chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with Infanrix for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no relevant medical history, concurrent conditions or concurrent medications. On 8/15/02, the subject received his fourth injection of Infanrix (553A2) into the left leg. Subsequently, the subject developed an injection site reaction characterized by swelling and redness. The reporter stated that the injection site was related to Infanrix administration. The injection site reaction resolved. This case has been linked to report A0381019A and a0381144 due to same reporter.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site warmth, Rash
Clinical narrative: A nurse reported the occurrence of a rash in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On 8/23/02, the subject received an injection of Infanrix. Later that day, an unspecified time post-immunization, the subject experienced a rash and an injection site reaction characterized by swelling and warmth. The subject was seen by a physician. The events persisted as of 8/26/02.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with Infanrix for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no medical history or or concurrent conditions. Concurrent medications were not specified. The subject experienced no adverse events following previous vaccinations. On an unspecified date, the subject received his fourth injections of Infanrix (552A2) administered with a 25 gauge, 1-inch needle. Subsequently, on 8/7/02, the subject experienced a "severe" injection site reaction characterized by swelling, an approximately 3-inch area of erythema distal to the injection site, warmth and pruritus. The follow-up reporter stated that the vaccine provider reported that the event was "Likely a local response" and was "treated for 5 to 10 days to cover unlikely secondary cellulitis." The follow-up reporter stated that the outcomes of the events were unknown as of 9/27/02 and that the events were possibly related to Infanrix administration. This report is considered serious (OMIC) as the follow-up reporter stated that the events jeopardized the pt or required intervention.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with Infanrix for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no medical history or or concurrent conditions. Concurrent medications were not specified. The subject experienced no adverse events following previous vaccinations. On an unspecified date, the subject received his fourth injections of Infanrix (552A2) administered with a 25 gauge, 1-inch needle. Subsequently, on 8/7/02, the subject experienced a "severe" injection site reaction characterized by swelling, an approximately 3-inch area of erythema distal to the injection site, warmth and pruritus. The follow-up reporter stated that the vaccine provider reported that the event was "Likely a local response" and was "treated for 5 to 10 days to cover unlikely secondary cellulitis." The follow-up reporter stated that the outcomes of the events were unknown as of 9/27/02 and that the events were possibly related to Infanrix administration. This report is considered serious (OMIC) as the follow-up reporter stated that the events jeopardized the pt or required intervention.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site reaction, Injection site warmth, Pruritus, Urticaria
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with Infanrix for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no medical history or concurrent conditions. Concurrent medications were not specified. The subject had not experienced any adverse events following previous vaccinations. On an unspecified date the subject received his 5th vaccination of Infanrix (566B2) administered with a 25 gauge 5/8 inch needle. Subsequently, on 8/16/02, he experienced an injection site reaction characterized by a red welt on the left leg measuring 2 3/4 inches, warmth, and itching. The subject did not develop a fever. However, Tylenol was administered. Follow up received stated that the events were possibly related to Infanrix administration and the outcomes of the events were unknown. This case is considered serious (OMIC) because the reporter stated that the events jeopardized the pt or required intervention.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported the occurrence of an injection site reaction in an 18 month old female who was vaccinated with Infanrix for prophylaxis. There was no relevant medical history, concurrent conditions, or concurrent medications. The subject had no adverse experiences following receipt of prior immunizations. On 8/26/02, the subject received her fourth injection of Infanrix (568A9) into the left leg. On that date, she also received an injection of IPOL. The following day, the subject's mother telephoned the physician's office to report that the subject had developed an injection site reaction characterized by redness and swelling at the Infanrix injection site. The reporter considered the injection site reaction to be related to Infanrix administration. The most recent info, received on 11/20/02, indicated that the injection site reaction resolved. This report has been linked to report A0379534A due to same reporter.
Age: 5.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with Infanrix for prophylaxis. There was no relevant medical history, concurrent conditions, or concurrent medications. The subject had no adverse experiences following receipt of prior immunizations. On 8/27/02, the subject received his fifth injection of Infanrix (568A9) into the left deltoid. On the same day, he also received an injection of IPOL into the right deltoid. Later that day, an unspecified time post-immunization, the subject developed an injection site reaction characterized by redness and swelling at the Infanrix injection site.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Cough, Infection, Laboratory test abnormal
Clinical narrative: A physician reported the occurrence of pertussis in a 10 month old male who was vaccinated with Infanrix for prophylaxis. The vaccine provider submitted a report directly to the local county health dept. The subject had no relevant medical history. He experienced no adverse events following previous immunizations. The subject received injections of Infanrix on 1/16/02 (527A2), 3/1/02 (527A2) and 5/1/02 (525A2). He also received injections of hep B vaccine (mnauf unk 1/16/02 and 3/1/02), IPOL (1/16/02, 3/1/02 and 5/1/02), Prevnar (1/16/02, 3/1/02 and 5/1/02), Hib (manuf unk 1/16/02, 3/1/02 and 5/1/02). Each injection of Infanrix was given in the same site as the Hib vaccine, rather than at separate sites as recommended. On 8/21/02, three months after the third injection of Infanrix, the subject developed a cough "for an extended time" and received unspecified treatment. On 8/26/02, the subject was seen in the local ER for what was thought to be reactive airway disease. A Bordatella parapertussis smear obtained on that date was positive. At the time of diagnosis, the subject was already receiving therapy with Augmentin for an incidental otitis media. The pertissus resolved after an unspecified period of time.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history and received no concurrent medications. He experienced no adverse events following previous immumizations. On 8/28/02 at 10:15, the subject received his fourth injection of Infanrix (545B9). At 17:00, it was noted that the subject had developed an injection site reaction characterized by redness, warmth, an area of swelling measuring 16cm by 10cm, and a 9cm area of induration. The subject was limping on his left leg. The subject was seen in the ER. The events resolved on 9/3/02.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: A health professional reported the occurrence of limb swelling in a 5 year old male who received Infanrix. The subject's medical history, concurrent conditioins, and concurrent medications were not provided. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the subject received an injection of Infanrix. On 4/20/02, post-immunization, the subject experienced limb swelling and was seen by a physician. The event was reported to have resolved on 4/27/02. The reporter considered the event to be related to Infanrix administration.
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: A physician reported the occurrence of limb swelling in a child of unspecified age and gender who was vaccinated with Infanrix for prophylaxis. The vaccine provider submitted a report directly to VAERS. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of Infanrix. At an unspecified time post-immunization, the subject developed "pretty serious" limb swelling. The subject was treated at a "minor emergency" center "and received treatment with an anti-inflammatory" drug. The reporter indicated that the event was probably related to Infanrix administration. As of 9/12/02, the outcome of the event was unknown. This report has been linked to report A0385107A due to same reporter.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old female who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 7/23/02, the subject received her fourth injection of Infanrix (566A2) into the right leg. On the same date, she received injections of Hib vaccine (manuf unk) and IPOL at unspecified injection sites. She was seen by the physician on 7/25/02 with an injection site reaction characterized by redness at the site of Infanrix administration and swelling of the right leg. As of 7/31/02, the injection site reaction had resolved. The reporting nurse stated that the injection site reaction was probably related to Infanrix administration.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unspecified. On 7/23/02, the subject received his fourth injection of Infanrix (556A2) into the right thigh. On the same date, he received an injection of IPOL at an unspecified site. He was seen by the physician on 7/25/02 with an injection site reaction characterized by redness at the site of Infanrix administration and swelling of the right leg. As of 7/31/02, the injection site reaction had resolved. The reporter stated that the injection site reaction was probably related to Infanrix administration.
Age: 1.8
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: This report describes the occurrence of an injection site reaction in a 20-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 patient's mother and has not been verified by an physician or other health care professional.  The subject had no relevant medical history or concurrent conditions.  He received no concurrent medications.  He experienced no adverse effects following previous immunizations.  On 09/12/2002, the subject received his fourth injection of Infanrix (lot DTPA541A9; expiration date 09/2003).  On 09/13/2002, he experienced an injection site reaction characterized by swelling and redness.  Additionally, he experienced a fever of 102 degrees Fahrnheit.  As of 09/16/2002, the injection site reaction had "improved' and the fever persisted.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurence of an injection site reaction in a 5-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (VAERS reference number, 189420).  The subject had no relevant medical history, concurrent conditions, or concurrent medications.  On 08/19/2002, the subject received his fifth injection of Infanrix (lot number DTPA553A2) into the left leg.  On 08/20/2002, the subject developed an injection site reaction characterized by swelling and redness.  The reporter stated that the injection site reaction was possibly due to Infanrix administration.  On an unspecified date, the injection site reaction resolved.  Comment:  This report has been linked to reports A0379054A & A0381144A due to same reporter.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity
Clinical narrative: A medical assistant reported the occurrence of injection site sensitivity in an 8-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 not reported.  The subject experienced no adverse events following previous immunizations.  On 09/04/2002, the subject received her fifth injection of Infanrix (lot DTPA526A9; expiration date 06/18/2003).  On the same date, she received an injection of inactivated poliomyelitis virus vaccine (IPOL).  Two days later, on 09/06/2002, she experienced "mild sensitivity with zero infection" at the Infanrix administration site.  She was seen in the physician's office and treated with loratadine syrup (Claritin).  As of 09/17/2002, the outcome of the event was unknown.  Comment: This report is linked to report A0381069A due to same reporter.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: A medical assistant reported the occurrence of a possible injection site infection in a 22-month-old female who was vaccinated with diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject had no known drug allergies.  On 02/19/2002, she experienced a bruise on the leg following receipt of combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax).  On 08/26/2002, the subject received her fourth injection of Infanrix (lot DTPA526A9; expiration date 06/2003).  On the same date, she received injections of haemophilus influenzae type b conjugate vaccine (manufacturer unknown) and varicella virus vaccine (Varivax).  On 09/09/2002, the subject developed an injection site reaction characterized by redness, pain and swelling.  In addition, she had a fever of 100.8 degrees Fahrenheit.  The physician thought that the events "may be due to an infection."  The vaccine provider prescribed cephalexin monohydrate (Keflex) on 09/09/2002.  The subject returned to the vaccine provider on 09/12/2002.  At that time the subject did not have a fever and the injection site was not swollen.  Therapy was changed to amoxicillin trihydrate/clavulanic acid (Augmentin) on 09/12/2002.  As of 09/17/2002, the outcome of the injection site infection was unknown.  Comment:  This reporter is linked to report A0381068A due to same reporter.
Age: 1.2
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 14-month-old male who was vaccinated with diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS.  The subject had no relevant medical history, concurrent conditions, or concurrent medications.  On 08/20/2002, the subject received his fourth injection of INfanrix (lot number DTPA553A2) into the right leg.  Subsequently, on 08/20/2002, the subject developed an injection site reaction characterized by swelling and redness.  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  The injection site reaction resolved.  Comment: This report has been linked to report A0379054A & A0381019A due to the same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: A nurse reported the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with diphteria and tetanus toxoids and acellular pertussis vaccine adsorbed (infanrix) for prophylaxis.  The subject's medical history, concurrent medical conditions, and concurrent medications were not specified.  On an unspecified date, the subject received an injection of INfanrix into the buttocks, which is not a recommended site for Infanrix administration.  At an unspecified time post-vaccination, the subject developed redness at the injection site.  Comment: The reporter indicated that two subjects experienced this event; however, they are not presently identifiable.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: This report describes the occurrence of gasping in a 5-month-old female who was vaccinated with diptheria and tetanus toxoids and aellular 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 health care professional.  The subject's medical history reportedly included premature birth and reflux.  There were reportedly no adverse experiences following previous immunizations.  Concurrent medications included ranitidine (Zantac).  On 09/17/2002, the subject received her second injection of Infanrix into her right leg.  Approximately 7 hours post-immunization, the subject "started screaming uncontrollably, gasping for breath, face very white and eyelids red."  Approximately 8 hours post-immunization, the subject was taken to the emergency room.  Her pulse was reportedly "fine".  The infant was able to successfully feed, so she was sent home.  On 09/14/2002, approximately 5 hours after her emergency room visit, the subject developed a fever of 101.8 degrees Fahrenheit.  Her mother administered ibuprofen (Motrin).  Two hours later, the subject's temperature was 99.6 degrees Fahrenheit.  Subsequently, the subject "started kicking right leg were the injection was given."  The mother checked the injection site and found it to be "hot, hard, red, and enlarged to the size of a dime."  The subject was taken to an urgent care center, where the injection site swelling was reportedly noted to be the "size of a quarter."  The physician reportedly made a diagnosis of injection site infection and prescribed amoxicillin.  However, the subject's parents did not fill the prescribption.  Instead, the mother administered ibuprofen and paracetamol (Tylenol).  The mother reported that the gasping, uncontrolable screaming, fever, and injection site warmth resolved on 09/15/2002.  The injection site redness, induration, and swelling resolved on 09/18/2002.  The outcome of the pallor and eyelid redness were not specified.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Ocular hyperaemia, Pyrexia, Screaming
Clinical narrative: This report describes the occurrence of gasping in a 5-month-old female who was vaccinated with diptheria and tetanus toxoids and aellular 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 health care professional.  The subject's medical history reportedly included premature birth and reflux.  There were reportedly no adverse experiences following previous immunizations.  Concurrent medications included ranitidine (Zantac).  On 09/17/2002, the subject received her second injection of Infanrix into her right leg.  Approximately 7 hours post-immunization, the subject "started screaming uncontrollably, gasping for breath, face very white and eyelids red."  Approximately 8 hours post-immunization, the subject was taken to the emergency room.  Her pulse was reportedly "fine".  The infant was able to successfully feed, so she was sent home.  On 09/14/2002, approximately 5 hours after her emergency room visit, the subject developed a fever of 101.8 degrees Fahrenheit.  Her mother administered ibuprofen (Motrin).  Two hours later, the subject's temperature was 99.6 degrees Fahrenheit.  Subsequently, the subject "started kicking right leg were the injection was given."  The mother checked the injection site and found it to be "hot, hard, red, and enlarged to the size of a dime."  The subject was taken to an urgent care center, where the injection site swelling was reportedly noted to be the "size of a quarter."  The physician reportedly made a diagnosis of injection site infection and prescribed amoxicillin.  However, the subject's parents did not fill the prescribption.  Instead, the mother administered ibuprofen and paracetamol (Tylenol).  The mother reported that the gasping, uncontrolable screaming, fever, and injection site warmth resolved on 09/15/2002.  The injection site redness, induration, and swelling resolved on 09/18/2002.  The outcome of the pallor and eyelid redness were not specified.
Age: 0.1
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Oedema peripheral
Clinical narrative: A health professional reported the occurrence of injection site cellulitis in a 10-month-old female who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  On 09/24/2002, the subject received an injection of Infanrix (lot DTPA572A2) into the left thigh.  On 09/25/2002, the subject developed limb swelling and redness at the injection site.  The subject was seen by a physician, who made a diagnosis of injection site cellulitis and prescribed azithromycin (Zithromax) and cool compresses.  The reporter stated that the injection site cellulitis was possibly related to Infanrix administration.  Comment:  This report has been linked to report A0381793A due to the same reporter.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A health professional reported the occurrence of injection site cellulitis in a 6-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 not provided.  On 09/23/2002, the subject received an injection of Infanrix (lot DTPA572A2) into the left thigh.  Two days later, on 09/25/2002, the subject developed swelling and redness at the injection site.  The subject was seen by the physician, who made a diagnosis of injection site cellulitis and prescribed cefprozil (Cefzil).  The reporter stated that the injection site cellulitis was possibly related to Infanrix administration.  Comment:  This report has been linked to report A0381792A due to the same reporter.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Generalised oedema, Urticaria
Clinical narrative: A physician reported the occurrence of limb swelling in an 18-month-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent medical conditions, and concurrent medications were not specified.  On 09/25/2002, the subject received injection of inactivated poliomyelitis virus vaccine (IPOL).  Later that day, and unspecified time post-immunization, the subject developed swelling from his groin to his knees.  The physician thought the subject had "bug bites".  Two days later, the physician determined the "bug bites" to be hives.  As of 10/01/2001, the hives persisted and the limb swelling had improved.  The reporting physician considered the limb swelling to be probably related to Infanrix administration and the hives to be unrelated to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4-year-old male who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, or concurrent medications were not provided.  The subject experienced no adverse events following previous immunizations.  on 09/11/2002, the subject received his fifth injection of Infanrix (lot DTPA572A2) into the left arm.  On that same day, he also received an injection of inactiated poliomyelitis virus vaccine (IPOL) at an unspecified site.  Within 24 hours post-immunization, on approximately 09/12/2002, the subject developed an injection site reaction characterized by "a red, swollen, tender area 9 inches in diameter at the injection site."  The injection site reaction resolved within 72 hours.  Initially, the reporter stated that the event was "probably related" to Infanrix administration.  On follow-up, the reporter stated that the event was "possibly related" to Infanrix administration.  Comment:  This report has been linked to report A0388102A due to same reporter.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A health care professional reported the occurrence of an injection site reaction in a 5-year-old male who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-021).  The subject's medical history includes fused L3-L4 and otitis.  Concurrent medications were not specified.  The subject had not experienced any adverse events following previous vaccinations.  On an unspecified date, the subject received his fifth dose of Infanrix (lot DTPA566B2).  Subsequently, on 08/15/2002, he experienced an injection site reaction characterized by a "10cm x 8cm sharply [defined] circular area of erythema and warmth on the left deltoid."  The physician examined the subject on 08/16/2002 and prescribed cephalexin monohydrate (Keflex).  The reporter stated that the outcomes of the events were unknown and that the events were possibly related to Infanrix administration.  This report is considered serious because the reporter stated that the events jeopardized the patient or required intervention.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A health care professional reported an injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-022).  The subject's medical history included recurrent otitis media.  Concurrent conditions and concurrent medications were not specified.  The subject experienced no adverse events following previous vaccinations.  On an unspecified date, the subject received her fifth injection of Infanrix (lot DTAP556622).  The Infanrix injection was administered with a 25 gauge 5/8 inch needle.  Subsequently, on 08/17/2002, the subject experienced an injection site reaction characterized by redness, swelling and warmth which covered 3/4 of her upper arm.  On 08/19/2002, the subject was examined by the physician who prescribed cephalexin monohydrate (Keflex).  The reporter stated that the outcomes of the events were unknown and that they were possibly related to Infanrix administration.  This case is considered serious because the reporter stated that the events jeopardized the patient or required intervention.
Age: 2.1
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 25-month-old male 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 not specified.  On 09/13/2002,  the subject received his fourth injection if Infanrix (lot DTPA571A2) into the left upper leg.  Two days later, the subject developed injection site cellulitis.  The subject was seen in the local emergency room.  The reporter considered the event to be related to Infanrix administration.  Comment:  This report has been linked to reports A0386782A, A0386783A, A0386784A, and A0386785A due to same reporter.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 6-month-old male who received diphtheria and tetanus toxoids and acelular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not specified.  On 03/20/2002, the subject received his third injection of Infanrix.  Two days later, the subject developed injection site cellulitis.  The reporter considered the event to be probably related to Infanrix administration.  The outcome of the event was not known.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids an acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-023).  The subject had no medical history or concurrent conditions.  The subject experienced no adverse events following previous immunizations.  Concurrent medications were unspecified.  On 07/31/2002, the subject received her fifth injection of Infanrix (lot DTPA566B2) administered with a 25-gauge, 5/8 inch needle.  On 08/01/2002, the subject developed an injection site reaction characterized by redness and swelling of her "entire leg".  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  As of 09/30/2002, the outcomes of the injection site was unknown.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 24-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state reference number C002-024).  The subject had no medical history or concurrent conditions.  The subject experienced no adverse events following previous immunizations.  Concurrent medications were not specified.  On 08/27/2002, the subject received her fourth injection of Infanrix (lot DTPA541A9).  Forty-eight hours later, on 08/29/2002, she developed an injection site reaction characterized by swelling and a 7-cm area of redness and induration.  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  As of 09/30/2002, the outcome of the injection site reaction was unknown.
Age: 3.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 3-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus coxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-025).  The subject had no medical history or concurrent conditions.  The subject experienced no adverse events following previous immunizations.  Concurrent medications were not specified.  On 08/26/2002, the subject received the fourth Infanrix injection (lot DTPA541A9).  On 08/28/2002, the subject developed an injection site reaction characterized by swelling and a 4-cm area of redness and induration.  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  As of 09/30/2002, the outcome of the injection site reaction was unknown.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: A nurse reported the occurrence of hives in a 5-year-old male who was vaccinated with diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-026).  The subject had no medical history or concurrent conditions.  He experienced no adverse events following previous immunizations.  Concurrent medications were not specified.  On 08/26/2002, the subject received his fifth injection of Infanrix (lot DTPA541A9).  On 08/28/2002 he developed an injection site reaction characterized by swelling and a 6.5cm - 7cm area of redness and induration.  Additionally, he developed hives on his back.  The reporter stated that the events were possibly related to Infanrix administration.  As of 09/30/2002, the outcome of the events were unknown.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Hypersensitivity
Clinical narrative: This report dexribes the occurrence of a food allergy in a 4-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  The subject had no reported medical history, concurrent conditions, or concurrent medications.  On approximately 07/19/2001, the subject received his first injection of Infanrix.  On this same date, the subject also received his second injection of hepatitis B vaccine recombinant (Engerix -B) and an injection of Haemophilus influenzae type b conjugate vaccine (manufacturer unknown).  Two months later, he was reported to have "dropped the charts" and to have developed "serious" food allergies.  As of 10/04/2002, the events reportedly persisted.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Lethargy
Clinical narrative: This report describes the occurrence of lethargy in a 2-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. This report was received from the pt's father and has not been verified by a physician or other health care professional. The pt's medical history, concurrent conditions and concurrent medications were not specified. In April 2002 the pt received her first injection of Infanrix. At that time, she also received an injection of Haemophilus influenzae type b conjugate vaccine (manufacturer unknown). Later on the date of immunization, she became lethargic. The event resolved one week later. She was subsequently immunized with diphtheria and tetanus toxoids and reportedly had no adverse experiences.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, IPV
Symptoms: Injection site erythema
Clinical narrative: A nurse reported the occurrence of redness at the injection site in a 4-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history included environmental allergies. Other relevant medical history and concurrent conditions were not provided. Concurrent medications included loratadine (Claritin) and fluticasone nasal spray (Flonase). On 10/03/2002 the pt received his 4th injection of Infanrix. On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and influenza virus vaccine (manufacturer unknown). The nurse stated that "immediately" after receiving the injection, the pt developed "slight" redness at the injection site. By 10/06/2002 the injection site redness increased in size to about 10" in diameter with a white center. The nurse stated that "the site had not been painful or feverish." The pt was treated with diphenhydramine with improvement. On 10/07/2002 the pt was seen by the pediatrician who noted that the injection site redness had decreased to about 5" in diameter and there was no hardness, tenderness or cellulitis. The physician recommended cold compresses and diphenhydramine as needed. The event had "almost" resolved on 10/07/2002.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a 4-year-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The reporter submitted a report directly to VAERS (VAERS ID, 185346). The pt's medical history, concurrent conditions and concurrent medications were not provided. On an unspecified date, the pt received an injection of Infanrix. On 05/02/2002 post-immunization the pt developed cellulitis at the injection site. The physician prescribed an unspecified antibiotic. The event was reported to have resolved on 05/04/2002. The reporter considered the event to be possibly related to Infanrix immunization.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The reporter submitted a report directly to VAERS (VAERS ID, 185347). The pt's medical history, concurrent conditions and concurrent medications were not provided. The pt had no adverse experiences following receipt of prior immunizations. On an unspecified date, the pt received an injection of Infanrix. On 04/25/2002 post-immunization the pt developed cellulitis at the injection site. The physician prescribed an unspecified antibiotic. The event was reported to have resolved as of 04/29/2002. The reporter considered the event to be possibly related to Infanrix immunization.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a child of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The vaccine provider submitted a report directly to VAERS. The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, the pt received an injection of Infanrix. At an unspecified time post-immunization, the pt experienced "pretty serious" limb swelling. The pt was seen at a "minor emergency" center. A diagnosis of injection site cellulitis was made and the physician prescribed an anti-inflammatory drug. The reporter considered the event to be probably related to Infanrix administration. As of 09/12/2002, the outcome of the event was unknown. Comment: This report has been linked to report A0380700A due to same reporter.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: A physician reported the occurrence of a seizure in an 18-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history included gastroesophageal reflux disease (GERD) and failure to thrive. He had no known allergies, received no concurrent medications and had experienced no adverse events following previous immunizations. The pt received his 4th injection of Infanrix on 11/04/2002 (lot DTAP575A2; expiry 04/09/2004). Later that day, the pt experienced a seizure. He was seen in the ER and treated with phenobarbital. Unspecified laboratory tests were performed. Computed tomography was "fine". The seizure resolved and the infant was sent home that evening. He was seen by his physician on 11/05/2002; at that time, his temperature was 104.2 degrees F. As of 11/11/2002, the outcome of the fever was unknown. The Infanrix immunization series was discontinued. Seizure is considered GSK medically serious.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Pyrexia
Clinical narrative: A pharmacist reported the occurrence of fever in a 24-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxia. Additional information was received from the pt's father. The pt's medical history included fever after an unspecified immunization administered at 1 year of age. Concurrent conditions and concurrent medications were not specified. The pt received injections of Infanrix on 01/09/2001, 03/16/2001, 05/17/2001 and 04/18/2002. On 11/12/2002 the pt inadvertently received his 5th injection of Infanrix at the age of 24 months, instead of the recommended age of 4 to 6 years. On 11/12/2002, the pt also received an injection of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). According to the pt's father, at an unspecified time post-immunization on 11/12/2002, the pt developed a fever.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 3-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were not specified. On 09/19/2002 the pt received his 4th injection of Infanrix (lot DTPA571A2) into the left upper leg. 36 hours later, the pt developed injection site cellulitis. The pt was seen in the local ER. The reporter considered the event to be related to Infanrix administration. Comment: This report has been linked to report A0382391A, A03836783A, A0386784A and A0386785A due to same reporter.
Age: 2.08
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Eye oedema, Oedema
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 25-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were not specified. On 09/23/2002, the pt received her 4th injection of Infanrix. 24 hours later, the pt developed swelling of the leg. 72 hours post-immunization, the pt developed injection site cellulitis and swollen eyes. The reporter considered the events to be related to Infanrix administration. Comment: This report has been linked to reports A0382391A, A0386782A, A0386784A and A0386785A due to same reporter.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Contusion, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 24-month-old female 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 specified. On 09/30/2002 the pt received her 4th injection of Infanrix (lot DTPA571A2) into the left upper leg. One day later, the subject developed redness at the injection site followed by bruising, itching, swelling and firmness 3 days post-immunization. The area of swelling measured 18.5 cm. The pt was seen by a physician, who made a diagnosis of injection site cellulitis. The reporter considered the injection site cellulitis to be related to Infanrix administration. Comment: This report has been linked to reports A0382391A, A0386782A, A0386783A, and A0386785A due to same reporter.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 24-month-old female 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 specified. On 09/30/2002 the pt received her 4th injection of Infanrix (lot DTPA571A2) into the left upper leg. One day later, the subject developed redness at the injection site followed by bruising, itching, swelling and firmness 3 days post-immunization. The area of swelling measured 18.5 cm. The pt was seen by a physician, who made a diagnosis of injection site cellulitis. The reporter considered the injection site cellulitis to be related to Infanrix administration. Comment: This report has been linked to reports A0382391A, A0386782A, A0386783A, and A0386785A due to same reporter.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 24 month old male who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 9/3/02, the subject received his fourth injection of Infanrix 9571A2) into the left upper leg. Forty-eight hours later, the subject developed injection site cellulitis. The subject was seen in the local ER. The reporter considered the event to be related to Infnarix administration.  This report has been linked to reports A0382391A, A0386782A, A0386783A and A0386784A due to same reporter.
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: A physician reported the occurrence of limb swelling in a male subject of unspecified age who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the subject received his fourth injection of Infanrix. Twelve days post-immunization, he developed limb swelling. The physician stated that he had not examined the subject.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported the occurrence of an injection site reaction in an 18 month old female who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not specified. On an unspecified date, the subject received her fourth injection of Infanrix (572A2). Within 12 hrs post-immunization, the subject developed an injection site reaction characterized by "normal" tenderness, redness, and swelling. The injection site reaction resolved within 72 hrs. The nurse reported the injection site reaction was possibly related to Infanrix administration. This report has been linked to report A0382174A due to same reporter.