chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Abdominal pain, Cough, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a pt who was vaccinated with a dose of varicella virus vaccine live (two lot #'s provided: Lot # 625903/0046H or Lot # 624441/1105E). Sometime between 01/17/04 and 02/05/04, the pt developed chickenpox with over 300 lesions.  The child may have experienced a fever above 103 degrees Fahrenheit, a cough, abdominal pain, and/or itching. The child received unknown symptomatic treatment. The child may have seen a physician. The reporter also indicated that 21 other students were vaccinated with a dose of varicella virus vaccine live and six students developed varicella with more than 50 lesions and fifteen students developed varicella with less than 50 lesions. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a pt who was vaccinated with a dose of varicella virus vaccine live (two lot #'s provided: Lot # 625903/0046H or Lot # 624441/1105E). Sometime between 01/17/04 and 02/05/04, the pt developed chickenpox with over 300 lesions.  The child may have experienced a fever above 103 degrees Fahrenheit, a cough, abdominal pain, and/or itching. The child received unknown symptomatic treatment. The child may have seen a physician. The reporter also indicated that 21 other students were vaccinated with a dose of varicella virus vaccine live and six students developed varicella with more than 50 lesions and fifteen students developed varicella with less than 50 lesions. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a RN concerning a 34 month old healthy male with an allergy to Amoxil and no medical history who on 03/11/02 was vaccinated with a dose of varicella virus vaccine live (Lot # 639488/0572L).  On 01/07/04 the pt developed chickenpox. The pt had spots on his back and multiple crusted areas on his chest and back and one vesicle on his chin. There were less than 50 lesions. There was no fever. Unspecified medical attention was sought and no treatment was required. It was noted that the pt had been exposed to his grandmother who had shingles. No product quality complaint was involved. It was also reported that the pt's sister was vaccinated with a dose of varicella virus vaccine live and also developed chickenpox (WAES # 0401USA00930).  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 7 year old male who in 98 was vaccinated with varicella virus vaccine live.  On 02/16/04 the pt was seen by the physician complaining of a sore throat and a slight fever. Upon examination the physician discovered a varicella rash on his trunk and groin area. The physician stated that the pt had greater than 50 lesions. The pt was not complaining of itch. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 7 year old male with autism who on 02/26/98 was vaccinated with varicella virus vaccine live (Lot # 624450/1423E).  On 02/14/04 the pt developed a varicella rash with 10 vesicular lesions and a sore throat. There was no fever or URI symptoms. The pt sought unspecified medical attention. There was no product quality complaint involved. The pt recovered. It was noted that the pt did not experience any adverse symptoms following prior vaccinations. There were no relevant diagnostic tests or lab data. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a woman in a physician's office concerning a 6 year old male with no past medical history who on 01/07/99 was vaccinated with a first dose of varicella virus vaccine live (Lot # 625385/0312H) in the left arm. There was no illness at the time of vaccination. On 02/09/04 the pt developed a mild case of chickenpox.  Additional information has been requested.   This is in follow-up to report(s) previously submitted on 5/14/2004. Information  has been received from a woman in a physician's office concerning a 6 year old male with no past medical history who on Jan 7, 1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot #625385/0312M) in the left arm. There was no illness at the time of the vaccination. On Feb 9, 2004 the patient developed a mild case of chicken pox. The patient recovered on Feb 16, 2004. No further information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a RN concerning an 11 year old male with allergic rhinitis and allergies to Suprax, Amoxicillin and "ceft" who on 11/07/00 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 634843/1868J). It was unknown if there was an illness at vaccination.  There were no concomitant medications. It was noted that the child developed mild varicella on approximately 01/16/04.  Follow up information received from a RN indicated that on 01/03/04, the pt developed pox bumps to his general body after being vaccinated against varicella and post exposure to varicella. No other symptoms were noted. The duration was unknown. No treatment was ordered.  There were no relevant diagnostic tests or lab data. The outcome was reported as recovered. The reporter also indicated that 2 of the pt's siblings developed varicella after vaccination with varicella virus vaccine live (WAES # 0401USA01995 & WAES # 0402USA01298).  Further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a RN concerning a 6 year old female with allergies to "sulfa" and PCN and with a medical condition at 34 weeks gestation (mild eczema) who on 11/07/00 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 634843/1868J).  It was unknown if there was an illness at the time of vaccination. There was no concomitant medication. The pt developed mild varicella on approximately 01/16/04.  Follow up information received from a RN indicated that on 01/23/04 the pt developed 2 pox bumps after being vaccinated against varicella (and after being exposed to varicella). No other symptoms were noted. The duration was unknown to the reporter. No treatment was ordered. There were no relevant diagnostic tests or lab data. The outcome was reported as recovered. The reporter also indicated tat 2 of the pt's siblings developed mild varicella after vaccination with varicella virus vaccine live (WAES # 0401USA01995 & WAES # 0402USA01297).  No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a female who on 08/05/02 was vaccinated with a dose of varicella virus vaccine live (Lot # 639432/0787L).  In July 2003, the pt presented with chickenpox and recovered without treatment. In Jan 2004, the pt developed zoster which was localized to her shoulder area. Unspecified medical attention was sought. Subsequently the pt recovered. There was no product complaint involved.  The reporter also indicated that the pt's brother (WAES # 0401USA01565) had similar experiences following exposure to varicella virus vaccine live.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Joint range of motion decreased
Clinical narrative: Information has been received from a RN concerning a 52 year old Hispanic female pt with no allergies and no past medical history who on 01/12/04 between 15:00 and 16:00 was vaccinated IM in the right deltoid with a dose of varicella virus vaccine live (Lot # 643596/0767M).  No previous doses were given at the same facility, but it was unknown if the pt received previous doses elsewhere. Concomitant vaccination on 01/12/04 between 15:00 and 16:00 included an IM dose in the right deltoid of DT (Lot # U0824AA).  No previous doses were given at the same facility, but it was unknown if the pt received previous doses elsewhere.  Concomitant therapy in Jan 2004 included tuberculin purified protein derivative. There was no illness at the time of vaccination. There were no adverse events following prior vaccination.  On 01/13/04 at approximately 5:30, the pt became red and swollen at the injection site and it became hard to move her right arm. On 01/14/04 it was still red and swollen and the pt developed little bumps at the injection site. On 01/15/04 in the morning, it was still hard to move her right arm. The redness spread to about 4 inches. The husband was advised to take the pt to the MD, but the pt did not seek medical attention and lab tests were not performed. By the evening of 01/15/04, the pt' symptoms improved. Subsequently, the pt recovered. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 21 year old white female with a concurrent condition of allergy to PCN and sulfa who on 12/16/03 between 13:00 and 13:30 was vaccinated in the left deltoid SC with a first dose of varicella virus vaccine live (Lot # 643596/0767M).  There was no illness at the time of vaccination. There was no adverse event following prior vaccinations.  On 12/16/03, between 13:00 and 13:30 the pt immediately developed pain at the injection site and between 7-8 PM a knot developed described as "blue/red in color 1/2 of a baseball in length and 1/4 inch raised".  The pt was diagnosed with cellulitis.  On 12/17/03, "the next day", the pt developed more pain in the left arm.  On 12/18/03, "two days after vaccination", the pt presented to her physician and she was prescribed antibiotics for 10 days. There were no diagnostic lab tests performed. On approximately 12/30/03, the pt recovered 5-6 days after the onset of symptoms. No further information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 11 year old male with no allergies who in 1996 was vaccinated with a dose of varicella virus vaccine live. In Jan 04, the child developed chickenpox which the physician described as a "full blown case". It was noted that the pt had more than 50 lesions all over his body. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information was provided at the time of this report. Additional information has been requested.
Age: 2.2
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Dermatitis bullous, Erythema multiforme, Feeling hot, Infection, Irritability
Clinical narrative: Information has been received from a health professional concerning a 26 month old female with no medical history or allergies who on 02/12/04, at 10:30AM, was vaccinated in the right thigh with a first dose of varicella virus vaccine live (Lot # 647246/0899N).  Concomitant vaccination the same day included a fourth dose of DTAP 3-component vaccine (+) tetanus toxoid (Infanrix)(Lot # 622A2) given in the right thigh and a fourth dose of Hib conj vaccine (Prohibit, Lot # UE096AA) given in the left thigh. At the time of vaccination, the pt had resolving bilateral otitis media and was on Amoxil. Two days post vaccination on 02/14/04, the child was taken to the ER covered head to toe with a blotchy rash. The pt was treated with an unspecified medicine and was released. On 02/18/04, it was reported that the pt was recovering with sequelae. There was no product quality complaint involved. Follow up information indicated that the pt developed a rash on 02/14/04.  The rash was described as a diffuse macular papular rash from head to toe, warm to touch with slight warmth bilaterally to knees and elbows. It was noted that the rash was erythema multiforme.  The pt was very irritable. She was treated with Benadryl which did not help and Zyrtec twice daily.  Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a NP concerning a 13 month old female pt with no past medical history who on 02/09/04 was vaccinated SC with a 0.5mL dose varicella virus vaccine live (Lot # 642997/0459M).  Concomitant therapy included Zyrtec. On 02/16/04, the pt began breaking out in lesions. On 02/18/04, the pt presented to the medical office with about 100 lesions scattered all over her body. Lab tests were not performed. Prescription drug treatment was not required. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a NP concerning a pt who, on approximately 02/02/04, was vaccinated with a dose of varicella virus vaccine live. On 02/16/04, about two weeks after receiving the vaccine, the pt developed cellulitis. Unspecified medical attention was sought and the pt was treated with an unspecified antibiotic. No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a RN concerning a 12 month old male birth triplet with no known allergies who on 02/03/04 was vaccinated in the left leg with a dose of varicella virus vaccine live (Lot # 644789/0329N).  The nurse reported that the pt experienced a local site reaction and developed hives at the site immediately post vaccination. The pt was observed for 45 minutes and was treated with oral Benadryl.  The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the pt's brother and sister experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01540 & 0402USA01541).  The nurse reported two other children who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01546 & 0402USA0547).  It was noted that the triplets had the worst reaction. The nurse also reported two other children who experienced a similar reaction after therapy with MMRII (WAES # 0402USA01554 & 0402USA01555).
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 29 year old female who on 08/01/96 & 10/01/96 was vaccinated with the first and second doses of VARIVAX. In April 1997, a negative titer was drawn. The pt is currently doing well. Unspecified medical attention was sought. There was no product quality complaint.  The reporter also indicated that one other pt had a negative titer (WAES # 0402USA01574).  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Dry skin, Fatigue, Lymphadenopathy, Mastitis
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that, three weeks after being vaccinated, the patient experienced muscle spasms of the neck and arm. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.   This is in follow up to report previously submitted on 05/14/2004. Information has been received from a pharmacist and a registered nurse concerning a 31 year old white female LPN with scoliosis and who is a nursing mother who on Dec 29 2003 was vaccinated subcutaenously in the right arm with a first dose of varicella vaccine live lot 646237/0545N and on Feb 4 2004 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live lot 547242/0895N. The patient had a questionable mild URI at the time of vaccination. It was reported that the patient had two episodes following vaccination. On Feb 13 0004 (also reported as approximately 2 weeks after the vaccination), she began to have back muscle pain and fatigue. The patient also experienced muscle spasms of the neck and arm. On Apr 12 2004 information was received that noted that the patient now complains of myalgias, paresthsis of the left arm, skin dryness, pimples, dry eyes, fatigue, mastitis (nursing mother, and small lymph nodes that are palpable in the fasia. Unspecified medical attention was sought. Diagnostic lab test included a CBC and ESR which were reported as OK and a RF which was negative. The patient has not yet recovered. It was also reported that the patient had a similar reaction to the first does of varicella virus vaccine live but not as severe. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscle spasms, Myalgia, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that, three weeks after being vaccinated, the patient experienced muscle spasms of the neck and arm. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.   This is in follow up to report previously submitted on 05/14/2004. Information has been received from a pharmacist and a registered nurse concerning a 31 year old white female LPN with scoliosis and who is a nursing mother who on Dec 29 2003 was vaccinated subcutaenously in the right arm with a first dose of varicella vaccine live lot 646237/0545N and on Feb 4 2004 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live lot 547242/0895N. The patient had a questionable mild URI at the time of vaccination. It was reported that the patient had two episodes following vaccination. On Feb 13 0004 (also reported as approximately 2 weeks after the vaccination), she began to have back muscle pain and fatigue. The patient also experienced muscle spasms of the neck and arm. On Apr 12 2004 information was received that noted that the patient now complains of myalgias, paresthsis of the left arm, skin dryness, pimples, dry eyes, fatigue, mastitis (nursing mother, and small lymph nodes that are palpable in the fasia. Unspecified medical attention was sought. Diagnostic lab test included a CBC and ESR which were reported as OK and a RF which was negative. The patient has not yet recovered. It was also reported that the patient had a similar reaction to the first does of varicella virus vaccine live but not as severe. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Pharyngolaryngeal pain, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6-year-old Bosnian male student with a history of ear infections and upper respiratory tract infections and with no known drug allergies who on 07-Nov-2003 was vaccinated SC with a first dose of a varicella virus vaccine live (Lot #641150/1177L). There was no illness at the time of vaccination. Concomitant therapy that day included a second dose of measles-mumps-rubella vaccine (Lot #642443/0339M) administered SC. He also was given a "TB" test. On 11-Feb-2004 the patient developed a papular rash with a red base. The child also had a red throat, upper respiratory tract infection, and itching with no fever. The number of lesions were not noted by the physician, but in his notes he called it mild chickenpox. He prescribed acyclovir and "hydroxazen hcl". It was also noted that on 07-Nov-2002, the patient had a TB test. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a licensed practical nurse indicated that on 11-Feb-2004 in the AM the patient developed a papular rash with red base that was scattered on the roof of his mouth, and his throat was red. His neck and chest were clear. He was noted to have a possible mild chickenpox. The outcome was reported as recovered. No further information is expected.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Skin ulcer, Upper respiratory tract infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6-year-old Bosnian male student with a history of ear infections and upper respiratory tract infections and with no known drug allergies who on 07-Nov-2003 was vaccinated SC with a first dose of a varicella virus vaccine live (Lot #641150/1177L). There was no illness at the time of vaccination. Concomitant therapy that day included a second dose of measles-mumps-rubella vaccine (Lot #642443/0339M) administered SC. He also was given a "TB" test. On 11-Feb-2004 the patient developed a papular rash with a red base. The child also had a red throat, upper respiratory tract infection, and itching with no fever. The number of lesions were not noted by the physician, but in his notes he called it mild chickenpox. He prescribed acyclovir and "hydroxazen hcl". It was also noted that on 07-Nov-2002, the patient had a TB test. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a licensed practical nurse indicated that on 11-Feb-2004 in the AM the patient developed a papular rash with red base that was scattered on the roof of his mouth, and his throat was red. His neck and chest were clear. He was noted to have a possible mild chickenpox. The outcome was reported as recovered. No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site mass, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 12-month-old white male with no allergies or medical history who on 03-Feb-2004 at 11:00 am was vaccinated SC in the right anterior thigh with a first dose of varicella virus vaccine live (lot #647246/0899N). Concomitant vaccination on the same day given in a different site included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no illness at the time of vaccination. On 17-Feb-2004, the patient's mother noted a quarter sized lump at the injection site. The patient also developed a low grade fever and some vomiting. The symptoms have since been reported to be resolving. Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Follow-up information was received from the nurse practitioner who indicated that on 15-Feb-2004 at 7:00 am. there was a right thigh "bump" at the injection site the size of a 25 cent piece. There were no extending streaks and it was noted to be red. The patient had a low-grade temperature less than 100.5 on 15-Feb-2004 and 17-Feb-2004. The patient vomited one to two times on 16-Feb-2004. He was noted to be on topical nystatin for diaper rash-yeast candidiasis. "Resolving 17-Feb-2004." No diagnostic laboratory tests were performed. The patient was noted to have recovered on 18-Feb-2004. It was also reported that the patient had no adverse events following prior vaccination. No further information is expected. Follow-up information was received on 16-Mar-2004 which pertained to events that occurred 12 days following vaccination with varicella virus vaccine live. This information contained the following adverse experience: diaper rash-yeast candidiasis (15-Feb-2004).
Age: 1.28
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial infection, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female patient who on 04-Aug-1998 (also reported as 24-Aug-1998) was vaccinated with dose of varicella virus vaccine live (Lot #624781/0056H). On 18-Feb-2003, the patient developed a rash. On 19-Feb-2004, the patient was seen. The patient presented with a vesicular rash with approximately 20 lesions on the face and neck. The patient did not require additional treatment. On 20-Feb-2004, the patient was seen again in the office and the physician changed the diagnosis to impetigo and decided it was not chickenpox. A product quality complaint was not involved. Additional information has been requested. The patient was treated with Cephalexin (Keflex) and mupirocin (Bactroban). On 02/22/2004 the patient recovered. Additional information is not expected.
Age: 0.08
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 11 week old female infant's mother (WAES #0402USA01716) who on 01-Dec-2003 was vaccinated with a 0.5 cc first dose of varicella virus vaccine live (lot #646230/0541N). On 17-Dec-2003 the mother developed a varicella skin rash. On 26-Dec-2003 the patient developed chicken pox and now has permanent scarring mostly on the trunk. The report indicated that the patient recovered. Unspecified medical attention was sought. The patient's mother (WAES 0402USA01716) also developed chicken pox. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old female birth triplet with no known allergies who on 03-Feb-2004 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 03-Feb-2004, the patient experienced a local site reaction and developed hives at site immediately post vaccination. The patient was observed for 45 minutes and was treated with oral diphenhydramine hydrochloride (Benadryl). The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the patient's brother experienced a similar reaction after therapy with varicella virus vaccine live  (WAES #0402USA01433 and 0402USA01541). The nurse reported two other children who experienced a similar reaction after therapy with varicella virus vaccine live (WAES #0402USA01546 and 0402USA01547). It was noted that the triplets had the worse reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES  #0402USA01554 and 0402USA01555).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male birth triplet with no known allergies who on 03-Feb-2004 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 03-Feb-2004, the patient experienced a local site reaction and developed hives at site immediately post vaccination. The patient was observed for 45 minutes and was treated with oral diphenhydramine hydrochloride (Benadryl). The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center of Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the patient's brother and sister experienced a similar reaction after therapy with varicella virus vaccine live (WAES #0402USA01433 and 402USA01540). The nurse reported two other children who experienced a similar reaction after therapy with varicella virus vaccine live (WAES#0402USA01546 and 0402 USA01547). It was noted that the triplets had the worst reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES #0402USA01554 and 0402US01555).
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male who on 10-Feb-2004 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 10-Feb-2004, the patient experienced a local site reaction and developed a hive at the site of injection. The patient was observed but not treatment was needed. The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that triplets experienced a similar reaction after therapy with varicella virus vaccine live  (WAES #0402USA01433 and 0402USA01540, and 0402USA01541). The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01547). It was noted that the triplets had the worse reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES  #0402USA01554 and 0402USA01555).
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female child who on 11-Feb-2004 was vaccinated in the left left with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 11-Feb-2004, the patient experienced a local site reaction and developed a 3/4 centimeter red area at the injection site. No treatment was needed. The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the patient's brother experienced a similar reaction after therapy with varicella virus vaccine live  (WAES #0402USA01433, 0402USA01540, and 0402USA01541). The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES #0402USA01546). It was noted that the triplets had the worse reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES  #0402USA01554 and 0402USA01555).
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 28-year-old female who completed the varicella virus vaccine live series in 2003. Subsequently, a negative titer was drawn. The patient is currently doing well. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that one other patient had a negative titer (WAES #0402USA01444). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old white female with no medical history and no allergies who on 09-Dec-2003 was vaccinated subcutaneously in the right leg with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11-Dec-2003 the patient started throwing up once a day every day until 30-Dec-2003. On 16-Dec-2003 the patient had a urine culture performed which noted greater than 10% pseudomonas aeruginosa in her urine. She was treated with ciprofloxacin 250 mg/5 ml, 2 ml BID, 40. On 29-Dec-2003 the patient had a urine culture performed which showed no growth at 48 hours. On 23-Dec-2003 the patient recovered. It was also reported that a 12 month old female was vaccinated with a dose of varicella virus vaccine live and developed vomiting (WAES #0310USA02971). No further information is expected.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure on 04/04/04
Age: 0.0
Sex: M
Vaccine: ANTH, IPV, MMR
Symptoms: Arthralgia, Tendonitis
Clinical narrative: Received vaccinations, to include second anthrax, in process of deployment.  Within 24 hours, the patient reports joint and surrounding tendon pain in the left knee.  Patient denies any trauma to the knee or leg.  The pain has continued and progressed to the point that he now limps.  The pain has migrated from the lateral aspect of the left kneecap to the ligaments and tendons surrounding the kneecap.  He was seen at the clinic 7 May 2004 and diagnosed with patellar tendonitis.  He was given a profile allowing tennis shoes instead of boots  and physical therapy was recommended.  The patient did not pursue physical therapy.  He now wears an ace bandage, applies Ben Gay and takes Motrin continually to control the pain.  He has not had a pain free interval since this began.
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Vomiting
Clinical narrative: pt states had vomiting and diarrhea after receiving Hep B injection and has had weakness since injection.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Infection
Clinical narrative: PATIENT RECIEVED VARIVAX IN 2000 AND NOW HE HAS THE CHICKEN POX. BEGAN BREAKING OUT ON 05-24-04.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis-type reaction. Vaccine site hot, red. Resolved with oral antibiotic. No sequelea.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash erythematous, Swelling, Urticaria
Clinical narrative: 74 y/o male with hx of pneumovax given on 5/19, developed left deltoid swelling, welts over torso and arms. The welts have nearly resolved but still a few on the right side of the body. No fever or chills. He did take keflex for 10 days finishing 4 days before the pneumovax was given for a finger lac. He has no swelling above the neck, no skin changes above the neck and no sob or cp.o; 1.5-2.5 raised areas on right chest that are 2mm in height and erythematous, no drainage. area on left arm at the elbow of erythema 6cm diameter, no open areas.  a/p allergic reaction to pneumovax. discussed option, pt not bothered enough to take medrol dose pack, will use hydroxyzine and call for any concerns.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5/24/04 7:30 PM MOM NOTICED RED,SWOLLEN,WARM AREA AT INJECTION SITE ON RIGHT UPPER ARM,ABOUT 2-3" IN SIZE. HE FELT WARM AS THOUGH HE MAY HAVE A FEVER THOUGH MOM DIDN'T TAKE HIS TEMPERATURE.  SHE GAVE HIM MOTRIN AND PUT HIM TO BED.  5/25/05 7:00 AM FELT FINE ALTHOUGH RUNNY NOSE. REDNESS,WARMTH, AND SWELLING CONTINUES.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm became swollen, red, warm, and hard to touch from the shoulder to 1 inch above the elbow approx. 30 hours after receiving vaccination at the site.
Age: 17.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: Mom called and states daughter has a rash on back with 6 red bumps noted.  Daughter c/o itchy rash on back.  Mom states daughter feels warm, but unable to take temperature, no thermometer.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Large local erythematous reaction that appeared within 5 minutes of giving the vaccine and spread rapidly to an area of about 6cm x 4 cm. It responded well to Benadryl and cool compress.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Conjunctivitis, Laboratory test abnormal, Rash maculo-papular
Clinical narrative: On 5-3-04, four days after receiving the MMR vaccine (04-29-04), the patient experienced conjunctivitis. He was taken to the pediatrician listed above and was given Amoxicillin and Tobramycin. On 5-11-04 a confluent, generalized maculopapular rash appeared and patient was taken back to pediatrician on 5-12-04 where blood was drawn for the 3 tests listed below.
Age: 2.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a RN concerning a 24 month old male pt in daycare who on 09/29/00 was vaccinated with a dose of varicella virus vaccine live (reporter unable to obtain lot #). There were no concomitant vaccinations. The reporter stated that the pt may have been vaccinated with improperly stored varicella virus vaccine live.  In late December 2003 or early Jan, the pt developed chickenpox. Unspecified medical attention was sought, but lab tests were not performed. Subsequently, the pt recovered from chickenpox. A product quality complaint was not involved. The reporter also mentioned other pt's who may have been vaccinated with improperly stored varicella virus vaccine live (WAES # 0403USA02035, 0403USA02038, 0403USA02039 & 0403USA02040).  These pt's included other children in the same daycare who also reported having chickenpox within the same time period (WAES # 0403USA02038 & 0403USA02039). Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 24 month old male pt in daycare who on 09/29/00 was vaccinated with a dose of varicella virus vaccine live (reporter unable to obtain lot #). There were no concomitant vaccinations. The reporter stated that the pt may have been vaccinated with improperly stored varicella virus vaccine live.  In late December 2003 or early Jan, the pt developed chickenpox. Unspecified medical attention was sought, but lab tests were not performed. Subsequently, the pt recovered from chickenpox. A product quality complaint was not involved. The reporter also mentioned other pt's who may have been vaccinated with improperly stored varicella virus vaccine live (WAES # 0403USA02035, 0403USA02038, 0403USA02039 & 0403USA02040).  These pt's included other children in the same daycare who also reported having chickenpox within the same time period (WAES # 0403USA02038 & 0403USA02039). Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live. Additional information has been requested.
Sex: M
Vaccine: MMR, MMR, VARCEL
Symptoms: Infection, Rash pustular
Clinical narrative: Information has been received from a RN concerning a 7 year old male who on 12/05/97 was vaccinated with a dose of varicella virus vaccine live (Lot # 624067/1100E).  Concomitant therapy included MMRII. The reporter stated that the pt may have been vaccinated with improperly stored varicella virus vaccine live on 12/05/99.  The mother reported that the pt has had "chickenpox twice" once in November 2002 and also on 01/05/04, the pt developed pus sores that scabbed over/chickenpox. Subsequently, the pt recovered from chickenpox. A product quality complaint was not involved. The reporter also mentioned other pt's who may have been vaccinated with improperly stored varicella virus vaccine live (WAES #0403USA00758, 0403USA02035, 0403USA02036, 0403USA02038 & 0403USA02040).  These pt's included three other children in the same daycare who also reported having chickenpox within the same time period (WAES #0403USA00758, 0403USA02036 & 0403USA02038).  Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live.  Additional information has been requested.
Sex: M
Vaccine: MMR, MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 7 year old male who on 12/05/97 was vaccinated with a dose of varicella virus vaccine live (Lot # 624067/1100E).  Concomitant therapy included MMRII. The reporter stated that the pt may have been vaccinated with improperly stored varicella virus vaccine live on 12/05/99.  The mother reported that the pt has had "chickenpox twice" once in November 2002 and also on 01/05/04, the pt developed pus sores that scabbed over/chickenpox. Subsequently, the pt recovered from chickenpox. A product quality complaint was not involved. The reporter also mentioned other pt's who may have been vaccinated with improperly stored varicella virus vaccine live (WAES #0403USA00758, 0403USA02035, 0403USA02036, 0403USA02038 & 0403USA02040).  These pt's included three other children in the same daycare who also reported having chickenpox within the same time period (WAES #0403USA00758, 0403USA02036 & 0403USA02038).  Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 19-July-2000 was vaccinated with a dose of varicella virus vaccine live (lot # not reported) for prophylaxis. Concomitant therapy included a dose of measles-mumps-rubella vaccine. On 30-Dec-2003 the patient was given a verbal diagnosis of chicken pox by a nurse practitioner. The registered nurse reported that the patient may have been vaccinated with an improperly stored varicella virus vaccine live. Subsequently, the patient recovered from the chicken pox. The reporter also mentioned other patients who may have been vaccinated with improperly stored varicella virus vaccine live (WAES #0403USA00758, 0403USA02035, 0403USA02036, 0403USA02039 and 0403USA02040). These patients included two other children in the same daycare who also reported having chickenpox within the same time period (WAES #0403USA00758 and 0403USA02039). Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live (WAES #0403USA02040). Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Medication error
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 19-July-2000 was vaccinated with a dose of varicella virus vaccine live (lot # not reported) for prophylaxis. Concomitant therapy included a dose of measles-mumps-rubella vaccine. On 30-Dec-2003 the patient was given a verbal diagnosis of chicken pox by a nurse practitioner. The registered nurse reported that the patient may have been vaccinated with an improperly stored varicella virus vaccine live. Subsequently, the patient recovered from the chicken pox. The reporter also mentioned other patients who may have been vaccinated with improperly stored varicella virus vaccine live (WAES #0403USA00758, 0403USA02035, 0403USA02036, 0403USA02039 and 0403USA02040). These patients included two other children in the same daycare who also reported having chickenpox within the same time period (WAES #0403USA00758 and 0403USA02039). Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live (WAES #0403USA02040). Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: ANTH, FLU3, HEPA, IPV, MEN, MMR, TTOX, TYP, YF, ANTH, FLU3, HEPA, IPV, MEN, MMR, YF
Symptoms: Condition aggravated, Fatigue, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from via a health professional through an enhanced surveillance program conducted by the Centers for Disease Control and Prevention concerning a 36 year old female patient, who is in the military, with a history of migraine headaches who on 1/7/03 was vaccinated with a dose of MMR. Secondary concomitant therapy on 1/7/03 included doses of hepatitis A vaccine, yellow fever virus vaccine, influenza virus vaccine, meningococcal vaccine, poliovirus vaccine, tetanus toxoid, and typhoid vaccine. Two to three days later, on approximately 1/9/03, the patient developed a migraine headache. She had a history of migraine headaches monthly prior to vaccination. After vaccination, the headaches increased in severity and frequency to several times per week. It was reported that the patient had a permanent disability from the migraines. On 12/20/03 an MRI of the brain with contrast was normal. Her medical records had been requested. It was reported that the patient had a permanent disability from the migraines.
Age: 36.0
Sex: F
Vaccine: ANTH, FLU3, HEPA, IPV, MEN, MMR, TTOX, TYP, YF, ANTH, FLU3, HEPA, IPV, MEN, MMR, YF
Symptoms: Migraine, Pruritus
Clinical narrative: Information has been received from via a health professional through an enhanced surveillance program conducted by the Centers for Disease Control and Prevention concerning a 36 year old female patient, who is in the military, with a history of migraine headaches who on 1/7/03 was vaccinated with a dose of MMR. Secondary concomitant therapy on 1/7/03 included doses of hepatitis A vaccine, yellow fever virus vaccine, influenza virus vaccine, meningococcal vaccine, poliovirus vaccine, tetanus toxoid, and typhoid vaccine. Two to three days later, on approximately 1/9/03, the patient developed a migraine headache. She had a history of migraine headaches monthly prior to vaccination. After vaccination, the headaches increased in severity and frequency to several times per week. It was reported that the patient had a permanent disability from the migraines. On 12/20/03 an MRI of the brain with contrast was normal. Her medical records had been requested. It was reported that the patient had a permanent disability from the migraines.
Age: 36.0
Sex: F
Vaccine: ANTH, FLU3, HEPA, IPV, MEN, MMR, TTOX, TYP, YF, ANTH, FLU3, HEPA, IPV, MEN, MMR, YF
Symptoms: Condition aggravated, Migraine
Clinical narrative: Information has been received from via a health professional through an enhanced surveillance program conducted by the Centers for Disease Control and Prevention concerning a 36 year old female patient, who is in the military, with a history of migraine headaches who on 1/7/03 was vaccinated with a dose of MMR. Secondary concomitant therapy on 1/7/03 included doses of hepatitis A vaccine, yellow fever virus vaccine, influenza virus vaccine, meningococcal vaccine, poliovirus vaccine, tetanus toxoid, and typhoid vaccine. Two to three days later, on approximately 1/9/03, the patient developed a migraine headache. She had a history of migraine headaches monthly prior to vaccination. After vaccination, the headaches increased in severity and frequency to several times per week. It was reported that the patient had a permanent disability from the migraines. On 12/20/03 an MRI of the brain with contrast was normal. Her medical records had been requested. It was reported that the patient had a permanent disability from the migraines.