chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on approximately 15-JUL-2007 was vaccinated subcutaneously with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot#657751/0779U). On approximately 15-JUL-2007 the patient developed an injection site reaction which included redness, soreness and swelling of the injection site area. The patient sought medical attention and was treated with ice, acetaminophen (TYLENOL) and ibuprofen for relief of symptoms. No labs were performed. At the time of this report the patient's status was not reported. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 17-JUL-2007 was erroneously vaccinated with varicella virus vaccine live (Oka/Merck) in place of zoster vaccine live (Oka/Merck). The nurse reports the event was a result of human error and not a case of product confusion. No symptoms have been reported. There was no product quality complaint. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 10 year old white male who at 9:40 on 13 JUL 2007, was vaccinated subcutaneously into left arm with a booster dose of varicella virus vaccine live (Oka/Merck) (Lot # 657647/0535U). On 14 JUL 2007, the following day, the patient developed a 2 inch non vesicular welt at the injection site, that was warm to touch and slightly painful. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a physician's assistant concerning a 10 year old female, with no pertinent medical history, who three to five years ago, it was approximately 2002, was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a rash on her chest, which the mother reported was chickenpox. The patient recovered from chickenpox on an undisclosed date. Unspecified medical attention was sought. There was no product quality complaint. There was no lab diagnostic studies performed. 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 (age and gender not reported) who on 05-JUL-2007 was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported that the incident was due to human error and not product confusion. The patient did not experience any known symptoms. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an undisclosed date, was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657109/0444U), and subsequently developed a non vesicular welt. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: DTAP, IPV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pustule, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a "1 year old" female who on 10-JUL-2007 was vaccinated subcutaneously with the first dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced "local injection site reaction that was hard, swollen, red and feverish to the touch". The patient sought unspecified medical attention. The patient was treated with diphenhydramine hydrochloride (BENADRYL) and the reaction had cleared up. Subsequently, the patient recovered from "local injection site reaction that was hard, swollen, red and feverish to the touch". No product quality complaint was involved. Follow up information was received from a physician who reports that 12 month old white female, with no pertinent medical history or allergies was vaccinated subcutaneously into the "left quad" with a first dose of varicella virus vaccine live (Oka/Merck) ("Lot # 04464") at 15:00 on 10-JUL-2007. Concomitant vaccine therapy that same day included a fourth dose, intramuscularly, into the right quad with diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Verol (+) tetanus toxoid (DTAP-IPV) (Lot # C2655AAFM) and a fourth dose, intramuscularly, into the right quad with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot # B58845H-FM). There was no illness at the time of vaccination. On 20-JUL-2007 the patient experienced swelling, redness and pustules at the sight of the injection. On 22 JUL 2007 the patient recovered from the swelling, redness and pustules at the right of the injection. The patient did not experience any adverse events following prior vaccinations. No diagnostic lab tests were performed.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a "9 year old" female who was vaccinated SC with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently "eight hours post vaccination" the patient experienced a local injection site reaction that was hard, swollen, red and feverish to the touch." The reaction had been of "softball-size." Medical attention was sought. The patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 11 year old female with asthma who on 18-JUL-2007 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657753/0781U) in the right quadricep. On 20-JUL-2007 the patient experienced a local injection site reaction that was hard, swollen, red and feverish to the touch. The reaction as being "softball-sized." Medical attention was sought. The physician suggested that the patient treat the reaction with Benadryl. No product complaint was involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician and a registered nurse concerning an 8 year old male who on 27-JUN-2007 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657412/0594U) in the right quadricep. On 30-JUN-2007, the patient experienced a local injection site reaction that was hard, swollen, red and feverish to touch. During a phone call on that day, the parent reported redness approximately the size of a silver dollar to the thigh. There was no high fever, behavioral changes or allergic response noted. "After receiving the chart note, it appears that the patient only had a mild localized reaction which was considered a normal problem associated with the vaccine." The physician counseled the parent to apply hydrocortisone cream or Benadryl to the site to treat the reaction and call back if symptoms worsen. "There were no further phone calls or visits regarding the reaction, so it can be assumed that the redness resolved on its own." Subsequently, the patient recovered from injection site reaction that was hard, swollen, red and feverish to touch. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 12 month old male who was vaccinated with his first single SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 65712/0594U). In July 2007, the patient developed an local injection site reaction that was hard, swollen, red and feverish to the touch. The reaction had been of "softball-size." Unspecified medical attention was sought. Physician suggested Benadryl (manufacturer unknown) for treatment of the injection site reaction. Recovery status unknown. No product quality complaint reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 18-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (fill# 656260/Lot# 1502F). On 18-JUL-2007, the patient developed redness around the injection site right after the dose that became hot to the touch more so than average. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Pruritus, Scab, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white female with no pertinent medical history or drug allergies, who on 06-JUL-2007 at 15:10 was vaccinated at 15:10 with the first 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 653306/0674U) in the left thigh. Concomitant vaccination on that day at 15:10 included a second SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot# 656034/0182U) in the right thigh. There was no illness at the time of vaccination. On 20-JUL-2007 at 09:40 (also reported as 23-JUL-2007 at 10:00), the patient developed chicken pox breaking out in 8 to 10 areas characterized as itching, fluid-filled and starting to scab over. No medical attention was sought. No labs were performed. On 26-JUL-2007 the patient recovered. There was no product quality complaint. Follow-up information has been received from a registered nurse who indicated the pox were on the left leg at the injection site around the navel, and on the chest and face. On 01-AUG-2007 the patient recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male who on 23-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient fainted. Unspecified medical attention was sought. At an unspecified time the patient recovered. No other information was provided. There was no product quality complaint involved. Additional information received indicated that no additional information is available.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 09-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#657943/0726U). There was no concomitant medication. Subsequently, the patient developed swelling of the right arm. The patient had two separate office visits and the swelling was diagnosed as cellulitis. There were no ER visits. The patient was treated with an unspecified antibiotic. The patient recovered. No other information was provided. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: Information has been received from a health professional concerning a 31 year old male who was vaccinated, on an undisclosed date, with varicella virus vaccine live (Oka/Merck) and three weeks later the patient developed a rash and pustules. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Mass, Skin warm
Clinical narrative: Information has been received from a consumer concerning her 15 year old female daughter, with no pertinent medical history, drug reaction or allergies, who on 18-JUN-2007 was vaccinated subcutaneously into the right arm with 0.5 mL varicella virus vaccine live (Oka/Merck). Concomitant therapy that same day included meningococcal vaccine (unspecified) and Gardasil. The following day, on 19-JUN-2007, the patient developed a large knot, the size of a baseball, on right arm. The right arm was the arm the patient received both varicella virus vaccine live (Oka/Merck) and meningococcal vaccine (unspecified). It was very hot to touch and looked like a huge red mound, which ran in a oblong pattern down her arm to two inches from her elbow. She received the human papillomavirus vaccine in her left arm. At the time of reporting the patient was considered recovered as of 25 JUN 2007. Unspecified medical attention was sought. There were no diagnostic studies performed. There was no product quality complaint. Additional information is not expected.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who on 21-MAY-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (656692/0457U) subcutaneously in the left arm. On 23-MAY-2007 the patient experienced red area where the vaccine was given, the size of a silver dollar. No pain was reported. Outcome of the patient was unknown. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning an 8-year-old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed chickenpox with lesions all over after vaccination. It is unspecified if medical attention was sought. No outcome was reported. No product quality complaint was issued. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a health professional concerning an 11 year old female who on 23-MAY-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (656692/0457U) subcutaneously in the right arm. On 25-MAY-2007, the patient experienced red area and itching at injection site. No illness at the time of vaccination. Outcome of the patient not reported. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug exposure during pregnancy, Premature baby, Premature labour
Clinical narrative: Information has been received from a health professional through the Merck pregnancy registry concerning a 17 year old female with no known medical history or allergies who on 08-SEP-2005 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 648943/0893P). Concomitant vaccination that day included hepatitis B vaccine, recomb (MSD). Concomitant therapy included amoxicillin (AMOXIL). On 28-SEP-2005 the patient reported being pregnancy with an LMP of 22-AUG-2005. No adverse experiences were reported. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. There was no product quality complaint involved. Follow-up information from health professional indicated that as of February 2006 there were no adverse experiences to either the mother or the fetus. Information regarding the birth of the patient's child was not available. Additional follow-up information indicated that the patient  was seen in the office on 22-FEB-2006, then the patient was transferred to a different office due to a "high risk pregnancy". Additional follow-up information indicated that the patient was transferred to a high risk practice at 33 weeks due to pre-term labor. On 29-APR-2007, at 35.5 weeks gestation, the patient delivered a baby girl. The apgars were reported to be 4 and 8. It was reported that the baby was transferred to the NICU for further care.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy, Pyelocaliectasis, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician through a Merck pregnancy registry concerning a 37 year old female with a penicillin allergy who on 05-JUL-2006 was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included prenatal vitamins (unspecified). On 27-JUN-2006, the office asked the patient to take a pregnancy test prior to vaccination. The patient did not take a pregnancy test prior to vaccination and was vaccinated on 05--JUL-2006. On 12-JUL-2006, a urine pregnancy test was positive. Unspecified medical attention was sought. At the time of this report, the pregnancy was not confirmed by a blood test. Date of LMP was reported as 01-JUN-2006. Estimated date of delivery is 08-MAR-2007. Follow-up information indicated that on 28-JUL-2006, an ultrasound was performed to confirm the patient's pregnancy. The result of the ultrasound indicated an 8 week EGA. The patient had no previous pregnancies. There was no maternal adverse event to the vaccine. No local reaction at the vaccination site, no chickenpox symptoms post vaccination, and no herpes zoster symptoms post vaccination. It was also reported that the patient was test for varicella antibodies before vaccination, the results were not reported. Further follow-up information was received from the physician and a nurse who reported that the patient underwent a level II ultrasound which revealed pyelectasis but then it resolved. On March 7, 2007, the patient delivered a healthy normal female infant. No Further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 05-NOV-1995 was vaccinated subcutaneously with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 609296/0441B). There was no concomitant medication. On 29-NOV-1995 the patient experienced a mild case of chickenpox. The patient sought unspecified medical attention. Subsequently, the patient recovered from chickenpox. The office is considering a booster dose. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician as an inquiry concerning a 3 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (No lot number was provided). Subsequently the patient may have potentially developed a case of shingles from varicella virus vaccine live (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an unknown number of patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that in the past 2-3 years the office had seen about one case of breakthrough varicella every 2-3 months. It was unknown if medical attention was sought. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that she did not have any additional information to provide. Follow-up information from the registered nurse indicated that the patient was a 4 year old female who at the age of 12 months old on 22-AUG-2003 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot # 645045/0208N). On 07-JUN-2007, the child was diagnosed with a case of breakthrough chickenpox after receiving subcutaneously in the left thigh a dose of varicella virus vaccine live (Oka/Merck). Approximately 20 to 30 vesicular and papular lesions and few crusted lesions on trunk and legs. The patient had a history of submucosal cleft palate repair done on August of 2004. On an unspecified date the patient recovered. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Amniocentesis, Drug exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from the pregnancy registry from a physician concerning a 33 year old pregnant female with no pertinent medical history and no drug reactions/allergies who on 10-SEP-2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) at another health clinic. There was no concomitant medication. On 10-SEP-2006 the patient was 4.5 weeks pregnant at the time of her vaccination with varicella virus vaccine live (Oka/Merck). On 20-DEC-2006 an ultrasound was completed for dating/placenta placement. On 09-JAN-2007 an amniocentesis was done and the result was abnormal serum screen. No further information is available. Unspecified medical attention was sought. There were no previous pregnancies. It is unknown if the patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The pregnancy outcome was a live birth, female born on 24-APR-2007, birth weight 6 lbs, 10 oz. The infant was normal. During the pregnancy the patient experienced insomnia and was treated Phenergan 25mg 1/2-1/1 PO Q prn. In addition, during pregnancy, the patient was taking PNV 1/1 PO daily. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 26-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot no. 657449/0597U). On 28-JUN-2007, the patient developed a 3 inch diameter of redness at injection site to her L arm. This is one of several reports received from the same source. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 mL, injection (Oka/Merck) (lot # and route not provided). Subsequently, the patients developed chickenpox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Further information has been received from a school nurse concerning a female who was vaccinated on 09-OCT-1996. The nurse reported that the patient developed chickenpox. The case was considered mild with minimal missed time at school (approximately 2-3 days out sick). This is one of several reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Full blood count, Ultrasound antenatal screen, Ultrasound scan normal
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 37 year old female with a history of unspecified IM pain medications causing nausea and vomiting, who on 07-SEP-2006 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (lot # 651280/0803R). It was unknown if the patient had a local reaction at the injection site or if the patient had varicella or herpes zoster symptoms post vaccination. Concomitant therapy included prenatal vitamins. It was unknown if the patient was tested for varicella antibodies prior to vaccination. "Around 11-OCT-2006 or 12-OCT-2006," the patient conceived with the date of her last menstrual period reported as 26-SEP-2006. Unspecified medical attention was sought. A prenatal profile consisting of a complete blood count and urine analysis was performed, the results were not reported. On 14-NOV-2006, at the patient's first OB visit, an ultrasound was performed and showed an intrauterine pregnancy and fetal heart, the estimated delivery date was confirmed to be 05-JUL-2007. It was reported that the patient had 2 previous pregnancies and 1 full term birth. No birth defects, stillbirths or miscarriages occurred in any previous pregnancy. No further information was provided. There was no product quality complaint involved. Follow up information form the registered nurse indicated that the patient had a serum alpha-fetoprotein test on 16-JAN-2007 which was within normal limits and a level II ultrasound on 01-FEB-2007, which was also within normal limits. It was noted that all routine prenatal testing was within normal limits. The patient was placed on therapy with famotidine (MSD) over the counter on 08-FEB-2007 for heartburn during pregnancy. On 04-JUL-2007, 39 weeks from her last menstrual period the patient gave birth to an 8 pound 13 ounce normal girl. There were no congenital anomalies. There were no complications during the pregnancy though she did have a prolonged 2nd stage labor with posterior occiput presentation. The patient had no infections or illnesses during pregnancy and no concurrent medical conditions. The baby had no feature of congenital varicella zoster syndrome. No further information was provided. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Urine analysis
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 37 year old female with a history of unspecified IM pain medications causing nausea and vomiting, who on 07-SEP-2006 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (lot # 651280/0803R). It was unknown if the patient had a local reaction at the injection site or if the patient had varicella or herpes zoster symptoms post vaccination. Concomitant therapy included prenatal vitamins. It was unknown if the patient was tested for varicella antibodies prior to vaccination. "Around 11-OCT-2006 or 12-OCT-2006," the patient conceived with the date of her last menstrual period reported as 26-SEP-2006. Unspecified medical attention was sought. A prenatal profile consisting of a complete blood count and urine analysis was performed, the results were not reported. On 14-NOV-2006, at the patient's first OB visit, an ultrasound was performed and showed an intrauterine pregnancy and fetal heart, the estimated delivery date was confirmed to be 05-JUL-2007. It was reported that the patient had 2 previous pregnancies and 1 full term birth. No birth defects, stillbirths or miscarriages occurred in any previous pregnancy. No further information was provided. There was no product quality complaint involved. Follow up information form the registered nurse indicated that the patient had a serum alpha-fetoprotein test on 16-JAN-2007 which was within normal limits and a level II ultrasound on 01-FEB-2007, which was also within normal limits. It was noted that all routine prenatal testing was within normal limits. The patient was placed on therapy with famotidine (MSD) over the counter on 08-FEB-2007 for heartburn during pregnancy. On 04-JUL-2007, 39 weeks from her last menstrual period the patient gave birth to an 8 pound 13 ounce normal girl. There were no congenital anomalies. There were no complications during the pregnancy though she did have a prolonged 2nd stage labor with posterior occiput presentation. The patient had no infections or illnesses during pregnancy and no concurrent medical conditions. The baby had no feature of congenital varicella zoster syndrome. No further information was provided. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Varicella
Clinical narrative: Information has been received from a physician concerning her 18 month old white son with no previous exposure to this or related drug, who on 23-MAY-2007 was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck) (lot number: "03394"). There were no concomitant medications. On approximately 30-MAY-2007 the patient developed chicken pox "from the chicken pox vaccine." On 31-MAY-2007 (for a duration of 10 days) the patient developed a fever of 102.7 and a rash over entire body. The rash had the appearance of chicken pox but did not seem to itch and the lesions never crusted over. The rash gradually disappeared. On 10-JUN-2007 the outcome was reported as recovered. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 8 year old white male with no medical history or drug allergies, who on 16-JUL-2007 at 15:30 was vaccinated with his second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656692/0457U) in the left arm. On 17-JUL-2007 in the AM, the patient developed redness, itching, and swelling at the injection site. No medical attention was sought. No labs were performed. Subsequently, the patient recovered on 20-JUL-2007. There was no product quality complaint. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old male who 6 years ago when he was 12-15 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Now after 6 years of vaccination the patient had developed chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 02-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot no 657449/0597U). On 05-JUL-2007 the patient called the office and reported that on 02-JUL-2007 she had a 4 inch diameter redness of injection site in the L arm. On 06-JUL-2007 the patient called again because of continued symptoms. This is one of several reports received from the same source. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 5 year old female who on 23-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot no 657759/0639U) in the right deltoid. On 26-JUL-2007 the patient developed an injection site rash which was described as red, swollen and painful to touch. The parents of the patient were told to apply ice to treat the rash. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 16 year daughter who on an unreported date was vaccinated with varicella virus vaccine live (Oka/Merck). The patient's younger sisters (13 and 11), had also previously immunized. The 11 year old and 13 year old recently had a breakthrough of chickenpox, but the 16 year old was not affected with the recent exposure. The patient, at around 8 years of age, approximately 1998, had developed a mild case of chickenpox. This is one of several reports received from the same. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Serology negative, Ultrasound antenatal screen normal, Urine analysis abnormal
Clinical narrative: Information has been received from a physician for the Merck pregnancy registry concerning a 23-year-old caucasian female hospital employee with a conception date of 13-DEC-2006 (previously reported as her last menstrual period was 12-DEC-2006) who on approximately 15-NOV-2006 and 27-DEC-2006 was vaccinated with her first and second doses of varicella virus vaccine live (Oka/Merck) (lot# 652630/0247F). She reported to the physician that she had performed two home pregnancy tests on 01-JAN-2007 which were positive (estimated LMP 28-NOV-2006, EDD 05-SEP-2007). Unspecified medical attention was sought. No additional information to report. There was no product quality complaint. Follow-up information indicated the patient underwent an ultrasound on 01-FEB-2007 which showed a viable pregnancy. No maternal adverse events related to the vaccine were noted. Follow-up information has been received from a physician indicating the patient underwent a routine screening for maternal serum alpha fetoprotein (KSAFP) on 22-MAR-2007 which revealed a negative result. It was unknown whether a local reaction at the vaccination site occurred from the previous doses of varicella virus vaccine live (Oka/Merck). No maternal adverse events were noted for varicella or Herpes zoster symptoms. Follow-up information has been received from a completed varicella virus vaccine live (Oka/Merck) questionnaire from an obstetrician and pediatrician indicating that the (full-term 7 lb 11 oz) normal male was born with no congenital anomalies or abnormalities or complications. The mother of the infant experienced mild pre-ecclampsia during pregnancy. There were no complications during labor/delivery, no infections or illness during pregnancy or concurrent medical conditions. Concurrent drug therapy during pregnancy included prenatal vitamins for routine care. The infant did not have any feature of congenital varicella zoster syndrome. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 11 year daughter who on an unreported date was vaccinated with varicella virus vaccine live (Oka/Merck). The patient, at 11 years of age, recently (2007) developed a case of chickenpox. The patient, along with her older sisters (16) and (13), had all been previously immunized. The 13 year old had a breakthrough at the same time as her 11 year old sister. The patient did not develop chickenpox following past exposures to the virus years ago when her oldest sister (16) exhibited a breakthrough case of chickenpox. This is one of several reports received from the same. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound antenatal screen normal, Ultrasound scan normal
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician concerning a 15 year old black female who on 01-FEB-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On the same day, after vaccination, an urine HCG test was performed and was positive. The patient's last menstrual period was reported to be "in very early January 2007." No additional information was provided. Follow-up information was received from a nurse practitioner. It was noted that varicella virus vaccine live (Oka/Merck) was not administered for immigration purposes and that the patient was not tested for varicella antibodies prior to vaccination. The patient had an ultrasound on 15-FEB-2007 which confirmed an EDD of 11-OCT-2007. The patient had an additional ultrasound on 04-JUN-2007 which was normal. The patient had no previous pregnancies. The patient had no local reaction at the injection site and no varicella or herpes zoster symptoms post vaccination. Additional information received indicated that concomitant therapy included prenatal vitamins. On 01-OCT-2007, 38 weeks from her last menstrual period the patient delivered a normal live born female. The newborn's weight was 3244 gm. There were no complications, no diagnostic tests, no infections, no illnesses and no concurrent medical conditions during pregnancy. The patient did have elevated blood pressure during labor, treatment of elevated  blood pressure was not reported. No further information was provided. No further information is expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 13 year old male who on 17-JAN-2006 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a non-serious localized injection site reaction described as a mild rash. It was unspecified if medical attention was sought. The rash resolved three days after receiving the vaccination. No further information was provided. Additional information is not expected. This is one of several reports from the same source.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old white female with phenylketonuria who on 29 JUN 2007 at 9:00 was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657405/0531U). Concomitant therapy that same day included an intramuscular first dose vaccination of hepatitis A vaccine (inactive) (Lot # "0282F") and intramuscular first dose vaccination of human papillomavirus vaccine (GARDASIL), (Lot # 655618/0186U). There was no illness at the time of vaccination. On 30-JUN-2007 the patient developed a three inch area of redness, swelling and pain at the injection site of "Varivax" (left arm) the patient's guardian elected to have the patient seen in the emergency room. On 02 JUL 2007 the site was observed to be only slightly red and tender to touch, with slight edema. No treatment was given. The patient was recovered on 02 JUL 2007. There were no lab diagnostic studies performed. There were no known adverse events following prior vaccinations. There was no product quality complaint. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female pediatric patient who on an unspecified date was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck), and subsequently developed breakthrough varicella (previously reported as a rash) about 3 years after vaccination. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected. This is one of several reports from the same source.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 10 year old female who on 10-JUL-2007 at approximately 13:00 was vaccinated SC in the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot#657099/0453U). Forty eight hours after receiving the vaccination the patient developed an "outbreak of zoster" which started on her neck and moved toward her armpit. The nurse also reported "some site reaction after receiving the shot." Concomitant vaccination at the same time included a booster dose IM of Adacel (Lot# C2690AA). Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Follow up information from the nurse, indicated that on 12-JUL-2007 the patient developed shingles in C-5 dermatome pattern on the left. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Initial and follow up information has been received from a physician concerning a 10 year old child who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with second dose of varicella virus vaccine live (Oka/Merck) (Lot Number 656077/1491F). Subsequently, within two to three days post vaccination, the patient developed a 10 cm area of redness and / or 6 X 6 area with a circular pattern with redness, warm to touch and pain. The reaction lasted approximately 1 week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female who on 16-JUL-2007 was vaccinated subcutaneously with a second single dose of varicella virus vaccine live (Oka/Merck) (Lot# 657620/0536U). Additional suspect vaccination included Gardasil vaccine (MSD). Other concomitant therapy included Menactra and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Within 12 hours of being vaccinated the patient developed a severe injection site reaction that continued to become "more severe." The injection site rash was about 7 inches in diameter and wrapped around the patients arm, was warm, hard to touch in the middle and was less red on the outside of the rash. On a follow-up visit to the doctor the next day (on 17-JUL-2007) the patient had a low grade fever and a general feeling of achiness. Nurse practitioner was concerned that the patient might have cellulitis. On the third day following vaccination the patient returned for another follow up visit, the rash had stabilized. It was noted that the nurse practitioner treated the patient with Benadryl. Lab studies for a white blood cell count were normal. No other information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Pain, Pyrexia, White blood cell count
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female who on 16-JUL-2007 was vaccinated subcutaneously with a second single dose of varicella virus vaccine live (Oka/Merck) (Lot# 657620/0536U). Additional suspect vaccination included Gardasil vaccine (MSD). Other concomitant therapy included Menactra and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Within 12 hours of being vaccinated the patient developed a severe injection site reaction that continued to become "more severe." The injection site rash was about 7 inches in diameter and wrapped around the patients arm, was warm, hard to touch in the middle and was less red on the outside of the rash. On a follow-up visit to the doctor the next day (on 17-JUL-2007) the patient had a low grade fever and a general feeling of achiness. Nurse practitioner was concerned that the patient might have cellulitis. On the third day following vaccination the patient returned for another follow up visit, the rash had stabilized. It was noted that the nurse practitioner treated the patient with Benadryl. Lab studies for a white blood cell count were normal. No other information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Incorrect route of drug administration, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning her 4 year old healthy daughter with no medical history who on 06-MAY-2004 was vaccinated with her first IM (previously reported as SC) dose of varicella virus vaccine live (Oka/Merck) (lot# 647709/1247N) in the left thigh. On approximately 07-APR-2007 at the age of 3 years, the patient developed breakthrough chickenpox with more than 50 lesions all over the body after being in contact with a child who had chickenpox. Unspecified medical attention was sought. The physician states it was definitely chickenpox. Subsequently, the patient recovered as she was noted to be fine. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed visiting nurse concerning 10 adult patients who have been vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). It was reported that in the last 1 month the 10 patients have complained of injection site redness, soreness and warm to touch. It was also reported that the lot number used for all patients was not the same. The patients sought unspecified medical attention. The patient's outcome was reported as "improved 48 hours after injection." There was no product quality complaint involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female who on 10-JUL-2007 was vaccinated subcutaneously with a second single dose of varicella virus vaccine live (Oka/Merck) (Lot#657620/0536U). Within 24 hours of vaccination the patient developed an injection site reaction that "grew to be about the size of a softball (about 5 inches in diameter)." It was noted that the reaction was "warm, puffy, and red." She sought medical attention and was treated with Benadryl and ice packs. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Culture negative, Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from an office manager concerning a 7 year old patient who on 16-OCT-2000 was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck) (lot# 631475/1003J). On 08 MAR 2007 a specimen, obtained from the patient's abdominal area, was sent for rapid viral culture test for chickenpox. Culture results noted no herpes simplex or varicella zoster isolated. Clinical observations, noted on 09 MAR 2007, including red spots, itching on trunk, legs and head, indicated the patient had a mild chickenpox breakthrough. The patient had been exposed to shingles two weeks prior. The patient sought unspecified medical attention. At the time of reporting the outcome was unknown. There was no product quality complaint 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 medical assistant concerning a male patient with no allergies and no medical history who on 11-JUN-2001 was vaccinated with a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 636575/1467K). There was no concomitant medication. The patient developed breakthrough chickenpox rash all over the body and was seen at the office on 16-APR-2007 for the diagnosis. No further information was available. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Additional information has been requested.