chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 7 year old son with no pertinent medical history or drug allergies who on 15-AUG-2001 and 27-AUG-2007 was vaccinated with his first and second dose of varicella virus vaccine live (Oka/Merck) (lot number not available). Concomitant therapy included "unspecified antibiotics." On 17-SEP-2007 the patient developed a mild case of chickenpox. No medical attention was sought. No lab or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information has been received from a physician's office indicating that the patient did not have an adverse event from the first SC dose of varicella virus vaccine live (Oka/Merck) (lot# 638818/0499L) in the right arm or the second SC dose in the left arm. No documentation of an event was in the patient's chart. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner (also reported as a pharmacist) concerning a patient who was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) but it was intended that they receive zoster vaccine live (Oka/Merck). A product quality complaint was not involved. No further information is available.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on 17-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658291/1100U) who experienced redness and induration at the injection site following vaccination. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 10 year old son with an allergy to ibuprofen (MOTRIN) and no other medical history who on 17-JUN-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number was not available). There was no concomitant medication. On 14-SEP-2007 the patient developed a mild case of chickenpox approximately 9 years later. Unspecified medical attention was sought. No lab or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on 21-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U) who experienced redness and induration at the injection site following vaccination. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female patient who on 10-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658291/1100U) who experienced redness and induration at the injection site following vaccination. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 13-year-old female who on 19-SEP-1995 was vaccinated with her first dose of VARIVAX (Merck) and received the second, subcutaneous, 0.5 ml dose on 17-JUL-2007 (lot # 657943/0726U). On 18-JUL-2007 the patient went to the emergency room with a lot of redness, swelling and erythema at the injection site. The patient sought medical attention on 20-JUL-2007 via an office visit. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on 23-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). On 24-AUG-2007 the patient developed a localized cellulitis rash at injection site. The patient sought unspecified medical attention. Subsequently, after therapy was stopped, the patient recovered. Therapy was not reintroduced. Additional information has been requested. The same physician also reported on the experience of the patient's brother WAES# 0703USA04942.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old male who in December 1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 20-AUG-2005 the patient developed shingles. On an unspecified date the patient recovered from shingles. A product quality complaint was not involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an 18-year-old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient experienced a "large injection site reaction". The physician reported that the patient was in the office for a follow up visit and appears to be doing better. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
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) (lot 652518/1021R) instead of zoster vaccine live (Oka/Merck). No symptoms noted. The nurse stated that the administering nurse grabbed the vaccine from the freezer where both vaccines are kept. She read the box and thought that it was a generic form of zoster vaccine live (Oka/Merck). The nurse further stated that the zoster vaccine live (Oka/Merck) box looks very generic (green and white colors only) and resembles other generic vaccine boxes. A product quality complaint was not involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 24-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 21-JUN-2007, the patient experienced rash on abdomen and chest- erythematous small papules. There was an outbreak in the patient's classroom. The parent called to report on 23-Jun-2007, definitely varicella. Subsequently, the patient recovered from rash on abdomen and chest - erythematous small papules on an unknown date. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office nurse concerning a 12 month old patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U). In January 2008, the patient experienced cellulitis at the injection site on the thigh. The patient was treated with an antibiotic (therapy unspecified). On an unspecified date the patient recovered. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
Age: 1.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/16/2008. Information has been received from a health professional concerning a 15 month old female who on 25-JAN-2008 was vaccinated with a 0.5 ml subcutaneous dose in the upper right leg of varicella virus vaccine live (Oka/Merck) (lot#"1580U"). Concomitant therapy included M-M-R II in the left leg, PedvaxHIB in the left leg, and Pediarix in the right leg. On 13-FEB-2008, the patient developed two varicella like eruptions, on her upper right thigh. Current patient was not reported. A product quality complaint was not reported. Follow-up information has been received from a registered nurse concerning this 16 month old female child with no known allergies who on 25-JAN-2008 was vaccinated SQ in the right thigh with a first dose of VARIVAX (Oka/Merck) (lot # 659420/1580U). There was no illness at the time of vaccination. Additional suspect vaccination included a first dose of MMR (lot # 653892/0538P) SQ in the left thigh. Concomitant vaccinations included a third dose of PEDIARIX (lot # AC21B127AA) IM in the right thigh and a third dose of ACTHIB (SPUF169A7) IM in the left thigh. Subsequently, on 02-FEB-2008 the patient developed two papules on her right anterior leg. There were no fluctuant masses underneath it. There were no lab studies performed. The patient was treated with KEFLEX "125" 1/2 teaspoons three times a day x 10 days and with ZOVIRAX ointment three times a day x 10 days. It was noted that the patient recovered on 17-FEB-2008. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Anger, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 10 year old male, with no medical history and no allergies, who was vaccinated with subcutaneous 0.5 ml doses of varicella virus vaccine live (Oka/Merck) on 17-SEP-1998 and 07-FEB-2008 (Lot# 659730/1781U). There was no concomitant medication. On 09-FEB-2008, the patient's mother called into the office to report that the patient had a hot patch on his left arm at the injection site, beginning on 07-FEB-2008. It was also reported that he had a low grade fever for 2 days, was very angry, and had a red inflamed area at the injection site. The patient was treated with ice and elevation. Subsequently the patient recovered. No laboratory or diagnostic tests were performed. No product quality complaint was involved. No other information was provided. Follow up information from the healthcare professional indicated that at 10:00 on 09-FEB-2008, the patient developed a low grade fever (specific values not reported), "angry" red reaction, and swelling. It was indicated the patient experienced the fever for two days. Additional follow-up information from the reporting health professional indicated that on 07-FEB-2008 at 14:00 (also reported as 15:00) the patient was vaccinated with his second dose of VARIVAX (lot # 659730/17910) in the left arm. On 08-FEB-2008 9 also reported as 09-FEB-2008 at 10:00) the patient experienced a low grade temperature for 2 days and was angry. The patient also developed a red, swollen upper arm. On 15-FEB-2008 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: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 10 year old male, with no medical history and no allergies, who was vaccinated with subcutaneous 0.5 ml doses of varicella virus vaccine live (Oka/Merck) on 17-SEP-1998 and 07-FEB-2008 (Lot# 659730/1781U). There was no concomitant medication. On 09-FEB-2008, the patient's mother called into the office to report that the patient had a hot patch on his left arm at the injection site, beginning on 07-FEB-2008. It was also reported that he had a low grade fever for 2 days, was very angry, and had a red inflamed area at the injection site. The patient was treated with ice and elevation. Subsequently the patient recovered. No laboratory or diagnostic tests were performed. No product quality complaint was involved. No other information was provided. Follow up information from the healthcare professional indicated that at 10:00 on 09-FEB-2008, the patient developed a low grade fever (specific values not reported), "angry" red reaction, and swelling. It was indicated the patient experienced the fever for two days. Additional follow-up information from the reporting health professional indicated that on 07-FEB-2008 at 14:00 (also reported as 15:00) the patient was vaccinated with his second dose of VARIVAX (lot # 659730/17910) in the left arm. On 08-FEB-2008 9 also reported as 09-FEB-2008 at 10:00) the patient experienced a low grade temperature for 2 days and was angry. The patient also developed a red, swollen upper arm. On 15-FEB-2008 the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with no pertinent medical history and no known drug reactions/allergies, who on 28-FEB-2008 was vaccinated with a 0.5 mL subcutaneous booster dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 657788/0719U). Concomitant vaccination included a dose of Menactra in the left arm. There was no concomitant medication. On 29-FEB-2008, the patient's mother phoned the physicians office to reported that the patient's left arm at the injection site was red, hot, tender to touch, and swollen to more than 5 centimeters. It was noted that the patient had also received a dose of Menactra in the same arm but at a different area. The patient was treated with ice and elevation. There were no laboratory or diagnostic studies performed. At the time of this report, the patient had not recovered. The patients vaccination history included on 27-MAY-1998, a first subcutaneous dose of varicella virus vaccine live (Oka/Merck). A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Follow up information from the health professional indicated that on 29-FEB-2009, the patient developed a local reaction with a 5 cm, large red welt-hot.  Current patient status was not reported.  This is one of two reports from the same source.  Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 65778/0719U). On 27-FEB-2008 the patient experience injection site redness and swelling. Subsequently, the patient recovered. No product quality complaint was involved. this is one of several reports from th same source. Additional information has been requested. Follow-up information from the health profession indicated that the event began on 28-FEB-2008 (previously reported as 27-FEB-2008), and described the event as hot, red, painful upper swellling. This is one of several reports from the some source. Additional in
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 65778/0719U). On 27-FEB-2008 the patient experience injection site redness and swelling. Subsequently, the patient recovered. No product quality complaint was involved. this is one of several reports from th same source. Additional information has been requested. Follow-up information from the health profession indicated that the event began on 28-FEB-2008 (previously reported as 27-FEB-2008), and described the event as hot, red, painful upper swellling. This is one of several reports from the some source. Additional in
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 659730/1781U). On 22-FEB-2008, the patient experienced injection site redness and swelling. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. Follow up information for the health professional indicated that on 22-FEB2008, the patient has developed a 2% inch hard red bump and swelling. Treatment was not reported.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 10 year old male who on 14-FEB-2008, at 14:45, was vaccinated into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 659730/1781U). On 15-FEB-2008, the patient developed redness and swelling at the injection site (also reported as red swollen large area) as well as a low grade fever.  At the time of reporting it was noted that the patient had recovered (date unspecified) from the redness and swelling at the injection site. The outcome of the low grade fever was not reported. Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports from the same source. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 10 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 659610/1654U). On 10-JAN-2008 the patient experienced injection site redness and swelling. Subsequently, the patient recovered. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. Follow up information from a health care professional indicated that on 11-Jan-2008, the patient developed red, large, swelling upper arm area that was also hot. Treatment was reported, on 14-JAN-2008, the patient had recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with varicella virus vaccine live (Oka/Merck). It was reported that the patient transmitted the varicella virus to the mother causing shingles. The mother sought unspecified medical treatment and her current status was not reported. No product quality complaint was reported. No further information was reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Dry skin, Erythema, Injection site erythema, Injection site scab, Injection site swelling
Clinical narrative: Information has been received from a representative concerning a 10 year old 150 lb. 4 oz, 58 inch female with an allergy to penicillin and history of similar injection site reactions to other unidentified vaccines who on 13-SEP-2007 received her second dose of 0.5 ml subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot # 657999/1005U). It was reported that she was well at the time of the vaccination. 5-6 days after receiving her second dose (dates not reported) she experienced swelling at the injection site. She was seen by the physician who implemented therapy with diphenhydramine (BENADRYL), and topical hydrocortisone cream. The patient fully recovered. No product quality complaint was received. No further information was available.  Follow up information by a registered nurse reported that on 13-SEP-2007, she developed a three inch area of redness, warmth, dry crusty feeling, light red area encircling it from arm pit to elbow, itchy, and that the puncture site was dark red, and crusted. Vaccination history included influenza virus vaccine (FLUZONE) (lot# 02512AA) intramuscular in the left deltoid (20-OCT-2007). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Scab, Skin warm
Clinical narrative: Information has been received from a representative concerning a 10 year old 150 lb. 4 oz, 58 inch female with an allergy to penicillin and history of similar injection site reactions to other unidentified vaccines who on 13-SEP-2007 received her second dose of 0.5 ml subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot # 657999/1005U). It was reported that she was well at the time of the vaccination. 5-6 days after receiving her second dose (dates not reported) she experienced swelling at the injection site. She was seen by the physician who implemented therapy with diphenhydramine (BENADRYL), and topical hydrocortisone cream. The patient fully recovered. No product quality complaint was received. No further information was available.  Follow up information by a registered nurse reported that on 13-SEP-2007, she developed a three inch area of redness, warmth, dry crusty feeling, light red area encircling it from arm pit to elbow, itchy, and that the puncture site was dark red, and crusted. Vaccination history included influenza virus vaccine (FLUZONE) (lot# 02512AA) intramuscular in the left deltoid (20-OCT-2007). Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 9-year-old male who on 07-DEC-1999 and 29-MAY-2007 was vaccinated with his first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 657194/0364U 2nd dose). On 21-SEP-2007 (about 4 months after second dose) the patient developed chicken pox. A visual diagnosis was made in the physician's office on 24-SEP-2007. No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Vaccination failure, Varicella
Clinical narrative: Information has been received from a health professional concerning a 5 year old white male with no medical history or allergies who on 25-JUN-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657650/0716U). Concomitant therapy included a fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), a fourth dose of poliovirus vaccine (manufacturer unknown) and a second dose of measles virus live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). There was no illness at the time of vaccination. On 28-JUL-2007 the patient broke out with chickenpox while on vaccination. No serious reaction was seen but it was reported that he could have been exposed to numerous people at attractions. The patient returned home and went to physician's office and was told it was a pretty bad case for having had both vaccines. At the time of report the patient was recovered. No diagnostic laboratory tests were undertaken. No medical attention was sought. Follow-up information received states that no real adverse reaction occurred, just that the vaccine did not protect from the disease. The patient received 2 immunizations but got chickenpox 6 weeks after the last immunization (also reported as 28-JUL-2007). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 26 year old female with no medical history or allergies who in 1995 was vaccinated SC with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) and on 28-SEP-2007 the patient received second SC 0.5 ml dose of vaccine. Concomitant therapy included fexofenadine hydrochloride (ALLEGRA) and vitamins. It was reported that "recently" the patient had low antibody titers. On 29-SEP-2007 the patient developed redness, tenderness and swelling at injection site. The area of swelling increased in size on 30-SEP-2007 but had subsequently improved. The patient called her physician on 01-OCT-2007 and was going to see the physician on 02-OCT-2007. At the time of report the patient was recovering. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information is not expected/
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Ear infection, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 4-year-old male who on 02-JUN-2004 was vaccinated subcutaneous with a second dose of varicella virus vaccine live (Oka/Merck). On 17-SEP-2007 the patient developed approximately 20 varicella-like lesions. On approximately 21-SEP-2007 (about four days after the patient's visit on 17-SEP-2007) the patient came back in with an ear infection. The physician treated the patient with antibiotics. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Body temperature increased, Fatigue, Inappropriate schedule of drug administration, Influenza like illness
Clinical narrative: Information has been received from a licensed practical nurse concerning her 13-year-old white daughter with an allergy to amoxicillin and clavulanic Acid (AUGMENTIN) and azithromycin (ZITHROMAX) who in June 1995, was vaccinated subcutaneous with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) and on 25-MAY-2007 (previously reported as in May-2007), the patient received a second subcutaneous 0.5 ml dose of varicella virus vaccine live (Oka/Merck (Lot # 654811/1260F). There was no concomitant therapy. There were no illnesses at the time of vaccination. It was reported that about in early June (7 days after vaccination) the patient experienced flu like symptoms, fatigue, body aches, malaise, low grade fever and a loss of appetite. The symptoms lasted about 3 days and then resolved. The patient was treated with OTC Ibuprofen. At the time of report the patient had recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning her 13-year-old white daughter with an allergy to amoxicillin and clavulanic Acid (AUGMENTIN) and azithromycin (ZITHROMAX) who in June 1995, was vaccinated subcutaneous with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) and on 25-MAY-2007 (previously reported as in May-2007), the patient received a second subcutaneous 0.5 ml dose of varicella virus vaccine live (Oka/Merck (Lot # 654811/1260F). There was no concomitant therapy. There were no illnesses at the time of vaccination. It was reported that about in early June (7 days after vaccination) the patient experienced flu like symptoms, fatigue, body aches, malaise, low grade fever and a loss of appetite. The symptoms lasted about 3 days and then resolved. The patient was treated with OTC Ibuprofen. At the time of report the patient had recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Foetal heart rate, Genital haemorrhage, Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/16/2008. Information has been received from a certified nurse midwife (CNM), for VARIVAX (Merck), via the Merck pregnancy registry product, concerning a 22 year old female patient with no pertinent medical history, who on 11-JAN-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # not reported). There was no concomitant medication. On approximately 25-JAN-2008 (2 weeks after vaccination) the patient became pregnant. Subsequently the patient experienced spotting after intercourse, but was otherwise "doing well". A beta-human chorionic gonadotropin (HCG) test was normal, and an ultrasound "showed" the heartbeat (dates not reported). The estimated date of delivery was 15-OCT-2008 (estimated date of LMP 09-JAN-2008). Follow up information has been received from a certified nurse midwife via a telephone call, indicating the patient transferred her prenatal care at 34 weeks gestation. The reporter heard from another healthcare professional that the baby (L.D. # 47305)was fine and doing well. The reporter offered to contact the patient and asked her to call us and provided for specific information. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning her husband who "many years ago", was vaccinated subsequently with 0.5ml of varicella virus vaccine live (Oka/Merck). Subsequently, on an unspecified date, the patient developed redness, warmth and swelling at injection site. Medical attention was not sought. There was no product quality complaint. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a male who on 26-SEP-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and on 22 DEC 2007 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658959/1352U). The injection site resembled cellulitis after receiving the second dose of varicella virus vaccine live (Oka/Merck) (date unspecified). Unspecified medical attention was sought. At the time of reporting the patient was recovered, date unspecified. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old male with no pertinent medical history and no drug reactions/allergies, who on 30-JAN-2008 was vaccinatedin the right arm SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot number: 659342/1517U). Concomitant vaccinations subcutaneous dose in the left arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and PREVNAR vaccine (CRM197). On 25-FEB-2008 the patient experienced chickenpox. The lesions began on 25-FEB-2008 and became worse on 26-FEB-2008. The patient did not present with a fever and was given diphenhydramine hydrochloride (BENADRYL) for symptomatic relief. No further information was available. There were no lab diagnostic studies performed. Unspecified medical attention was sought,  the patient was seen by the physician. On unspecified date, the patient had recovered. There was no product quality complaint. Further information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female who on 06-FEB-2002 and 20-FEB-2008 was vaccinated subcutaneous with a first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 659610/1654U) - applies to 2nd dose). On approximately 20-FEB-2008, post vaccination, the patient developed a reaction at the injection site that resembled cellulitis following the second vaccination. The patient sought unspecified medical attention. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Information has been received from a healthcare professional concerning a 7-year-old white female with an allergy to ibuprofen who on 06-NOV-2007 at 10:15 am was vaccinated in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 658425/1182U). On 08-NOV-2007 the patient experienced right lateral/posterior arm with redness, 8x10 cm with central induration and warmth with tenderness. The patient sought unspecified medical attention and was treated with antibiotic therapy ("ABT"). No diagnostic labs were performed. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.75
Sex: F
Vaccine: DTAPHEPBIP, HEP, VARCEL
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: This is in follow-up to report (s) previously submitted on 05/16/2008. Information has been received from a pediatrician's office concerning a 8 year old white female consumer with no known allergies and no pertinent medical history who on 24-AUG-2001 was vaccinated at another office with varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and hepatitis B vaccine, recomb (manufacturer unknown). Subsequently, on 21-FEB-2008 the patient developed crops of erythemous lesions on her body behind her ears, arms, face and eye lids, about 3-4 dozen spots, no pustules. Medical attention was sought, the patient was seen in the pediatrician's office at 3:30 pm, there were no lab studies performed. The patient was diagnosed with atypical chicken pox. At the time of the report the patient had not recovered, she currently had an outbreak.  It was reported that the patient was doing very well. Additional information has been requested. Addition information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Pruritus, Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female consumer with no known allergies or pertinent medical history who on 18-DEC-2007 was vaccinated SQ with a second dose of 0.5ml of varicella virus vaccine live (Oka/Merck) (lot # 659610/1654U). The patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot number unspecified) on 05-DEC-2001. There was no illness at the time of this vaccination. Concomitant vaccinations on 18-DEC-2007 included a first dose of HAVRIX (lot # AHA6BZ11AA) in the left arm. Subsequently, on 27-FEB-2008 the patient developed varicella. She had 4 to 5 blisters and pruritus. The patient was seen by the physician, who diagnosed her with varicella. There were no lab studies performed. The patient recovered 10 days later in 08-Mar-2008. There was no product quality complaint involved. Additional information has been requested. The patient's brother also had an adverse event after vaccination with varicella virus vaccine live (Merck) (waes # 0802USA060811). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning a female patient (date of birth 07-FEB-2007), who on an unknown date was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot # 659727/1771U). Subsequently the patient had a reaction described as "developed a single hive near the injection site". The outcome of the event was not specified. This is one of six reports received from the same source. The CMA requested a lot check. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 27-JUN-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 26-FEB-2008 the patient was seen in the office and the chickenpox was "visually diagnosed" by the physician. No further information was available. There were no lab diagnostic studies performed. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Erythema, Injection site pain, Injection site vesicles, Rash papular
Clinical narrative: Information has been received from a health professional concerning an 8 year old female with no known allergies and a history of microscopic hematuria, who on 20-FEB-2008 was vaccinated with a second 0.5 ml subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# "L5006"). Concomitant vaccination included a dose in her right arm of hepatitis A vaccine (inactive) (manufacturer unspecified) and a dose in the right arm of influenza virus vaccine (manufacturer unspecified). The health professional reported that the erythmea, and papulule/blister began at 12:00 hours on 23-FEB-2008 (3-5 days post vaccination). It was indicated by the health professional that there were no other rashes or sytemic complaints and that the patient was afebrile. On 25-FEB-2008, the patient was seen in the office and complained of soreness at injection site of the left arm. Within 24 hours (26-FEB-2008, also reported as 23-FEB-2008), the patient developed blisters around the injection site. It was reported that the patient's mother treated the patient with oral diphenhydramine (BENADRYL) and cold compresses. On 28-FEB-2008, the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Swollen tongue, Urticaria
Clinical narrative: Information has been received from a health professional concerning a "7 or 8 year old " male who on an unspecified date, was vaccinated with a second dose of varicella virus vaccine live (Merck) (lot# 659727/1771U). The healthcare worker reported that the patient developed an "anaphylactic reaction" to the VARIVAX vaccine(Merck). It was indicated that the patient developed a swollen tongue with difficulty breathing, and had hives all over his body. Treatment included epinephrine, BENADRYL, and observation for 3 hours. It was indicated that when the patient left the office he had recovered. A product quality complaint was not reported. The healthcare worker requested a lot check. This is one of 3 reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008. a standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements for the Center and was released.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 9 year old 75 lb. male with no known allergies and no pertinent medical history, who on 16-MAY-2007 was vaccinated with a second 0.5 mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot number: 657195/0366U). There was no concomitant medication. There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. On 27-FEB-2008, (also reported as 26-FEB-2008), the patient developed pruritus and varicella of 15 to 20 blisters. No other symptoms were noted. There was no laboratory or diagnostic studies performed. On an unspecified date, the patient had recovered. His vaccination history included on 10-MAY-1999, a first dose of varicella virus vaccine live (Oka/Merck) 9lot# 630027/0312). Follow-up information indicated no new information. This is one of two reports from the same source. No additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Cough, Nasopharyngitis, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old patient who on 07-APR-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient has not received a second dose of varicella virus vaccine live (Oka/Merck). On approximately 26-FEB-2008, he presented to the physician with cold like symptoms, coughing for one day and then a rash appeared on the eyelid margin, lower left back, abdomen, and extremities. He had diffuse vesicles and rash, plus or minus pruritus. The physician is reporting the event as chicken pox. The physician indicated that no emergency visit was needed. At the time of this report the patient had not recovered. A product quality  complaint was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/16/2008. Information has been received from a health professional concerning a 4 year old female with no pertinent medical history and no known drug reactions/allergies, who on 27-FEB-2008 was vaccinated with a second 0.5 mL subcutaneous dose in the right arm of varicella virus vaccine, live (Oka/Merck) (lot# 659727/1771U). Concomitant vaccination included a second dose in the left arm of M-M-R II, a fourth dose in the right arm of poliovirus vaccine (manufacturer unspecified), and a fifth dose in the left arm of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified). On 27-FEB-2008, 5 to 10 seconds after receiving the varicella virus vaccine live (Oka/Merck) vaccination, she developed a single hive about one inch from the injection site. It was indicated that the single hive was 2 mm. by 2 mm. in diameter. Specific treatment was not reported. It was reported that the hive was still present when the patient left the physician's office. Her vaccination history included on 14-OCT-2004, a first dose of varicella virus vaccine, live (Oka/Merck). A product quality complaint was not reported. A lot check was requested by the reporter. This is one of three reports from the same source.  A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements for the Center for Bilogics Evaluation and Research and was released.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter who was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). On approximately 15-NOV-2007,"around 15-NOV-2007 or 19-NOV-2007, the patient developed a mild case of chickenpox." The patient sought medical attention through the physician. Subsequently, the patient recovered. There was no product quality complaint. No further information is available.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 year old male with no pertinent medical history, and seasonal allergy and allergic reaction to Ceclor who on 05-DEC-1996 was vaccinated subcutaneously into the left arm with varicella virus vaccine live (Oka/Merck) 0.5 mL into the left arm (Lot #619676/1104D) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 618389/0888D) subcutaneously into the right arm. It was also reported that the patient received unspecified "allergy injections", no further information provided. There was no illness at the time of vaccination. The patient presented to the doctor's office on 25-NOV-2007 with a total of 12 to 15 vesicular, papular lesions scattered all over his body. The patient did not have a fever. The patient was treated with topical Benadryl, as needed. At the time of reporting the patient had recovered on an unspecified date. Medical attention was sought. There was no product quality complaint. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a mother concerning her 2 year old daughter who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On approximately 15-NOV-2007 or 19-NOV-2007, the patient developed a mild case of chicken pox. Subsequently, the patient recovered on an unspecified date. It was reported that the patient sought unspecified medical attention by the physician. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
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  developed a varicella like rash. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. No additional information regarding this event was available, as the office was unable to identify the patient. No additional information is expected.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no pertinent medical history and no drug reactions/allergies, who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Prevnar. The physician reported that the patient experienced a full blown case of the chickenpox after receiving vaccination. No additional adverse event information was provided. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a registered pharmacist concerning a 72 year old male who on approximately 13-NOV-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck)(MSD). It was an error and not product confusion. No additional information was available. Unspecified medical attention was sought. There was no product quality complaint. additional information has been requested.