chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old female patient who was diagnosed with molluscum a couple years ago. The patient was vaccinated with the first dose of VARIVAX (Merck) at 12 months of age and the second dose of VARIVAX (Merck) (lot# 658936/1350U) at 5 years old. There was no concomitant medication. Subsequently the patient presented with chickenpox at the age 7. The patient sought unspecified medical attention. At the time of the report, the patient's chickenpox persisted. Follow up information received from a nurse practitioner concerning a 7 year old female patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions, and no adverse event following prior vaccinations, who was vaccinated with the first dose of VARIVAX (Merck) (lot # 656577/0447U) in the left leg on 13-JUL-2007, and the second dose of VARIVAX (Merck) (lot # 660061/0090X, previously reported as 658936/1350U) on 07-JUN-2008. On 25-JUN-2010 the patient had case of varicella despite having received 2 doses of VARIVAX (Merck). There were no labs or diagnostic tests performed. The patient recovered at time of the reporting. Additional information is not expected.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Antibody test positive, Bacterial test, Blister, Full blood count, HIV test
Clinical narrative: Information has been received from a physician concerning a 15 month old female patient with no pertinent medical history or no drug reaction or allergy who on 30-MAR-2010 was vaccinated SC with a dose of VARIVAX (Merck) (lot# 665209/1153Y). There was no concomitant medication. On 23-JUN-2010 the patient broke out in "shingles". The patient sought unspecified medical attention. Lab diagnostic studies included bacterial and viral culture, CBC and HIV test. But the results were not reported. It was reported that they had not improved, but had gotten worse. Follow up information was received from a medical assistant who reported that the patient was recovering. Follow-up information has been received from a physician. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 30-MAR-2010, the 15 month old patient (also reported as 16 month old) was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot# 665209/1153Y) SC into her left thigh. On 23-JUN-2010, the patient experienced shingles, unilateral, left sided, dermatomes 5-7, number of lesions was over 100 vesicles. The rash did not occur at the site of injection. The patient was afebrile and there was no pain. Other systemic symptoms included fussiness. There was no history of chickenpox or shingles, no major medical condition and no concurrent condition. There was no recent exposure to chickenpox or herpes zoster. Varicella zoster virus antibody test showed vericella/herpes. On 30-JUN-2010, the specimen was sent to the laboratory, and the PCR result from the specimen showed HSV1 and HSV2 which identified the presence of VZV Merck vaccine strain. At the time of reporting, the patient was not recovered yet. Follow up information was received from a physician who reported that a lesion sample was collected on 30-JUN-2010. The sample same taken from a lesion and swab of unroofed vesicle. VZV DNA was amplified. The PCR result from the scab specimen identified the presence of VZV Merck vaccine strain. Follow up information has been received from a medical assistant concerning the 15 month old female patient with no pre-existing allergies, birth defects or medical conditions and no adverse event following prior vaccination who on 30-MAR-2010 at 13:15 was vaccinated with the first dose of VARIVAX (Merck) (lot number 665209/1153Y) subcutaneously at left thigh, the first dose of MMR II (MSD) (lot number 665213/0945Y) subcutaneously at right thigh, and the first dose of VAQTA (MSD) (lot number 667009/0095Z) intramuscularly at left thigh. There was no concomitant medication. On 25-JUN-2010 the patient developed Herpes Zoster. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Irritability, Polymerase chain reaction, Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 month old female patient with no pertinent medical history or no drug reaction or allergy who on 30-MAR-2010 was vaccinated SC with a dose of VARIVAX (Merck) (lot# 665209/1153Y). There was no concomitant medication. On 23-JUN-2010 the patient broke out in "shingles". The patient sought unspecified medical attention. Lab diagnostic studies included bacterial and viral culture, CBC and HIV test. But the results were not reported. It was reported that they had not improved, but had gotten worse. Follow up information was received from a medical assistant who reported that the patient was recovering. Follow-up information has been received from a physician. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 30-MAR-2010, the 15 month old patient (also reported as 16 month old) was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot# 665209/1153Y) SC into her left thigh. On 23-JUN-2010, the patient experienced shingles, unilateral, left sided, dermatomes 5-7, number of lesions was over 100 vesicles. The rash did not occur at the site of injection. The patient was afebrile and there was no pain. Other systemic symptoms included fussiness. There was no history of chickenpox or shingles, no major medical condition and no concurrent condition. There was no recent exposure to chickenpox or herpes zoster. Varicella zoster virus antibody test showed vericella/herpes. On 30-JUN-2010, the specimen was sent to the laboratory, and the PCR result from the specimen showed HSV1 and HSV2 which identified the presence of VZV Merck vaccine strain. At the time of reporting, the patient was not recovered yet. Follow up information was received from a physician who reported that a lesion sample was collected on 30-JUN-2010. The sample same taken from a lesion and swab of unroofed vesicle. VZV DNA was amplified. The PCR result from the scab specimen identified the presence of VZV Merck vaccine strain. Follow up information has been received from a medical assistant concerning the 15 month old female patient with no pre-existing allergies, birth defects or medical conditions and no adverse event following prior vaccination who on 30-MAR-2010 at 13:15 was vaccinated with the first dose of VARIVAX (Merck) (lot number 665209/1153Y) subcutaneously at left thigh, the first dose of MMR II (MSD) (lot number 665213/0945Y) subcutaneously at right thigh, and the first dose of VAQTA (MSD) (lot number 667009/0095Z) intramuscularly at left thigh. There was no concomitant medication. On 25-JUN-2010 the patient developed Herpes Zoster. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral test
Clinical narrative: Information has been received from a physician concerning a 15 month old female patient with no pertinent medical history or no drug reaction or allergy who on 30-MAR-2010 was vaccinated SC with a dose of VARIVAX (Merck) (lot# 665209/1153Y). There was no concomitant medication. On 23-JUN-2010 the patient broke out in "shingles". The patient sought unspecified medical attention. Lab diagnostic studies included bacterial and viral culture, CBC and HIV test. But the results were not reported. It was reported that they had not improved, but had gotten worse. Follow up information was received from a medical assistant who reported that the patient was recovering. Follow-up information has been received from a physician. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 30-MAR-2010, the 15 month old patient (also reported as 16 month old) was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot# 665209/1153Y) SC into her left thigh. On 23-JUN-2010, the patient experienced shingles, unilateral, left sided, dermatomes 5-7, number of lesions was over 100 vesicles. The rash did not occur at the site of injection. The patient was afebrile and there was no pain. Other systemic symptoms included fussiness. There was no history of chickenpox or shingles, no major medical condition and no concurrent condition. There was no recent exposure to chickenpox or herpes zoster. Varicella zoster virus antibody test showed vericella/herpes. On 30-JUN-2010, the specimen was sent to the laboratory, and the PCR result from the specimen showed HSV1 and HSV2 which identified the presence of VZV Merck vaccine strain. At the time of reporting, the patient was not recovered yet. Follow up information was received from a physician who reported that a lesion sample was collected on 30-JUN-2010. The sample same taken from a lesion and swab of unroofed vesicle. VZV DNA was amplified. The PCR result from the scab specimen identified the presence of VZV Merck vaccine strain. Follow up information has been received from a medical assistant concerning the 15 month old female patient with no pre-existing allergies, birth defects or medical conditions and no adverse event following prior vaccination who on 30-MAR-2010 at 13:15 was vaccinated with the first dose of VARIVAX (Merck) (lot number 665209/1153Y) subcutaneously at left thigh, the first dose of MMR II (MSD) (lot number 665213/0945Y) subcutaneously at right thigh, and the first dose of VAQTA (MSD) (lot number 667009/0095Z) intramuscularly at left thigh. There was no concomitant medication. On 25-JUN-2010 the patient developed Herpes Zoster. On an unspecified date the patient recovered. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Headache, Pyrexia, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 24 year old male patient who on 04-JUN-2010 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included ALLEGRA. On 24-JUN-2010 the patient experienced severe headache and fever. On 26-JUN-2010 the patient broke out with 5-7 vesicles which tested positive for varicella. The patient sought unspecified medical attention. Lab test for varicella antibody showed positive. No treatment was required at this time. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Rash, Rash maculo-papular
Clinical narrative: Information has been received from an office manager concerning a patient who on 28-JUN-2010 was vaccinated with a dose of VARIVAX (Merck) IM instead of SC. No adverse effects were reported. Follow-up information received from an office manager concerning a 12 year old male patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions, and no adverse event following prior vaccinations, who on 28-JUN-2010 at 11:30 am was vaccinated with the second dose of VARIVAX (Merck) (lot # 665575/1229Y, in the left deltoid) IM instead of SC. Concomitant therapy included the first dose of MENACTRA (unspecified, sanofi, lot # U3465AA, IM ) in the right deltoid and the sixth dose of BOOSTRIX (lot # AC52B061EA, IM) in the left deltoid on 28-JUN-2010 at 11:30 am. It was reported that the patient did develop rash on 23-AUG-2010, diagnosed as 704.8. The patient's brother had rash 2 days earlier, and both in hot tub during previous week. The event was described as macro papular rash on torso, upper arms and slightly on the upper legs. There were no labs or diagnostic tests performed. At time of report, the patient recovered. Additional information is not expected. The patient's brother information has been captured in WAES # 1009USA05027.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse, concerning a male patient, who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided). The nurse reported that the patient had varicella twice (dates not reported). The patient's outcome was unknown at the time of reporting. It was unknown if the patient sought medical attention. This is one of several reports from the same source. 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 concerning a patient who "last week" on approximately 21-JUN-2010 was intended to receive ZOSTAVAX (Merck), was inadvertently administered subcutaneously a 0.5 ml dose of VARIVAX (Merck). No adverse symptoms reported. The patient's outcome was unknown. No further information is available.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a now 29 year old female who in 2006 was vaccinated with 2 doses of VARIVAX (Merck). Concomitant therapy included LEVOTHROID. On an unspecified date, titer was negative. The patient did not seek medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Information has been received from a physician concerning an "adolescent" female who was vaccinated with VARIVAX (Merck) (Lot# unknown). Subsequently, the physician reported that the patient received a dose of VARIVAX (Merck) and had an immediately reaction. The area where she received the shot became red. At the time of the report, the patient was recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no known drug allergies and no pertinent medical history who on 26-JUL-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot# 666726/0028Z). There was no concomitant medication. On 28-JUL-2010 ("2 days after the vaccination") the patient experienced rash and hives. The patient did not seek medical attention. There was no lab or diagnostic test performed. On 02-AUG-2010 ("5 days after the appearance of hives"), the patient recovered from rash and hives. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an "8 year old" male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). Subsequently, on an unspecified date the patient experienced shingles. Unspecified medical attention was sought. The patient recovered from shingles after on unknown therapy. After experiencing shingles, on an unspecified date, the patient was administered the second dose of VARIVAX (Merck). This is the first of two sibling cases received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old patient who on 22-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 666863/0467Z), 0.5 mL (route of administration not reported). Concomitant therapy included BOOSTRIX. It was reported that on 23-JUL-2010 the patient experienced localized reaction, discomfort, swelling, redness at the injection site after receiving VARIVAX (Merck) (unknown whether this was the first or second dose). At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with no pertinent medical history and no allergies who on 18-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported). On an unspecified date, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # not reported). Concomitant therapy included oral contraceptives (unspecified). Subsequently, the patient's titer was low. Unspecified medical attention was sought via office visit. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Blister, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male patient with no pertinent medical history and no allergies who on 03-AUG-2010 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 666728/0341Z). Concomitant therapy included PREVNAR 13. On 23-AUG-2010 ("2 days ago"), the patient developed chickenpox. The patient had more than 25 lesions from head to toe. Few lesions had been scabbed over but most were still blisters. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. The patient's chickenpox persisted. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 15 year old male with no pertinent medical history who on 25-OCT-2000 was vaccinated subcutaneously with one 0.5 mL dose of VARIVAX (Merck) (LOT# not reported). In July 2010, the patient was diagnosed with shingles. Unspecified medical attention was sought. No further details were provided at this time. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 11 year old male with attention deficit/hyperactivity disorder (ADHD) and penicillin allergy who on 23-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). Concomitant therapy included FOCALIN. After receiving the vaccine, the patient experienced redness and swelling of his left arm at the injection site. There were no lab diagnostic studies performed. The patient sought medical attention via visiting to school nurse. The patient's redness and swelling of his left arm at the injection site persisted. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a "10 year old" male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). Subsequently, on an unspecified date the patient experienced shingles. Unspecified medical attention was sought. The patient recovered from shingles after on unknown therapy. After experiencing shingles, on an unspecified date, the patient was administered the second dose of VARIVAX (Merck). This is the second of two sibling cases received from same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning a 38 year old (now 52 year old) female patient with breast cancer and no drug reactions/allergies on 16-FEB-1996, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). In May 1996, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# not reported). On October 2009, the patient was vaccinated with the third dose of VARIVAX (Merck) (lot # 665025/0992Y). Concomitant therapy included AROMASIN, EFFEXOR and multivitamins (unspecified). The patient  had antibody titers test performed. The physician stated that the patient continued to have negative titer even after receiving three doses of VARIVAX (Merck). The patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician who reported that on 21-OCT-2009, the patient with bee sting allergy and osteopenia and a history of breast cancer, was vaccinated intramuscularly in the left arm with the second or third dose (not sure) of VARIVAX (Merck) (lot # 665025/0992Y). On 06-AUG-2010, a varicella zoster virus IgG test performed was <0.9. Failed to show immune response to vaccine. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Information has been received from a physician concerning a 3-4 year old female patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (Lot # and route not reported). On approximately 18-AUG-2010, she was vaccinated with the 0.5ml second dose of VARIVAX (Merck) (Lot # 666923/0344Z), (route no reported). There was no concomitant therapy. The physician stated that two days after she received the second dose, on approximately 20-AUG-2010, the patient experienced redness at the injection side. Physician also reported that the patient was around a shingles patient at this time during this time. At the time of the report, the outcome of the patient was no reported. The patient sought unspecified medical attention. Follow-up information was received from a physician who stated that 36 months old female patient who on 09-AUG-2010, was vaccinated SQ into the left arm with the second dose of VARIVAX (Merck) (Lot # 666367/0248Z). At the time of vaccination the patient was suffering from otitis media. Otitis media was treated with amoxicillin. It was reported that on 10-AUG-2010, the patient experienced swollen upper left arm, warm to touch but had full range of movement (FROM). On 10-AUG-2010 had fever 101". At the time of the report, the patient had recovered. The patient did not seek medical attention. No further information is expected.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient with drug reactions or allergies to penicillin and no pertinent medical history who on 28-APR-2006 was vaccinated subcutaneously with an 0.5 ml dose of VARIVAX (Merck) (Lot # 652723/1128R, expiration date unavailable). There was no concomitant medication. On 02-MAR-2010, the patient was diagnosed with shingles. The distribution of the rash was right leg and hip. The patient was treated with acyclovir and fully recovered on an unspecified date. Lab diagnostics studies were not performed. Patient sought medical attention by an office visit. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site reaction, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient who on 02-AUG-2010, was vaccinated with a dose of VARIVAX (Lot # 666765/0088Z). Concomitant vaccinations included a dose of MMR II (MSD) and a dose of PNEUMOVAX 23 (manufacturer unspecified). It was reported, that the patient developed a varicella-like rash at the injection site of VARIVAX, immediately after the administration. At the time of the report, the patient's outcome for varicella-like rash at the injection site was not 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 school nurse (registered nurse) concerning a 5 year old female who on 03-FEB-2010 was vaccinated with VARIVAX (Merck) (lot# not reported). On 21-AUG-2010 (10 days ago) the patient developed chickenpox. The nurse stated initially the child's physician was not certain if it was chickenpox but the mom getting shingles prompted him to say the child had chickenpox. Medical attention was sought by office visit. At the time of the report the patient had not recovered. It was reported the the pregnant mother of the child diagnosed with a mild case of shingles after the child developed chickenpox. Follow up information has been received from the registered nurse indicated that there was no "exposure to VARIVAX". Again there was no adverse reaction to the VARIVAX (Merck), none were given. Follow up information has been received from the registered nurse concerning the 4 year old (previously reported as 5 year old) female patient who on 03-FEB-2010 was vaccinated with a dose of VARIVAX (Merck) (lot number unavailable). In August 2010 the patient developed chickenpox. On an unspecified date the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood glucose increased, Ketonuria, Nasal congestion, Urine analysis abnormal, Urine ketone body present
Clinical narrative: Information has been received from a Registered Nurse concerning an 11 year old female patient with diabetes and no drug reactions or allergies who last week on approximately 24-AUG-2010 was vaccinated by an unspecified route with an unspecified dose of VARIVAX (Merck) (Lot# unknown). Concomitant therapy included insulin. The school nurse reported that the patient on 31-AUG-2010, presented with an elevated blood glucose level, ketonuria and a stuffy nose. The school nurse reported that the blood glucose levels on 31-AUG-2010 and 01-SEP-2010, where both in the 400s, and that the patient tested positive for ketonuria on both days. No specific values were available. The school nurse stated that she conferred with the patient's parents and physician and reported that the patient's physician ordered an increase in the quantity of insulin. At the time of the report, the patient was recovering. The patient sought medical attention by seeing school nurse. Follow up information has been received from a Registered Nurse who indicated that the patient was a student who on 09-AUG-2010, was vaccinated with a dose of VARIVAX (Merck) into her right arm. Secondary suspect vaccination included a dose of GARDASIL (Lot# 663451/0216Y) given IM into her left deltoid. It was reported that on 31-AUG-2010, the patient's blood sugar ran high for several weeks. Illness at the time of vaccination included increased blood sugar and body spilling out ketones in urine. According to the reporting nurse, the physician thought that it might be an insulin per mal function and the patient had improved with using insulin syringes again. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 26-AUG-2010, was inadvertently vaccinated with VARIVAX (Merck) (Lot# not reported). The patient was intended to receive ZOSTAVAX (Merck). No adverse symptoms were reported. No further information is available.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old male patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) in his arm. Concomitant therapy included BENADRYL. Shortly after vaccination, the patient developed a red mark at the injection site which became softball size. Unspecified medical attention was sought. No further injection was given and he was treated with BENADRYL that made the reaction go away. At the time of this report, the patient had recovered from a red mark at the injection site. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient with a history of coxsackie viral infection (about 2 weeks before vaccination with VARIVAX (Merck)) who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot # not reported). About 14 days after vaccination, the patient developed a generalized rash. The patient was taken to the Emergency Room but not admitted to the hospital. She was treated with antihistamines and oral fluids. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received concerning a 10 year old patient who was vaccinated with the first dose of VARIVAX (Merck) (Lot # not reported). Currently, the patient presented with mild case of the chickenpox after receiving the first dose of VARIVAX (Merck). The patient did not seek medical attention. At the time of reporting, the patient was recovering. The patient's sibling also presented with a mild case of the chickenpox after received the first dose of VARIVAX (Merck) (WAES#1009USA00534). No further information is available.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Drug exposure during pregnancy, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning his 14 year old sister with no known medical history and no known drug reactions/allergies, who on 25-AUG-2010 was vaccinated with VARIVAX (Merck) (Dose/Frequency: unspecified) (Lot#/ Exp. Date: unspecified). There was no concomitant therapy. The patient was pregnant before she got the vaccine shot. She had bruising, swelling and pain at the injection site. The patient was at the hospital for 4 to 5 hours. They did blood work on her, results not provided. The patient's bruising, swelling and pain at the injection site persisted. The patient sought medical attention by going to the hospital. Additional information is not expected.
Age: 1.8
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 21 month old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male patient who on an unspecified date was vaccinated with 0.5ml dose of VARIVAX (Merck) (lot# not reported). On an unspecified date, the patient broke out with chickenpox. On an unspecified date the patient recovered from chickenpox. The patient sought unknown medical attention. Additional information has been requested. The patient's sibling also experienced chickenpox after receiving 0.5ml dose of VARIVAX (Merck) (WAES # 1009USA00557).
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning an adolescent patient who within the last two weeks (in August 2010) was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided). The nurse reported that the patient experienced normal redness around the injection area (in August 2010). The nurse reported that BENADRYL took care of the redness. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received concerning that an 11 year old patient who was on an unspecified date vaccinated with the first dose of VARIVAX (Merck) (Lot # not reported). Subsequently, the patient presented with mild case of the chickenpox. It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. The patient's sibling also presented with a mild case of the chickenpox after received the first dose of VARIVAX (Merck) (WAES#1009USA00399). No further information is available.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 8 year old female patient who on an unspecified date was vaccinated with 0.5ml dose of VARIVAX (Merck) (lot# not reported). On an unspecified date, the patient broke out with chickenpox. On an unspecified date the patient recovered from chickenpox. The patient sought unknown medical attention. Additional information has been requested. The patient's sibling also experienced chickenpox after receiving 0.5ml dose of VARIVAX (Merck) (WAES # 1009USA00415).
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning her child who on an unspecified date, were vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced injection site reactions of rash, redness and swelling. At the time of this report, the patient was recovering. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a child patient who on approximately 03-AUG-2010 "a month ago" was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported). Subsequently, on an unspecified date, the patient's are was red, swollen and warm at injection site. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Rash vesicular
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 14 month old female patient with eczema and no drug reaction or allergies; who on 27-AUG-2010 was vaccinated with VARIVAX (Merck) (Lot #, dose and route no reported). Concomitant therapy included Hib conj vaccine (unspecified carrier) (manufacturer unknown). The pharmacist reported that on 30-AUG-2010, the patient developed varicella like rash after receiving a dose of VARIVAX (Merck). She developed "pimple" like rash around the face, upper chest and scalp. No laboratory tests were performed. At the time of the report, the patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an approximately 8 year old (8 or 9) year old male patient who on approximately 25-AUG-2010 (within the last two weeks), was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). Concomitant therapies included vaccination with a dose of meningococcal vaccine (unspecified) (manufacturer unspecified) (Lot # not provided) and a dose of TDAP (manufacturer unspecified) (Lot # not provided). The physician reported that the patient after receiving a dose of VARIVAX (Merck) experienced syncope in the office and was observed in office for an hour. Patient recovered in office. Follow-up information was received from a medical assistant who clarify that the patient was 11 year old. The medical assistant also stated that the patient never received VARIVAX (Merck) and the physician diagnosed the syncopal episode as being related to anxiety over an injection. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a immunization consultant that she heard from the school nurse concerning an approximately 7 year old female who on 08-OCT-2004 and 07-OCT-2008 was vaccinated subcutaneously with a first and second dose of VARIVAX (Merck) (lot # for the 1st dose of 644795/0335N). It was reported that the patient who had 2 doses of VARIVAX (Merck) and broke out in chicken pox. The patient's symptom improved on therapy. As of 08-SEP-2010 the patient's outcome was unknown. Follow-up information received from the Immunization Consultant, Supervisor indicating that she did not have the lot number for the second dose of VARIVAX (Merck) that was administered on 07-OCT-2008. The patient developed a generalized rash, less than 50 lesions which were mostly fluid filled and itchy. The patient had developed a fever (temperature unknown to reporter). The patient was diagnosed with chickenpox on 07-SEP-2010. The reporter thought that the patient had recovered and was back to school. The Immunization Consultant, Supervisor did not have any additional information and stated that she would call back it she did receive additional information.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a male in his 60's who on 04-AUG-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 665423/1295Y) (route no reported). The nurse reported that about 2 weeks after his first vaccination on approximately 18-AUG-2010, the patient developed a rash. The rash was described as mild and "bubbled" on his arm and leg. The nurse stated that the patient had done a yard before he developed the rash. On an unspecified date, the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health department employee concerning a male child patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck). After vaccination the patient experienced shingles. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician who received a phone call from an unspecified physician concerning an 18 month old patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (Lot# not reported) and ten days after the vaccination the patient was diagnosed with "full blown varicella". At the time of the report, the patient was recovering. It was unknown if the patient sought medical attention. Attempts are being made to verify the existence of an identifiable patient and reporter.
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 student patient with no know pre-existing allergies, birth defects or medical conditions who on 05-OCT-2006 was vaccinated with the first dose of VARIVAX (Merck) (Lot # and route no reported) and on 24-FEB-2010 was vaccinated SQ into the left thigh with the second dose of VARIVAX (Merck) (lot # 665209/1153Y). Concomitant therapy included the second dose of MMR (lot # 663521/1759X) SC into the left thigh, hepatitis A vaccine (lot # 665114/0739Y) IM into the right vastus and DAPTACEL (lot # C3142A) IM into the left vastus. The physician reported that on 27-AUG-2010 the patient was diagnosed with chickenpox beside she had both doses of VARIVAX (Merck). On 07-SEP-2010 the patient had recovered from chickenpox. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a child patient who on approximately 30-AUG-2010 "week of 30-AUG-2010", was vaccinated with a dose of VARIVAX (Merck) (Lot#: 667293/0640Z). Lab diagnostics studies were not performed. Subsequently, on an unspecified date, the patient's area was very red, swollen and painful at injection site. There was a picture of the reaction if needed. Office staff member felt it was more of a reaction "than she had ever seen". At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a child patient who on approximately 30-AUG-2010 "week of 30-AUG-2010", was vaccinated with a dose of VARIVAX (Merck) (Lot# 667293/0640Z). Lab diagnostics studies were not performed. Subsequently, on an unspecified date, the patient's area was very red, swollen and painful at injection site. Skin around site was hard and the child was going to see the physician on 03-SEP-2010. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner and from a physician concerning a patient who on an unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (Lot# not reported) and on approximately 07-SEP-2010 "last week", the patient experienced chickenpox. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Seroconversion test negative, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning an about 20 year old female who "at 5 years of age" in 1995 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). "Recent" in 2010, antibody titer test showed that she failed to seroconvert. Unspecified medical attention was sought. No further information is available.
Age: 1.0
Sex: F
Vaccine: FLUX, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 12 month old female daughter of her husband's coworker who on 10-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) in one leg (dose, route and lot number unspecified). Concomitant therapy included a dose of influenza virus vaccine (unspecified) and a dose of PREVNAR in the other leg. Within 45 minutes (on 10-SEP-2010), the patient experienced fever, swelling and redness at the VARIVAX (Merck) injection site. The patient developed few varicella-like lesions on her trunk, five days later, (on approximately 15-SEP-2010). At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date, was vaccinated with VARIVAX (Merck). A couple of weeks later, the patient developed a reaction to the vaccine. The patient developed a rash. The doctor did not specify if it was a varicella type rash. At the time of the report, the outcomes were unknown. The patient sought an unknown medical attention. Additional information has been requested.
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a 0.5mL dose of VARIVAX (Merck). Secondary suspect included MMR II (MSD), for the treatment of prophylaxis (dose not reported). Concomitant therapy included poliovirus vaccine inactivated (unspecified) (manufacturer unknown) and another unspecified vaccine. The patient had localized redness and swelling within 5 minutes after vaccination, that was pretty severe, and the patient was kept at the office for about an hour. It was unknown if the vaccinations at the same site or which vaccine was administered at the site where the Adverse Event occurred. They gave him an unspecified medication to treat the adverse event. At the time of the report, the outcomes adverse events improved. 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 registered nurse (R.N.) concerning a patient who on 15-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # unknown) instead of ZOSTAVAX (Merck) due to human error. No adverse effect was reported. Follow-up information has been received from a registered nurse BSN who reported that the 75 year old retired patient on 15-SEP-2010 afternoon was vaccinated subcutaneously into the left arm with the first dose of VARIVAX (Merck) in the afternoon. ZOSTAVAX (Merck) was to be given. No adverse events. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Amniocentesis abnormal, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who in June 2010, was vaccinated with a dose of VARIVAX (Merck) when she was around 2 weeks pregnant. Concomitant therapy included prenatal vitamin (unspecified) more than 200 doses. At the time of the report the patient was 17 weeks 3 days pregnant. No adverse reactions reported. No lab diagnostics studies were performed. Date of last menstrual period (LMP): 18-May-2010, estimate delivered date (EDD): 22-Feb-2011. Follow-up information has been received from an initial pregnancy questionnaire concerning a female patient without history of previous pregnancies, pre-term births or miscarriages and no live births who in June 2010, was vaccinated with a dose of VARIVAX (Merck). The physician stated that on 06-OCT-2010, a routine ultrasound was performed and the results were normal. On an unspecified date an ultrasound was performed and showed that hyperechoic amniotic fluid was noted at 40 weeks of gestation. On 25-FEB-2011 delivered a normal, healthy male baby weighing 7 pounds, 3 ounces at 40 weeks and 3 days of gestation. It was reported that the infant was normal, with no congenital anomalies and there were no other complications. The patient had a normal labor/delivery with no complications, no concurrent medical conditions, no diagnostic tests were performed during pregnancy and no infections or illness during pregnancy. It was unknown if the patient was tested for varicella antibodies before vaccination with VZV containing vaccine. There were no local reaction at vaccination site, varicella (chickenpox) symptoms post vaccination or herpes zoster (shingles) symptoms post vaccination. Additional information is not expected.