chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: This report describes the occurrence of hives in a male infant who was vaccinated with Infanrix. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional. The subject reportedly experienced hives following each injection of Engerix B, (please see report A0388123A). Concurrent conditions and medications were not specified. On an unspecified date, the subject received his first injection of Infanrix. At an unspecified time post-immunization, the subject reportedly developed hives. The mother reported that the subject developed hives after each subsequent injection of Infanrix. The mother stated that the subject was evaluated by a dermatologist, who reportedly "suggested" that the subject "might have a reaction to the vaccines." Treatment and outcome of the hives were not reported.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Retching, Vomiting
Clinical narrative: A physician reported the occurrence of vomiting in a 7 month old male who was vaccinated with Infanrix for prophylaxis. This report was received from other manufacturer (HQ48182250OCT2002). The subject's medical history, concurrent conditions, and concurrent medications were not reported. ON 8/12/02, the subject received an injection of Infanrix. One day later, on 10/13/02, the subject developed vomiting and retching. The outcomes of these events were unknown.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion
Clinical narrative: A nurse reported the occurrence of possible seizures in a 4 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history, concurrent conditions, or concurrent medications. The subject had experienced no adverse events following previous immunizations. On 12/9/02, the subject received his first injection of Infanrix (574A2). On the same date, he received an injection of Haemophilus influenzae type B conjugate vaccine (manuf unk). Approximately one hour later, the subject experienced a possible seizure. He was taken to the local ER. The reuslts of two electroencephalograms were reported as normal. As of 1/29/03, the event had resolved. The reporting physician considered the event to be possibly related to Infanrix administration. The Infanrix immunization series was discontinued. The reporting physician considered the event to be non-serious; however, seizure is considered medically serious (OMIC).
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: A physician reported the occurrence of screaming in a 3 month old female who received Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 11/25/02, the subject received her first injection of Infanrix (565A9). Later that day, the subject began screaming. The screaming lasted eight hours and resolved without treatment. This report has been linked to report A0389494A due to same reporter.
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Crying
Clinical narrative: A physician reported the occurrence of screaming episodes in a 4 month old male who received Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. The subject experienced no adverse events following his first injection of Infanrix. On 12/10/02, the subject received his second injection of Infanrix (565A9). On the same day, at an unspecified time post-immunization, the subject experienced an episode of screaming lasting more than two hours. The event resolved without medical treatment on 12/10/02.
Age: 1.9
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Gait disturbance, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 23 month old female who was vaccinated with Infanrix for prophylaxis. The vaccine provider submitted a report directly to VAERS. The subject had no reported medical history and was described as a "well child." She had no known drug allergies and received no concurrent medications. On 10/28/02, the subject received her fourth injection of Infanrix (557A2). On 10/29/02, the subject developed an area of injection site redness greater than three inches; the injection site was painful to the touch. The subject had noticeable limping and was febrile. The affected thigh area measured 26cm horizontally and 19.5cm vertically with a circumference of 37cm. The subject was seen in the ER, where the physician made a diagnosis of injection site cellulitis. She was treated with IM injections of ceftriaxone 750mg on 10/29/02 and 10/30/02. The reporting nurse considered the injection site cellulitis to be related to Infanrix administration. The injection site cellulitis resolved on 11/14/02. This report has been linked to reports A0389653A, A0389651A and A0389650A due to same reporter.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 24 month old female who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history reported and was described as a "well child" with no know drug allergies. The subject received no concurrent medications. The subject received her fourth injection of Infanrix on 9/25/02 (557A2). On 9/27/02, the subject developed an injection site reaction characterized by a four-inch red, swollen area around the thigh. As of 12/17/02, the injection site reaction had resolved. This report has been linked to reports A0389651A, A0389653A, and A0389649A due to same reporter.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Oedema peripheral
Clinical narrative: A nurse described the occurrence of limb swelling in a 15 month old female who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history and was described as a "well child" with no known drug allergies. Concurrent medications were not reported. The subject received her fourth injection of Infanrix on 9/9/02 (557A2). On 9/11/02, the subject developed an injection site reaction characterized by redness, pain and swelling from the knee to the groin. The injection site reaction was treated with Ibuprofen or paracetamol on 9/11/02. As of 12/17/02, the injection site reaction had resolved. This report has been linked to reports A0389650A, A0389653A, and A0389649A due to same reporter.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Oedema peripheral
Clinical narrative: A nurse described the occurrence of limb swelling in a 12 month old male who was vaccinated with Infanrix for prophylaxis. The subject was described as a "well child" with an allergy to amoxicillin. There were no concurrent medications reported. The subject received his fourth injection of Infanrix on 9/24/02 (557A2) at the age of 12 months, rather than at the recommended age of 15 to 20 months. On 9/24/02, the subject also received injections of Comvax and MMR II. On 9/25/02, the subject developed an injection site reaction characterized by redness and swelling from the knee to the groin. As of 12/17/02, the injection site reaction had resolved.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: A pharmacist reported the occurrence of an injection site reaction in a 4 year old female who received Infanrix for prophylaxis. The subject had no known drug allergies or adverse experiences following previous immunizations. Concurrent conditions and medications were not specified. On 10/31/01, the subject received her fifth injection of Infanrix (517a2) into the left deltoid. On 11/1/01, the subject developed an injection site reaction characterized by soreness, redness, warmth, and inudration that extended from above the shoulder to mid arm. On an unspecified date, the injection site reaction resolved. This report has been linked to reports A0389699A, A0389700A, A0389701A, and A0365783A due to the same reporter.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: A pharmacist reported the occurrence of an injection site reaction in an 18 month old female who received Infanrix for prophylaxis. The subject had no known drug allergies or adverse experiences following previous immunizations. Concurrent conditions and medications were not specified. On 4/10/02, the subject received her fourth injection of Infanrix (530A2) into the left deltoid. On the same day, the subject received her fourth injection of Hib-titer into the right deltoid. One day later, the subject developed an injection site reaction characterized by soreness, redness, and a 5cm by 7cm area of induration. The reporter considered the injection site reaction to be related to Infanrix administration. This report has been linked to reports A1389698A, A0389699A, A0389701a, and A0365783A due to same reporter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: A pharmacist reported the occurrence of an injection site reaction in a 5 year old female who received Infanrix for prophylaxis. The subject's medical history included allergies to amoxicillin and possibly sulfa. The subject experienced no adverse events following previous immunizations. On 4/1/02, the subject received his fifth injeciton of Infanrix (538A2) into the left deltoid. On the same day, the subject also received injections of MMR II and IPOL. One day later, the subject developed an injection site reaction characterized by soreness and a 4cm by 5.5cm area of redness with a raised, hard urticarial border at the site of Infanrix adminsitration. On an unspecified date, the injection site reaction resolved. The reporter considered the injection site reaction to related to Infanrix administration. This report has been linked to reports A0389698a, A0389699a, A0389700A, and A0365783A due to same reporter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: A pharmacist reported the occurrence of an injection site reaction in a 5 year old female who received Infanrix for prophylaxis. The subject's medical history included allergies to amoxicillin and possibly sulfa. The subject experienced no adverse events following previous immunizations. On 4/1/02, the subject received his fifth injeciton of Infanrix (538A2) into the left deltoid. On the same day, the subject also received injections of MMR II and IPOL. One day later, the subject developed an injection site reaction characterized by soreness and a 4cm by 5.5cm area of redness with a raised, hard urticarial border at the site of Infanrix adminsitration. On an unspecified date, the injection site reaction resolved. The reporter considered the injection site reaction to related to Infanrix administration. This report has been linked to reports A0389698a, A0389699a, A0389700A, and A0365783A due to same reporter.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Screaming
Clinical narrative: This report describes the occurrence of uncontrollable crying in a 2-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  The subject reportedly had no medical history, concurrent conditions, or concomitant medications.  On 12/20/2002, the subject received an injection of Infanrix (lot DTPA574A2).  On the same date, he reportedly received an injection of combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax).  The mother stated that at an unspecified time post-immunization, on 12/20/2002, "My child had a severe reaction, uncontrollable crying for three hours."  The subject's pediatrician reportedly recommended paracetamol (Tylenol) which "significantly" helped.  As of 012/30/2002, the event had reportedly resolved.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Lethargy, Screaming
Clinical narrative: This report describes the occurrence of lethargy in an approximately 3-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This report was received from the subject's mother, who is a nurse.  The subject reportedly had no relevant medical history, concurrent conditions, or concurrent medications.  On 12/17/2002, the subject received his first injection of Infanrix.  On that same date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL), and Haemophilus influenzae type b conjugate vaccine (manufacturer unknown).  At an unspecified time post-immunization, on 12/17/2002, the subject reportedly began to experience intermittent and recurrent inconsolable crying and lethargy.  The nurse considered the events to be probably related to Infanrix administration.  The events resolved on 12/26/2002.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This report describes the occurrence of arm swelling in a 7-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  The subject's medical history, concurrent conditions, and concurrent medications were not specified.  Approximately one year ago, in 2002, the subject received an injection of Infanrix, which is not recommended for immunizing individuals 7 years of age or older.  At an unspecified time post-immunization, the subject experienced "swelling in his arm."
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Irritability
Clinical narrative: A nurse reported the occurrence of irritability in a 18-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manufacturer unknown) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  The subject experienced no adverse events following previous immunizations.  On an unspecified date, the subject received her fourth injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manufacturer unknown).  At an unspecified time on the day of immunization, the subject experienced "extreme" irritability.  The mother described the subject as being "really loving and hugging her one minute and then the next minute the child turned evil.  She would start hitting and fussing."  The event continued for two days and then resolved.  The reporting nurse considered the event to be possibly related to vaccine administration.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: This report describes limb swelling in a 5-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This reort was received from the subject's mother and has not been verified by a physician or other healthcare practitioner.  The subject was described as a "healthy child" with no relevant medical history or concurrent medications.  On 01/29/2003, the subject reportedly received his first injection of Infanrix administered in the right arm.  The mother stated that one hour later, the subject's "arm swelled up between shoulder and elbow.  [The] size doubled, very red, hot and itchy, and [the child was] fussy.  Swollen for five days and still somewhat obvious."  Reportedly, the subject was seen by the physician.  The mother stated that no follow-up treatment was provided; the physician reportedly only advised the mother to "watch it for any further problems."  The mother considered the events to be probably related to Infanrix administration.  As of 02/10/2003, the events had reportedly improved.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 18-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  On 02/11/2003, the subject received an Infanrix injection (lot number DTPA578A9).  Subsequently, the subject received an injection site cellulitis; the diagnosis was made by the vaccine provider.  The reporting nurse did not know if the vaccine provider had examined the subject or prescribed any medication.  The reporting nurse stated that the event was possibly related to Infanrix administration.  As of 02/18/2003, the outcome of the event was unknown.  Comment:  This is one of five subjects, out of 19 children immunized, who developed injection site cellulitis following receipt of Infanrix lot DTPA578A9.  Please see reports A0398143A, A0398144A, A0398145A, and A0398146A.
Age: 1.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: A nurse reported the occurrence of vomiting in an 18-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The vaccine provider submitted this report directly to VAERS.  The subject had no relevant medical history, concurrent conditions, or concurrent medications.  The subject experienced no adverse events following previous immunizations.  On 01/29/2003, the subject received her fourth injection of Infanrix (lot number DTPA586A9).  On the same date, she received an injection of inactivated poliomyelitis virus vaccine (IPOL).  On 01/30/2003 the subject developed a "high" fever, swelling of the left thigh that extended from hip to knee, and vomiting.  She was seen by a physician.  The events resolved after a "couple of days."  The reporting nurse considered the events to be related to Infanrix administration.  Comment: This is one of four subjects from this facility, out of more than 30 children immunized, who experienced adverse events following receipt of two lots of Infanrix.  Please see reports A0399834A, A0399836A and A0399837A.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in an 4-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  On 02/11/2003, the subject received an Infanrix injection (lot DTPA578A9).  Subsequently, the subject experienced injection site cellulitis; the diagnosis was made by the vaccine provider.  The reporting nurse did not know if the vaccine provider had examined subject or prescribed any medication.  The reporting nurse stated that the event was possibly related to Infanrix administration.  As of 02/18/2003, the outcome of the event was unknown.  Comment: This is one of five subjects, out of 19 children immunized, who developed injection site cellulitis following receipt of Infanrix lot DTPA578A9.  Please see reports A0397194A, A0398144A, A0398145A, and A0398146A.
Age: 1.3
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 15-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  On 02/11/2003, the subject received an Infanrix injection (lot DTPA578A9).  Subsequently, the subject experienced injection site cellulitis; the diagnosis was made by the vaccine provider.  The reporting nurse did not know if the vaccine provider had examined the subject or prescribed any medication.  The reporting nurse stated that the event was possibly related to Infanrix administration.  As of 02/18/2003, the outcome of the event was unknown.  Comment:  This is one of five subjects, out of 19 children immunized, who developed injection site cellulitis following receipt of Infanrix lot DTPA578A9.  Please see reports A0397194A, A0398143A, A0398145A, and A0398146A.
Age: 1.4
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 16-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's relevant medical history, concurrent conditions, and concurrent medications were unknown.  On 02/11/2003, the subject received an Infanrix injection (lot DTPA578A9).  Subsequently, the subject experienced injection site cellulitis; the diagnosis was made by the vaccine provider.  The reporting nurse did not know if the vaccine provider had examined the subject or prescribed any medicine.  The reporting nurse stated that the event was possibly related to Infanrix administration.  As of 02/18/2003, the outcome of the event was unknown.  Comment:  This is one of five subjects, out of 19 children immunized, who developed injection site cellulitis following receipt of Infanrix lot DTPA578A9.  Please see reports A039719A, A0398143A, A0398144A, and A0398146A.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 5-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications where unknown.  On 02/11/2003, the subject received an Infanrix injection (lot DTPA578A9).  Subsequently, the subject experienced injection site cellulitis; the diagnosis was made by the vaccine provider.  The reporting nurse did not know if the vaccine provider had examined the subject or prescribed any medication.  The reporting nurse stated that this event was possibly related to Infanrix administration.  As of 02/18/2003, the outcome of the event was unknown.  Comment:  This is one of five subjects, out of 19 children immunized, who developed injection site cellulitis following receipt of Infanrix lot DTPA578A9.  Please see reports A0397194A, A0398143A, A0398144A, and A0398145A.
Sex: U
Vaccine: DTAP
Symptoms: Injection site abscess, Injection site oedema
Clinical narrative: A physician reported the occurrence of an injection site abscess in a pt of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, the pt received the 5th injection of Infanrix (lot "583132"). At an unspecified time post-immunization, the pt developed an injection site abscess with swelling. The outcome of the abscess was not reported. Comment: The reporter indicated that 4 other subjects had experienced arm swelling subsequent to receiving Infanrix lot "583132". They are not presently identifiable. The reported "583132" is not a valid lot number.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 5-year-old male who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The vaccine provider submitted this report directly to VAERS.  The subject had no relevant medical history, concurrent conditions, or concurrent medications.  The subject experienced no adverse events following previous immunizations.  On 01/31/2003, the subject received his fifth injection of Infanrix (lot DTPA582b2).  On the same date, he received injections of inactivated poliomyelitis virus vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II).  On 02/03/2003, three days post-immunization, the subject developed a "huge red rash"  that was the "size of a baseball" at the Infanrix injection site, and swelling of the entire thigh to the knee.  He was seen by the physician, who made a diagnosis of injection site cellulitis and prescribed unspecified antibiotics.  The reporting nurse considered the injection site cellulitis to be related to Infanrix administration.  The injection site cellulitis resolved by 02/13/2003.  Comment:  This is one of four subjects from this facility, out of more than 30 children immunized, who experienced adverse events following receipt of two lots of Infanrix.  Please see reports A0397368A, A0399836A, and A0399837A.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 6-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxia. The vaccine provider submitted a report directly to VAERS. The pt had no medical history, concurrent conditions or concurent medications. The pt experienced no adverse events following previous immunizations. On 02/11/2003 the pt received his 3rd injection of Infanrix (lot DTPA586A9). On the same date, he received injectinos of 7-valent pneumoccal conjugate vaccine (Prevnar, Lederle Labs). These vaccines were not injected into the same leg as Infanrix. On 02/12/2003 the pt developed an injection site reaction characterized by a "big red raised area, hot to touch". The pt was seen by the physician. The reporting nurse considered the injection site reaction to be related to Infanrix administration. The most recent information was received on 04/01/2003. As of 03/28/2003, the outcome of the injection site reaction was unknown. Comment: This is one of 4 subjects from this facility, out of more than 30 children immunized, who experienced adverse events following receipt of two lots of Infanrix. Please see reports A0397368A, A0399834A and A0399837A.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A nurse reported the occurrence of injection site reaction in a 18-month-old male who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The vaccine provider submitted this report directly to VAERS.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  The subject experienced no adverse events following previous immunizations.  On 02/11/2003, the subject received his fourth injection of Infanrix (lot DTPA586A9).  On the same date, he received an injection of poliomyelitis virus vaccine (IPOL).  On 02/12/2003, the subject experienced an injection site reaction characterized by a "very swollen, purple, indurated 9 x 9 mm area"  at the site of Infanrix administration.  In addition, his whole right upper thigh was "swollen and pink."  The subject was seen by the physician.  The reporting nurse considered the injection site reaction to be related to Infanrix administration.  The injection site reaction resolved after an unspecified period of time.  Comment:  This is one of four subjects from this facility, out of more than 30 children immunized, who experienced adverse events following receipts of two lots of Infanrix.  Please see reports A0397368A, A0399834A, and A0399836A.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Feeling hot
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a 4-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. The pt was described as a "well child". The pt had no adverse experiences following previous immunizations. On an unspecified date, the pt received an injection of Infanrix (lot DTPA382B2). Subsequently on 02/18/2003 the pt developed a "huge" area of and warmth at the injection site. The pt was seen in the local ER, where the physician made a diagnosis of injection site cellulitis. The injection site cellulitis resolved after an unspecified period of time.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: A healthcare professional reported the occurrence of injection site cellulitis in a 9-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 03/06/2003 the pt received an injection of Infanrix (lot DTPA568B9) which is not recommended for immunizing individuals 7 years of age or older. On 03/11/2003, 5 days post-immunization, he developed cellulitis at the injection site. He was seen by the physician on 03/13/2003. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: A medical assistant reported the occurrence of injection site cellulitis in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the Centers for Disease Control and Prevention (CDC). The pt's medical history, concurrent conditions and concurrent medications were not reported. The pt experienced no adverse events following previous immunizations. On 03/19/2003 the pt received her 5th injection of Infanrix (lot DTPA541E9. On the same date the pt received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles, mumps and rubella virus vaccine (MMR II, Merck). Initially, the reporter stated that the subject developed injection site edema and blisters on 03/20/2003. On follow-up, she indicated that the reaction began on 03/18/2003. However, the follow-up information still reported date of immunization as 03/19/2003. The pt was seen by the physician. A diagnosis of injection site cellulitis was made. The reporting medical assistant considered the injection site cellulitis to be related to Infanrix administration. The most recent information was received on 04/09/2003. As of 04/01/2003, the outcome of the injection site cellulitis was unknown. Comment: This is one of two subjects who experienced injection site cellulitis after receiving Infanrix lot DTPA541E9. For the report of the other subject, please see report A0401522A.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Facial palsy
Clinical narrative: Bells Palsy - Prednisone pain med
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Oedema
Clinical narrative: Dad notified swelling redness Lt arm on 5/22/03 pm, Seen in the office 5/23/03 10am, area of redness no swelling at injection site 4"x2".  No other reaction.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: 2 weeks post small pox pt had complaint of chest pain (sharp), off and on for approx 1 week. Pt history of heart surgery, pt was cleared by MD at field tent clinic.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphangitis
Clinical narrative: Lymphangitis post smallpox vaccination
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: 20 YO ENLISTED SOLDIER EXPERIENCED CHEST PAIN 2 WEEKS S/P SMALLPOX VACCENATION. DIAGNOSED AS PERICARDITS BY SYMPTOMS. PTS SYMPTOMS RESOLVED WITH NSAIDS
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Abdominal pain, Asthenia, Cholecystitis, Diarrhoea, Gastroenteritis
Clinical narrative: 5/14/03-fever, vomiting, diarrhea, severe stomach cramps.  4/15/03-PMD visit, hospitalized, IV's.,testing.  5/18/03 evening, sent home, very weak
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia, Vomiting
Clinical narrative: 5/14/03-fever, vomiting, diarrhea, severe stomach cramps.  4/15/03-PMD visit, hospitalized, IV's.,testing.  5/18/03 evening, sent home, very weak
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: Patient had misinterpreted the "patient medical history and consent form" and indicated that he was a smallpox revaccinee -- when he had indeed never received a smallpox vaccination before.  The smallpox vaccine was administered with 15 jabs.  The correct history was delineated by happenstance after vaccination while the patient remained in the vaccination clinic. There were no immediate adverse reactions noted.  The patient was appropriately reassured that he was not at increased risk for AEs based on data from the smallpox eradication program which reported that primary or revaccinees receiving 15 jabs did not have increased frequency of AEs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: A healthcare professional reported the occurrence of injection site cellulitis in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject's medical history included environmental allergies. Concurrent medications were not specified. On 5/12/03, the subject received his fifth injection of Infanrix (lot DTPA594A2). On the same date, he received injections of inactivated poliomyelitis virus vaccine (IPOL) and MMR (MMR II). On 5/12/03, four hours post-immunization, the subject developed severe cellulitis at the site of Infanrix administration and was hospitalized for an unspecified period of time. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A healthcare professional reported the occurrence of injection site cellulitis in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject's medical history included environmental allergies. Concurrent medications were not specified. On 5/12/03, the subject received his fifth injection of Infanrix (lot DTPA594A2). On the same date, he received injections of inactivated poliomyelitis virus vaccine (IPOL) and MMR (MMR II). On 5/12/03, four hours post-immunization, the subject developed severe cellulitis at the site of Infanrix administration and was hospitalized for an unspecified period of time. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
Age: 67.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema
Clinical narrative: Prolonged scab fell off 5/21/03. Pain in arm from fingers to neck - starting mid April. Decreased strength with lifting. Continuing but pain is less. Worse when twisting. Pain began after heavy lifting.
Age: 67.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Asthenia, Injection site reaction, Pain
Clinical narrative: Prolonged scab fell off 5/21/03. Pain in arm from fingers to neck - starting mid April. Decreased strength with lifting. Continuing but pain is less. Worse when twisting. Pain began after heavy lifting.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Diarrhoea, Erythema, Hypotonia, Irritability, Otitis media
Clinical narrative: Information has been received from a health professional concerning a 15 month old female patient, with no previous history of allergies, who on 12/10/98 was vaccinated with a dose of MMR (second generation) (lot # 627849/1009H). Concomitant therapy on 12/10/98 included a dose of haemophilus B conjugate vaccine (manufacturer unknown) (lot # unknown) (also reported as a dose of diphtheria toxoid/pertussis vaccine/teta into the left thigh). On 12/10/98 the patient experienced fever of 105 degrees F. A parent called the office on 12/14/98 to let them know that the child had a fever of 105 degrees F since 12/10/98 and continued on until 12/10/98 and 12/12/98. It was reported that the child went limp and was taken to the emergency room (ER) on 12/12/98. A treatment record from the emergency room was not available. The emergency room physicians reported to the mother that the fever was to be expected. The mother reported no treatment to the practice. As of 12/14/98 the fever persisted. The child was seen at the practice on 12/22/98 with a 1 day history of fever of 104 degrees F, a 3-day history of irritability, a runny nose, and diarrhea. The patient was diagnosed with left otitis and was treated with amoxicillin. The patient's fever was 97.6 degrees F (axillary) at the time of the visit. It was noted that the child had an allergy to cefprozil that was diagnosed on 5/99. It was also noted that the patient's arm became red following vaccination with a dose of diphtheria toxoid/pertussis vaccine/teta and a dose of poliovirus vaccine inactivated on 5/6/03. It was reported that the patient recovered from her experiences. It was reported that the child is now school-aged and the physician will not give the MMR (second generation) vaccination due to the experience that occurred in 1998. It also reported that the physician may have to do allergy testing on the patient. Upon internal review, child went limp and fever of 105 degrees were considered to be important medical events (OMIC). Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a health professional concerning a 15 month old female patient, with no previous history of allergies, who on 12/10/98 was vaccinated with a dose of MMR (second generation) (lot # 627849/1009H). Concomitant therapy on 12/10/98 included a dose of haemophilus B conjugate vaccine (manufacturer unknown) (lot # unknown) (also reported as a dose of diphtheria toxoid/pertussis vaccine/teta into the left thigh). On 12/10/98 the patient experienced fever of 105 degrees F. A parent called the office on 12/14/98 to let them know that the child had a fever of 105 degrees F since 12/10/98 and continued on until 12/10/98 and 12/12/98. It was reported that the child went limp and was taken to the emergency room (ER) on 12/12/98. A treatment record from the emergency room was not available. The emergency room physicians reported to the mother that the fever was to be expected. The mother reported no treatment to the practice. As of 12/14/98 the fever persisted. The child was seen at the practice on 12/22/98 with a 1 day history of fever of 104 degrees F, a 3-day history of irritability, a runny nose, and diarrhea. The patient was diagnosed with left otitis and was treated with amoxicillin. The patient's fever was 97.6 degrees F (axillary) at the time of the visit. It was noted that the child had an allergy to cefprozil that was diagnosed on 5/99. It was also noted that the patient's arm became red following vaccination with a dose of diphtheria toxoid/pertussis vaccine/teta and a dose of poliovirus vaccine inactivated on 5/6/03. It was reported that the patient recovered from her experiences. It was reported that the child is now school-aged and the physician will not give the MMR (second generation) vaccination due to the experience that occurred in 1998. It also reported that the physician may have to do allergy testing on the patient. Upon internal review, child went limp and fever of 105 degrees were considered to be important medical events (OMIC). Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Affect lability, Cerebrovascular accident, Encephalitis, Facial palsy, Hemiparesis
Clinical narrative: Left sided weakness/facial droop, leg weakness and arm. Diagnosed with a stroke (CVA). The 60 day follow up states it was determined by a neurologist that the pt's symptoms were not related to the vaccine. Discharge Summary received on 8/27/2003 states encephalitis and mood disorder.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Screaming reaction.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Autism, Coordination abnormal, Mental impairment, Speech disorder
Clinical narrative: After getting MMR/Chicken Pox, he could no longer talk, comprehend, language further damage. UL DPT on 10/15/2001. Running in circles, loss of eye contact, loss of speech, loss of understanding speech.   A follow up report received 6/5/2003 adds: Diagnosed with Autism 12/02. 60 day follow up received on 8/6/03 states he cannot speak as he did before he got his shots and does not understand language as he did before. Also, lost coordination.
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Respiratory failure
Clinical narrative: Patient was seen at hospital on 5/13/03 following immunizations earlier that day. Was in respiratory failure and transported to another hospital.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Joint range of motion decreased, Myelitis transverse, Neuropathy, Paralysis
Clinical narrative: 5/12/03 temp 99.3, unable to move limbs or stand; alert and talking. Admitted by doctor to medical center; testing treatment. Diagnosed Transverse Myelitis. Some improvement daily; transferred to hospital rehab 5/21/03 for further therapy. 5/14/03 School nurse called health department saying student in hospital. The 60 day follow up received on 8/6/03 states per family doctor's office nurse, will continue to take therapy for "fine motor skills" next few months. The medical record states per review of initial hospital record, diagnosis at that  time was cervical radiculapathy.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Fatigue, Laboratory test abnormal, Pyrexia, White blood cell count increased
Clinical narrative: Lower back pain started 5/5/03 at approx. 1700 hours. Pt experienced increased fatigue for the next 2 days. Fever began the evening of 5/7-101.5F at home and 99.5 upon presentation to ER. Hospitalization on 5/7 for increased WBC and fever. Has been hospitalized for 1 day as of 5/8/03. Pt has hisotry of splenectomy 1988.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 103.8 less than 24 hours after vaccine.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Acne, Somnolence
Clinical narrative: Acne and "slept a lot" for 2 weeks.
Age: 28.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Pt received Anthrax B on 05/20/03. She left office with no reactions. She returned to the office stating site was hot and itchy. She also states it had never happened before from the previous 6 last Anthrax vaccinations. Pt states she had exercised that afternoon. She denies having a fever or any other symptoms. She was also seen that day for wart removal. Will follow with pt on Tuesday.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Rash papular
Clinical narrative: Left arm erythema, swelling, papules, induration. Treated for cellulitis/allergic reaction.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Agitation, Erythema
Clinical narrative: Pt crying prior to receiving injections. Once injections administered, parent states child became reddened generally from head to toe. Pt screaming and crying, flailing uncontrollably. Episode lasted approx 15 minutes. Dytan po tsp given and within 15 minutes pt happy without redness except at areas of pressure point (where held).
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Redness, slight swelling, increased warmth around DTaP site. 4 x 3.5 cm. Not tender.
Age: 15.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unintended pregnancy
Clinical narrative: Pt was given an MMR and Varicella on 3/13/03. At that time she stated she was not pregnant and was taking birth control pills. Pt was advised to avoid pregnancy for one month and was counseled about the risks of pregnancy after MMR and Varicella. Pt is pregnant now, date of conception approx 4/5/03.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm red/swollen/hot from shoulder to elbow - first noted 6 hours after injection, resolving (mild redness only) when seen 70 hours after.
Age: 3.0
Sex: F
Vaccine: DT, HEP, VARCEL
Symptoms: Infection, Injection site vesicles
Clinical narrative: Pt vesicles x 7 on her body, 12 days after receiving Varivax. Examined on 5/22/03. Diagnosed with mild chickenpox.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR
Symptoms: Tremor
Clinical narrative: Mother and child in for second set of vaccines on 05/05/2003. When asked if child had any reactions from previous set, mother replied he woke up about 2 AM after day of shots, shaking uncontrollably. No fever, alert. Fell back to sleep in about 45 minutes after first waking. Shaking lasted approx 45 minutes.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Onset in evening following injection. Swelling, erythema on left arm from scapula to 2" below elbow. Maximum swelling at 48 hours. Resolved by 5/19/03. Low grade fever of 99.7 for 24 hours. Parent gave ibuprofen and Benadryl. Used cool compresses.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: 2-3 cm swollen tender area on left thigh, minimal erythema.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Redness, swelling, itching. Erythema 5 cm x 5 cm. Hot to the touch.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Oedema
Clinical narrative: 5/19/03: Redness, swelling, warm to touch evening of injection. Pt also reports episode of dizziness, lasting only seconds that evening. 5/21/03: Area of injection improving but still some redness and swelling.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on both legs. Temp.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Tenderness
Clinical narrative: DTaP placed on right arm on 5/19/03. Presented 5/21/03 with 5 cm round erythematous, tender around injection site.
Age: 1.7
Sex: M
Vaccine: DTAP, PNC
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Right shoulder soreness, redness, 24 hours after DTaP given; slightly indurated ~ 4 x 3 area.
Age: 4.8
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Left deltoid area swollen, redenned, warm and tender ~ 2 1/2 circular area.  Patient complained of itching and pain to area.  Diagnosis with allergic reaction secondary to vaccines and cellulitis secondary to vaccines.  Immunizations given on 05/07/2003 reaction began 05/08/2003.  Came to MD office 05/09/2003 for visit with provider.
Age: 4.8
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Left deltoid area swollen, redenned, warm and tender ~ 2 1/2 circular area.  Patient complained of itching and pain to area.  Diagnosis with allergic reaction secondary to vaccines and cellulitis secondary to vaccines.  Immunizations given on 05/07/2003 reaction began 05/08/2003.  Came to MD office 05/09/2003 for visit with provider.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash: 05/20; Fever 102.6: 05/20