chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via a company representative and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medications/vaccines, concurrent medical conditions and medical history were not provided. On an unspecified date, the patient received the booster dose of Infanrix in the deltoid. At an unspecified time post immunization, the patient developed an injection site reaction characterized by swelling and redness. The outcome of the event was unknown. Comment: The reporter indicated that three additional patient's experienced the same events following receipt of Infanrix during the same week. Each patient received the 18 month or 4 year dose of vaccine. Identifiers are currently available for only one of these three patients.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the arm of a 3 year old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 15Oct2003, the pt received the 5th dose of Infanrix in her left arm. The following day, on 16Oct2003, the pt developed swelling and blistering of her left arm from the injection site to her elbow. The pt was seen at the physician's office and treated with an unspecified antibiotic, ibuprofen, and steroids. The events resolved approximately five days later, on 20Oct2003. The reporter considered the events to be possibly related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence cellulitis in an 18 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt had no relevant medical history and received no concurrent medications. This pt had no adverse experiences following previous immunizations.  On 04Nov2003, the pt received his fourth dose of Infanrix in the left thigh. Also on 04Nov2003, the pt received poliomyelitis virus vaccine inactivated (IPOL). At an unspecified time on 04Nov2003, the pt experienced cellulitis and an injection site reaction characterized by redness and swelling. The pt was seen in a physician's office and treated with an unspecified antibiotic. The events resolved after an unspecified period of time. The nurse considered the events to be possibly related to vaccination with Infanrix.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a 12 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 12May2003, the pt received Infanrix. On 12May2003, the pt also received Haemophilus influenzae type b vaccine, and 7-valent pneumococcal conjugate vaccine (Prevnar) Two days later, on 14May2003, the pt experienced an injection site reaction with redness, swelling and pain at the Infanrix injection site. The pt was seen at the physician's office. The events resolved. The nurse considered the events possibly related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 08May2003, the pt received Infanrix. On 08May2003, the pt also received Poliomyelitis vaccine inactivated (IPOL) and measles, mumps and rubella virus vaccine (MMR). Two days later, on 10May2003, the pt experienced an injection site reaction with redness, swelling and pain at the injection site. The injection site reaction occurred at the site of Infanrix administration. The pt was seen at the ER. The events resolved.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Erythema, Screaming, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of bilateral leg swelling in a four month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 18Nov03, the pt received the second dose of Infanrix injected into the right thigh. The same day the pt received Haemophilus influenzae type b conjugate vaccine, poliomyelitis virus vaccine (IPOL), and 7-valent pneumococcal conjugate vaccine (Prevnar). The sites for the administration of the concurrent vaccinations were not specified. On an unspecified time post-immunization, on 18Nov03, the pt experienced redness and swelling of both legs and inconsolable crying. The events resolved on 20Nov03. The immunization series with Infanrix was discontinued. The physician considered the events were probably related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of arm swelling in a five year old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 13Nov03, the pt received the fifth dose of Infanrix injected into the right arm. Two days post immunization, on 15Nov03, the pt experienced a red, hot and swollen arm and was seen at the physician's office. The event improved as of 21Nov03. The physician considered the event was probably related to vaccination with Infanrix.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2 months old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history and concurrent conditions were not reported. The pt received no concurrent medications.  On 17Nov2003 the pt received the first dose of Infanrix. On the same date the pt also received Haemophilus influenzae type b conjugate vaccine, poliomyelitis virus vaccine (IPOL), and 7-valent pneumococcal conjugate vaccine (Prevnar). At an unspecified time post-immunization, on 17Nov03, the pt experienced a fever and was examined at the physician's office. The event resolved the following day. The physician considered the fever to possibly be related to vaccination with Infanrix.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Mental retardation severity unspecified
Clinical narrative: This case was reported by a consumer and described the occurrence of delays in development in her 14 month old daughter who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). This case has not been verified by a physician or health care professional.   The subject's medical history, concurrent conditions, and concurrent medications were not reported.  On 04Nov02 at two months of age, the pt received the first dose of Infanrix. The mother of the pt reported that her daughter received her second dose one year later. This represented a schedule of one year between the first and second doses which is longer than the recommended schedule of two months between first and second doses of Infanrix. On an unspecified date in 2003, the pt reportedly developed "developmental delays in speech, eating solid foods, and walking".
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history and concurrent conditions were not reported. The pt received no concurrent medications. On 18Nov03, the pt received the first dose of Infanrix. On the same date the pt received Haemophilus influenzae type b conjugate vaccine, poliomyelitis virus vaccine (IPOL), and 7-valent pneumococcal conjugate vaccine (Prevnar). At an unspecified time post-immunization, on 18Nov03, the pt experienced a fever and was examined at the physician's office. The event resolved the same day. The physician considered the fever to possibly be related to vaccination with Infanrix.
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an allergic reaction in a female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date, the pt received diphtheria and tetanus toxoids and acellular pertussis vaccine (dose number not specified). At an unknown time after administration of diphtheria and tetanus toxoids and acellular pertussis vaccine, unspecified tests revealed that the pt developed an allergic reaction to an unspecified component of the vaccine.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site mass, Swelling
Clinical narrative: This case was reported by a medical assistant and described the occurrence of leg knots in a 15 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 13Jan04, the pt received the fourth dose of Infanrix in her left leg. The following day, on 14Jan2003, the pt's mother called the physician's office and reported that the pt experienced a knot in her leg and swelling and redness of the leg. The reporter did not specify the site of the reaction. The leg swelling and redness resolved on 16Jan2004 and the knot in the leg resolved on an unspecified date. The medical assistant considered the leg knot, swelling and redness to be related to the vaccination with Infanrix.
Sex: M
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Medication error, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of anaphylaxis in an adult male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine. The pt reported a history of anaphylaxis with DTP in the past, as well as anaphylactic reactions to bee stings. Concomitant immunization included influenza vaccine. On an unspecified date, the pt received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine and influenza vaccine. At an unspecified time following administration of diphtheria and tetanus toxoids and acellular pertussis vaccine and influenza vaccine, the pt experienced anaphylaxis. The outcome of the event is unknown. DTPa vaccine is contraindicated in pt's with a history of anaphylaxis following administration of DTP. DTPa vaccine is also not recommended for immunizing individuals seven years of age or older. Anaphylaxis was assessed as medically serious. (OMIC)
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site cellulitis in an 18 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 19Feb2004 the pt received the fourth dose of Infanrix. The day after receiving Infanrix, on 20Feb2004, the pt experienced injection site cellulitis. The pt was treated with unspecified antibiotic therapy and the event improved. The nurse considered that the event was possibly related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site cellulitis  in an 18 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  ON 20Feb2004 the pt received the fourth dose of Infanrix. The day after receiving Infanrix, on 21Feb04, the pt experienced injection site cellulitis. The pt was treated with unspecified antibiotic possibly related to vaccination with Infanrix.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site induration, Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site cellulitis in a 21 month old male patient who received diphtheria toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. In 24 or 25 February 2004, the patient received the fourth dose of Infanrix in the left arm. Approximately twelve hours after Infanrix vaccination, on 25 February 2004, the patient experienced injection site cellulitis characterized by an 8 centimeter by 6 centimeter hard indurated mass on his left bicep, which required medical attention in the doctor's office. The mass appeared from below the shoulder, to above the elbow. The patient was treated with cephalexin. The events resolved on an unspecified date in March 2004. The reporting physician considered the events were probably related to vaccination with Infanrix.
Age: 1.54
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of cellulitis in an 18 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 03Mar04, the pt received the fourth dose of Infanrix. Approximately one day following the administration of Infanrix, on 04Mar04, the pt experienced cellulitis, redness, erythema, swelling and was warm to touch. The pt was see at a physician's office. The events were unresolved. The reporting nurse considered the events to probably be related to vaccination with Infanrix and due to something with the lot number.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of cellulitis in an 4 year old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 03Mar04, the pt received the fifth dose of Infanrix. Approximately one day following the administration of Infanrix, on 04Mar04, the pt experienced cellulitis, redness, erythema, swelling and was warm to touch. The pt was see at a physician's office. The events were unresolved. The reporting nurse considered the events to probably be related to vaccination with Infanrix and due to something with the lot number.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling face, Throat tightness
Clinical narrative: This case was reported by a consumer and described the occurrence of the throat closing in a 4 year old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). A physician or other health care professional has not verified this report. On 03Dec2003, the pt received the fifth dose of Infanrix. On the same day, the pt received injections of poliomyelitis virus vaccine and measles mumps and rubella virus vaccine. At an unspecified time following the administration of Infanrix, on 03Dec03, the pt experienced swelling of his face and his throat closed. The pt was seen at a physician's office. On an unspecified date the events resolved.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: This case was reported by a pharmacist and described the occurrence of seizure in a 2 year old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Dtpa, unknown manufacturer). On an unspecified date the pt received a dose of Dtpa. Approximately one week following the administration of Dtpa, the pt experienced a seizure. The pt required medical attention. On an unspecified date, the event resolved. Seizure was assessed as medically serious. (OMIC)
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received form a physician concerning a 28 year old female who in 2003 was vaccinated with a series of varicella virus vaccine live. It was reported that a recent titer did not show full seroconversion.  The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female patient who was vaccinated on 28OCT2003 with a dose of varicella virus vaccine live. One day prior to chickenpox break through, on 17NOV2003 the patient developed a fever. The patient presented to the doctor office on 17NOV2003, with 5 to 6 "pox" over the torso, and some on arm and face. It was noted that the patient had no treatment. It was also noted that the patient's outcome was not recovered. The nurse also stated that the varicella virus vaccine live had a temperature exposure during a hurricane and this was the vaccine that had the break through. No product quality complaint was involved. It was noted that two male patients form the same source, had similar experiences. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 20 month old male patient who was vaccinated on 27OCT2003 with a dose of varicella virus vaccine live. One day prior to chickenpox break through, on 13NOV2003 the patient developed a fever. The patient presented to the doctor office on 14NOV2003, with 5 to 6 pox over torso, and some on arm and face. It was noted that the patient had no treatment. It was also noted that the patient's outcome was not recovered. The nurse also stated that the varicella virus vaccine live had a temperature exposure during a hurricane and this was the vaccine that had the break through. No product quality complaint was involved. It was noted that a female and a male patient from the same source, had similar experiences. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a physician concerning a previously healthy 8 year old male with no past medical history and no known allergies who on 23MAR1998 was vaccinated with a dose of varicella virus vaccine live when he was approximately 1 to 1.5 years of age. There were no concomitant medications. Subsequently, the patient developed breakthrough varicella. The specimens from the child were DFA negative for herpes, and DFA for varicella only had a few cells. A specimen from the child's vesicular lesions were in viral culture and will be submitted for PCR. Follow up information received on 23JAN2004 indicated that the specimen received for PCR analysis was inadequate. Follow up information indicated that the specimen was obtained on 09JAN2004 and sent to the laboratory on 09JAN2004. The source of the specimen was a lesion and it was mixed with vesicle and papule. The specimen arrived in the laboratory on 20JAN2004. The VZV DNA was not amplified. The B-globin, and no strain ID. The type of adverse experience was a rash on the right elbow. The herpes zoster was on the "right elbow; 3 times".  The child had no recent exposure to chickenpox or to shingles.  Follow-up information confirmed the diagnosis was herpes zoster. The reporter stated that the initial description of breakthrough varicella was not correct. The patient had herpes zoster three times by clinical description and had not had any natural disease by history. Subsequently, the patient recovered. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female patient with no illness at the time of vaccination and no pre existing allergies or medical conditions who on 10JUN1999 was vaccinated IM in the left upper arm with a first dose of varicella virus vaccine live. Concomitant therapy administered on 10JUN1999 included a third dose of poliovirus vaccine inactivated IPOL administered SC in the right arm. On 09JAN2004 the patient developed, " a few vesicles on red base on chin, back, extremities." The licensed practical nurse reported the patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a female who on 31MAY2000 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy the same day included measles virus vaccine live, poliovirus vaccine inactivated and tuberculin purified protein derivative. Subsequently, the patient developed mild chickenpox after a sibling had chickenpox. The parent of the child reported this to the nurse on 08OCT2003. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other patient's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a female who on 22SEP2003 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy the same day included measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live and tuberculin purified protein derivative. On 05NOV2003, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other patient's had similar experiences following exposure to varicella virus live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a patient who on 27APR1999 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 09JAN2004 the patient broke out with shingles. Unspecified medical attention was sought. There was no laboratory or diagnostic studies performed. There was no product quality complaint involved. It was reported that therapy with varicella virus vaccine live was discontinued on 27APR1999. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 16 month old previously healthy male with no past medical history, including chickenpox, and no concurrent conditions who on 27AUG2003 was vaccinated SC in the right arm with 0.5ml dose of varicella virus vaccine live. It was also reported that the child "was vaccinated at approximately 18 months of age". There was no concomitant medication. There was no recent known exposure to wild type VZV. The physician indicated that the patient developed a breakthrough varicella. On 29DEC2003 through 01JAN2004 the patient developed approximately 12 to 14 lesions. On 09JAN2004, the child was in the office again and continued to develop lesions. The child's mother indicated that patches of lesions were "still popping up in various places". Unspecified medical attention was sought. There was no product quality complaint. No laboratory diagnostic studies were performed. Follow up information received from the physician indicated that the rash did not occur at the site of injection post-vaccination. The patient's maximum temperature was 103 degrees Fahrenheit. Other systemic symptoms included pruritus. The type of adverse experience was a rash that was a papule, vesicle and crust. It was noted to be "varicella".  The child had no recent exposure to chickenpox or shingles. Additional follow up information received on 23JAN2004 indicated that the specimen received for PCR analysis was inadequate (large dry swab sent). Follow up information indicated that the specimen was obtained on 13JAN2004 and sent to the laboratory 13JAN2004. The VZV DNA was not amplified. The B globin DNA was not amplified. The interpretation was inadequate specimen, negative for B globin and not strain ID. Additional follow up information indicated that the patient had been seen by a dermatologist and the diagnosis is not varicella. No other information was available. No further information is expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Medication error, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old unemployed Hispanic female with scoliosis who's 4 year old son was vaccinated on 03DEC2003 with a dose of varicella virus vaccine live. The son had no reaction or rash post vaccination. The 28 year old female pt was not sick at the time of her  son's vaccination. On 18DEC2003, the 28 year old female patient developed chickenpox. On 18DEC2003, the pt was seen for a doctor visit and was diagnosed. Laboratory tests were not performed. The pt's chickenpox included blisters from 18DEC2003 to 28DEC2003. fever from 18DEC2003 to 19DEC2003 and "achy bones" from 18DEC2003 to 20DEC2003. The pt recovered after two weeks. A product quality complaint was not involved. The reporter also mentioned that the son's father developed chickenpox after the son was vaccinated with varicella virus vaccine live. It was noted that the family recently immigrated from Cuba on 17NOV2003. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Information has been received from a physician concerning her 11 year old Asian daughter with no allergies or medical history who on 21FEB1996 was vaccinated in the arm with a 0.5ml first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that, on an unspecified date, the patient's body was covered with lesion. No hospitalization was needed. No further information was provided.
Age: 6.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male with no past medical history on 23JUL1998 was vaccinated with a first dose of varicella virus vaccine live, in the right arm. Concomitant therapy that day included a third dose of hepatitis b virus vaccine rHBsAg, in the left arm. There was no illness at the time of vaccination. Between 26DEC2003 and 30DEC2003 the pt developed "red spots and some fluid filled." On 30DEC2003, the pt developed 20 scattered scabs on face, trunk, extremities. The pt sought medical attention and was treated symptomatically. There were no relevant diagnostic or laboratory tests performed. The pt recovered. It was reported that the pt did not have any adverse events following prior vaccinations. It was noted that the pt on 24OCT1998 received a fourth dose of Hib conj vaccine, in the right arm, and a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, in the left arm. It was also reported that on 24APR1998 the pt had a Mantoux test. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old health female with no allergies and no medical history who on 08NOV1999 was vaccinated with a dose of varicella virus vaccine live. On 11JAN2004 the pt developed chicken pox. The pt had spots on her back and multiple crusted area on her chest and back. There were less than 50 lesions . There was no fever . Unspecified medical attention ws sough and no treatment was required. It was noted that the pt had been exposed to her grandmother who had shingles. No product quality complaint was involved. I was also reported that the pt's brother was vaccinated with a dose of varicella virus vaccine live and developed chickenpox. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 14AUG1997 was vaccinated with a second dose of varicella virus vaccine live. On 10JAN2004, also reported as 12JAN2004, the patient was exposed to chickenpox and developed breakthrough. It was also indicated that the child developed varicella disease. The case of breakthrough was moderate. The child was covered with lesions, more than 50. Treatment was calamine lotion. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a pharmacist concerning a child in a household who was vaccinated with a dose of varicella virus vaccine live. It was noted that the child's sibling acquired the varicella transmission virus. Addition information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female with no allergies or medical history who at one year of age, in approximately 2002, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Approximately, one year later, in 2003, the patient broke out with a mild case of varicella. Unspecified medical attention was sought and no treatment or prescription drug was required. No diagnostic laboratory tests were performed. Subsequently, the event abated and the patient recovered. It was noted that therapy with varicella virus vaccine live was "discontinued." A product quality complaint was not involved. Additional information has been requested. The licensed practical nurse also reported another patient who broke out in a rash after therapy with varicella virus vaccine live.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Medication error, Pain, Pyrexia, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 41 year old unemployed Hispanic male patient with an allergy to penicillin who's 4 year old son was vaccinated on 03DEC2003 with a dose of varicella virus vaccine live. The son had no reaction or rash post vaccination. The 41 year old male patient was not sick at the time of his son's vaccination. On 05JAN2004, the 41 year old male patient developed chickenpox. On 05JAN2004, the patient was seen at a health center when he only had a fever. On 06JAN2004, the patient had a doctor's visit at a different health center and was diagnosed. Laboratory tests were not performed. The patient's chickenpox included fever from 05JAN2004 to 06JAN2004, "achy bones" from 05JAN2004 to 06JAN2004 and blisters from 06JAN2004 to 16JAN2004. The patient recovered after two weeks. A product quality complaint was not involved. The reporter also mentioned that the son's mother developed chickenpox after the son was vaccinated with varicella virus vaccine live. It was noted that the family recently immigrated from Cuba on 17NOV2003. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Encephalitis, Laboratory test abnormal, Lethargy, Malaise
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on an unspecified date was vaccinated with varicella virus vaccine live. On 12/24/03 the patient developed a fever. It was reported that from 12/25/03 through 12/30/03 the child developed a mild varicella like rash that consisted of roughly 30 lesions. From 12/31/03 through 1/1/04 the child seemed to be getting better. On 1/2/04 the child started to feel ill, described as lethargy and fever. On 1/03/04 the child was admitted to the hospital due to encephalitis. Both CSF and MRI were abnormal. The child was started on an unspecified antiviral therapy. On 1/8/04 the child was still in the hospital. Polymerase chain reaction was completed and negative for varicella, HSV, and enterovirus. On 1/14/04 it was reported that the child was still hospitalized and considered to be recovering. There was no product quality complaint involved. The reporter considered the patient's experience to be life threatening. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on an unspecified date was vaccinated with varicella virus vaccine live. On 12/24/03 the patient developed a fever. It was reported that from 12/25/03 through 12/30/03 the child developed a mild varicella like rash that consisted of roughly 30 lesions. From 12/31/03 through 1/1/04 the child seemed to be getting better. On 1/2/04 the child started to feel ill, described as lethargy and fever. On 1/03/04 the child was admitted to the hospital due to encephalitis. Both CSF and MRI were abnormal. The child was started on an unspecified antiviral therapy. On 1/8/04 the child was still in the hospital. Polymerase chain reaction was completed and negative for varicella, HSV, and enterovirus. On 1/14/04 it was reported that the child was still hospitalized and considered to be recovering. There was no product quality complaint involved. The reporter considered the patient's experience to be life threatening. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old patient who on 02MAY1997 was vaccinated with a dose of varicella virus vaccine live . On 12JAN2004 the patient was seen at the office with chickenpox greater than 50 lesions, head to toe. It was noted that the patient had a fever of 101.9F. Treatment included eye drops, diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol). As per follow up report: It was noted that the patient recovered. There was no product quality complaint involved. A patient from the same source had a similar experience (WAES0403USA03047). No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with one dose of varicella virus vaccine live. It was reported by the patient's husband that her assay shows very little immunity. Unspecified medical attention as sought. No further information was available. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a child who, about one year ago, in 2003, was vaccinated with a dose of varicella virus vaccine live. Recently, the patient presented with about 10 lesions which was thought to be break through chickenpox. The patient had no symptoms or fever. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a 16 year old male who "sometime in the past" was vaccinated with varicella virus vaccine live. "Recently" the patient developed a mild case of chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12-month-old male with no allergies or medical history who was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Twelve days later, the patient broke out in a rash. Unspecified medical attention was sought and no treatment or prescription drug was required. No diagnostic laboratory tests were performed. Subsequently, the even abated and the patient recovered. It was noted that therapy with varicella virus vaccine live was "discontinued." A product quality complaint was not involved. Additional information has been requested. The licensed practical nurse also reported another patient who broke out in a mild case of varicella after therapy with varicella virus vaccine live (WAES #0401USA00992).
Age: 7.0
Sex: F
Vaccine: DTP, IPV, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 7 year old child with no known medical history who on 15-Aug-2001 was vaccinated with a dose of varicella virus vaccine live (lot # 638653/0233L). Concomitant vaccination the same day included poliovirus vaccine inactivated (unspecified) and diphtheria toxoid (+) pertussis vaccine  (unspecified) (+) tetanus toxoid. On 11-Jan-2004 the patient developed chickenpox. The rash began on 13-Jan-2004 and she developed a fever of 103 F. The only treatment was ibuprofen (Motrin) for fever. The chickenpox was described as mild with about 10 lesions on her trunk and legs. There were no lab or diagnostic studies performed. Medical attention was not sought. There was no product quality complaint involved. Follow up information indicated that the office has no record of the child receiving varicella virus vaccine live. They reported that they only got a report of the child having a mild case of chicken pox. They reported that it must have been done in another office, but they do not know who administered it. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a nurse concerning a 10 year old male who was vaccinated with varicella virus vaccine live and subsequently developed chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male who on 19-Sep-1995 was vaccinated with a dose of varicella virus vaccine live (Lot #609289/0433B). On 10-Jan-2004 the patient presented with a low grade fever and about 30 vesicular lesions on his face and chest. The patient was prescribed amoxicillin (+) clavulanate potassium (Augmentin) as a prophylaxis against secondary infections. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Headache, Infection, Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a medical assistant and employee at a physician office concerning a 5 year old white male patient with a penicillin and amoxicillin (+) clavulanate potassium (Augmentin) allergy and history of a tonsillectomy, who on 25-June-1999 was vaccinated in the left arm with a dose of varicella virus vaccine live (Lot #630679/0427J). Concomitant vaccine therapy administered on 25-Jun-1999 included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #630633/0132J) administered in the right arm. The medical assistant reported that on 16-Jan-2004, the patient presented to the physician office with multiple vesicular lesions, approximately 20 lesions. Additional information from an employee at the physician's office reported the patient's rash stated on his chest, legs, neck, arms, ankles and bottom and he had one lesion in his mouth. The patient's mother told the nurse that the patient had a low grade fever, but no fever was evident at the office. The patient also had a headache. It was noted that the patient was seen by the physician, who prescribed diphenhydramine hydrochloride (Benadryl) and calamine lotion to treat the patient. There were no laboratory or diagnostic tests performed. There was no product quality complaint reported. The patient recovered on 20-Jan-2004. No additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no relevant medical history and no known drug allergies who on the morning of 06-Jan-2004 was vaccinated in the right thigh with a first dose of varicella virus vaccine live (lot #646310/0577N). On the morning of 06-Jan-2004 the patient was also vaccinated in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #646118/0614N). There was no other concomitant medications. On 16-Jan-2004 the patient developed a rash of more than ten lesions or "spots". There was no fever. There were no diagnostic laboratory tests performed. Unspecified medical attention was sought and no treatment was prescribed. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old male with developmental delay and no known allergies who on 29-Dec-1999 was vaccinated with a first dose of varicella virus vaccine live (lt #631772/1031K), subcutaneously in the left arm. There was no concomitant medication or illness at the time of vaccination. On 19-Dec-2003 the patient was seen after developing less than 50 lesions on his trunk the day before, on 18-Dec-2003, with itching and a fever. It was also reported that on 18-Dec-2003 the patient developed a "spare papular vesicular rash on trunk, itchy." The patient reportedly had breakthrough chicken pox. The patient was prescribed acetaminophen (Tylenol) or oatmeal baths as needed. Subsequently, the patient recovered from breakthrough chicken pox. There were no relevant diagnostic or laboratory tests. There was no product quality complaint involved. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old male with developmental delay and no known allergies who on 29-Dec-1999 was vaccinated with a first dose of varicella virus vaccine live (lt #631772/1031K), subcutaneously in the left arm. There was no concomitant medication or illness at the time of vaccination. On 19-Dec-2003 the patient was seen after developing less than 50 lesions on his trunk the day before, on 18-Dec-2003, with itching and a fever. It was also reported that on 18-Dec-2003 the patient developed a "spare papular vesicular rash on trunk, itchy." The patient reportedly had breakthrough chicken pox. The patient was prescribed acetaminophen (Tylenol) or oatmeal baths as needed. Subsequently, the patient recovered from breakthrough chicken pox. There were no relevant diagnostic or laboratory tests. There was no product quality complaint involved. No further information is expected.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 year old black male with no pertinent medical history and no known allergies who on 16-Oct-1998 was vaccinated in the left arm with a dose of varicella virus vaccine live (Lot #626960/0847H). There was no illness at the time of vaccination. Concomitant therapy that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #628404/1175H) administered in the right arm. On 18-Jan-20404 the patient presented to the physician's office with a case of chickenpox breakthrough. The child was noted to have a papular, vesicular rash that first appeared on his stomach and then spread to the rest of his body. No fever was noted. The child was treated with acetaminophen (Tylenol), diphenhydramine hydrochloride (Benadryl), and rest. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information indicated that the adverse event onset was on 17-Jan-2004. Seventy-two percent of the lesions were on his stomach, with more lesions daily moving to his legs and arms. Treatment included diphenhydramine hydrochloride (Benadryl), acetaminophen (Tylenol), and rest. Additional follow up information indicated that the patient developed a rash with vesicles that started on the patient's stomach and "spread all over" over several days. Additional follow-up information indicated that the patient recovered 5 days after onset. The reporter indicated that she had seen two other cases of breakthrough chickenpox in the last couple of months. No further information is expected.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning herself, an approximately 36 year old female with no known allergies and no medical history, who on an unspecified date in 1996, when she was a resident, was vaccinated with two doses of varicella virus vaccine live (Lot number not available). There was no concomitant medication. The physician reported that recently she was tested and was found to be "titer negative". No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Infection, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 12-month old black male with a history of mild physiologic peripheral branch pulmonary stenosis who on 30-Dec-2003 was vaccinated SC in the left arm with a 0.5 ml first dose of varicella virus vaccine live (lot #647088/0853N; diluent lot #645833/0304N). There was no concomitant medication. There was no illness at the time of vaccination. On 10-Jan-2004, the patient broke out with blisters on a red base at the injection site and abdomen. The patient was afebrile and was otherwise doing well. The patient was diagnosed with varicella after vaccination. He was treated symptomatically and a prescription drug was not required. No diagnostic laboratory tests were performed. At the time of the report, the experience was still being treated and the outcome was unknown. Additional information was received from the registered nurse which indicated that on 11-Jan-2004, the patient started breaking out with several blisters on a red base at the injection site and abdomen. There was no adverse reaction. The patient was treated symptomatically and recovered without a problem. No further information is expected.