chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Radiculitis brachial
Clinical narrative: This report describes the occurrence of brachial plexus neuritis in a 4 month old male who received Infanrix. This report was received from the vaccinee's mother, who is a physical therapist. The vaccinee had no relevant medical history. Concurrent conditions and concurrent medications were not specified. Following previous vaccinations, the vaccinee experienced "just normal things, like swelling, slight fever, crying, lack of appetite (mild to moderate only)." On 3/26/02, the vaccinee received his second injection of Infanrix. On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL), combination Haemophilus influenzae type B conjugate/hep B (Comvax), and Prevnar. Three hours post immunization, the vaccinee "was not using his left arm as much" and had a loss of appetite. The subject was seen by a physician, who reportedly made a diagnosis of brachial plexus neuritis. The mother reported that no treatment was given. The mother stated that the vaccinee had "80% of use (of left arm) within evening." The loss of appetite lasted "only for several days." The mother stated that the brachial plexus neuritis and loss of appetite had improved. The mother is a physical therapist and will be given her child therapy as soon as the physician approves. As of 4/16/02, the events were ongoing.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: Report A0366401A describes limb swelling in a 4 year old female vaccinee who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not provided. During the week of 4/15/02, the vaccinee received her fifth injection of Infanrix in her left arm. An unspecified time later that week, she experienced redness and swelling from the left deltoid to the left elbow. Treatment and outcome were not provided. The vaccine provider considered these events to be probably related to Infanrix administration. Please refer to case numbers A0366403A and A0366404A by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: Report A0366404A describes limb swelling in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not provided. During the week of 4/15/02, the vaccinee received his fifth injection of Infanrix in his left arm. At unspecified time later that week, he experienced redness and swelling from the left side to the left elbow. Treatment and outcome were not provided. The vaccine provider considered the events to be probably related to Infanrix administration. Please refer to case numbers A0366401A and A0366404A by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Report A0366404A describes limb swelling in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not provided. During the week of 4/15/02, the vaccinee received his fifth injection of Infanrix in his left arm. An unspecified time later that week, he experienced redness and swelling from the left deltoid to the left elbow. Treatment and outcome were not provided. The vaccine provider considered the events to be probably related to Infanrix administration. Please refer to case numbers A0366401A and A0366403A by the same reporter.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: A medical assistant reported the occurrence of an injection site reaction in a 6 month old male who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 12/12/01, the vaccinee received his first injection of Infanrix without adverse event. On 2/12/02, the vaccinee received an injection of Tripedia without adverse event. On 4/17/02, the vaccinee received an injection of Infanrix (547A2). On 4/19/02, he developed an injection site reaction characterized by a large lump (knot) and redness. He was seen by the physician. The reporter stated that these adverse events were probably related to Infanrix administration. As of 4/22/02, the outcomes of the events were unknown.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: A medical assistant reported the occurrence of an injection site reaction in a 7 month old male who received Infanrix. The subject's medical history and concurrent conditions were not specified. The vaccinee was taking no concurrent medications. On 11/22/01, the vaccinee received his first injection of Infanrix without adverse event. On 1/22/02, the vaccinee received an injection of Tripedia without adverse event. On 4/17/02, the vaccinee received an injection of Infanrix (547A2). On 4/19/02, he developed an injection site reaction characterized by a large lump (knot) and redness. He was seen by the physician. The reporter stated that these adverse events were probably related to Infanrix administration and were ongoing as of 4/22/02.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: A medical assistant reported the occurrence of an injection site reaction in a 6 month old female who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 12/16/01, the vaccinee received her first injection of Infanrix without adverse event. On 2/16/01, the vaccinee received an injection of Tripedia without adverse event. On 4/18/02, the vaccinee received an injection of Infanrix (547A2). On 4/20/02, she developed an injection site reaction characterized by a large lump (knot) and redness. She was seen by the physician. The reporter stated that these adverse events were probably related to Infanrix administration. The outcomes of the events were unknown as of 4/22/02.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 2 month old male who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 4/24/02, the vaccinee received his first injection of Infanrix. On the same date, he received injections of Comvax, Prevnar, and IPOL. On 4/24/02, at an unspecified time post-immunization, the vaccinee developed an injection site reaction characterized by warmth and flushing. The events resolved on 4/24/02.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Contusion, Injection site erythema, Injection site reaction
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 16 month old male who received Infanrix. The vaccinee had no relevant medical history or concurrent mediations. On 4/22/02, the vaccinee received his fourth injection of Infanrix. On the same date, he received an injection site reaction characterized by redness and bruising. He was treated at the physician's office with Benadryl. As of 4/26/02, the symptoms have resolved.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site mass, Injection site oedema, Injection site reaction
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 4 year old vaccinee of unspecified gender who received Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not specified. On 4/24/02,the vaccinee recieved the fifth injection of Infanrix. On the same date, the vaccinee received injections of IPOL, MMR II, and Varivax. Subsequently, the vaccinee developed an injection site reaction characterized by "unusual" swelling and a hard knot "half-way through arm." As of 4/29/02, the adverse events had resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A physician reported the occurence of an injection site reaction in a 15-month-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided.  The vaccinee had no adverse experiences following receipt of prior immunizations.  On 04/26/2002, the vaccinee received her fourth injection of INfanrix.  On that date, she also received an injection of inactivated poliomyelitis virus vaccine (IPOL).  On 04/27/2002, the vaccinee experienced an injection site reaction at the site of Infranrix administration characterized by swelling, redness and warmth.  The reaction was described as "hive-like" and measuring three inches by two inches.  The vaccinee was seen by the physician.  The injection site reaction resolved on 04/30/2002.  The reporter considered the events to be probably related to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 4-year-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine (Infanrix).  There was no relevant medical history.  The vaccinee had no adverse experiences following receipt of prior immunizations.  On 04/24/2002, the vaccinee received his fifth injection of Infanrix.  On that date, he also received an injection of inactivated poliomyelitis virus vaccine (IPOL).  On 04/25/2002, the vaccinee developed an injection site reaction characterized by swelling, redness and warmth.  The vaccinee was seen by a physician.  The injection site reaction resolved on 04/28/2002.  The reporter considered the event to be probably related to Infanrix administration.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 5-year-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  There was no relevant medical history.  The vaccinee had no adverse experiences following receipt of prior immunizations.  On 05/01/2002, the vaccinee received her fifth injection of Infanrix.  The vaccinee received an application of tuberculin purified protein derivative on the same day.  On 05/02/2002, the vaccinee developed an injection site reaction characterized by redness and swelling.  On 05/04/2002, the vaccinee was seen by the physician, who noted an area of redness and swelling at the injection site measuring five inches in diameter.  The physician suspected that the vaccinee may be allergic to tetanus toxoid and prescribed cetirizine hydrochloride (Zyrtec).  The reaction had improved by 05/06/2002.  The reporter considered the event to be probably related to Infanrix administration.
Age: 0.9
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 9-month-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee had no relevant medical history and received no concurrent medications.  She had experienced no adverse events following previous vaccinations.  On 04/03/2002, the vaccinee received her third injection of Infanrix (Lot DTPA552A2) and her third injection of hepatitis B vaccine recombinant (Engerix-B, lot ENG5209C9).  At an unspecified time post-immunization on 04/03/2002, the vaccinee experienced an injection site reaction characterized by oval, red, hardness with spreading redness at the site of Infanrix administration.  Additionally, the vaccinee experienced an injection site reaction at the Engerix-B injection site also characterized by oval, red, hardness with spreading redness.  The vaccinee was seen by a physician on 04/04/2002.  The physician prescribed paracetamol (Tylenol) and cold compresses.  The reporter stated that the injection site reactions were probably related to vaccine administration.  The injection site reactions resolved on 04/05/2002.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee had no relevant medical history and received no concurrent medications.  On 05/01/2002, the vaccinee received his fourth injection of Infanrix.  On the same date, in the opposite leg, the vaccinee received an injection of 7-valent pneumococcal conjugate vaccine (Prevnar) or varicella virus vaccine (Varivax).  That day, and unspecified time post-immunization, the vaccinee experienced an injection site reaction characterized by a "long, oval shaped, hard, red area toward the groin."  The vaccinee also experienced the "same reaction" in the opposite leg.  The child was seen by the physician on 05/02/2002.  The physician prescribed paracetamol (Tylenol) and cold compresses.  The reporter stated that the injection site reaction was probably related to Infanrix administration.  The injection site reaction resolved on 05/03/2002.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: A physician reported the occurrence of an injection site reaction in a vaccinee of unspecified gender and age who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided.  On an unspecified date in 2002, the vaccinee received an injection of Infanrix.  On the second or third day post-immunization, the vaccinee developed an injection site reaction characterized by a very large, red, inflamed spot on the injection site measuring four inches by three inches.  The injection site reaction resolved after an unspecified period of time.  The vaccinee provider considered the event to be related to Infanrix administration.  Please refer to case number A0375913A from the same source.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Body temperature increased, Otitis media, Screaming, Urticaria
Clinical narrative: This report describes an ear infection in a 2-month-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  This report was received from the vaccinee's mother and has not been verified by a physician or healthcare professional.  The mother also reported some of the events to Wyeth (Reference number, HQ2290213MAY2002.)  The vaccinee's medical history reportedly included reflux treated with ranitidine (Zantac); intolerance to breast milk; and allergies to dairy, rice, peanuts, barley, Baker's yeast, and "possibly" wheat.  It was stated that following the receipt of an injection of hepatitis B vaccine (manufacturer unknown) after birth, patient was "up all night, restless, crying and seemed to be in pain".  On 09/20/1999, the vaccinee received her first injection of Infanrix (lot DTPA909A2).  That same day, she experienced a low-grade fever and crying, both of which resolved.  It was reported that within one week of vaccination, approximately on 09/26/1999, the vaccinee experienced hives, a cold, and an ear infection.  These events resolved by 09/28/1999.  The mother reported that in mid-October 1999, the vaccinee experienced an upper respiratory infection which resolved in late October 1999.  The vaccinee received her second injection of Infanrix (lot DTPA909A2) on 11/05/1999.  According to the mother, on approximately 11/24/1999, the vaccinee became "physically agitated-kicking, thrashing". The mother thought this might be a seizure.  These events resolved after one hour.  Reportedly, the pediatrician considered the events to be "unlikely" related to Infanrix administration.  The mother stated that her daughter seemed to be "chronically ill" for weeks after each vaccination.  As of 05/10/2002, all events had resolved.  At six months of age, the vaccinee received her third injection of Infanrix without adverse event.  The Infanrix injection schedule was delayed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: A physician reported the occurence of an injection site reaction in a 5-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  On 06/05/2002, the subject received his fifth injection of Infanrix (lot DTPA552A2).  He also received injections of inactivated poliomyelitis vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II).  In addition, he received an application of tuberculin purified protein derivative.  On 06/06/2002, one day post-immunization, the subject experienced an injection site reaction characterized by a 7.5 cm by 8cm area of swelling, tenderness, and redness.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: A physician reported the occurrence of a fever in a 5-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were unknown.  The vaccinee had not experienced any adverse events following pervious immunizations.  On 05/07/2002, the vaccinee received his fifth injection of Infanrix (lot DTPA548A2).  On 05/10/2002, he returned to the physician's office with a fever and an injection site reaction characterized by swelling and redness.  The events were treated with paracetamol (Tylenol) and applications of ice.  These events resolved on 05/10/2002.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: A healthcare professional reported the occurence of limb swelling in a five-year-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  The subject had no adverse experiences following receipt of four previous diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed injections.  On an unspecified date, the subject received her fifth injection of Infanrix.  On 05/15/2002, post-immunization, the subject developed limb swelling and was seen by a physician.  The event was reported to have resolved on 05/21/2002 and was considered by the reporter to be related to Infanrix administration.
Age: 1.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in an 18-month-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history and concurrent medications were not specified.  On 05/28/2002, the vaccinee received her fourth injection of Infanrix (lot DTPA542A2; expiration date 09/24/2003).  On the same date, she also received an injection of inactivated poliomyelitis virus vaccine (IPOL) in the opposite arm.  That evening, she began to develop an injection site reaction characterized by redness and swelling that progressively got worse.  The swelling eventually extended to include half her forearm.  the vaccinee was seen by a physician.  The reporter stated that the events were probably related to Infanrix administration.  As of 05/30/2002, the events were unresolved; the limb swelling was "worse".
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: A nurse reported the occurence of injection site soreness in a 34-year-old female who inadvertenly received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were not specified.  On 05/28/2002, the vaccinee inadvertently received a "booster" injection of Infanrix (lot DTPA542A2; expiration date 09/24/2003), rather than tetanus toxoid..Subsequently, she experienced a sore arm.  The outcome of the event was not stated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  There was no relevant medical history.  Concurrent medications were not specified.  On 05/31/2002, the child received an injection of Infanrix; the number of previous injections of Infanrix was not specified.  On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II).  Later that day, the thigh into which Infanrix had been injected swelled to twice the size of his other thigh.  On 06/01/2002, the child was seen in the emergency room.  Initially, a diagnosis of cellulitis was made, but the diagnosis was later changed to injection site reaction.  Treatment included tapering doses of precnisone.  These events resolved on 06/03/2002.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  There was no relevant medical history.  Concurrent conditions were not provided.  On 05/31/2002, the vaccinee received her fifth injection of Infanrix into her left leg.  On that date, she also received injectoins of inactivated poliomyelitis virus vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II) into her right thigh.  On 06/01/2002, the vaccinee developed an injection site reaction at the site of Infanrix administration described as "red, hot, and enlarged," and itching of the "whole anterior left thigh." The vaccinee was seen by a physician and treated with unspecified antibiotics.  The most recent information, received on 09/17/2002, did not report the outcome of these events.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in an 18-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were not provided.  On 06/03/2002, the vaccinee received an injection of Infanrix.  The number of previous injections of Infanrix was not reported.  Sometime after the injection, he developed an injection site reaction characterized by redness, heat, hardness, and a "softball size" area of swelling.  The injection site reaction presisted as of 06/06/2002.  The reporter considered these events to be probably related to Infanrix administration.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in an 18-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were not specified.  On 05/28/2002, the vaccinee received his fourth injection of Infanrix (lot DTPA542A2; expiration date 09/24/2003).  On the same date, he also received an injection of inactivated poliomyelitis virus vaccine (IPOL) into the opposite arm.  That evening, he began to develop an injection site reaction characterized by redness and local swelling that progressively got worse.  The swelling extended to include half of his forearm.  The vaccinee was seen by a physician.  The reporter stated that the events were probably related to Infanrix administration.  As of 05/30/2002, the events were "worse".
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of a injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were not specified.  On 05/28/2002, the vaccinee received her fifth injection of Infanrix (lot DTPA542A2; expiration date 09/24/2003).  On the same date, she also received an injection of inactivated poliomyelitis virus vaccine (IPOL) into the opposite arm.  That evening, she began to develop an injection site reaction characterized by redness and swelling that progressively got worse.  The swelling extended to involve her entire arm.  The vaccinee was seen by a physician.  The reporter stated that the events were probably related to Infanrix administration.  As of 05/30/2002, the events were "worse".
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Rash erythematous
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15-month-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  The subject received his first injection of Infanrix on 04/18/2001 without adverse event.  He received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Tripedia) on 06/18/2001 without adverse event.  He received an injection of Infarix on 09/21/2001 without adverse event.  On 06/05/2002, the subject received another injection of Infanrix.  Two days later, on 06/07/2002, the subject developed an injection site reaction characterized by a "hard knot" and redness.  The caregiver was instructed to apply ice to area and to apply hydrocortisone cream if itching developed.  The injection site reaction was resolving as of 06/11/2002.  Comments:  The reporter stated that approximately six or more patients had experienced the same type of reactions with this particular lot of Infanrix; however, they are not presently identifiable.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: Report A0371755A describes an injection site reaction in a 4-year-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  This report was received from a manufacturer (HQ475104FEB2001).  Medical history, concurrent conditions, and concurrent mediations were not specified.  On 12/17/2002, the vaccinee received an injection of Infanrix.  On 12/18/2002, the vaccinee developed an injection site reaction.  Treatment and outcome were not specified.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The medical history, concurrent conditions and concurrent medications were not provided. On 06/04/2002 the child received an injection of Infanrix. The number of previous injections of Infanrix was not reported. Sometime after the injection, he developed an injection site reaction characterized by a 4-inch area of redness that was hot and hard. The outcomes of these events were not reported. The reporter considered these events to be related to Infanrix administration.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Pain
Clinical narrative: A nurse reported the occurrence of an injection site reaction in an 18-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). There was no relevant medical history. On 05/19/2002 the vaccinee received his 4th injection of Infanrix into his right leg. On that date he also received an injection of measles, mumps and rubella virus vaccine (M-M-R II, Merck) into his left leg. Post-immunization, the vaccinee developed an injection site reaction at the site of Infanrix administration characterized by pain, swelling, redness and a large "knot" measuring 3" by 4". On 06/20/2002 the vaccinee was seen by a physician, who prescribed cold compresses and paracetamol (Tylenol). The reporter considered the injection site reaction to be probably related to Infanrix administration.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 12-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). There was no relevant medical history, concurrent conditions or concurrent medications. The pt had no adverse experiences following receipt of prior immunizations. On 06/18/2002, the pt received his third injection of Infanrix (lot DTPA552A2). On that date, he also received injections of measles, mumps and rubella virus vaccine (MMR II, Merck); inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur); combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax, Merck); and varicella virus vaccine (Varivax, Merck). On 06/20/2002 the pt was seen by the physician and he was observed to have developed an injection site reaction characterized by swelling, redness, and warmth at the site of Infanrix administration. The physician prescribed diphenhydramine and the injection site reaction improved. The reporter considered the injection site reaction to be possibly related to Infanrix administration. Comments: The reporter indicated that this was a second subject experienced an unspecified adverse experience following receipt of Infanrix lot DTPA552A2. However, the subject is not presently identifiable.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability
Clinical narrative: A nurse reported the occurrence of fussiness in a 2-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were not provided. On 04/23/2002 the pt received his first injection of Infanrix into the left leg. On that date, he also received injections of Haemophilus influenzae type b conjugate vaccine (manufacturer unknown), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). Later that evening, the pt was fussy for over 3 hours. The fussiness resolved the next morning.
Sex: U
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Report A0372678A describes "seizure-like symptoms" in a vaccinee of unspecified age and gender who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Medical history, concurrent conditions and concurrent medications were not provided. During the week of 06/10/2002 the week of 06/10/2002, the pt received an injection of Infanrix; the number of previous injections of Infanrix was not reported. An unspecified time post-immunization, the pt experienced "seizure-like symptoms". Treatment and outcome were not known. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site oedema, Rash
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The vaccine provider submitted this report directly to VAERS. There was no relevant medical history, concurrent conditions or concomitant medications. On 06/20/2002 the vaccinee received his 5th injection of Infanrix. On that date he also received an injection of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). At an unspecified time of the day of immunization, he developed an injection site reaction characterized by a 12.5cm by 20cm area of rash with an edematous area inside the rash area. The injection site reaction resolved 4 days later. The reporter stated that the injection site reaction was related to Infanrix administration.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site infection, Injection site oedema, Injection site warmth
Clinical narrative: A physician reported the occurrence of an injection site infection in a subject of unspecified age and gender 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 unknown. On 06/03/2002 the pt received the 5th injection of Infanrix (lot DTPA552A2). Post-immunization on 06/03/2002 the pt developed "severe" swelling and red streaking in the arm. The area was hot to the touch. The pt was seen by a physician, who noted that a needle smaller than 5/8 inch was used to administer the vaccine. The physician made a diagnosis of injection site infection and prescribed amoxicillin clavulanate (Augmentin). As of 06/26/2002, the outcome of the event was unknown.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: A physician reported the occurrence of fever in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The medical history, concurrent conditions and concurrent medications were unknown. The pt had not experienced any adverse events following previous immunizations. On 05/20/2002 the pt received her 5th injection of Infanrix (lot DTPA524A2). On 05/23/2002 she returned to the physician's office with a fever and an injection site reaction characterized by swelling and redness. The physician prescribed paracetamol (Tylenol) and applications of ice. These events resolved on 05/23/2002.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. The pt had no relevant medical history, concurrent conditions or concurrent medications. On 04/29/2002 the pt received his 5th injection of Infanrix (lot DTPA 546A2). On 05/01/2002, he developed an injection site reaction characterized by redness, swelling, warmth and welts "the size of golf balls". The pt was seen by a physician. The reporter stated that the injection site reaction was related to Infanrix administration. As of 10/08/2002 the injection site reaction had resolved.
Age: 1.3
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Irritability, Pruritus, Rash
Clinical narrative: A physician reported the occurrence of an itchy rash in a 16-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. On 07/11/2002 the pt received his 4th injection of Infanrix. On the same date he received an injection of varicella virus vaccine (Varivax, Merck). On 07/12/2002 the pt was very cranky when going to bed. On 07/13/2003 the pt awoke with a very itchy rash on his face, inner thighs and trunk. The pt was seen by the physician on 07/16/2002; the rash persisted at that time. The physician prescribed diphenhydramine hydrochloride (Benadryl). An in-depth discussion of environmental factors to cause the rash "did not reveal anything substantial". As of 07/17/2002, the events were ongoing.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 16-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. On 07/18/2002 the pt received his 4th injection of Infanrix (lot DTPA536A9). Post-immunization, on 07/18/2002 the pt developed an injection site reaction characterized by "swelling as big as a grapefruit" and a "knot". The reporter stated that the injection site reaction was possibly related to Infanrix administration. As of 07/22/2002 the injection site reaction persisted. The reporter indicated that 4 other subjects developed a knot at the injection site following receipt of Infanrix lot DTPA536A9. However, they were not identifiable.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 4-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history included possible "mild" nasal allergies and "moderate" nasal congestion. The pt had no adverse experiences following receipt of prior immunizations. There were no concurrent medications. On 07/22/2002 the pt received his 5th injection of Infanrix into his left leg. On the same date, post-immunization, the pt developed an injection site reaction characterized by swelling, redness, tenderness and warmth. The pt was seen by a physician, who noted the swelling and redness measuring 4" in diameter. By 07/25/2002 the injection site swelling was slowly decreasing, injection site redness was increasing, and injection site tenderness persisted. Outcome of the injection site warmth was not reported.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were unknown. On 07/19/2002 the pt received her 5th injection of Infanrix into the righth thigh (lot DTPA566A2; expiry, 02/11/2004). On the same date, she received an injection of inactivated poliomyelitis virus vaccine (IPOL; Aventis Pasteur) into the left thigh. On 07/20/2002 she developed limb swelling and redness at the site of Infanrix administration. She was seen by the physician, who made a diagnosis of injection site cellulitis and prescribed unspecified antibiotics. The injection site cellulitis resolved four to five days after immunization. The reporter stated that the injection site cellulitis was probably related to Infanrix administration.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 2-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt had no known allergies or other medical history, concurrent medical conditions, or concurrent medications. The pt experienced no adverse events following previous immunizations. On 07/31/2002, the pt received her 4th injection of Infanrix (lot DTPA526A9) into the right leg. On the same day, she also received injections of hepatitis B vaccine (manufacturer unknown) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). One day later, on 08/01/2002 the pt developed an injection site reaction characterized by redness measuring 1.5" by 2.5", warmth and hardness at the site of Infanrix administration. The pt was treated with diphenhydramine (Benadryl). The reporter considered the injection site reaction to be probably related to Infanrix administration. Comment: This report has been linked to reports A0376898A and A0376899A due to same reporter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site warmth, Rash
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt had no known allergies or other medical history or concurrent medications. The pt experienced no adverse events following previous immunizations. On 07/31/2002 the pt received her 5th injectino of Infanrix (lot DTPA548A2) into the right leg. On the same day the pt received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles, mumps and rubella virus vaccine (MMR II, Merck). One day later the pt developed an injection site reaction characterized by a 4-inch by 4-inch area of red rash, warmth and hardness at the Infanrix injection site. The pt was treated with diphenhydramine (Benadryl). The reporter considered the injection site reaction to be probably related to Infanrix administration. Comment: This report has been linked to reports A0376897A and A0376898A due to same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: This report describes injection site swelling in a subject of unspecified age and gender who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date, the pt received an injection of Infanrix; it was not known if the pt had received previous injections of Infanrix. Subsequently, the pt experienced injection site swelling. As of 08/07/2002, the outcome of the event was unknown.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 6-month make who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt's brother had a "similar" reaction to Infanrix when he was 6 months old and was seen in the ER. On 08/05/2002 the pt received his 3rd injection of Infanrix. 24 hours later, he experienced an injection site reaction characterized by induration, erythema and swelling. He was seen by the physician. As of 08/08/2002, the injection site reaction persisted.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 6-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, the pt received an injection of Infanrix; it was not known if he had received previous doses of Infanrix. In August 2001 he experienced an injection site reaction characterized by induration, erythema and swelling. He was seen in the ER. As of 08/07/2002 the outcomes of the injection site reaction was unknown.
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: A physician reported the occurrence of injection site erythema in a male child of unspecified age who received Infanrix. The vaccine provider submitted this report directly to the Centers for Disease Control and Prevention. The subject's medical history was unknown. He received no concurrent medications or vaccines. On 8/16/02, he received his fourth injection of Infanrix (567A2). Post-immunization, on 8/16/02, he experienced injection site erythema that was "6 by 6cm up to 10 by 12cm in the lateral thigh." The subject was seen by the physician. The physician stated that the injection site erythema was probably related to Infanrix administration.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: A nurse reported the occurrence of limb swelling in a 5 year old male who received Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not specified. The subject had no adverse experiences following previous immunizations. On an unspecified date, the vaccinee received his fifth injection of Infanrix. Subsequently, on 5/4/02, he experienced "abnormal swelling of the arm." This event resolved on an unspecified date. The reporter stated that the limb swelling was related to
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: 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 female who received Infanrix for prophylaxis. The vaccine provider submitted this report directly to VAERS. The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided. On 7/31/02, the vaccinee received her fourth injection of Infanrix (566B2) into her right leg. At an unspecified time post-immunization, she developed an injection site reaction characterized by large areas of erythema and an area of warmth and swelling measuring two inches by three inches. Two days later, the injection site reaction resolved. The reporter considered the injection site reaction to be probably related to Infanrix administration.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: A nurse reported the occurrence of injection site redness in a 6 year old male who was vaccinated with Infanrix for prophylaxis. The vacicnee's medical history included unspecified allergies. The vaccinee had no adverse experiences following receipt of prior immunizations. There were no concurrent medications. On 8/14/02, the vaccinee received on injection of Infanrix (526E9); the number of previous injections of Infanrix was not reported. One day post-immunization, on 8/15/02, the vaccinee developed an area of redness at the injection site measuring 10cm by 5cm. He was seen by the physician, who prescribed Zyrtec. As of 8/16/02, the outcome of this event was unknown. The reporting nurse indicated that an additional vaccinee experienced this event; however, that subject is currently not identifiable.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: A nurse reported the occurrence of limb swelling in a 3 year old male who was vaccinated with Infanrix for prophylaxis. There was no relevant medical history, concurrent conditions, or concurrent medication. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the vaccinee received an injection of Infanrix (528E9); the number of previous injections of Infanrix was not reported. One day post-immunization, the subject's mother telephoned the vaccine provider and reported that the thigh into which Infanrix had been injected had swelled to twice the size of his other thigh. The physician prescribed Zyrtec. The event resolved after "several days."
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: A nurse reported the occurrence of injection site redness in a 16 month old male who was vaccinated with Infanrix for prophylaxis. There was no relevant medical history, concurrent conditions, or concurrent medication. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the vaccinee received an injection of Infanrix (528E9); the number of previous injections of Infanrix was not reported. One day post-immunization, the vaccinee developed an area of redness at the injection site measuring 10cm by 7cm. The vaccinee was seen by the physician, who prescribed Zyrtec. This event resolved after "several days."