chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male patient with no known drug allergies or pertinent medical history who on 01-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 665959/1408Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subcutaneously, on approximately 01-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. The office was contacted by phone, on 15-APR-2010. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Macule, Polymerase chain reaction, Pruritus, Scab
Clinical narrative: Information has been received from an office manager at a physician practice concerning a 10 year old male patient with no drug reactions/allergies who in 2001, at "age one", was vaccinated with a dose of VARIVAX (Merck) and now he had confirmed chickenpox (on approximately 08-MAY-2010). The patient had several itchy lesions all over the body. The school nurse reported that there was an outbreak of chickenpox at school with 20 cases. The patient had an office visit on 08-MAY-2010. Specimen was sent for testing (result not provided). At the time of the report the patient's status was unknown. Additional information has been received from a health care worker regarding a WPS letter they received. No further information is provided. Follow up information has been received from a physician concerning the 10 year old male patient who on 29-JAN-2001 was vaccinated SC in the left leg with the first dose of VARIVAX (Merck) (Lot# 636569/0926K). On 08-MAY-2010 the patient had confirmed chickenpox. No rash occurred at the site of injection or elsewhere within 42 hours of the vaccination. The specimen was collected for PCR and result of PCR was positive. There was no photo taken. The patient had no recent exposure to chickenpox or herpes zoster. Physician exam revealed the patient was afebrile at 98.7 and with multiple itchy lesions all over his body. The one on the right forearm now was crusting but the others were still flat and bright pink macules or some had microvesicles in the center. The patient had several on his scalp now as well and one on the bottom of the left foot. The patient's father reported that the patient woke up with some on his face yesterday morning and before that which he thought he just had bug bites. The physician thought the patient was contagious for chickenpox at school and the school should be alerted. A viral culture was taken from a blister, a tiny microvesicle on his back and would be sent to the laboratory for culture. The patient should be bathed with a quarter to half cup each of baking soda and cornstarch and frequent bathing could keep these spots from getting infected. The physician also recommended TYLENOL or MOTRIN for fever or discomfort and should generic to avoid the recalled forms. The patient recovered at the time of report. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine, Viral test positive
Clinical narrative: Information has been received from an office manager at a physician practice concerning a 10 year old male patient with no drug reactions/allergies who in 2001, at "age one", was vaccinated with a dose of VARIVAX (Merck) and now he had confirmed chickenpox (on approximately 08-MAY-2010). The patient had several itchy lesions all over the body. The school nurse reported that there was an outbreak of chickenpox at school with 20 cases. The patient had an office visit on 08-MAY-2010. Specimen was sent for testing (result not provided). At the time of the report the patient's status was unknown. Additional information has been received from a health care worker regarding a WPS letter they received. No further information is provided. Follow up information has been received from a physician concerning the 10 year old male patient who on 29-JAN-2001 was vaccinated SC in the left leg with the first dose of VARIVAX (Merck) (Lot# 636569/0926K). On 08-MAY-2010 the patient had confirmed chickenpox. No rash occurred at the site of injection or elsewhere within 42 hours of the vaccination. The specimen was collected for PCR and result of PCR was positive. There was no photo taken. The patient had no recent exposure to chickenpox or herpes zoster. Physician exam revealed the patient was afebrile at 98.7 and with multiple itchy lesions all over his body. The one on the right forearm now was crusting but the others were still flat and bright pink macules or some had microvesicles in the center. The patient had several on his scalp now as well and one on the bottom of the left foot. The patient's father reported that the patient woke up with some on his face yesterday morning and before that which he thought he just had bug bites. The physician thought the patient was contagious for chickenpox at school and the school should be alerted. A viral culture was taken from a blister, a tiny microvesicle on his back and would be sent to the laboratory for culture. The patient should be bathed with a quarter to half cup each of baking soda and cornstarch and frequent bathing could keep these spots from getting infected. The physician also recommended TYLENOL or MOTRIN for fever or discomfort and should generic to avoid the recalled forms. The patient recovered at the time of report. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a patient who on unknown dates was vaccinated with two doses of VARIVAX (Merck). Subsequently the patient experienced chickenpox after getting two doses of VARIVAX (Merck). The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Oral herpes
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 25 year old female patient with unknown relevant medical history and past drug history, who on an unknown date started VARIVAX (Merck), unknown dose and frequency, for unknown indication. On 24-MAR-2010, the patient was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included unspecified oral contraceptives. On 26-MAR-2010 the patient developed a cold sore on her lip. It was unknown if there was any relevant laboratory data. It was reported that as of 26-MAR-2010, it was unknown if the patient continued on VARIVAX (Merck), and the cold sore on her lip had not abated. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 11-MAY-2010 was vaccinated SC with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). There was no adverse event reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Swelling
Clinical narrative: Information has been received from a Bachelor of Science in Nursing concerning a 12 year old male patient who on 27-MAR-2010 was vaccinated subcutaneously in the left arm with the second dose of VARIVAX (Merck) (lot number 665411/1158Y). The same day the patient was administered in the left arm with a dose of TDap (lot number G3246BA) and MENACTRA (lot number 230158A). It was reported that one day after the patient received VARIVAX (Merck) had fever of 101 degrees for 8 hours and halo effect that was 2 circles, 3 quarter of an inch wide with no open wounds, pink on the inner circle and white on the outer layer. The nurse stated that the swelling was going down and the patient was doing better. The nurse reported that she felt as though the fever was due to the other vaccines the patient received that day because none of the other vaccines were given in the same arm. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning his "about 6 or 7 year old" son with no known drug reactions or allergies or pertinent medical history who in approximately 2000, was vaccinated with the second dose of VARIVAX (Merck). The physician reported that his son developed a mild case of chickenpox in first grade, after being immunized a year prior, with the second dose of VARIVAX (Merck). Physician reported that this happened nine years ago (approximately in 2001), and that on unspecified date, the patient had recovered. No lab tests were performed. The patient sought unspecified medical attention. It was reported that on an unspecified date, the patient had recovered. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 5 year old male with no known pertinent medical history or drug reactions/allergies who on 10-JAN-2006 was vaccinated with a first dose of VARIVAX (Merck) (lot# 651175/0423R) 0.5 ml SQ. On 10-JAN-2006, the patient also received a dose of poliovirus vaccine inactivated (unspecified). On 17-AUG-2009, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 664322/0660Y) 0.5 ml SQ. Other suspect therapy included a dose of MMR II (MSD) on 10-JAN-2006 and another dose of MMR II (MSD) on 17-AUG-2009. Concomitant therapy included DTaP. On 29-MAR-2010 the patient experienced chickenpox. The patient's chickenpox persisted. No labs were performed. The patient sought medical attention in the office. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health care professional concerning a patient who on 11-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (lot # not reported). No other details provided. It was not specified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Physician's assistant concerning 3 patients who were vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No symptoms were reported. It was unknown if the patient sought medical attention. No further information is available.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Rash generalised, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old male with no pertinent medical history and no drug allergies, who on 19-MAR-2010 was vaccinated with the first dose of VARIVAX (Merck) (0.5ml, SC, lot # 665763/1296Y) and later that day had a fever. There was no concomitant medication. He awoke with a rash on 01-APR-2010 and was seen in the office. On exam he had less than 50 lesions scattered on his trunk, back and face. Diagnosis was chickenpox. There were no labs or diagnostic tests performed. The patient's chickenpox persisted. Follow up information has been received from a registered nurse concerning a 15 year old male student with no illness at time of vaccination and no drug allergies, who on 19-MAR-2010 at p.m. was vaccinated with the first dose of VARIVAX (Merck) (SC, lot # 665763/1296Y) in the right deltoid. On the same day, the patient was also vaccinated with the first dose of ADACEL (Sanofi, lot # UF544AA) IM in the right deltoid and the first dose of MENACTRA (Sanofi, lot # U3054AA) IM in the left deltoid at p.m. The patient had a fever after receiving immunization on 19-MAR-2010. On 01-APR-2010 he noticed a generalized rash on his trunk and face with lesions similar to chickenpox. The patient did not seek medical attention and recovered on 05-APR-2010. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Cardiomyopathy, Dyspnoea, Palpitations, Type III immune complex mediated reaction, Ventricular extrasystoles
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). It was reported that the patient did not have adverse events associated with the first dose. The second dose was given eight weeks after the first dose, an about 4 to 5 later, the patient developed an arthus reaction, cardiac palpitation and premature ventricular contraction (PVC), the patient become short of breath and was diagnosed with cardiomyopathy. It was reported that some of these symptoms may have been presented before vaccination. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a 65 year old male patient who on 12-MAY-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot # not provided) instead of ZOSTAVAX (Merck). No adverse symptoms noted. This was not product confusion, it was a human error. The patient sought unspecified medical attention. Follow up information has been received from a office manager concerning an 65 year old male patient with no illness at the time of vaccination, penicillin allergy and enteric coated medication allergy who on 12-MAY-2010 at 10:15 am was inadvertently vaccinated with a first dose of VARIVAX (Merck) (lot # 665025/0992Y) subcutaneously into his left arm instead of ZOSTAVAX (Merck). No adverse events were reported. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male with a history of tubes in the ears and no drug reactions or allergies who on 30-APR-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (lot# 665990/1437Y) into the upper lateral thigh. Concomitant therapy included VAQTA (manufacturer unknown) and PREVNAR. On 11-MAY-2010 the patient was seen in the office with adverse reaction. The child had firm erythematous area on upper left lateral thigh with 3.5 centimeter by 3 centimeter, induration palpable 5 centimeter by 4.5 centimeter. There was no fluctuations, no tenderness, palpable warm to touch, or no drainage from site. No laboratory diagnostics studies were performed. The child was treated with KEFLEX. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Tuberculin test negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female patient with sulfonamide allergy who on 11-MAY-2010 was vaccinated SQ in the left upper armarea with a 0.5 ml dose of VARIVAX (Merck) (lot number 661984/1429Y, expiration date 16-OCT-2011). Secondary suspect therapy included a dose of ADACEL given in the left deltoid muscle. Concomitant therapy included unspecified oral contraceptive. The patient was also administered a tuberculin skin test on 11-MAY-2010. On 13-MAY-2010, the patient came to the office to read the tuberculin skin test; which was negative, and was found to have a "50 cent piece size" area of redness, swelling, induration and warmth at the site of the ADACEL injection. The patient had a similar injection site reaction at the site of administration of VARIVAX (Merck), but the reaction was "25 cent piece size". The patient was prescribed oral BENADRYL and warm compresses. At the time of the report the patient was recovering. The patient sought medical attention by an office visit. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 75 year old male patient who on 13-MAY-2010 was vaccinated SQ with a 0.5 ML dose of VARIVAX (Merck) into the left arm (lot number 664934/0882Y, exp 22-JUN-2011) instead of ZOSTAVAX (Merck). Medical assistant reported that there were no adverse effects at this time. The patient sought for unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with 2 doses of VARIVAX (Merck), and developed chickenpox. The chickenpox developed more than a year after the second dose. The patient received unspecified medical attention. On an unknown date, the patient recovered from chickenpox. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a 26 year old female pharmacist with no pertinent medical history who in approximately January 1996, "14 years ago" was vaccinated with a dose VARIVAX (Merck) (0.5 ml, SC). There was no concomitant medication. On 07-MAY-2010 varicella antibody titers was performed and the result was negative. Unspecified medical attention was sought. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 18-MAY-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error. No adverse effect reported. Follow up information has been received from the registered nurse who reported that the patient called to the office on 21-MAY-2010 and complained of swelling, red streak and itchiness. All effects were starting to go away. There was no treatment. The nurse stated the patient had allergy to cefaclor. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year or old female patient who on unspecified dates was vaccinated with two doses of VARIVAX (Merck). Two months ago (approximately 18-MAR-2010), the patient experienced a case of chickenpox. No lot numbers were provided. The patient sought unspecified medical attention and was treated with unspecified therapy. At the time of the report, the patient recovered. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Allergy test negative, Injection site erythema, Injection site urticaria
Clinical narrative: Information has been received from a consumer concerning her 13 month old daughter who on 25-NOV-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. On 25-NOV-2009, within seconds after receiving VARIVAX (Merck), the patient developed a hive on her leg less than an inch below injection site. The hive was red raised area with a white spot in middle. She was treated with an antihistamine. The area cleared in about 5 to 8 hours. A few weeks later she developed a red raised circle about the size of a pickle jar lid at the site of injection. She was treated with an antiviral. At the time of this report, the patient had recovered. This is one of several reports from the same source. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female nurse who 7 years ago, in approximately 2003, was vaccinated with the first dose of VARIVAX (Merck). The registered nurse reported that on 05-APR-2010, the nurse received a dose of VARIVAX (Merck). She needed to receive the vaccine because her varicella titer came back negative. On 06-APR-2010, the nurse developed one hive on the injection site. At the time of the report, the patient had not recovered from the hive on the injection site. The nurse sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Scar, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with a history of adenoidectomy who was vaccinated with a dose of VARIVAX (Merck) on 10-JUN-2005 and 15-MAY-2009. On 16-FEB-2010 the patient developed a moderate case of chickenpox. It was reported that the patient had a few scars from the chickenpox. The patient sought medical attention by an office visit. On an unknown date the patient recovered from chickenpox. The outcome of scars from the chickenpox was unknown. Follow up information has been received from a physician who indicated that the child with no illness at the time of vaccination, no pre-existing allergies, no birth defects and no medical conditions had not been vaccinated in her office. On 16-FEB-2010 the patient came to her office with rash that was typical of chickenpox. On an unknown date the patient recovered from chickenpox. No laboratory or diagnostic studies were performed. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a practice manager and a 38 year old female licensed practical nurse concerning the nurse with no pertinent medical history or no drug reactions or allergy who on 18-MAY-2010 was administering VARIVAX (Merck) (lot# 666693/1707Y, expired date: 04-DEC-2011) to a child and some of the vaccine got into the nurse's right eye. There was no concomitant medication. On 18-MAY-2010, the nurse experienced burning but recovered after the eye was washed out with water. The nurse sought unspecified medical attention. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse/immunization coordinator concerning a 61 year old female patient who on 25-MAR-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided) instead of ZOSTAVAX (Merck). NO adverse effects were reported. The patient did not seek medical attention. Follow up information has been received from a licensed practical nurse who reported that on 25-MAR-2010 the patient with no pertinent medical history was vaccinated IM with a dose of VARIVAX (Merck) (Lot number 665418/1162Y, expiration date: August 2013) instead of ZOSTAVAX (Merck). No further information is available.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 45 year old female patient with no pertinent medical history and no drug reactions/allergies who about one year ago, in approximately 2009 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included YAZ (oral contraceptive). About 6-8 months ago, the patient developed recurrent shingles and visited the office for medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Herpes virus infection, Herpes zoster
Clinical narrative: Information has been received from a physician concerning her now 4 year old son who at 15 months of age (in approximately 2007) was vaccinated with a dose of VARIVAX (Merck). When at 19 months of age (in approximately 2007), the patient developed shingles. The patient had about 20 herpes zoster lesions along the T10 dermatome. The patient did not seem to have pain. Unspecified medical attention was sought. On an unknown date, the patient had recovered from. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an adult patient who on 08-APR-2010 was vaccinated inadvertently with a dose of VARIVAX (Merck) route and lot # unknown instead of ZOSTAVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 7 year old patient with no pertinent medical history or drug reactions/allergies who on 30-DEC-2003 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). There was no concomitant medication. On 10-MAY-2010 the patient came into the office and was diagnosed with varicella. The nurse reported that the patient had less than about 100 vesicles on the left knee to the hip. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Follow up information has been received from a registered nurse. It was reported that the male patient with attention deficit disorder and depression, on 30-DEC-2003 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). The nurse reported that the patient was diagnosed with chickenpox on 10-MAY-2010 with less than 100 vesicles. The lesions began on 08-MAY-2010. The lesions cleaned up on 15-MAY-2010. On 17-MAY-2010 the patient returned to school with out complications. The patient did not required an emergency room/doctor visit. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.16
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Macule, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 28 month old female patient with no drug allergies or pertinent medical history who on 10-FEB-2009 was vaccinated with a first dose of series of VARIVAX (Merck) (Lot number not provided), a dose of MMR II (MSD) (Lot number not provided) and a dose of VAQTA (manufacturer unknown). The nurse reported that on 07-MAY-2010 the patient came into the office and was diagnosed with chickenpox. The nurse stated that the patient had 50 to 70 varicella like rash. At the time of the report the patient was recovering. Follow up information has been received from a registered nurse who reported that the patient with no pre-existing allergies, birth defects, medical conditions, no illness at the time of vaccination, no known adverse events following prior vaccination, on 05-MAY-2010 experienced chicken pox. On 07-MAY-2010, the patient was diagnosed with chickenpox. The patient presented with 50-75 macules in the left flank and in the axilla and he was afebrile. There were no labs performed. On 11-MAY-2010 the patient went to a follow-up visit at the office, the chicken pox was eaning up without complications. On the same day the patient recovered. The patient did not require an emergency room/doctor visit (previously reported as the patient went to the office). This is one of several reports received from the same source. No further information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Herpes simplex serology, Nausea, Papule
Clinical narrative: Information has been received from a register nurse concerning a 12 year old female patient with asthma who on 07-OCT-1998 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# not reported). On 02-JAN-2008, the patient was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (658999/1490U). Concomitant therapy included albuterol and FLOVENT. On 16-MAY-2010 the patient developed chickenpox. The patient was seen at the office today with a 3 day history of fever of 102F, rash that appeared yesterday, with approximately 50 to 100 lesions. The nurse said that no treatment was given just verbal precautions to parent to watch for infection. At the time of this report, the patient was recovering. Follow up information has been received from the nurse who reported that on 02-JAN-2008, the patient was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (658999/1490U) into the left arm. On 16-MAY-2010, the patient was seen in office after 3 days history of nausea, temperature 102F and rash that started on 18-MAY-2010. It was noted that the patient have approximately 50 scattered erythematous papules on the trunk, face and extremities, viral culture were performed and result was positive for varicella. There were no illnesses at time of vaccination. At the time of this report, the patient had recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with Merck vaccine strain. A lesion sample was collected on 19-MAY-2010. The sample was taken from upper chest. On 20-MAY-2010, the sample was sent to the laboratory. The herpes simplex/varicella zoster rapid culture was performed on 25-MAY-2010 and its result was "not isolated" VZV rapid culture was also performed on the same day with result "varicella zoster isolated". Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine, Varicella virus test positive, Viral test positive
Clinical narrative: Information has been received from a register nurse concerning a 12 year old female patient with asthma who on 07-OCT-1998 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# not reported). On 02-JAN-2008, the patient was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (658999/1490U). Concomitant therapy included albuterol and FLOVENT. On 16-MAY-2010 the patient developed chickenpox. The patient was seen at the office today with a 3 day history of fever of 102F, rash that appeared yesterday, with approximately 50 to 100 lesions. The nurse said that no treatment was given just verbal precautions to parent to watch for infection. At the time of this report, the patient was recovering. Follow up information has been received from the nurse who reported that on 02-JAN-2008, the patient was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (658999/1490U) into the left arm. On 16-MAY-2010, the patient was seen in office after 3 days history of nausea, temperature 102F and rash that started on 18-MAY-2010. It was noted that the patient have approximately 50 scattered erythematous papules on the trunk, face and extremities, viral culture were performed and result was positive for varicella. There were no illnesses at time of vaccination. At the time of this report, the patient had recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with Merck vaccine strain. A lesion sample was collected on 19-MAY-2010. The sample was taken from upper chest. On 20-MAY-2010, the sample was sent to the laboratory. The herpes simplex/varicella zoster rapid culture was performed on 25-MAY-2010 and its result was "not isolated" VZV rapid culture was also performed on the same day with result "varicella zoster isolated". Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: This case was reported by a healthcare professional (the subject's mother) and described the occurrence of swelling arm in a 4-year-old female subject who was vaccinated with INFANRIX (SmithKline Beecham). On 24 June 2003 the subject received 5th dose of INFANRIX (.5 ml, unknown route, left arm). On 24 June 2003, less than one day after vaccination with INFANRIX, the subject experienced swelling arm and hive. The circumference of her arm increased with swelling, and she could not help but scratch the itch. The healthcare professional reported that it took 2-3 weeks for swelling of her arm to resolve. On 7 July 2003, the events were resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The subject had not had any reactions to any vaccinations before or since.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 47 month old patient with no pertinent medical history and no allergies who on an unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (lot# 656575/0445U). Concomitant vaccination included MMR and PREVNAR (manufacturer unspecified). On 18-MAY-2010 the patient came into the office with a mild varicella rash. There were no laboratory diagnostics studies performed. At the time of this report, the patient was recovering. Follow up information has been received from the registered nurse concerning the female child who on 19-JUN-2007 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 656575/0445U) into the left deltoid. There was no illness at time of vaccination. On 18-MAY-2010, at 10:00, the patient was see in the office and she was diagnosed with chickenpox. Follow up visit on 25-MAY-2010, the chickenpox was resolving without complication. The patient was also reported to be recovered on 25-MAY-2010. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 10 year old patient with no pertinent medical history and no drug reactions/allergies who on 10-FEB-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot# 647241/0894N, expiration date unspecified). Concomitant vaccine administered on the same day included M-M-R II (lot# 646431/0679N). On 16-AUG-2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# 657944/1003U, expiration date unspecified). On 18-MAY-2010 the patient came into the office and was diagnosed with chickenpox. The nurse reported that the patient had multiple varicella like rashes from the upper left torso and had multiple varicella like rashes above the eyebrow. No laboratory tests were performed. The nurse reported that the patient was recovering. In follow-up, the nurse indicated that the female patient received the first dose of VARIVAX (Merck) (lot# 647241/0894N) into right arm in the office on 10-FEB-2004 and the second dose of VARIVAX (Merck) (lot# 657944/1003U) SC into the left thigh out of the office on 16-AUG-2007. On 18-MAY-2010 the patient was diagnosed with chickenpox after 6 days of rash. On 25-MAY-2010 the patient recovered from chickenpox after 5 complications. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 5 year old patient with no pertinent medical history and no drug reactions/allergies who on 16-AUG-2005 and on 29-AUG-2008 was vaccinated with the first and the second doses of VARIVAX (Merck) (lot number and expiration date not provided). The second dose was received at another office. There was no concomitant medication. On 19-MAY-2010 the patient came into the office with 5 to 10 varicella like bumps on the buttocks area and also an another region of the body it was itchy. The nurse reported that the patient was diagnosed as varicella. No laboratory tests were performed. At the time of the report, the patient was recovering. In follow-up, the nurse indicated that on 16-AUG-2005 the female patient received the first dose of VARIVAX (Merck) (lot number 660331/0485X) into the left arm/left thigh. On 29-AUG-2008 the patient received the second dose of VARIVAX (Merck) (lot number not reported) subcutaneously. On 10-MAY-2010 the patient was seen in the office and was diagnosed with chickenpox with 10 papules peri area and no fever. On 18-MAY-2010 the patient's mother stated that "all spots gone per phone". On 18-MAY-2010 the patient recovered from chickenpox. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site papule, Rash papular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 12 months old male patient with no pertinent medical history, drug reactions or allergies who on 06-MAY-2010 was vaccinated SQ in the left leg with a 0.5 mL dose of VARIVAX (Merck) (lot number 665886/1590Y). Concomitant therapy included MMR II administered in the right leg and PREVNAR administered in the left leg. Nurse reported that on 15-MAY-2010, the patient broke out with chickenpox on the left leg and at the injection site. By 19-MAY-2010, the patient had lots of chickenpox (full front, back, up on the neck and legs). At the time of reporting, the patient was recovering from the event. No laboratory diagnostic studies were performed. The patient sought medical attention, the patient visit the office. Follow up information has been received from the licensed practical nurse who reported that a male patient with esophageal reflux, and no illness at the time of vaccination, on 06-MAY-2010 was vaccinated with a first dose of VARIVAX (Merck) (Lot # 665886/1590Y), SQ in the left thigh at 17:00. The patient concomitantly received on the same day a first dose of MMR II (Lot # 664888/0765Y), and a first dose of PREVNAR (Lot # E44526), also at 17:00. On 17-MAY-2010 (previously reported as 15-MAY-2010) the patient was in office due to developing at the injection site area few isolated red spots in the periphery - few raised papules. On 19-MAY-2010 the patient back to office due to spreading - scattered erythematous small popular lesions. It was reported that the patient recovered on an unspecified date. Vaccine information statements (VIS) sheets were given to parents. Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site discolouration, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 16 months old granddaughter who on 20-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided) and a dose of MMR II (Lot # not provided). The patient experienced black and blue mark at the injection site as well as fever. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Scab, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old female patient with no pertinent medical history or drug reactions who on 30-APR-2010 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 666057/1450Y). There was no concomitant medication. On 17-MAY-2010, the patient developed 10 red, vesicular lesions on the left shin. On 24-MAY-2010 the patient was seen in the office. The lesions were "crust over and the patient was prescribed BENADRYL. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering . Additional information is not expected.
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: Food allergy, Rash generalised
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of rash all over body in a 2-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), Rotavirus vaccine, Hepatitis B vaccine, Hib and (non-gsk) PREVNAR. A physician or other health care professional has not verified this report. On an unspecified date in November 2009 the subject received 1st dose of INFANRIX (unknown route, unknown thigh). It was unknown whether the subject received concurrent vaccinations. One day after vaccination with INFANRIX, the subject experienced rash all over body. After the next vaccination with INFANRIX the event recurred. On an unspecified date the subject received unspecified dose of Rotavirus vaccine. At an unspecified time after vaccination with Rotavirus vaccine, the subject experienced unspecified food allergies. On an unspecified date at 4-months-old, the subject received 2nd dose of INFANRIX (details unknown) unspecified dose of Hepatitis B vaccine (details unknown), unspecified dose of Hib (details unknown), and unspecified dose of PREVNAR (details unknown). One day after vaccination with INFANRIX, Hepatitis B vaccine, Hib, and PREVNAR, the subject experienced rash all over body, and at an unspecified time after vaccination with INFANRIX, Hepatitis B vaccine, Hib, and PREVNAR, the subject experienced food allergies. The consumer reported that the events were worse after the vaccinations received at 4-months-old. At the time of reporting the rash all over body was resolved and the food allergies were unresolved.
Age: 0.06
Sex: F
Vaccine: DTAP
Symptoms: Asthma, Crying, Erythema, Immediate post-injection reaction, Urticaria
Clinical narrative: This case was reported by a consumer (the subjects mother) and described the occurrence of crying in a 5-week-old female subject who was vaccinated with DTaP vaccine (Manufacturer unknown). A physician or other health care professional has not verified this report. On an unspecified date in June 1999 the subject received unspecified dose of DTaP vaccine (details unknown). In June 1999, immediately after vaccination with DTaP vaccine, the subject experienced crying and within hours of vaccination had developed red hives all over her body. The subject sought medical attention at a doctors office. The subject was treated with TYLENOL. The events were resolved within 24 hours. The consumer reported that the subject has received other vaccinations since, but no pertussis vaccinations. The physician documented the event at that time. The subject went on to develop bronchial asthma at the age of 3 to 4, but outgrew it.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Injection site erythema, Injection site hypersensitivity, Screaming
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of injection site redness in a 2-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included HIBERIX GlaxoSmithKline; unknown; right thigh given on 26 August 2010. On 26 August 2010 at 11:00 the subject received 1st dose of INFANRIX (.5 ml, unknown route, left thigh). On the afternoon of 26 August 2010, less than one day after vaccination with INFANRIX, the subject experienced injection site redness, sensitivity at injection site, crying and screaming. The subject received INFANRIX in his left leg and HIBERIX in his right leg. His left leg was red and sensitive to the touch following vaccination. At the time of reporting the events were unresolved.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of fever in a 8-year-old female subject who was vaccinated with DTaP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of DTaP vaccine (details unknown). At an unspecified time after vaccination with DTaP vaccine, the subject experienced fever and increased heart rate. At the time of reporting the events were resolved.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Crying, Erythema, Screaming
Clinical narrative: This case was reported by a consumer via another manufacturer and described the occurrence of screaming in a 2-month-old subject of unspecified gender who was vaccinated with DTaP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of DTaP vaccine (unknown). At an unspecified time after vaccination with DTaP vaccine, the subject experienced screaming, crying and a red area on their leg. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Diarrhoea, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a female subject of unspecified age who was vaccinated with Influenza vaccine (GlaxoSmithKline), DTP (A or W not known). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism. There were no concurrent medications. On an unspecified date "in the past', the subject received unspecified dose of Influenza vaccine (unknown), unspecified dose of DTP (A or W not known) (unknown). At an unspecified time after vaccination with DTP (A or W not known) and Influenza vaccine, the subject experienced headache and diarrhea. At the time of reporting the outcome of the headache and diarrhea were unspecified. The subject reported a case for her son, see A0883807A.
Age: 1.12
Sex: M
Vaccine: DTAP
Symptoms: Herpes zoster, Impetigo, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a 14-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 January 2011 the subject received 1st dose of INFANRIX (unknown, right thigh). On 01 January 2011 the parent brought in the subject, a 14 month old breastfed, natural birth son to the emergency room (ER) after a fall. The ER staff recommended a tetanus shot and once it was discovered the subject had had no vaccinations to date, consent was obtained and a primary INFANRIX vaccine was injected into this right thigh leg. On 20 January 2011, 19 days after vaccination with INFANRIX, the subject experienced shingles, impetigo and rash. On 20 January 2011, the mother noticed a rash on the subject's right upper face which she believed to be Impetigo. Since that time the rash had worsened spreading to his forehead, upper and lower eyelids, upper cheek and ending behind his ear. The subject has been seen by his primary care physician, dermatologist and ophthalmologist and his shingles treated with two antibiotics and two topical medications without benefit. The mother now regrets allowing the subject to be vaccinated in the ER at all. It was indicated that the subject's birth weight was 22 pounds however there was a possibility she was mistakenly reported the subject's weight at the time of the vaccination. The subject was treated with antibiotics and unspecified medications. At the time of reporting the shingles, impetigo and rash were worse.
Age: 40.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient with no pertinent medical history or drug reactions who on 04-MAY-2010 was vaccinated with a standard dose of VARIVAX (Merck). Concomitant therapy included ADACEL. On 21-MAY-2010 (last Friday) the patient had rash on her neck, face, and abdomen. She had about dozen lesions. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from this event. Additional information has been requested.