chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Heart rate increased
Clinical narrative: He is a school employee receiving the Hepatitis B serie. Dose #1 was given on 3/26/04 then second dose was given on 4/30/04. Around 9:30 am on 4/30/04 before administering the second dose I had asked him if he had any reaction to first dose. He said he had no problems. So then the second dose was administered. Then on 5/3/04 around 9:00 am Monday morning school nurse called to visit with me about him. He was complaining of fast heart beat a day after having the injection. I advised nurse to tell him to see Primary Physician for check up. On 5/23/04 I had a follow-up visit with him. He stated having a wellness check 2 weeks and an EKG was done and showed normal. Heart palpitations was discussed at that time. Physician stated heart palpitations was related to high caffeine intake- Instructed patient that dose #3 would not be given unless I had written permission from Primary Physician pt has no histroy of heart problems or blood pressure problems. Pt also states that since changes in diet he has not had any more problems.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Oedema
Clinical narrative: Redness, swelling right lower part of thigh.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Feeling cold, Myalgia, Urticaria
Clinical narrative: Pt. received Pneumovax vaccine in left arm at 13:00 on 05/18/04. He complained his arm got sore shortly after. By evening he got chilled & put heat on the area. Later broke out in hives went to hospital where they gave him a shot and some pills to take. Don't know what they were.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Complains of rash for 2 days- diagnosis of Varicella.
Age: 4.0
Sex: M
Vaccine: HEP, HIBV, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Complains of rash for 2 days- diagnosis of Varicella.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema, Tenderness
Clinical narrative: Swelling, redness, tenderness 4 cm x 10 cm. Inferior to injection site. Afebrile. Treatment Benadryl & Augmentin Sorgupizion for cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Left arm red from elbow to shoulder warm to touch. Mom applied ice gave Benadryl- Seen in ER- continue with Benadryl.
Age: 44.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Left arm swollen from elbow to shoulder, warm to touch, red, itches. Seen by MD; steroids given and ice applied.
Age: 1.3
Sex: M
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Child with 6"x8" induration left deltoid area. Area red, swollen and painful; hot to touch. No cold pack used or Tylenol given to child by parents.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Pyrexia, Swelling
Clinical narrative: Mom states patient had immunization yesterday and his arm is very swollen and hot. States child has a slight fever.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Photosensitivity reaction
Clinical narrative: This report describes the occurrence of photosensitivity in a 6 month old infant who  was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. This report was received from the subject's parent and has not been verified by a physician or health care professional. The subject's medical history and concurrent medical conditions were not specified. Concurrent medications included Ranitidine (Zantac, GSK). The subject received the injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed on 16MAY2002 and 22JULY2002. On that date, the subject also received an injection of combination
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Pyrexia
Clinical narrative: A physician reported that his 2 year old son developed fever after vaccination 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. On 21MAR2003, approximately 24 hours post-immunization, the subject developed a fever of approximately 103 degrees Fahrenheit. At an unspecified time post -immunization, the subject developed an injection site reaction characterized by induration and erythema. The subject was treated with unspecified antipyretics. As of 25MAR2003, the events persisted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
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 adsorbed for prophylaxis. The vaccine provider submitted this report directly to VAERS.  The subject had no known allergies, adverse experiences following receipt of previous immunizations, concurrent conditions, or concurrent medications. The subject received his fifth injection of Infanrix on 31Mar2003 into his right arm. He also received injections of inactivated poliomyelitis virus vaccine and measles, mumps and rubella virus vaccine into his left arm. On 01APR2003, the subject presented to the local emergency room with redness and swelling of his entire right arm. The emergency room physician made a diagnosis of cellulitis and prescribed an unspecified antibiotic. On 02APRIL2003, the subject was seen by the vaccine provider, who thought the events represented "just a local reaction to the vaccine." The vaccine provider discontinued antibiotic therapy. The events resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
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 adsorbed for prophylaxis. The subject had no known allergies and no adverse experiences following receipt of previous immunizations. Other medical history included epistaxis (03FEB2003). Concurrent conditions were not reported. There were no concurrent medications. the subject received his fifth injection of Infanrix on 01APR2003 into his left arm, a one inch needle with proper technique was used for the injection. He also received injections of inactivated poliomyelitis virus vaccine and measles, mumps and rubella virus vaccine in a separate limp. On 03APR2003, the subject presented to the vaccine provider with an injection site reaction characterized by swelling, itching and redness involving the upper left arm. The subject had full range of motion. The vaccine provider made a diagnosis of DTaP reaction and prescribed cool compresses, ibuprofen,  and diphenhydramine. The outcome of the events was unknown as of 20MAY2003.
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: A nurse reported the occurrence of injection site swelling in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. The subject experienced no adverse events following previous immunizations. In approximately March 2003, the subject received his fourth injection of Infanrix. Within 48 hours post-immunization, he developed swelling of the upper thigh into which the vaccine had been administered. The swelling resolved after an unspecified period of time.
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: A nurse reported the occurrence of injection site swelling in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. The subject experienced no adverse events following previous immunizations. In approximately March 2003, the subject received his fourth injection of Infanrix. Within 48 hours post immunization , he developed swelling of the upper thigh into which the vaccine had been administered. The swelling resolved after an unspecified period of time.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: A nurse reported the occurrence of injection site swelling in an approximately 2 year 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 unknown. The subject experienced no adverse events following previous immunizations. In approximately March 2003, the subject received his fourth injection of Infanrix. Within 48 hours post immunization , he developed swelling of the upper thigh into which the vaccine had been administered. The swelling resolved after an unspecified period of time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported the occurrence of an allergic reaction in a 4 year old male who was vaccinated with diphtheria and tetanus toxoids and acelluar pertussis vaccine adsorbed for prophylaxis. The subject had no known drug allergies. Other medical history, concurrent condition, and concurrent medications were not reported. On 02APR2003, the subject received his fourth injection of Infanrix injected into the right buttock, which is not recommended as a site for Infanrix administration. On the same date, he received a tuberculin skin test , his second injection of measles, mumps, and rubella virus vaccine, and his fourth injection of inactivated poliomyelitis virus vaccine. On 02APR2003, post immunization, the subject developed swelling and redness at the site of Infanrix administration. On 04APR2003, the child was seen by the physician to read the tuberculin test. At that time, the physician observed that the redness and swelling "went a little ways down the leg " of the subject. The physician made a diagnosis of "likely allergic reaction to pertussis" and prescribed prednisolone and amoxicillin clavulanate. The allergic reactions resolved on 05APR2003. The reporting nurse stated that the Infanrix immunization series had been discontinued; immunization "will likely proceed "with just DT (pediatric diphtheria and tetanus toxoids)"
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: A nurse reported the occurrence of vomiting in a 4 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The vaccine provider submitted this report directly to the local public health department. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 4/23/03, the subject received her second injection of Infanrix (lot DTPA592A9). During the evening of 4/23/03, the subject developed chills, fever, and vomiting. Comment: The reporter indicated that two additional subject experienced these events after receiving Infanrix lot DTPA592A9. However, these subjects are not presently identifiable.
Sex: M
Vaccine: DTAP
Symptoms: Aggression, Cough, Depression, Fatigue, Injection site erythema
Clinical narrative: This report described the occurrence of an injection site reaction in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed 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, concurrent conditions, and concurrent medications were not reported. On 4/22/03, the subject reportedly received his fifth injection of Infanrix. The mother stated that her son developed an injection site reaction characterized by redness and swelling within 24 hours of immunization. He also developed fever. Reportedly the physician suggested that the mother apply cold packs to the injection site and give her son ibuprofen. As of 4/25/03, the events reportedly persisted. On 7/15/03, the mother reported, Our pediatrician saw [the subject] for his local reaction (redness, swelling from elbow to shoulder). She did not evaluate him for his systemic reaction - low grade fever, and behavioral issues - irritability, aggressiveness, short term memory problems, alternating periods of hyperactivity versus extreme tiredness and depression (two days), cold and cough, spaciness (staring), feeling of bowel movement need when urinating, several urinary accidents, etc. The mother did not report the outcomes of these events, except that the depression resolved after two days. She declined to grant authorization to contact the pediatrician.
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling, Irritability, Memory impairment, Psychomotor hyperactivity
Clinical narrative: This report described the occurrence of an injection site reaction in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed 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, concurrent conditions, and concurrent medications were not reported. On 4/22/03, the subject reportedly received his fifth injection of Infanrix. The mother stated that her son developed an injection site reaction characterized by redness and swelling within 24 hours of immunization. He also developed fever. Reportedly the physician suggested that the mother apply cold packs to the injection site and give her son ibuprofen. As of 4/25/03, the events reportedly persisted. On 7/15/03, the mother reported, Our pediatrician saw [the subject] for his local reaction (redness, swelling from elbow to shoulder). She did not evaluate him for his systemic reaction - low grade fever, and behavioral issues - irritability, aggressiveness, short term memory problems, alternating periods of hyperactivity versus extreme tiredness and depression (two days), cold and cough, spaciness (staring), feeling of bowel movement need when urinating, several urinary accidents, etc. The mother did not report the outcomes of these events, except that the depression resolved after two days. She declined to grant authorization to contact the pediatrician.
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Staring, Urinary incontinence
Clinical narrative: This report described the occurrence of an injection site reaction in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed 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, concurrent conditions, and concurrent medications were not reported. On 4/22/03, the subject reportedly received his fifth injection of Infanrix. The mother stated that her son developed an injection site reaction characterized by redness and swelling within 24 hours of immunization. He also developed fever. Reportedly the physician suggested that the mother apply cold packs to the injection site and give her son ibuprofen. As of 4/25/03, the events reportedly persisted. On 7/15/03, the mother reported, Our pediatrician saw [the subject] for his local reaction (redness, swelling from elbow to shoulder). She did not evaluate him for his systemic reaction - low grade fever, and behavioral issues - irritability, aggressiveness, short term memory problems, alternating periods of hyperactivity versus extreme tiredness and depression (two days), cold and cough, spaciness (staring), feeling of bowel movement need when urinating, several urinary accidents, etc. The mother did not report the outcomes of these events, except that the depression resolved after two days. She declined to grant authorization to contact the pediatrician.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: A physician reported the occurrence of an injection site reaction in a female child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 4/24/03, the subject received her fourth injection of infanrix (lot DTPA572A). On an unspecified date post-immunization, the subject developed an injection site reaction characterized by redness and warmth. As of 4/28/03, the outcome of the injection site reaction was unknown. The reporter considered the injection site reaction to be probably related to Infanrix administration.
Sex: M
Vaccine: DTAP
Symptoms: Coma, Staring
Clinical narrative: This report describes the occurrence of staring in an approximately 2- to 3- year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the subject's father and has not been verified by a physician or other healthcare professional. There was no reported medical history, concurrent conditions, or concurrent medications. Reportedly, one to two years ago, the subject received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The father reported that the subject was zombie-like on the same day he received the injection. Reportedly, the subject just stared for the first 18 hours. The father stated that after the 18 hour, his son started to return to normal. Reportedly, the following day, complete resolution occurred.
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a female child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in March 2003, the subject received her fourth injection of Infanrix (lot DTPA572A). On an unspecified date post-immunization, the subject developed injection site cellulitis characterized by redness, swelling, and warmth involving the subject's upper arm. As of 4/28/03, the outcome of the injection site cellulitis was unknown. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A physician reported the occurrence of an injection site reaction in a female child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 4/22/03, the subject received her fourth injection of Infanrix (lot DTPA572A). On an unspecified date post-immunization, the subject developed an injection site reaction characterized by redness, warmth, and swelling larger than a 50-cent piece. The injection site reaction resolved after an unspecified period of time. The reporter considered the injection site reaction to be probably related to Infanrix administration.
Age: 1.4
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a 17 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject was described as a well child. The subject had no adverse experiences following previous immunizations. On an unspecified date, the subject received an injection of Infanrix (lot DTPA382B2). Subsequently, on 2/13/03, the subject developed a severe local reaction characterized by swelling, redness, and pain. The physician made a diagnosis of injection site cellulitis. The injection site cellulitis resolved after an unspecified period of time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Irritability
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The vaccine provider submitted this report directly to the local health department. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 5/17/03, the subject received his fifth injection of Infanrix (lot DTPA586A9) in the left arm. On the same date, he received an injection of inactivated poliomyelitis virus vaccine in the left arm and an injection of MMR in the right arm. On 3/18/03, 24-hours post immunization, the subject developed an injection site reaction characterized by pain, swelling, and inflammation. The subject's left arm was stiff. The subject also experienced irritability and a low grade fever. The events resolved on 3/20/03. The reporting nurse considered the events to be related to Infanrix administration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The vaccine provider submitted this report directly to the local health department. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 5/17/03, the subject received his fifth injection of Infanrix (lot DTPA586A9) in the left arm. On the same date, he received an injection of inactivated poliomyelitis virus vaccine in the left arm and an injection of MMR in the right arm. On 3/18/03, 24-hours post immunization, the subject developed an injection site reaction characterized by pain, swelling, and inflammation. The subject's left arm was stiff. The subject also experienced irritability and a low grade fever. The events resolved on 3/20/03. The reporting nurse considered the events to be related to Infanrix administration.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Acne, Rash erythematous, Urticaria
Clinical narrative: This report describes the occurrence of a raised rash in a 19 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional. The subject was reportedly allergic to ibuprofen. The mother stated that at the age of 10 months, the subject received ibuprofen and subsequently turned blue and was swollen and was taken to the hospital. No other medical history or concurrent conditions were reported. The subject reportedly received no concurrent medications or vaccines. On an unspecified date, the subject received her first injection of Infanrix. Reportedly, the subject subsequently developed a rash which went away before seven days. In April 2003, the subject reportedly received her second injection of Infanrix. The mother stated that on 4/25/03, the subject developed two tiny pimples on nose which became worse. Reportedly, after 4/25/03, the subject developed hives everywhere except scalp. The mother stated that, additionally, the subject developed a raised rash that looked like strep rash which was more prominent on the right leg. The mother reportedly called the physician. The mother reported that she administered diphenhydramine hydrochloride to the subject. As of 5/2/03, the raised rash and hives reportedly persisted.
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 diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received the fifth injection of Infanrix (lot DTPA541E9). Subsequently, the subject developed significant limb swelling. As of 4/29/03, the outcome of the limb swelling was unknown. Comment: The reporter indicated that eight subjects experienced significant limb swelling after receiving Infanrix lot DTPA54E9. However, these subjects are not presently identifiable.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported the occurrence of a possible allergic reaction in a 5 year old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received the fifth injection of Infanrix (lot DTPA586B9). Subsequently, on 4/9/03, the subject developed injection site swelling measuring greater than 4cm and injection site redness. The subject was seen by the physician, who almost admitted the subject to the hospital, because he thought that the subject may have been experiencing an allergic reaction to Infanrix. The possible allergic reaction resolved on 4/17/03. The reporting nurse considered the possible allergic reaction to be related to Infanrix administration.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: A nurse reported the occurrence of limb swelling in a child of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. In April 2003 or May 2003, the subject received the fifth injection of Infanrix (lot DTPA592A9). At an unspecified time post-immunization, the subject developed limb swelling and an injection site reaction characterized by redness and pain. The reporting nurse thought this vaccine may not have been stored properly prior to delivery to her. As of 5/5/03, the events persisted. Comment: The reporting nurse indicated that 36 children experienced these same events following receipt of Infanrix lot DTPA592A9. The subject's received the third, fourth, or fifth injection in the immunization series. However, they are not presently identifiable.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: A physician reported the occurrence of uncontrollable crying in a 4 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history included eczema. Concurrent conditions were not reported. The subject received no concurrent medications. The subject had no adverse experiences following previous immunizations. On 5/5/03, the subject received her second injection of Infanrix (lot DTPA583A2). On 5/7/03, 56 hours post immunization, the subject cried uncontrollably for 5.5 hours. On 5/8/03, the subject was seen by the physician. At that time, the crying had resolved and the subject seemed fine.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A physician reported the occurrence of an injection site reaction in a child of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in May 2003, the subject received the fifth injection of Infanrix (lot DTPA572A2). Within one week post-immunization, the subject developed an injection site reaction characterized by swelling and redness. The reporter considered the injection site reaction to be probably related to Infanrix administration. As of 5/15/03, the outcome of the injection site reaction was unknown.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Pyrexia
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 absorbed for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 2/25/03, the subject received his fifth injection of Infanrix (lot DTPA567A2). On the same date, he also received injections of inactivated poliomyelitis virus vaccine and MMR vaccine. Later that day, he developed an injection site reaction at the site of Infanrix administration. On 2/26/03, the subject presented to the physician, who observed a 10cm by 11cm area of redness, mild tenderness, and warmth. In addition, he had a fever. The physician prescribed an unspecified antibiotic. The reporting nurse considered the events to be related to Infanrix administration. The events resolved on 3/5/03.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 2/26/03, the subject received his fifth injection of Infanrix (lot DTPA567A2). On that date, he also received injections of inactivated poliomyelitis virus vaccine and MMR vaccine. Later that day, he developed an injection site reaction at the site of Infanrix administration. On 2/27/03, the subject presented to the physician, who observed an 11cm by 14cm area of redness and warmth. On 2/28 03, the affected area measured 20cm by 16cm. The reporting nurse considered the injection site reaction to be related to Infanrix administration. The injection site reaction resolved after an unspecified period of time.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: A health professional reported the occurrence of limb swelling in a 4 year old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in May 2003, the subject received the fifth injection of Infanrix (lot DTPA586A9). Subsequently, the subject developed hugely abnormal limb swelling. The subject was seen by the physician. The reporter considered the limb swelling to be possibly related to Infanrix administration. As of 5/15/03, the event persisted. Comment: The reporter indicated that three 4 year old children developed limb swelling following receipt of Infanrix lot DTPA586A9. However, they are not presently identifiable.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A healthcare professional reported the occurrence of injection site cellulitis in a 4 year old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 5/12/03, the subject received her fifth injection of Infanrix (lot DTPA594A2). On the same date, she received injections of inactivated poliomyelitis and MMR. The subject developed early cellulitis at the site of Infanrix administration, within 24 to 48 hours post immunization, and was seen by the physician. Unspecified antibiotics and diphenhydramine hydrochloride were prescribed. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: A healthcare professional reported the occurrence of hives in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 5/15/03, the subject received his fifth injection of Infanrix (lot DTPA594A2). On the same date, he received injections of inactivated poliomyelitis virus vaccine, and MMR. On 5/15/03, one to two hours post immunization, the subject developed hives on the ears and face. The parents telephoned the physician and were instructed to administer diphenhydramine hydrochloride and to keep the area cool. The reporter considered the hives to be probably related to Infanrix administration.
Sex: U
Vaccine: DTAP
Symptoms: Crying, Injection site erythema, Vomiting
Clinical narrative: A nurse reported the occurrence of vomiting in an infant of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. In May 2003, the subject received an injection of Infanrix (lot DTPA586B9). In May 2003, at an unspecified time post immunization, the subject developed vomiting, cried excessively, and developed redness at the injection site. The infant was seen by a physician. The reporter considered the vomiting, injection site redness and excessive crying to be possibly related to Infanrix administration. As of 5/15/03, the events persisted. Comment: The reporter indicated that ten unidentified infants experienced these events following receipt of Infanrix lot DTPA586B9. However, these infants are not presently identifiable.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 19 month old male who was vaccinated with DTAP (Infanrix) for prophylaxis. The pt had no relevant medical history, concurrent conditions or concurrent medications. This pt had no adverse experiences following previous immunizations. On 05/12/03, the pt received the fourth injection of Infanrix (Lot # DTPA589A2). On the same date, he also received an injection of IPV.  On 05/14/03, two days post-immunization, the pt developed an injection site reaction characterized by redness and swelling at the site of Infanrix administration.  The pt was seen by the physician. The injection site reaction resolved on 05/19/03.  The reporting physician considered the injection site reaction to be related to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A medical assistant reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with DTAP (Infanrix) for prophylaxis.  The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 05/14/03, the subject received his fifth injection of Infanrix (Lot # DTPA596A2).  On 05/16/03, two days post-immunization, he developed an injection site reaction characterized by swelling and redness. The subject was seen by the physician, who prescribed Benadryl. The injection site reaction resolved on 05/18/03.  The reporter considered the injection site reaction to be unrelated to Infanrix administration.
Sex: U
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 child of unspecified age and gender who was vaccinated with DTAP (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. In April 2003, the subject received the fifth injection of Infanrix. "Within hours" post-immunization, the subject developed an injection site reaction characterized by redness, swelling and induration. The injection site reaction "was still present almost four weeks after administration".
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A medical assistant reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with DTAP (Infanrix) for prophylaxis.  The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 05/15/03, the subject received his fifth injection of IPV. On 05/16/03 one day post-immunization, the subject developed an injection site reaction characterized by swelling and redness. The subject was seen by the physician, who prescribed Benadryl. The injection site reaction resolved on 05/18/03.  The reporter considered the injection site reaction to be unrelated to Infanrix.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash in an 8 week old pt who received DTAP (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the pt received Infanrix. At an unknown time post-immunization, the pt experienced a "big" rash on a leg, "severe" lethargy and a fever of 101 to 102 degrees Fahrenheit. The pt was seen by the physician on 05/23/03. The physician prescribed cold compress, paracetamol and applications of ice. The outcomes of the events were unknown. The reporting physician considered the events were probably related to vaccination with Infanrix Lot # DTPA574A2.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a 4 year old female pt who had received Infanrix injection for prophylaxis.  The pt had no known drug allergies. On 05/21/03 the pt received the 5th dose of Infanrix in the left leg. On the same date, she received an injection of MMRII in the left leg. On 05/22/03, one day post-immunization, the pt experienced an injection site reaction characterized by swelling, itching, warmth, redness and soreness. The affected area was "baseball size". The subject was seen by the physician; no medical treatment was provided. The events were worse on 05/23/03.  The reporting physician considered the events were probably related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Erythema, Feeling hot, Injection site mass, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a 4 year old female pt who had received Infanrix injection for prophylaxis.  The pt had no known drug allergies. On 05/21/03 the pt received the 5th dose of Infanrix in the left leg. On the same date, she received an injection of MMRII in the left leg. On 05/22/03, one day post-immunization, the pt experienced an injection site reaction characterized by swelling, itching, warmth, redness and soreness. The affected area was "baseball size". The subject was seen by the physician; no medical treatment was provided. The events were worse on 05/23/03.  The reporting physician considered the events were probably related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Myalgia, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a 4 year old female pt who had received Infanrix injection for prophylaxis.  The pt had no known drug allergies. On 05/21/03 the pt received the 5th dose of Infanrix in the left leg. On the same date, she received an injection of MMRII in the left leg. On 05/22/03, one day post-immunization, the pt experienced an injection site reaction characterized by swelling, itching, warmth, redness and soreness. The affected area was "baseball size". The subject was seen by the physician; no medical treatment was provided. The events were worse on 05/23/03.  The reporting physician considered the events were probably related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: This case was reported by a nurse and described the occurrence of limb swelling in a 5 year old male who received DTAP (Infanrix) for prophylaxis. On 07/09/03 the pt received the fifth dose of Infanrix. Within 24 hours post-immunization on 07/10/03, the pt experienced a "more than usual reaction" characterized by a "large amount" of swelling extending from shoulder to elbow, redness, and warmth. The pt was seen by the physician. The events resolved after an unspecified period of time. The nurse considered the events to be possibly related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Aggression, Injection site oedema, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of behavioral changes in a 5 year old male pt who received DTAP (Infanrix) for prophylaxis. A physician or other health care professional has not verified this report. In April 2003 the pt received the 5th dose of Infanrix. At an unknown time post-immunization, the pt experienced behavioral changes, aggression, low-grade fever and "severe" upper arm swelling. The outcome of the events is unknown. The reporter declined to provide additional information and declined to grant authorization to manufacturer to contact the vaccine provider.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a health professional and described the occurrence of injection site cellulitis in a 5 year old male pt who received DTAP (Infanrix) for prophylaxis. The pt had no known drug allergies. The pt's other medical history and concurrent conditions were not reported. Concurrent medications included Depakote.  On 05/30/03 the pt received the 5th dose of Infanrix.  On 06/02/03, 3 days post-immunization, the pt experienced injection site cellulitis. The pt was seen by the physician and treated with an IM injection of Rocephin, and a seven day course of oral Augmentin. The pt was seen by the physician on 06/03/03.  The event had improved. The reporter considered the event was probably related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old female pt who received DTAP (Infanrix) for prophylaxis. On 06/03/03 the pt received the 4th dose of Infanrix. One day post-immunization on 06/04/03 the pt experienced an injection site reaction characterized by a 10-cm by 12cm area of induration, as well as, swelling, warmth and redness. The pt was seen by the physician. Additional information was received from another nurse at the facility on 09/10/03.  The events had improved as of 09/02/03.  The nurse considered the events to be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a pt who received DTAP (Infanrix) for prophylaxis. On an unspecified date, the pt received the 4th dose of Infanrix. At an unknown time post-immunization, the pt experienced an injection site reaction characterized by swelling, redness and itching. A healthcare professional was consulted regarding the events. The events resolved after an unspecified period of time. Comment: The reporter indicated that three subjects experienced these events following receipt of Infanrix Lot # DTPA594A2 for the fourth dose in the immunization series. However, the subjects are not presently identifiable.
Sex: U
Vaccine: DTAP
Symptoms: Oedema
Clinical narrative: This case was reported by a health professional and described the occurrence of limb swelling in a pt who received DTAP (Infanrix) for prophylaxis. On an unspecified date, the pt received Infanrix. At an unknown time post-immunization, the pt experienced limb swelling. The outcome of the event is unknown. On 07/28/03 the reporter stated that she could not identify the pt. Therefore no further information was available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old female pt who received DTAP (Infanrix) for prophylaxis. On 05/29/03 the pt received the 4th dose of Infanrix. On 05/29/03, at an unspecified time post-immunization, the pt experienced an injection site reaction characterized by a 10x12cm area of induration, as well as swelling, redness, and warmth. The pt was seen by the physician on 06/04/03.  The events had resolved by then, without treatment. The nurse considered the events were probably related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain, Irritability, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a 4 year old male pt who received DTAP (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the local health department. On 05/07/03 the pt received the 5th dose of Infanrix in the left arm. On the same date, he received an injection of IPV in the left arm and MMRII in the right arm. On 05/08/03, 24 hours post-immunization, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt also experienced irritability and low-grade fever. The events resolved by 05/10/03.  The nurse considered the events were related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain, Irritability, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 year old female pt who received DTAP (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the local health department. On 04/17/03 the pt received the 5th dose of Infanrix in the left arm. On the same date, she received an injection of inactivated IPV in the left arm and an injection of MMRII in the right arm.  On 04/18/04, 24 hours post-immunization, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt's left arm was stiff. The pt also experienced irritability and low-grade fever. The events resolved on 04/20/03.  The nurse considered the events were related to vaccination with Infanrix.