chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 31 year old female with no pertinent medical history or drug allergies who on 19-MAR-2007 and 15-APR-2007 was vaccinated SC with the first and second 0.5 ml doses of varicella virus vaccine live (Oka/Merck) (lot# 656078/0169U). There was no concomitant medication. On 06-DEC-2007 the patient experienced a negative titer result from labs at the physician's office. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a patient who was  vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In December 2007 the patient's mother reported the patient developed a rash which she thought looked like chickenpox. The nurse indicated the patient would be seen in the office later on this afternoon. At the time of reporting that patient's status was unknown. The nurse reported they were having a lot of cases of chickenpox in their office, sometimes 1-2 cases a week. Most of the cases were following varicella virus vaccine live (Oka/Merck). She further explained that they have been reporting the cases via the rep and also to the state. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash papular, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning an 8-year-old male with no pertinent medical history or drug allergies who on 19-JAN-2001 was vaccinated subcutaneously in the left arm with a dose of varicella virus vaccine live (Oka/Merck) (lot# 635191/0939K). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown) and tuberculin purified protein derivative (manufacturer unknown). On 20-DEC-2007 the patient experienced chickenpox. The patient was examined in the office on 22-DEC-2007 and there were 8 to 10 papules that were itchy on the face, chest and arms. The patient did not have a fever. No laboratory or diagnostic tests were performed. The outcome was reported as recovering. No product quality complaint was involved. Follow up information has been received concerning a white male who received a subcutaneous dose in the right arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 635281/0405K) on 19-Jan-2001. There was no illness at the time of vaccination. On 20-DEC-2007 the patient had 8-10 papule vesicular lesions on the face, chest and arms. On an unspecified date, the patient recovered and is done care. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from the father of an 8-year-old male who in October of 2007, was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U, product circular# 7999916). The father reported that "my son has been having fevers since his second dose of varicella virus vaccine live (Oka/Merck) in October". Unspecified medical attention was sought. The outcome was not reported. No product quality complaint was involved. Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old white female with a history of asthma and no known drug allergies who on 28-APR-2005 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) (lot# 648307/0582P). The illness at the time of vaccination was nasal congestion. On 30-NOV-2007 the patient developed one spot on the left side of her back. It was unknown whether medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an 8-year-old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658594/1330U). On an unspecified date (post vaccination) the patient experienced an injection site reaction. The office suspected the diluent and disposed of all diluent of that lot number (lot number unavailable). At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 3-year-old female who at the age of one-year, in approximately 2005, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 29-Dec-2007, the patient developed shingles. The patient was treated with acyclovir. No other information was available from the physician. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine  live (Oka/Merck). Subsequently the patient's IGG levels came back negative. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician assistant concerning a 6-year-old patient with no pertinent medical history or allergies who on 14-AUG-2007 was vaccinated subcutaneous with a second dose of varicella virus vaccine live (Oka/Merck) (lot # "0856U"). There was no concomitant medication. On an unspecified date the patient developed a varicella-like rash of 50 lesions or less. The patient sought medical attention via an office exam on 12-SEP-2007. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Information has been received from a health professional concerning a 34 year old female who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced itching and a raised area at the injection site. The raised area lasted 3 days and the patient has recovered. It was also reported that the patient was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) intramuscularly. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an approximately 9 year old white male on 07-DEC-1999 and 25-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) SC. There was no concomitant medication. The physician reported that the patient was seen on 24-SEP-2007 with papular vesicular rash developing over 3 days, compatible with varicella. Subsequently, the patient recovered from papular vesicular rash.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with no pertinent medical history, and a drug hypersensitivity to ranitidine hydrochloride (ZANTAC) who on 01-APR-2004 was vaccinated subcutaneously into the right arm with a booster dose, 0.5 ml, of varicella virus vaccine live (Oka/Merck) (Lot # 658373/1116U). There was no concomitant medication. Subsequently the patient developed a 3-4 cm raised wheel and erythematous. At the time of reporting the patient was recovering, and "the reaction was beginning to fade". Medical attention was sought. The patient was seen in the office on 08 OCT 2007. There was no product quality complaint. There were no lab diagnostic studies performed. A lot check has been requested by the reporter. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme, Pain, Pharyngolaryngeal pain, Pyrexia, Rash pruritic
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 55-year-old female with allergies to prochlorperazine maleate (COMPAZINE) and nickel who on 18-DEC-2007 was vaccinated subcutaneously in the left arm with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot# 656279/1503F). Concomitant therapy included levothyroxine Na (SYNTHROID), atorvastatin calcium (LIPITOR) and zaleplon (SONATA). On 03-JAN-2008 the patient developed a fever, sore throat and itchy rash. The patient called the physician's office and was referred to an unspecified dermatologist who diagnosed the patient with chickenpox. The patient had bumps (red dots) on her back, stomach, face and neck. The patient also reported feeling achy. The patient was prescribed valacyclovir hydrochloride (VALTREX) 1 gm, TID for 10 days. The RN spoke to the patient on 10-JAN-2008 and the patient was "doing better". At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been received from a registered nurse. Additional concurrent condition includes hyperlipidemia and medical history was reported as thyroid cancer and kidney cancer. Allergic reations were described as prochlorperazine maleate (COMPAZINE) which was associated with seizures and nickel associated with a rash. There was no recent exposures to chickenpox or shingles. It was reported that the vaccination with varicella virus vaccine live (Oka/Merck) was given in the right upper arm not the left arm as previously reported. On 01-JAN-2008 (previously reported as 03-JAN-2008) the patient developed a sore throat, fever, and rash. The rash was described as macule type with distribution "all over". This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 55-year-old female with allergies to prochlorperazine maleate (COMPAZINE) and nickel who on 18-DEC-2007 was vaccinated subcutaneously in the left arm with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot# 656279/1503F). Concomitant therapy included levothyroxine Na (SYNTHROID), atorvastatin calcium (LIPITOR) and zaleplon (SONATA). On 03-JAN-2008 the patient developed a fever, sore throat and itchy rash. The patient called the physician's office and was referred to an unspecified dermatologist who diagnosed the patient with chickenpox. The patient had bumps (red dots) on her back, stomach, face and neck. The patient also reported feeling achy. The patient was prescribed valacyclovir hydrochloride (VALTREX) 1 gm, TID for 10 days. The RN spoke to the patient on 10-JAN-2008 and the patient was "doing better". At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been received from a registered nurse. Additional concurrent condition includes hyperlipidemia and medical history was reported as thyroid cancer and kidney cancer. Allergic reations were described as prochlorperazine maleate (COMPAZINE) which was associated with seizures and nickel associated with a rash. There was no recent exposures to chickenpox or shingles. It was reported that the vaccination with varicella virus vaccine live (Oka/Merck) was given in the right upper arm not the left arm as previously reported. On 01-JAN-2008 (previously reported as 03-JAN-2008) the patient developed a sore throat, fever, and rash. The rash was described as macule type with distribution "all over". This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a female with no pertinent medical history, drug reactions or allergies who in 2003 received two subcutaneous doses, 0.5 ml, of varicella virus vaccine live (Oka/Merck). The nurse reported that it had "recently" been discovered, in 2007, that the patient had negative antibody titers. There were no problems reported. Medical attention was sought. The patient was examined in the office. There was no concomitant therapy. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Neck mass
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 14 year old female, who in 2006 was vaccinated with varicella virus vaccine live (Oka/Merck). In 2006 the patient developed a lump on her neck shortly after receiving her vaccination with varicella virus vaccine live (Oka/Merck), which her mother reported "eventually fully recovered". There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning his daughter who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced breakthrough varicella characterized by a few papular vesicles. The physician suspected non-wild type varicella. Medical attention was sought. The patient's outcome was recovered. There was no product quality complaint. This is one of several reports from the same source. No further information is available.
Age: 0.9
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, Blood immunoglobulin M, Pyrexia, Rash vesicular, Scab
Clinical narrative: Information has been received from a physician concerning a 2 year old male patient no pertinent medical history and no drug reactions/allergies, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) in approximately June 2006 at approximately 1 year of age. The patient was adopted at 8 months of age and have been in contact with biological mother during her pregnancy. She had no history of chickenpox or zoster during pregnancy and the patient had not had chicken pox. On 29-SEP-2007 the patient had one week of fever followed by 10 vesicular lesions on left arm(8), 1 on lower hand and 1 on the back in midvertibral line. Herpes zoster - dermatome C6-C7. The lesions and fever are resolved. On 05-OCT-2007 diagnostics studies performed included: FAMA 1:64 and IgM<2. The crusted lesions sample was obtained on 05-OCT-2007 from his back, (waiting for other samples to arrive). The patient did not have a recent exposure to chickenpox or shingles. There was no product quality complaint. Follow-up information has been received. The patient was enrolled in the Varicella Zoster 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 the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 05-OCT-2007. The sample was taken from a back lesion crust. The PCR results for the specimen identified the presence of: Vaccine. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: VARCEL
Symptoms: Serology test
Clinical narrative: Information has been received from a physician concerning a 2 year old male patient no pertinent medical history and no drug reactions/allergies, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) in approximately June 2006 at approximately 1 year of age. The patient was adopted at 8 months of age and have been in contact with biological mother during her pregnancy. She had no history of chickenpox or zoster during pregnancy and the patient had not had chicken pox. On 29-SEP-2007 the patient had one week of fever followed by 10 vesicular lesions on left arm(8), 1 on lower hand and 1 on the back in midvertibral line. Herpes zoster - dermatome C6-C7. The lesions and fever are resolved. On 05-OCT-2007 diagnostics studies performed included: FAMA 1:64 and IgM<2. The crusted lesions sample was obtained on 05-OCT-2007 from his back, (waiting for other samples to arrive). The patient did not have a recent exposure to chickenpox or shingles. There was no product quality complaint. Follow-up information has been received. The patient was enrolled in the Varicella Zoster 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 the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 05-OCT-2007. The sample was taken from a back lesion crust. The PCR results for the specimen identified the presence of: Vaccine. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse who stated that on 26-DEC-2007 she was inadvertently vaccinated SC with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). She was administered the vaccine at a "walk in clinic". No adverse experience was related to this event. No further information was available. There was no product quality complaint.  Further information has been received from the nurse who reported that the patient was vaccinated with VARIVAX (LOT # 654590/1324U) on 24-DEC-2007 at 2:19 PM in the left deltoid.  The nurse reported that t he medical assistant took the wrong med instead of ZOSTAVAX (Merck) from the freezer.  The medical assistant realized the mistake and the patient was called back to the office.  It was reported that the patient had recovered on 26-DEC-2007.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old male with a history of hypertension, impotence, hyperlipidemia, lipoprotein deficiencies, osteoarthritis and a codeine allergy, who on 09-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD) due to medical error not product confusion. There was no illness at the time of vaccination. It was noted that the patient's wife currently had shingles and the patient never had chicken pox in the past. No medical attention was sought. The patient's outcome was unknown. There was no product quality complaint. Follow-up information has been received from a nurse indicating that the patient received a dose of varicella virus vaccine live (Oka/Merck) (lot# 656261/1495F) instead of zoster vaccine live (MSD). The patient was noted to be doing well. The nurse stated that there was no product confusion and that it was medical error. "The doctor had ordered the wrong vaccine." Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated on 12-DEC-2007 with varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U). On 14-DEC-2007, the patient developed "a softball sized lump at the injection site." Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 14-month-old female daughter with no pertinent medical history or allergies who in January 2003, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) 3 days later was diagnosed with chickenpox. There was no concomitant medication. On 08-OCT-2007 the patient was diagnosed with a second case of chickenpox. The patient sought unspecified medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 07-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U). On 09-DEC-2007 the patient developed "a softball sized limp at the injection site." The patient developed a fever of 103 F (date not provided). This report is one of several from the same source. Further information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic, Rash pustular, Scab, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an approximately 12 month old female who was vaccinated with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (no lot number available). Concomitant vaccinations administered that same day included "standard vaccines at 12 months of age." In 2007 within 4 months after vaccination, the patient developed 15 lesions. Unspecified medical attention was sought. The outcome was unknown. There was no product quality complaint. Follow-up information received from the reporting registered nurse indicated that a 7 year old female with no pre-existing conditions or allergies who on approximately 13-SEP-2001 and 14-SEP-2007 was vaccinated SC with the first and second doses of varicella virus vaccine live (Oka/Merck) (lot# 1105U) in the left arm. There was no illness at the time of vaccination. No other vaccines were administered within 4 weeks of second vaccine. On 20-SEP-2007 the patient started breaking out with red bumps 50 or so (previously reported as 15 skin lesions) in the pubic area, legs, neck, scalp and back as reported by patient's mother. The patient also developed clear pustules on the red bumps that were itchy. It was noted that the pustules did break open and crust over. There was no fever. The child was not seen at clinic, but her mother called for advice to see if child was contagious. No labs or diagnostic studies were performed. Subsequently, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Blood test normal, Electroencephalogram normal, Gait disturbance, Head banging
Clinical narrative: Information has been received from a dentist concerning her 10 year old son with PMH significant for ADHD since kindergarten, ear infections, colds, bronchiolitis at 6 months of age, and febrile seizures (previously reported as no pertinent medical history), who on 19-JUL-2006 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot number: 652727/0428F). Concomitant therapy included methylphenidate hydrochloride (RITALIN) twice a day was discontinued, (reporter  noted that the methylphenidate hydrochloride (RITALIN) was discontinued on 2 occasions with no change in symptoms). On 21-JUL-2006, two days post vaccination, the patient experienced uncontrolled "ticks" throughout the whole body (tongue sticking out, arms waving, leg banging) that caused head "thrashing" for weeks and interfered with walking. The most severe period of the "ticks" was 2 weeks post vaccination on 02-AUG-2006 and was accompanied by a stiff neck and numbness in 1 leg (pins and needles, "could barely walk"). At approximately 3 weeks post vaccination, the patient developed vesicular rash with 10 total lesions. By September 2006, he had an x-ray of the legs which was negative. During this time frame, he developed round, large, red, ulcerated, fluid-filled, outbreaks (vesicles) sporadically throughout his body. He continued with the "outbreaks" and "ticks" until December 2006 when the "ticks" subsided and the "outbreaks" improved (still with some "ticks" mostly in his face and shaking of his head (in a "no" Motion). In May 2007, the cycle began again with tremendous "ticks" and a severe "outbreak" in arms, face, head and all through his inner thighs bilaterally, similar in appearance to previous rash, although more "aggressive" and was accompanied by crusting over of lesions and scarring. The "outbreak" spread to his arms and back but those areas were not as bad as his legs. The patient was taken to several specialists and had extensive neurological testing including for molluscum - all negative. It was noted that a pediatrician thought the rash resembled shingles. "Two weeks ago", the patient also developed 1 lesion on the arm and 1 lesion on his back. Over the past month, the "ticks" were still present and seemed to be linked to the "outbreak". The more severe the "outbreak", the more severe the "ticks". No further information was available. Lab diagnostic studies performed included: x-ray of the legs to rule out cysts (negative). MRI and EEG negative for seizure/tumor, unspecified neurologic testing negative. Unspecified medical attention was sought through multiple office visits and specialists. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Nerve conduction studies normal, Nuclear magnetic resonance imaging normal, Rash vesicular
Clinical narrative: Information has been received from a dentist concerning her 10 year old son with PMH significant for ADHD since kindergarten, ear infections, colds, bronchiolitis at 6 months of age, and febrile seizures (previously reported as no pertinent medical history), who on 19-JUL-2006 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot number: 652727/0428F). Concomitant therapy included methylphenidate hydrochloride (RITALIN) twice a day was discontinued, (reporter  noted that the methylphenidate hydrochloride (RITALIN) was discontinued on 2 occasions with no change in symptoms). On 21-JUL-2006, two days post vaccination, the patient experienced uncontrolled "ticks" throughout the whole body (tongue sticking out, arms waving, leg banging) that caused head "thrashing" for weeks and interfered with walking. The most severe period of the "ticks" was 2 weeks post vaccination on 02-AUG-2006 and was accompanied by a stiff neck and numbness in 1 leg (pins and needles, "could barely walk"). At approximately 3 weeks post vaccination, the patient developed vesicular rash with 10 total lesions. By September 2006, he had an x-ray of the legs which was negative. During this time frame, he developed round, large, red, ulcerated, fluid-filled, outbreaks (vesicles) sporadically throughout his body. He continued with the "outbreaks" and "ticks" until December 2006 when the "ticks" subsided and the "outbreaks" improved (still with some "ticks" mostly in his face and shaking of his head (in a "no" Motion). In May 2007, the cycle began again with tremendous "ticks" and a severe "outbreak" in arms, face, head and all through his inner thighs bilaterally, similar in appearance to previous rash, although more "aggressive" and was accompanied by crusting over of lesions and scarring. The "outbreak" spread to his arms and back but those areas were not as bad as his legs. The patient was taken to several specialists and had extensive neurological testing including for molluscum - all negative. It was noted that a pediatrician thought the rash resembled shingles. "Two weeks ago", the patient also developed 1 lesion on the arm and 1 lesion on his back. Over the past month, the "ticks" were still present and seemed to be linked to the "outbreak". The more severe the "outbreak", the more severe the "ticks". No further information was available. Lab diagnostic studies performed included: x-ray of the legs to rule out cysts (negative). MRI and EEG negative for seizure/tumor, unspecified neurologic testing negative. Unspecified medical attention was sought through multiple office visits and specialists. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Scar, Tic, X-ray normal
Clinical narrative: Information has been received from a dentist concerning her 10 year old son with PMH significant for ADHD since kindergarten, ear infections, colds, bronchiolitis at 6 months of age, and febrile seizures (previously reported as no pertinent medical history), who on 19-JUL-2006 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot number: 652727/0428F). Concomitant therapy included methylphenidate hydrochloride (RITALIN) twice a day was discontinued, (reporter  noted that the methylphenidate hydrochloride (RITALIN) was discontinued on 2 occasions with no change in symptoms). On 21-JUL-2006, two days post vaccination, the patient experienced uncontrolled "ticks" throughout the whole body (tongue sticking out, arms waving, leg banging) that caused head "thrashing" for weeks and interfered with walking. The most severe period of the "ticks" was 2 weeks post vaccination on 02-AUG-2006 and was accompanied by a stiff neck and numbness in 1 leg (pins and needles, "could barely walk"). At approximately 3 weeks post vaccination, the patient developed vesicular rash with 10 total lesions. By September 2006, he had an x-ray of the legs which was negative. During this time frame, he developed round, large, red, ulcerated, fluid-filled, outbreaks (vesicles) sporadically throughout his body. He continued with the "outbreaks" and "ticks" until December 2006 when the "ticks" subsided and the "outbreaks" improved (still with some "ticks" mostly in his face and shaking of his head (in a "no" Motion). In May 2007, the cycle began again with tremendous "ticks" and a severe "outbreak" in arms, face, head and all through his inner thighs bilaterally, similar in appearance to previous rash, although more "aggressive" and was accompanied by crusting over of lesions and scarring. The "outbreak" spread to his arms and back but those areas were not as bad as his legs. The patient was taken to several specialists and had extensive neurological testing including for molluscum - all negative. It was noted that a pediatrician thought the rash resembled shingles. "Two weeks ago", the patient also developed 1 lesion on the arm and 1 lesion on his back. Over the past month, the "ticks" were still present and seemed to be linked to the "outbreak". The more severe the "outbreak", the more severe the "ticks". No further information was available. Lab diagnostic studies performed included: x-ray of the legs to rule out cysts (negative). MRI and EEG negative for seizure/tumor, unspecified neurologic testing negative. Unspecified medical attention was sought through multiple office visits and specialists. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a nurse concerning a 5 year old female with no known medical history who on 26-May-2003 was vaccinated with a first dose  and 17-Sep-2007 was vaccinated SQ with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). The patient experienced red and inflamed area at the injection site immediately after the vaccination. Medical attention was sought. The patient was recovered. No product quality complaint was involved. This is one of multiple reports of the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 12 year old male who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # not provided). The physician reported that the patient was diagnosed with shingles after receiving a dose of varicella virus vaccine live (Oka/Merck). It was not known how long after the vaccine was given that the shingles occurred. The patient sought unidentified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a patient who on 08-JAN-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) by accident instead of zoster vaccine live (Oka/Merck) due to computer error. The patient was not experiencing any known symptoms. No further information was available. There was no product quality complaint. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with no medical history who on 06-APR-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. There was no illness at the time of vaccination. On 24-SEP-2007 the patient developed rash for 2 days and was diagnosed in the office on 26-SEP-2007 with approximately 100 lesions. No diagnostic laboratory tests were undertaken. On 02-OCT-2007 the patient recovered. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot#656425/1182U). On an unspecified date after receiving the vaccine, she developed redness at the injection site. Medical attention sought, and current patient status was not reported. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot#/1182U). On an unspecified date after receiving the vaccine, she developed redness at the injection site. Medical attention sought, and current patient status was not reported. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Ear pain, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old white male with an allergy amoxicillin and strawberries who on 06-AUG-2002 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck) (lot # 640488/0267M). There were no illness at the time of vaccination. On 24-SEP-2007 the patient developed 15 papular lesions on his lower abdomen and buttock as well as an earache. No diagnostic labs were performed. On 02-OCT-2007 (also reported as 02-OCT-2006), the patient recovered. It was reported the patient's sibling had an adverse experience WAES #0712USA01634. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Ear infection, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 4-year-old male with no pre-existing allergies, birth defects or medical conditions who on 02-JUN-2004 and 12-JUN-2007 was vaccinated with his first and second dose of varicella virus vaccine live (Oka/Merck). There were no illnesses at the time of vaccination. On 17-SEP-2007 the patient was diagnosed and treated for "less than or equal to 20 lesions appearing to be varicella". On 21-SEP-2007, 4 days later, the patient was seen in the office for an ear infection and was given antibiotics. At the time of the report the patient's status was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Skin depigmentation, Varicella
Clinical narrative: Information has been received from the mother of a 4-year-old male with no pertinent medical history, who "at the age of one" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. "In the winter of 2004", the patient developed chickenpox. "It was a mild case". There were no laboratory or diagnostic studies performed. The son had a booster of varicella virus vaccine live (Oka/Merck) in April of 2007. On 01-Jan-2008 her son had bright red cheeks and a fever. On 03-Jan-2008 her son had one or two spots on his back. On 07-Jan-2008, the mother noticed more spots on the back, one on the neck, one on an unspecified cheek and on "the front". The spots were itchy. The school nurse put an unspecified medicine on them but did not feel he had chickenpox since he had been vaccinated twice and had gotten chickenpox in the past. The son was seen by the pediatrician at an unspecified time who diagnosed him with having chickenpox. The mother mentioned the second outbreak was even milder than the first outbreak. The outcome was reported as not recovered. No product quality complaint was involved. It was also reported that two of the patient's siblings developed adverse events following vaccine administration (WAES numbers: 0801USA02225 and 0801USA02100). Follow-up information was received from the physician's office which indicated that they were unable to provide follow-up information because they could not identify the patient. This is one of several reports from the same reporter. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Skin warm, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with no pertinent medical history, with an allergy to amoxicillin (+) clavulanate potassium (AUGMENTIN) who on 04-SEP-2007 was vaccinated subcutaneously into the left arm with a second dose varicella virus vaccine live (Oka/Merck) (Lot # 658422/1030U). Concomitant vaccine therapy that same day included a first dose of human papillomavirus vaccine, for the treatment of prophylaxis, administered intramuscularly into the left thigh (Lot # 658558/1061U), a first dose of hepatitis A vaccine (inactive) (HAVRIX) administered intramuscularly into the left thigh (Lot# AHAVB196AA), a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) administered intramuscularly into the right arm (Lot# AC52B024AA) and a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) administered intramuscularly into the right thigh (Lot # 1061U). On 06-SEP-2007 the patient developed a red, hard, welt "about the size of a silver dollar", which was warm to touch. There was no illness at the time of vaccination. There were no diagnostic tests performed. The patient had no prior history of adverse events following prior vaccinations. The patient recovered on an unspecified date. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Local reaction, Local swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated subcutaneously with a second dose of with varicella virus vaccine live (Oka/Merck) (lot# 655995/1303F). Two or three days later she experienced "red, wheel like localized site reaction that was swollen and warm to touch." No medical attention was sought. It was reported that this did not happen with the first dose, just the booster shot. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information has been received from the company representative which indicated that there wasn't any additional information to provide regarding the adverse experiences. The physician does not want to provide any additional information either. This is one of several reports from the same reporter. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 16 year old female with an allergy to penicillin who on 19-SEP-2007 @ 15:00 was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 658197/0853U). Concomitant vaccine therapy that same day included a first dose of Gardasil for the treatment of prophylaxis administered into the left arm (Lot # 658488/0930U) and a first dose of Menactra administered into the right arm (Lot # U2386BA). On an unknown date the patient developed a mildly warm, swollen right tricep area. There was no illness at the time of vaccination. There were no diagnostic tests performed. The patient recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her daughter with no pertinent medical history, drug reactions or allergies who at approximately one year of age was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On an unspecified date in approximately the winter of 2004 the patient developed a mild case of chickenpox. There was no concomitant medication. At the time of reporting the patient had recovered on an unspecified date. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated subcutaneously with a second dose of with varicella virus vaccine live (Oka/Merck) (lot# 658299/1020U). Two or three days later he experienced "red, wheel like localized site reaction that was swollen warm to touch". No medical attention was sought. It was reported that this did not happen with the first dose, just the booster shot. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information was received from a company representative who indicated that there wasn't any additional information to provide regarding the advise experiences. The physician does not want to provide any additional information either. This one of several reports from the same reporter. No further information is available.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 36 year old male with no pertinent medical history and allergies to penicillin and aspirin and a "severe reaction to gamma globulin", who on 26-DEC-2007 was vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). Concomitant vaccine therapy that same day included tetanus toxoid. On 09-JAN-2008, approximately 13 days post vaccination the patient developed a mild rash with 1-2 lesions resembling "mild vesicles" and subsequently developed 35 lesions with no new lesions since 10 JAN 2008. The patient was treated with diphenhydramine hydrochloride (BENADRYL). At the time of reporting the patient had not yet recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female who on 14-JAN-2008 was inadvertently vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (lot number: /0109U). No other information. Unspecified medical attention was sought in the office. There was no product quality complaint. Additional information has been requested.
Age: 1.65
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/16/2000. Information has been received from a certified medical assistant concerning a 46 month old female with a history of early onset of delivery and no drug reactions/allergies, who on 14-OCT-2005 was vaccinated SC with a 0.5 mL dose of VARIVAX vaccine(Merck) (lot number: 648083/0072P). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and influenza virus vaccine (unspecified). On 06-JAN-2008, the patient was diagnosed with chickenpox. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought through a telephone call from the patient's mother. There was no product quality complaint. Follow-up information indicated that the patient was examined by the physician on 14-JAN-2008 and it was determined that her rash was not varicella. No further information was available. Additional follow-up information received indicated that it was determined not to be chickenpox. No additional information is expected.
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician's assistant concerning their son who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (manufacturer unspecified). Concomitant therapy included a dose of influenza virus vaccine (unspecified) given on the same day in the same arm. Subsequently, a few days following the vaccinations, the patient developed chicken pox. The patient sought unspecified medical attention. Subsequently, the patient recovered from chicken pox. No product quality complaint was involved. Additional information is not expected.