chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning a 11 year old white female twin who on 06-AUG-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 661445/0525X).  On the same day, the patient received a dose of GARDASIL (lot # 659435/1265U), left deltoid, received a dose of VAQTA (lot # AHAVB243AA), the patient was vaccinated also with the fifth dose of ADACEL (lot # C2995AA) and received with a dose of MENACTRA, (lot # 42544AA).  On 07-AUG-2008, the patient experienced redness in left arm, pain and swelling at the injection site.  The patient may have also experienced fever and/or itching and burning while getting injected with the vaccine.  On 09-AUG-2008, the patient recovered.  The reporter has requested a lot check due the patients having adverse experiences.  The patient sought medical attention by calling the office.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  This is one of several reported provided by the same source.  The patient's twin also experienced adverse events.  (WAES# 0808USA03476).  No additional information is expected.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Ear pain, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 12 month old healthy patient who on 17-JUL-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 659457/1913U). Concomitant vaccination included a first dose of MMR and a first dose of Hep A (manufacturer unknown). On 23-JUL-2008 the patient had diarrhea and ear pain. On 28-JUL-2008 the patient was diagnosed with full chicken pox characterized by less than 50 lesions. On 28-JUL-2008 the patient had a temperature of 102 degrees F, scattered vesicular rash on body with pruritus. On 31-JUL-2008 the patient experienced vesicular rash on tongue and body. The patient's rash cleared on 07-AUG-2008. The patient was considered fully recovered on 07-AUG-2008. The patient's temperature was 99.4 degrees F. Patient's relevant diagnostics included a physical examination. On 07-AUG-2008, the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot # 65778/1861U). Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 12 month old healthy patient who on 17-JUL-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 659457/1913U). Concomitant vaccination included a first dose of MMR and a first dose of Hep A (manufacturer unknown). On 23-JUL-2008 the patient had diarrhea and ear pain. On 28-JUL-2008 the patient was diagnosed with full chicken pox characterized by less than 50 lesions. On 28-JUL-2008 the patient had a temperature of 102 degrees F, scattered vesicular rash on body with pruritus. On 31-JUL-2008 the patient experienced vesicular rash on tongue and body. The patient's rash cleared on 07-AUG-2008. The patient was considered fully recovered on 07-AUG-2008. The patient's temperature was 99.4 degrees F. Patient's relevant diagnostics included a physical examination. On 07-AUG-2008, the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot # 65778/1861U). Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker and the nurse concerning a 63 year old female who on 02-AUG-2008 was vaccinated with a dose of VARIVAX rather than ZOSTAVAX. The healthcare worker reported no product confusion, just nursing error. No problems reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. The nurse said that she did not known how the error occurred. But the patient was notified and had no adverse event. Follow-up information was received from the healthcare worker which reported that she could not provide additional adverse events information. The patient had no problems, and the patient will get ZOSTAVAX in 28 days.  Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site papule, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old female with allergic rhinitis and a history of "HAO" who on 16-JUL-2008 at 11:00 was vaccinated subcutaneously in right arm with the second dose of VARIVAX (Merck) (LOT # 659456/1912U).  There was no concomitant medication.  On 17-JUL-2008 the patient developed tender, papule, redness and swelling at the injection site.  Subsequently, the patient recovered from the symptoms.  Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a company representative concerning her daughter a 7 year old female with pollen allergy who in approximately July 2007, was vaccinated with VARIVAX (Oka/Merck). In July 2008 the patient experienced chicken pox after vaccination approximately 1 year ago. It was a mild case on the trunk area. Subsequently, the patient recovered from chicken pox. The patient sought medical attention. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 10 year old male who on 13-AUG-2008 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (lot no. 660082/1977U) into the right deltoid. Concomitant therapy included the first dose of HAVRIX (lot no. AHNVB289BA) given intramuscularly and tuberculin in purified protein derivative (lot no. 62412) given intradermal. On 15-AUG-2008, "within 48 hours of the vaccination", the patient developed a local reaction after administration of VARIVAX. He developed an approximately 2 inch in diameter, raised red area at the injection site, which was erythema, tenderness, local pruritic and swelling without significant induration. There was no follow specified unless not improved. At the time of this report, the outcome was unknown. The patient sought unspecified medical attention. 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 of the Center for Biological Evaluation and Research and was released. This is one of several reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 14 year old female who at 4:00 pm on 21-AUG-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot# 657786/0717U) SQ in her left arm. Additional suspect vaccine included a first dose of GARDASIL (lot# 655620/0171U) IM in her left deltoid. Concomitant vaccination included a second dose of BOOSTRIX (lot# reported as AC52B015BA) IM in her right deltoid on the same day. A few hours after the injections (also reported as at 5:30 pm on 23-AUG-2007), the VARIVAX (Oka/Merck) injection site developed minimal swelling for 24 hours and small quarter size amount of redness. Two days later, the swelling and redness were 1.5 to 2 inches above and below the injection site. The injection site developed lots of heat, the swelling spread to at least 2 inches outward and it looked like the patient had 2 arms. The swelling made it difficult for the patient to move her arm. The swelling stayed for one week, then gradually decreased over 3 to 4 days. The redness disappeared after one week. No other problems had occurred since the swelling resolved. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no known pertinent medical history or drug reactions/allergies who on 13-Aug-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot# 660082/19770) 0.5ml SQ in her left deltoid. Concomitant therapy included MMR-II (MSD). On 15-Aug-2008, within 48 hours of the vaccination, the patient developed a 2 inch diameter warm, tender, pruritic and red raised local reaction at the injection site without significant induration. The nurse requested a lot check. 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 research was released. This is one of several reports from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a 41 year old female with Graves disease and an allergy to cephalexin who in April 1998, was vaccinated with the second dose of VARIVAX (Oka/ Merck). In July 2008, the patient went to her primary care physician for a regular check up. Since the patient received VARIVAX (Oka/Merck) about 10 years ago, she asked the physician if she needed to be revaccinated or if she was protected for life. The physician stated that she could do a titer test to find out. The titer test demonstrated that the patient was not immune to varicella (chicken pox). No further information available.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse, concerning her 5 year old son, who on 12-MAY-2004 was vaccinated with VARIVAX (Oka/Merck). On 21-FEB-2007, the patient was vaccinated with MMR II (+) VARIVAX (Oka/Merck upgrade process). (MSD). On 20-AUG-2008, the patient developed a mild case chickenpox. The child had about 50 lesions and a fever of 100.1F. The patient was treated with BENADRYL and AVEENO baths as needed. At the time of report, the patient had not recovered. The patient sought medical attention in the office. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 10 year old male with mold allergy and reactive airway disease who on 13-Aug-2008 was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX (Merck) (lot no. 660082/1977U) into the right deltoid. Concomitant therapy included the first dose of HAVRIX (lot no. AHAUB259BA) given intramuscularly and tuberculin purified protein derivative (lot no. 62412) given intradermal. On 15-Aug-2008, "within 48 hours of the vaccination", the patient developed a local reaction after administration of VARIVAX (Merck). He developed a local reaction after administration of VARIVAX (Merck). He developed an approximately 2 inch in diameter, raised red area at the injection site, which was erythema, tenderness, local pruritic and swelling without significant induration. There was no follow specified unless not improved. At the time of this report, the outcome was unknown. The patient sought unspecified medical attention. A standard lot check investigated was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin infection, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 3 year old male who on 27-FEB-2006 was vaccinated subcutaneously with one 0.5 ml dose of VARIVAX (Oka/Merck).  Subsequently, on an unspecified date, the patient developed chickenpox on the abdomen and at other site. The child was seen on 21-AUG-2008, had no fever or discomfort, but was given an unspecified antibiotic to treat skin infections from a couple of vesicles. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 16-AUG-2008, was vaccinated subcutaneously into the left arm with a second dose of VARIVAX (Oka/Merck) (lot # 660495/0431X).  On 18-AUG-2008, when she woke up, the patient notice a large area of swelling and redness at the site of injection.  Patient was advised to apply cold compresses and use MOTRIN and TYLENOL for discomfort and call back if reaction doesn't disappear in 24- 48 hours.  Her outcome was unknown.  No further information is available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 24-MAR-2008, was vaccinated with a dose of VARIVAX vaccine (Oka/Merck), 0.5ml, subcutaneously in her right arm. On 24-MAR-2008, the patient experienced swelling and tenderness at the injection site. The physician reported that the symptoms were treated with ADVIL and cold compress. On approximately 26-MAR-2008, the patient recovered. The patient sought medical attention. This is one of two reports received from the same source. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired drug administered, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nursing student concerning her 4 year old daughter who on 22-JUL-2005 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) 0.5 ml (Lot number not reported).  On 21-AUG-2008 she was vaccinated with a second dose of VARIVAX (Oka/Merck) (Lot #654130/0920F) which had expired on 27-JUL-2008.  The patient also received MMR II (MSD), DTAP (manufacturer unknown) and (Vero)  IPOL on the same date.  On 21-AUG-2008, the patient complained her leg hurt and later developed a fever.  On 22-Aug-2008, the patient recovered.  The patient sought medical attention from her mother.  There was no product quality complaint.   Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Full blood count, Immunology test
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 07-AUG-2008, was vaccinated with her first dose of VARIVAX vaccine (Oka/Merck) (Lot # 658576/1271U). Concomitant therapy also included on 07-AUG-2008, at the same appointment, second dose of MMR II vaccine (Lot # 656617/0416U), and PEDIARIX. Two days after vaccination the patient experienced generalized vesicular rash described by the physician as a"classic chickenpox". The diagnosis of chickenpox was confirmed by a dermatologist. The patient has itching and was still breaking out all over her body. The patient has been prescribed BENADRYL and ATARAX. Laboratories test included: Complete blood count (CBC), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), protein C and Complement Activity Enzyme Immunoassay (CH50) (results not provided). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Protein C, Pruritus, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 07-AUG-2008, was vaccinated with her first dose of VARIVAX vaccine (Oka/Merck) (Lot # 658576/1271U). Concomitant therapy also included on 07-AUG-2008, at the same appointment, second dose of MMR II vaccine (Lot # 656617/0416U), and PEDIARIX. Two days after vaccination the patient experienced generalized vesicular rash described by the physician as a"classic chickenpox". The diagnosis of chickenpox was confirmed by a dermatologist. The patient has itching and was still breaking out all over her body. The patient has been prescribed BENADRYL and ATARAX. Laboratories test included: Complete blood count (CBC), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), protein C and Complement Activity Enzyme Immunoassay (CH50) (results not provided). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Information has been received from a female who "last week" (on approximately 15-AUG-2008) was vaccinated with one dose of VARIVAX (Merck) 0.5ml SQ.  Subsequently the patient experienced an itching bump at the injection site and itchiness on her palms.  It was unspecified if the patient sought medical attention.  No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no illnesses at the time of vaccination, who on 04-FEB-2004 was vaccinated with VARIVAX (Oka/Merck). The patient received the second dose of VARIVAX at 1:41 p.m. (Oka/Merck) (661444/0529X) on 11-AUG-2008, and two days later, on 13-AUG-2008, developed a fever and rash on her face, torso, arms and buttocks. There were no vesicles or pustules. The patient was instructed to treat with calamine lotion. Subsequently the patient recovered. Medical attention was sought at the physician office. No further information is available.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 14 year old patient with allergy to unspecified medication who on 12-DEC-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 18-JUN-2008( also reported on 18-AUG-2008) the patient had a full blown chicken pox. On an unspecified date the patient recovered from a full blown chicken pox. The patient sought medical attention and saw the physician. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Lip swelling, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 16 year old male who in 1996 was vaccinated with VARIVAX (Oka/Merck).  On 27-JUN-2008 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot # 659739/0269X).  Concomitant therapy included HAVRIX.  The patient had rash the date after VARIVAX (Oka/Merck) was given.  The rash was first on the chest and then spread to the legs and arms.  One week later, approximately on 04-JUL-2008 the patient experienced swollen and red lip and swollen and red lip.   Unspecified if a reaction developed after the first dose.  Medical attention was sought at the physician's office.  This case was already reported to VAERS from the physician's office.  Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 10 year old patient with allergy to unspecified medication who on 28-Dec-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck). In July 2008, the patient had a full blown chicken pox. On an unspecified date the patient recovered from a full blown chicken pox. The patient sought medical attention and saw the physician. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Information has been received from a nurse practitioner, concerning to "couple of youngsters", who were vaccinated with the second dose of VARIVAX (Oka/Merck). The patients experienced itching and large swelling after the second dose of VARIVAX (Oka/Merck). The patients sought medical attention. 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. Follow-up information has been received from a Licensed Practical Nurse, concerning a 12 year old male patient, who was vaccinated with VARIVAX (Oka/Merck) (Lot # 660671/0430X). Subsequently, the patient experienced itching, large swelling and fever. The patient recovered from the itching and swelling. The outcome of fever was not reported. Further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a female who a year ago was suppose to get ZOSTAVAX (Merck), but by mistake the prescription was written for VARIVAX. The consumer reported that she had then received three doses of VARIVAX. No AE involved. Consumer did not want to provide physician information. Further information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a consumer concerning a 10 year old male son with no previous medical history reported, who on 19-AUG-2008 was vaccinated with 0.5 mL VARIVAX (Oka/Merck).  There was no concomitant medication.  On 20-AUG-2008, the patient experienced rash around the injection site.  As of 22-AUG-2008 the injection site rash persisted.  The patient did not seek medical attention.  There was no product quality complaint.  No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning three patients who on an unspecified date, were vaccinated with a dose of VARIVAX (Merck) (Lot number not reported).  The patients developed an injection site reaction.  There was no product quality complaint.  (Also refer to WAES #0808USA02461).  Follow-up information has been received from a Licensed Practical Nurse, concerning an 10 years old female patient who was vaccinated with a dose of VARIVAX (Merck) (Lot #660402/0271X).  The patient experienced red and swollen upper arm from injection site.  Further information is expected.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 7 year (estimated, age unit was not provided) old patient with an allergy to unspecified medication who on 30-NOV-2001 was vaccinated with VARIVAX vaccine (Oka/Merck) (lot # 639780/0579L). In July 2008, the patient developed full blown chickenpox. Subsequently, the patient recovered. The patient was seen by a physician. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who was vaccinated with VARIVAX (Oka/Merck). Subsequently the patient experienced a rash. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist, concerning a 67 year old male patient who was vaccinated with a dose of VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake because one technician said to another one that the patient needed the shingles vaccine and when the other technician saw the packaging he said that the vaccine shown was the one for the shingles not realizing that he was looking at the wrong vaccine.  The pharmacist reported that then the vaccine was sent to the patients primary care office to be administered to the patient.  At the clinic the nurse administering the vaccine did not do a final check and gave then the wrong vaccine to the patient.  The pharmacist stated it was not product confusion.  No adverse reaction were reported.  The pharmacist also reported the patient's wife received the wrong vaccine (refer to 0809USA00001).  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male with no pertinent medical history who on 10-SEP-1997 was vaccinated with the first dose of VARIVAX vaccine (Oka/Merck) and on 06-JUN-2007 was vaccinated with the second dose of VARIVAX vaccine (Oka/Merck) (lot# 652556/0246F). Subsequently the patient experienced a mild case of chickenpox (onset date was not reported).  the patient had about 40 pox on his face and back. The patient was taken to a doctor. As of 26-AUG-2008, the patient was recovering from chickenpox. No additional information is available
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning her son who was vaccinated with VARIVAX (Oka/Merck) a while ago.  The patient developed a circular rash around injection site.  The pharmacist stated the she does not remember where the injection site was, and can not be sure the reaction was caused by VARIVAX (Oka/Merck) or another vaccine.  Unspecified medical attention was sought.  The patient recovered.  No further information is available.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning her 18 year old daughter with no known allergies or pertinent medical history and no illness at time of vaccination, who on 13-AUG-2008 at 0900, was vaccinated with the second dose of VARIVAX (Merck) (Lot #657787/0718U) subcutaneously at the upper left arm.  Other concomitant therapy include, on 13-AUG-2008 at 9:00 AM was vaccinated with the first dose of tuberculin purified protein derivative (manufacturer unknown) (Lot # C2808AC) intradermal into the left forearm.  Vaccines were administered at another primary care provider's office.  There was no illness at the time of vaccination.  Post vaccination, on 13-AUG-2008, at 1800, the patient experienced hotness, tenderness, swelling around injection site which looked like cellulitis like reaction with some lesions on the entire upper arm near the injection site, no fever.  On 18-AUG-2008, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Blood urine present, Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse; concerning a friend of hers who developed shingles 3 days after her children received a booster for VARIVAX (Merck). The patient had not recovered. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Feeling hot, Rash
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12 year old female who on 18-DEC-1998 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) (lot # 628147/1262H) in his left thigh. There is no illness at the time of vaccination. On 21-AUG-2008 the patient felt warm. The patient took "vonceted" one time and the symptom improved. On approximately 24-AUG-2008 the patient's mother noted that the patient developed rash. The patient was seen in the office. More than 50 vesicles of varying sizes staged on trunk with face were found. At the time of this report, the events persisted. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyskinesia, Underdose
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 13 year old male who on 25-AUG-2008 was vaccinated subcutaneously with a partial second dose of VARIVAX (Merck) (lot #660405/0272X) because the patient jerked during the administration. The patient was seen at the office. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Secondary transmission, Varicella
Clinical narrative: Information has been received from a nurse concerning a female grandmother of a child who received the second dose of VARIVAX (Merck) (Lot # 654756/13335F) on 18-JUN-2008. Grandmother spent 10 days with the child and 3 days later went to the emergency room for the rash. The child did not have a rash. The emergency room physician thought that the grandmother contracted the chickenpox naturally. VZV analysis offered but the nurse declined since she did not think that it was related to VARIVAX (Merck). No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an "almost 5 years old" male who in November 2007, was vaccinated with his second dose of VARIVAX (Merck).  Within the past week, on approximately 22-AUG-2008 the patient developed "4 spots" on his back.  The physician also mentioned that the patient had several "bug bites" on his legs.  No fever had been noted.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who was vaccinated with a second dose of VARIVAX (Merck). One day or two after the second vaccination, the patient broke out with chickenpox in the mouth, around neck and face. On 26-AUG-2008 the patient was seen at the office for a second follow-up. No laboratory or diagnostics tests were performed. At the time of this report, the patient was recovering. Additional information has been requested. Follow up information has been received from a physician by a complete questionnaire concerning a 13 year old female patient with allergic reaction to SEPTRA and CEFZIL, who on 26-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (Lot# 659204/1470U) intramuscularly. On 26-AUG-2008 the patient developed a rash. On an unspecified date in 2008 the patient's symptoms disappeared. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with VARIVAX (Merck). Subsequently the patient developed herpes zoster. A zoster specimen confirmed recombination of vaccine strain and wild type varicella zoster virus in this patient. This is one of several reports from the same source.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 6 year old son, who on 13-AUG-2008 was vaccinated with VARIVAX (Merck), 0.5 mL, subcutaneously. Subsequently, on 23-AUG-2008, the child developed chicken pox. There was no concomitant medication. As of 28-AUG-2008, the date of this report, the child was recovering from chickenpox. The patient sought unspecified medical attention. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist, concerning a 67 year old female patient who was vaccinated with a dose of VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake because one technician said to another one that the patient needed the shingles vaccine and when the other technician saw the packaging he said that the vaccine shown was the one for shingles not realizing that he was looking at the wrong vaccine. The pharmacist reported that hen the vaccine was sent to the patient's primary care office to be administered to the patient. At the clinic the nurse administering the vaccine did not do a final check and gave then the wrong vaccine to the patient. The pharmacist stated it was not a product confusion. There were no adverse reactions reported. The pharmacist also reported the patient's husband who received the wrong vaccine (refer WAES 0808USA04634). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with VARIVAX (Oka/Merck).  Subsequently the patient developed herpes ZOSTER.  A ZOSTER specimen confirmed recombination of vaccine strain and wild type VARICELLA ZOSTER virus in this patient.  This is one of several reports from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse at the health care department who received a faxed report from a registered nurse, concerning a case of breakthrough chickenpox from a 21 month old male who on 03-DEC-2007 was vaccinated with a single dose of VARIVAX (Merck). On 20-AUG-2008, the patient developed lesions. The distribution of character of the lesions was not provided but was described as "less than 50 lesions". The case was reported to the pediatric office by the child's mother by phone. No additional information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccine positive rechallenge, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (lot number, injection site and route not reported). Subsequently the patient developed a very mild case of chickenpox, very few lesions. On an unspecified date, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number, injection site and route not reported). Subsequently the patient developed a break through case of chickenpox. The patient went to the physician's office. Subsequently, the patient recovered from chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date, was vaccinated with a dose of VARIVAX (Merck). The physician reported that the patient developed a chickenpox rash 9 days after vaccination. It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a nurse and a consumer concerning her 10 year old daughter who is a student with an amoxicillin allergy and well controlled but moderate asthma, who on 04-Aug-2008, was vaccinated with the second dose of VARIVAX (Merck) (lot no. 660495/0431X) SC, into the left arm at approximately 15:30 pm. Concomitant therapy included Montelukast Sodium (MSD), ADVAIR, ZYRTEC and ASTELIN. On 05-Aug-2008, one day after receiving the second dose of VARIVAX (Oka/Merck) the patient reported area of redness and tenderness at the injection site in left arm and pain in in the same arm. The physician suggested BENADRYL. The patient was seen in an emergency room because the swelling had increased. The emergency room prescribed MOTRIN. The nurse reported that days after, the patient recovered from the symptoms. There were no lab tests preformed. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male who on 28-JUN-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot number, injection site and route not reported). On 06-AUG-2008, the patient went to the doctor's office with rash. According to the physician, the rash looked like varicella, or rash from vaccine or the vaccine didn't work. Unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a male patient with Crohn's disease who on an unspecified date was vaccinated with VARIVAX (Merck).  Concomitant therapy included immunomodulatory drugs.  It was reported that the patient did not seroconvert from VARIVAX (Merck) vaccination.  The patient had received 2 doses of VARIVAX (Merck) in the past.  But when titer was drawn recently, his titer came back as 0.43 which is less than the protection level of 0.9.  At the time of the report the patient had not recovered.  The patient sought medical attention.  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Varicella post vaccine
Clinical narrative: Initial and follow up information has been received from a physician concerning a 9 year old male who in 1999, also re was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported). In 1999 the patient developed chickenpox after receiving the vaccine. On approximately 28-JUL-2008, also reported as 2 weeks ago, the patient developed chickenpox with nausea, vomiting and fever. In follow-up the physician reported that there was no adverse event. "The kids simply got chickenpox after being vaccinated". It was reported that the patient had routine office visit. The patient's events persisted. 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 physician concerning a 10 year old female with no known allergies who on 05-AUG-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot no. 660826/0424X). There was no concomitant medication. On an unspecified date the patient developed red, swollen softball size spot at the injection site. The outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 12 year old male patient who on 11-AUG-1997 was vaccinated with a dose of VARIVAX (Merck) (lot# 660407/0103X), subcutaneously into his left arm. Concomitant therapy included Tdap. The nurse reported that the patient developed hives over his whole body one week after vaccination with VARIVAX, on approximately 18-AUG-1997. The patient was treated with prednisone and ZYRTEC. At the time of the report, the patient had not recovered. The patient sought medical attention by phone. Follow-up information indicated per the physician, that the patient did not have an adverse experience following VARIVAX. No further information is available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old female patient who on 20-AUG-2005, was vaccinated with the first dose of VARIVAX (Merck) 0.5 ml subcutaneously. On 23-AUG-2008, the patient was administered her second dose of VARIVAX (Merck) (lot#659740/0165X) 0.5 ml subcutaneously. The physician reported that on 25-AUG-2008, the patient developed a 3 inch by 3 inch area of swelling at the injection site. The patient was treated with BENADRYL and ice compresses and the symptoms were improving. At the time of the report, the patient was recovering. This is one of two reports received 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 of the center and was released. No further information is available.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 19-AUG-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 659740/0165X) 0.5 ml SQ.  On 19-AUG-2008 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) 0.5 ml SQ in the left thigh.  Concomitant therapy included a dose of DTAP.  On 21-AUG-2008 the patient experienced swelling at the injection site.  On 26-AUG-2008 the patient developed 8 scattered vesicular lesions.  The patient was treated with BENADRYL and ice compresses.  The patient sought medical attention via an office exam.  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 of the Center for Biologics Evaluation and Research and was released.  This is one of several reports from the same source.  No further information in available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect storage of drug, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning two or three patients who were vaccinated with VARIVAX (Merck) that was stored improperly. The vials of VARIVAX (Merck) were stored in the freezer with 8 degrees Fahrenheit for one month. No adverse effect reported. No product quality complaint was involved. Follow-up information was received from a registered nurse (R.N.) concerning a 48 month old male with no drug allergies and with birth weight of 7 lb 5 oz and 1 sibling who on 08-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) in the thigh (lot # 658763/1341U). On that same day, secondary suspect therapy included MMR II (MSD) (lot # 654895/0745U). Other concomitant therapy included DTaP (lot # AC14BB661AA) and POLIOVAX (lot # AO126). There was no illness at time of vaccination. On 10-AUG-2008, the patient experienced red, swelling, tender at injection site. Subsequently, the patient recovered. No lab tests performed. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no known pertinent medical history or drug reactions/allergies who on 16-AUG-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot# 659740/0165X) 0.5 ml SQ. There was no concomitant medication. On 18-AUG-2008 the patient developed 6 scattered vesicular lesions with an erythematous base. The patient sought medical attention via an office exam. 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 of the Center and was released. This is one of several reports from the same source. No further information is available.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning an 8 year old female with no pertinent medical history and no history of drug reactions or allergies who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) (lot#: 660083/0488X) and hepatitis A vaccine (manufacturer unknown). On 12-JUL-2008 the patient developed a severe injection site reaction with pain. The patient went to the emergency room, but was not admitted. The patient's outcome was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site vesicles, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician's assistant concerning a 4 year old female who on 20-DEC-2004 was vaccinated with the first dose of VARIVAX (Oka/Merck). No reaction was reported after the first dose. On 04-AUG-2008 the patient was vaccinated with the second dose of VARIVAX (Oka/Merck). Subsequently the patient had a rash and small pin size blisters at the injection site. The patient's outcome was unknown. The patient contacted physician's assistant. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 9 year old male who on 14-FEB-2000 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot #631773/1033J).  On 16-AUG-2008 the patient developed a 50-500 lesions vesicular rash in the groin, chest and limbs.  Medical attention was sought via a telephone call.  No laboratory or diagnostics tests were performed.  At the time of this report, the patient recovered.  Follow up information was received from the R.N. who reported that the child was vaccinated subcutaneously with a first dose of VARIVAX (Merck) in his right arm on 14-FEB-2000.  The child's mother called and reported that the child's rash had not resolved, so the child went to see a dermatologist.  He was diagnosed with an "autoimmnune" type rash and not a case of varicella.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female patient whose son in 1999 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number not reported).  On approximately 28-JUL-2008 the patient developed chickenpox.  In follow-up the physician reported that there was no adverse event.  "The kids simply got chickenpox after being vaccinated."  It was reported that the patient had routine office visit, no other work up was needed.  Additional information is not expected.