physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of tight feeling in arm in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There were no concurrent medications. On an unspecified date on or before 24 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number not provided). The nurse reported that the lot number of Infanrix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in th arm," injection site redness and swelling injection site. The subject was seen at physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.