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 and described the occurrence of tight feeling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(Infanrix, GlaxoSmithKline) for prophylaxis. There was no concurrent medications. On an unspecified date on or before 24 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number not provided). The nurse reported that the lot number of Infanrix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in the arm," injection site redness and swelling injection site. The subject was seen at a physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of tight feeling in arm in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There were no concurrent medications. On unspecified date on or before 24 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number not provided). The nurse reported that lot number of Infanrix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in the arm," injection site redness and swelling injection site. The subject was seen at physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of injection site redness in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The physician reported several subjects experienced an injection site reaction following receipt of Infanrix, however, a specified number of subjects was not reported. On unspecified date on or before 25 April 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number not reported; lot AC14A006AA). At an unspecified time after vaccination with Infanrix, on an date on or before 25 April 2006, the subject experienced injection site redness and swelling injection site. The outcome of the events was not reported.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Crying, High-pitched crying, Irritability, Lethargy
Clinical narrative: This case was reported by a pharmacist and described the occurrence of crying in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The reporter is the mother of the subject. On 25 April 2006 the subject received lst dose of Infanrix in the left thigh. On 25 April 2006, the subject also received Haemophilus influenzae type b conjugate vaccine (non-GSK, manufacturer unknown), 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 25 April 2006, approximately 90 minutes after vaccination with Infanrix, the subject "became very fussy and cried non-stop for about three hours." The crying was described as "high pitched." The reporter stated that, "Once the crying subsided," the subject became lethargic and developed a "low-grade" fever. The subject was treated with paracetamol (Tylenol). On 26 April 2006, the subject was seen by a pediatrician. The reporter stated that the pediatrician "found no signs of neurological complications." At the time of initial reporting, 26 April 2006, the outcome of the fussiness was not reported and the lethargy and low-grade fever were ongoing.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of crying in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The reporter is the mother of the subject. On 25 April 2006 the subject received lst dose of Infanrix in the left thigh. On 25 April 2006, the subject also received Haemophilus influenzae type b conjugate vaccine (non-GSK, manufacturer unknown), 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 25 April 2006, approximately 90 minutes after vaccination with Infanrix, the subject "became very fussy and cried non-stop for about three hours." The crying was described as "high pitched." The reporter stated that, "Once the crying subsided," the subject became lethargic and developed a "low-grade" fever. The subject was treated with paracetamol (Tylenol). On 26 April 2006, the subject was seen by a pediatrician. The reporter stated that the pediatrician "found no signs of neurological complications." At the time of initial reporting, 26 April 2006, the outcome of the fussiness was not reported and the lethargy and low-grade fever were ongoing.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction, Pyrexia, Urticaria
Clinical narrative: This case was reported by a physician to sales representative and described the occurrence of welt injection site in a 4-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On unspecified date in 2005 or before 26 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number and lot number not reported.) On the same day, the subject also received inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II vaccine, Merck). At an unspecified time following receipt of Infanrix, less than one year after vaccination with Infanrix, the subject experienced "a welt at the injection site of Infanrix every time (the subject) has a fever." The outcome of the events was not reported.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of allergy in a 4-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified). The reporter is the mother of the subject. The mother "has allergies to tetanus." There were no concurrent medications. On an unspecified date in July 2001, the subject received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline; dose number and lot number not reported). At an unspecified time following receipt of Infanrix, in July 2001, the subject experienced injection site redness and swelling injection site. The events resolved on an unspecified date in July 2001. On an unspecified date in 2004, the sujbect received a dose of Dtpa (unknown manufacturer; dose number and lot number not reported). At an unspecified time following receipt of Dtpa, on an unspecified date in 2004, the subject again experienced injection site redness and swelling injection site. The reporter stated that, "they believe my daughter may be allergic to one of the components of the vaccine." The outcome of the injection site reaction in 2004 and the allergy were not reported. The reporter considered the events were related to vaccination with Dtpa and Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Oedema peripheral
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling arm in a child subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The nurse reported that "a number of" subjects experienced a reaction following receipt of the 4th dose of Infanrix, however , a specific number of subjects was not reported. On 01 May2006, the subject received 4th dose of Infanrix in an unspecified arm (lot AC14B021-incomplete lot number). The nurse reported that, on 02 May 2006, the subject experienced a large local reaction to the vaccination that was manifested by "swelling of the entire upper arm," injection site warmth and injection site redness. On 01May 2006, the patient also received a separate injection of inactivated poliomyelitis virus vaccine (IPOL Aventis Paateur) and MMR vaccine (manufacturer unknown). The reporter considered that the events were possibly related to the use of Infanrix. The outcome of the events was not reported.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Oedema peripheral
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling arm in a 5 year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The nurse reported that "a number of" subjects experienced a reaction following receipt of the 5th dose of Infanrix, however, a specific number of subjects was not reported. On 02 May 2006, the subject received 5th dose of Infanrix in the left deltoid (lot AC14B021-incomplete lot number). The nurse reported that on 02 May 2006 after vaccination with "Infanrix-Tip-lock" the subject experienced "large local reaction to the vaccination" manifested by "swelling of the entire upper arm," injection site warmth and injection site redness. The area of swelling and erythema was five by ten inches over the injection site. The subject was treated with ibuprofen. The nurse considered that the events were possibly related to the use of Infanrix. The outcome of the events is unknown.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 2-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 02 May 2006 the subject received 3rd dose of Infanrix in the right thigh. On 03 May 2006, 1 day after vaccination with Infanrix, the subject experienced injection site redness, injection site blisters and "yellow/purple spots" at the injection site. The subject was seen at the physician's office. At the time of initial reporting, 05 May 2006, the events were ongoing.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site soreness in a 38-year-old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. The reporter is the husband of the subject. A physician or other health care professional has not verified this report. Concurrent medications included Methylphenidate hydrochloride (Concerta) for an unspecified indication. On 05 April 2006 at 1:30 p.m., the subject received two doses of Dtpa rather than the intended administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. The subject was injected in "the arm." The specified sites of injections were not reported. Dtpa is not recommended for immunizing individuals 7 years of age or older. On 05 April 2006 at 1:30 p.m., immediately after vaccination with two doses of Dtpa, the subject experienced injection site soreness. At the time of initial reporting, 05 April 2006, the injection site soreness was ongoing.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of injection site pruritis in a 15 month old female child who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On 03 May 2006, the subject received a 4th dose of Infanrix (lot AC14B018AA). On 05 May 2006, two days after vaccination with Infanrix, the subject experienced site pruritis, injection site redness and swelling injection site. The outcome of the events was not reported. No adverse events were reported with previous administrations of Infanrix to this subject. In the reporter's opinion, the events were related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of injection site pruritus in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 11 May 2006, the subject received a dose of Infanrix (dose number not provided; lot AC14B018AA). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 May 2006, the subject experienced injection site pruritus, injection site redness and swelling injection site. The outcome of the events was not reported.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of limb swelling in a 15 moth-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date in May 2006, the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in My 2006 before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on the event was unresolved. Causality was unknown
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of limb swelling in subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis.  On an unspecified date in May 2006, the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in May 2006 before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on the event was unresolved. Causality was unknown
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date in May 2006, the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in May 2006 before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on the event was unresolved. Causality was unknown
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling in a 5 year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date, the subject received a dose of Infanrix (dose number not specified, lot number AC14A008AA). on an unspecified date before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling, redness and bruising. At the time of reporting, the outcome and causality was unknown
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of a swollen area around the injection site in 5-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTPa, unknown manufacturer) for prophylaxis. The subject had no concomitant medications or relevant medical history. The subject's concurrent conditions were not reported. This subject had no adverse events following receipt of prior immunizations. On 11 April 2005, the subject received the 5th dose of DTPa (lot number, expiration date and route unknown). On an unspecified day in April 2005, after vaccination with DTPa on 11 April 2005, the subject developed an 8-10 inch area around the injection site that was red, swollen, painful and itchy. The subject's parent notified the physician's office and stated that topical diphenhydramine (Benadryl) did not work for the subject and oral Benadryl was going to be tried. The events resolved on an unknown date. Follow-up received on 26 July 2006 from the vaccine responsible physician indicated that the events were not serious and possibly related to the diphtheria and tetanus toxoids and acellular pertussis vaccine.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This case was reported by a consumer and described the occurrence of swollen leg in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. The reporter is the subject's father. A physician or other health care professional has not verified this report. On an unspecified date on or before 15 May 2006, the subject received a dose of Dtpa at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, on an unspecified date on or before 15 May 2006, the subject experienced swollen leg, erythema of leg, and leg "was warm to the touch." At the time of initial reporting, 15 May 2006, the outcome of the events was not reported. Report received via Merck & Co., Inc.
Sex: U
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. On an unspecified date on or before 19 May 2006, the subject received a dose of Dtpa (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, the subject experienced "high" fever and "excessive" crying. The subject was seen at physician's office. the outcome of the events was not reported. Report received via Merck & Co., Inc.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. on an unspecified date in June 2006, the subject received a dose of Infanrix (lot number and dose number were not reported) at an unspecified site of administration. On an unspecified date on or before 27 June 2006 after vaccination with Infanrix, the subject experienced limb swelling and redness. The outcome of the events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by  a nurse to a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in June 2006, the subject received a dose of Infanrix (lot number and dose number were not reported) at an unspecified site of administration. On an unspecified date on or before 27 June 2006 after vaccination with Infanrix, the subject experienced limb swelling and redness. The outcome of the events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoid and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in June 2006, the subject received a dose of Infanrix (lot number and dose number were not reported) at an unspecified site of administration. On an unspecified date on or before 27 June 2006 after vaccination with Infanrix, the subject experienced limb swelling and redness. The outcome of the events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse to sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoid and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in June 2006, the subject received a dose of Infanrix (lot number and dose number were not reported) at an unspecified site of administration. On an unspecified date on or before 27 June 2006 after vaccination with Infanrix, the subject experienced limb swelling and redness. The outcome of the events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of limb swelling from the injection site to the elbow in an unspecified number of subjects of unspecified age and gender who were vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. It was reported that lately, the physician's office had been noticing that with the majority of the 5th doses that have been given with Infanrix, the children have had swelling from the injection site to the elbow. The subjects had received Tripedia or Daptacel for their first four doses of the series. At the time of reporting the outcome of the events were was unspecified.
Sex: M
Vaccine: DTP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male child subject of unspecified age who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine (DTP (A or W not known), manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date the subject received an unspecified dose of DTP (A or W not known). At an unspecified time after vaccination with DTP (A or W not known), the subject experienced fever according to the subject's mother. The outcome of the event was unknown. This report was received via Merck and Co, Inc.
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of limb swelling in a child female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unknown) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date on or before 13 July 2006, the subject received the 4th dose of Dtpa (unknown manufacturer and lot number). Site of injection was the left arm. Concurrent vaccination included measles, mumps, and rubella vaccine (MMR, unknown manufacturer, dose number and lot number). On 13 July 2006, at an unspecified time after vaccination with Dtpa, the subject experienced limb swelling. At the time of reporting the event was unresolved. The physician considered the event was possibly related to vaccination with Dtpa.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of 20 cm by 20 cm swollen area at injection site in a 5-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. Previous and/or concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine; Merck given on 17 July 2006; live attenuated oral poliomyelitis vaccine; Aventis Pasteur given on 17 July 2006. The subject had no relevant medical history. The subject's concurrent medications were not provided. The subject had no adverse events following previous vaccinations. On 17 July 2006, the subject received the 5th dose of Infanrix (lot number AC14B036AA, intramuscular, left thigh). At an unspecified time after vaccination with Infanrix, the subject experienced injection site redness and warm to touch injection site. On 19 July 2006, the subject developed 20 cm by 20 cm swollen area at the injection site. The subject was prescribed diphenhydramine hydrochloride (Benadryl), ice and ibuprofen (Motrin). At the time of reporting, the events were resolved. The attenuated measles, mumps (strain not specified), rubella vaccine and live attenuated oral poliomyelitis vaccine injection sites did not have the same reaction as the Infanrix injection site.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described a 7-year-old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There were no concurrent medications. On 26 July 2006, the subject inadvertently received an unspecified 0.5 ml dose of Infanrix (lot number AC14B027AA) rather than the intended administration of tetanus and diphtheria toxoid). Site of administration was left arm. Infanrix is not recommended fro immunizing individuals 7 years of age or older. concurrent vaccinations given on the same date included hepatitis B vaccine (manufacturer unknown), injection of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles, mumps and rubella vaccine (manufacturer known).
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 14 August 2006 the subject received 5th dose of Infanrix, intramuscularly, in the left thigh (lot AC14B033AA). On14 August 2006, the subject also received measles, mumps and rubella vaccine, strain not specified (MMR II, Merck) at an unspecified site of injection. On 15 August 206, 1 day after vaccination with Infanrix, the subject experienced injection site cellulitis, injection site redness, injection site warmth and swelling injection site. The subject was seen at a physician's office. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of initial reporting, 17 August 2006, the events were ongoing. The healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up information received on 05 September 2006 indicated that the events completely resolved and were related to treatment with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 14 August 2006 the subject received 5th dose of Infanrix, intramuscularly, in the left thigh (lot AC14B033AA). On 16 August 2006, 2 days after vaccination with Infanrix, the subject experienced injection site cellulitis, injection site redness, injection site warmth and swelling injection site. The subject was seen at a physician's office. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of initial reporting, 17 August 2006, the events were ongoing. The healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up information received on 06 September 2006 indicated that the events completely resolved by 20 August 2006. The reporter considered the events to be  related to treatment with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 24 July 2006 the subject received 5th dose of Infanrix, intramuscularly, in the left thigh (lot AC14B033AA). On 24 July 2006, the subject also received measles, mumps and rubella vaccine, strain not specified (MMR II, Merck) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) at an unspecified site of injection. On 25 July 2006, 1 day after vaccination with Infanrix, the subject experienced injection site cellulitis, injection site redness, injection site warmth and swelling injection site. The subject was seen at a physician's office. The healthcare professional considered the events were clinically significant (or requiring intervention). The events resolved on an unspecified date on or after 25 July 2006 and on or before 17 August 2006. The healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up information received on 05 September 2006 indicated that the events did completely resolved and were related to treatment with Infanrix.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of foot pain in a 22-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The subject has no medical history or concurrent conditions. Concurrent vaccinations received on the same day as Infanrix (16 August 2006) included hepatitis A vaccine (Vaqta; Merck; lot 0511F with expiration 18 October 2008) and pneumococcal vaccine, (Prevnar; Wyeth Labs; lot B08649A with expiration 31 January 2008) given intramuscularly in the left thigh. On 16 August 2006 at 15:45 the subject received 4th dose of Infanrix (lot number AC14B032AA, expiration 02 November 2008) at 0.5 ml, intramuscularly in the left thigh. On 17 August 2006, at 06:00 following vaccination with Infanrix, the subject experienced foot pain, leg pain, sensitivity to the touch on the feet and legs, injection site redness and injection site swelling. It was also reported that the subject was crying and fussy. At the time of reporting the events improved. The healthcare professional considered the events were possibly related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The subject has no known drug allergies. Concurrent conditions were not provided. Concurrent vaccinations administered on the same date as Infanrix, 21 August 2006, included inactivated poliomyelitis virus vaccine (IPOL; Aventis Pasteur; lot and expiration not provided) and live attenuated measles, mumps, rubella vaccine (MMR; Merck; lot number and expiration not provided). On 21 August 2006 the subject received 5th dose of Infanrix (lot AC14B033AA, expiration 02 November 2008)  at 0.5 ml, intramuscularly in the right thigh. On 22 August 2006, after vaccination with Infanrix, the subject experienced injection site redness (2 inches), injection site warmth and hardening at the injection site. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unspecified. the healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up received on 31 August 2006, indicated that the subject was vaccinated with Infanrix on 17 August 2006. The same day the subject experienced unspecified symptoms that was diagnosed as cellulitis. The subject was treated with keflex. At an unspecified time, the symptoms resolved. The reporter considered that the events were related to the use of Infanrix. Comment: The physician indicated that he is "positive" that there is a quality assurance issue with this lot of Infanrix, due to the number of adverse events he has seen with the lot. The physician did not indicate how many subject had adverse experiences, other than the one described above, and did not specify the nature of any other adverse experiences.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Infanrix, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received 5th dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, on or before 30 August 2006, the subject experienced cellulitis from the shoulder to the elbow. The nurse was trying to determine "if there is an issue with the lot or if the injections were given subcutaneously rather than intramuscularly. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting the events were resolved.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Infanrix, GlaxoSmithKline. On an unspecified date the subject received 5th dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, on or before 30 August 2006, the subject experienced cellulitis from the shoulder to the elbow. The nurse was trying to determine if there is an issue with the lot or if the injections were given subcutaneously rather than intramuscularly. This case was assessed as medically serious by GSK. The subject was treated with antibiotics (Antibiotic). At the time of reporting the events were resolved.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Infanrix, GlaxoSmithKline. On an unspecified date the subject received 5th dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, on or before 30 August 2006, the subject experienced cellulitis from the shoulder to the elbow. The nurse was trying to determine "if there is an issue with the lot or if the injections were given subcutaneously rather than intramuscularly. This case was assessed as medically serious by GSK. The subject was treated with antibiotics (Antibiotic). At the time of reporting the events were resolved.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in a 4 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On 05 September, the subject received a dose of Infanrix (dose number and lot number not reported). Following administration of Infanrix, 05 September 2006, the subject experienced swelling at the injection site. At the time of reporting, 06 September 2006, the event was ongoing. The healthcare professional considered the event was probably related to vaccination with Infanrix. Follow-up information received on on 22 September 2006 indicated that the event began on 05 September 2006 and was resolved by 12 September 2006. The Infanrix dose received prior to the reaction was the subject's 5th dose in the series. The reporter considered the event to be related to Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 08 September 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 08 September 2006, the subject experienced "a large localized reaction measuring 150 mm" at the injection site of Infanrix. The outcome of the event was not reported.
Sex: U
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 08 September 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 08 September 2006, the subject experienced "a large localized reaction"  at the injection site of Infanrix. The outcome of the event was not reported.
Sex: U
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 08 September 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 08 September 2006, the subject experienced "a large localized reaction" at the injection site of Infanrix. The outcome of the event was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of redness in a 4-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There was no relevant medical history. The subject's concurrent conditions were not reported. Concurrent vaccinations administered on 19 September 2006 included hepatitis A vaccine (Havrix, GlaxoSmithKline) and live attenuated oral poliomyelitis vaccine (Aventis Pasteur). Concurrent medications included "vitamins". On 19 September 2006 at 15:20 the subject received 4th dose of Infanrix (0.5 ml, intramuscular, left arm). On 19 September 2006, less than one day after vaccination with Infanrix, the subject experienced 14 x 14 area of redness and 14 x 14 area of swelling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up information received on 23 October 2006 indicated that the subject developed dermatitis and the onset date for the event and symptoms was actually 21 September 2006. The outcome of the events was not known and the reporter stated that the events were related to treatment with Infanrix.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Subject was born 4 weeks premature.  On 21 April 2003 the subject received 1st dose of Infanrix. On an unspecified date, the subject experienced fever of approximately 100 degrees Fahrenheit. Within 12 hours fever resolved. Further information was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse to sales representative and described the occurrence of swelling arm in a 4-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline), live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II vaccine), and inactivated poliomyelitis virus vaccine (IPOL) for prophylaxis. The subject's medical history included two days in the neonatal intensive care unit for tachypnea following birth. On 29 August 2006 the subject received 5th dose of Infanrix in the left arm, and unspecified doses of MMR II vaccine and IPOL. The injection sites for the MMR II vaccine and IPOL were not provided. On 31 August 2006, 2 days after vaccination with IPOL, Infanrix and MMR II vaccine, the subject experienced swelling of forearm up to the injection site, injection site redness and injection site warmth. At the time of initial reporting, 04 October 2006, the events had improved. The nurse considered the events were probably related to vaccination with Infanrix, MMR II vaccine and IPOL.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included family history of diabetes. On 24 August 2006 the subject received 5th dose of Infanrix in the left arm. On 24 August 2006, the subject also received measles, mumps and rubella vaccine, strain not specified (MMRII vaccine, Merck), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and hepatitis A vaccine (unspecified manufacturer). On 26 August 2006, 2 days after vaccination with Infanrix, the subject experienced swelling injection site, injection site warmth and injection site redness. At the time of initial reporting, 04 October 2006, the events were improved. The nurse considered the events were probably related to vaccination with Infanrix.