chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Abdominal pain upper, Apnoea, Back pain, Face oedema, Laboratory test abnormal
Clinical narrative: Imm. on 3/2/02, Tuesday On Friday, 4/5/02, c/o @ school of stomachache and backache school, Called mom, by time she got there, the child's face was swollen Called dr's office, told to bring right in, On way, he stopped breathing, Called 911, pulled over and gave artificial respirations until ambulance arrived. Transported to hospital, gave Benadryl, Did fine, DC from ER. went to Dr's office, Tested positive for MMR and one day later (4/29/02)for Hepatitis B. Dr called and meds givedn right away. No problems since.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Lymphadenopathy
Clinical narrative: Pt given DTAP in left thigh on 5/22/02 and became red and continues to be red despite cool compresses. Seen in office on 5/24/02 with left thigh erythema 5cm X 3cm area and induration over lateral surface with 2nd area of erythema over left inguinal area with 2cm lymphadenopathy. Dx'd with cellulitis and given Augmentin ES 600mg X 1 in office then put on Keflex 250mg tid X 10 days.
Age: 5.0
Sex: F
Vaccine: DTP, IPV
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Enlarged node on left axilla with redness to anterior and posterior back; no other reported injury. Treated with local heat and antibiotics with resolution.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Skin ulcer
Clinical narrative: Received Smallpox vaccine in left deltoid on 5/14/02. On 5/21/02, primary response. Returned on 5/23/02 with vesicular lesion (right hand) over 2nd metacarpal; auto-innoculation. On 5/28/02, decreased lesion on right hand with scab formation but no redness.
Age: 83.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal, Laboratory test abnormal
Clinical narrative: Pt had been Hbsag and Hbsab negative. After receiving 2 doses of Engerix-B vaccine, he sero-converted to Hbsag (+) and has remained (+) since. Liver enzymes had also been being normal but is now elevated (abnormal). From history; hepatic function was not an issue.
Age: 1.6
Sex: F
Vaccine: DTAP, IPV, TTOX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This report describes injection site redness and swelling in a 19-month ol female who received DTaP. In 04/00, the vaccinee received her first dose of Infanrix; No adverse events were reported. On 02/26/01, the vaccinee received her second dose of Infanrix. She also received IPv IM, ACTHIB IM. Post-vaccination, on 02/26/01, the vaccinee experienced redness and swelling at the site of the injection. The pt was taken to the local hospital following the incident, where an unspecified intravenous antibiotic was administered.  The vaccinee recovered on 02/27/01 w/out complications. The vaccine provider considered these events to be posssibly related to the administration of IPOL and ACTHIb. As of 03/06/01, the outcome of the events were recovered. The Infanrix dosing schedule was interrupted.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This report describes injection site swelling and redness in a 17 month old male who received DTaP. Concomitant vaccines (dates unspecified) were inactivated poliomyelitis vaccine, and  haemophilus influenza B vaccine. On 03/0101, the vaccinee received his second dose of DTaP. Post-vaccination on 03/01/01, the vaccinee experienced redness and swelling at the injection site. He was treated with ceftriaxone sodium IM 500 mg per day for three days from 03/02/01 to 04/04/01 and diphenhydramine hydrochloride 5cc every six hrs from 03/02/01 to 03/04/01. DTaP was stopped due to adverse events, and the dosing schedule of DTaP was interrupted. The vaccinee recovered w/out complications on 03/02/01. As of 03/06/01, the outcome of the adverse events was recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: This report descibed redness and swelling at the injection site in a 5 year old male who received DTaP. Concomitant vaccine: intramuscular poliomyelitis virus vaccine. On 03/05/01, the vaccinee received his first left thigh dose of DTaP and a left thigh dose of IPV. "Within one day" post-vaccination, the vaccinee experienced localized redness and swelling. He had an 8 cm wheal/flare at the injection site. A doctor visit was required. The vaccinee was treated on 03/07/01 with cetirizine hydrochloride two teaspoons per day As of 03/08/01, the outcome of the event was unresolved.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Decreased appetite, Injection site haemorrhage, Injection site oedema, Injection site pain
Clinical narrative: Case reference number 1998027650-1, is a clinical trial report from study 217744/027, a phase III multicenter, randomized, controlled primary vaccination study to assess the lot-to-lot consistency of the production method of Biologicals DTaP-HBV-IPV and Hib conjugate vaccines when mixed extemporaneously and given in a single injection and compared to commercially available vaccines in healthy infants. this case refers to a 3 month old male pt. The subject received a dose of DtaP, Hep B, Hib and IPV vaccines on 11/10/1998. One day after vaccines were given, on 11/10/1998, the child's mother called to say the subject had experienced a possible local reaction to the vaccine. The mother stated the injection sites on the left leg were swollen with a small amount of pus coming from the sites. The subject was evaluated at the physician's office. No fever, gastrointestinal complaints, pain and loss of appetite was seen. Three distinct circular scabs were seen with surrounding vesicles, which were confluent with underlying ecchymosis through most of the left anterior thigh. The physician ruled out that the subject was immunocompromised, and he was treated with Elocon ointment. The vaccination course was stopped. The subject recovered from the event on 12/09/1998. The investigator reported the event was serious and probably related to study vaccine and also associated with a reaction to immnizations. Local reactions to vaccines is a serious and listed event adequately reflected in the investigator's brochure.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Report 20010063351 described heat, redness, and pain at the injection site in a five year old male who received DTaP. The vaccinee had no known drug allergies and medical history was denied. On 03/05/01, the vaccinee received his first right thigh dose of Infanrix, a right thigh dose of MMR, a left thigh dose of IPV and a left thigh dose of varicella vaccine. "Within 1-2 days" post-vaccination, the vaccinee experienced baseball-sized redness, heat, and pain at the injection site. An ER visit was required, and the vaccinee was given unspecified treatment on 03/07/2001. As of 03/08/2001, the outcome of the event is unresolved.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This report described arm cellulitis (injection site) in a vaccinee of unspecified gender and age who received DTaP. On an unspecified date, the vaccinee received the fifth dose of DTaP. the first four doses of DTaP were p[roduced by an unknown manufacturer. subsequently, the vaccinee experienced left arm cellulitis A doctor visit was required, and the vaccinee was treated with cefalxinmonohydrate. Symptoms resolved in 24 hrs. As of 03/21/01, the outcome of the event is resolved.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Urticaria
Clinical narrative: No adverse events were reported after dose 1 and dose 2 of DTaP. On 03/21/01, the vaccinee received his third IM dose of DTaP, his second IM dose of Hemophilus b conjugate and Hepatitis B (recombinant) vaccine and his third IM dose of Prevnar. On 03/22/92, he experienced "severe" and generalized urticaria. On 03/22/01, he started treatment with Benadryl every 6 to 8 hours orally for hives. The urticaria resolved on 04/05/01, at which time the Benadryl treatment was stopped and DTaP was discontinued. The reporting physician stated that the adverse event was possibly related to the DTaP. As of 04/24/01, the outcome of the event was resolved
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: On an unspecified date, the vaccinee received her fifth dose of DTaP. On 04/26/00, she developed swelling at her injection site. As of 03/30/01, the outcome of the event is unknown.
Sex: U
Vaccine: DTAP, OPV, PNC
Symptoms: Convulsion
Clinical narrative: This report described seizure in a "child" of unspecified age and gender who received DTaP. On an unspecified date, the vaccinee received a dose of DTaP , Prevnar and IPV. Subsequently, the vaccinee experienced a seizure. As of 04/06/01, the outcome of the adverse event is unknown.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: On 01/08/01 13:30, the vaccinee received the third  dose of DTaP, the first dose of Prevnar, the third dose of haemophilus b conjugate vaccine and third dose of IPV. the vaccinee was prophylactically treated with acetaminophen. Approximately 3.5 hrs post-immunization, he became fussy. On 01/09/01 05:00, he was hot and developed a fever of 104 degrees F. He recovered that day at 09:00. As of 04/10/01, the outcome of the adverse event is resolved.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Pallor
Clinical narrative: Report 20010092611 described lethargy and pallor in a two month old male who adsorbed (Infanrix) for prophylaxis of diphtheria, tetanus and pertussis. Reportedly, the vaccinee had no allergies or medical history. Reportedly, he took no concomitant medications. On 04/11/2001 11:00, the pt received his first 0.5 ml left thigh dose of Infanrix. "Within minutes" post-vaccination, the vaccinee became lethargic and very pale. There was no loss of consciousness. Within 15 minutes, the vaccinee's color had had returned. After an additional fifteen minutes, the vaccinee was mroe alert and took some of his bottle. The vaccinee stayed in the physician's office for "a while" to be observed. As of 04/11/2001, the adverse events were resolving.
Sex: U
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: Report 2001011457-1 describes a bump at the injection site of an unspecified number of children of unspecified age and gender who received injections of Infanrix at unspecified dates, the children received their fouth dose of Infanrix. Some of the children received vaccine from lot DTPA986A2, and some received vaccine from lot DTPA992A2. No other vaccines were injected into the same leg as Infanrix. At some later time, the parents of the children reported that the children had developed a bump at the injection site. All the children recovered. The reporter was unable to specify the number of children who experienced this event and was unable to provide identifiers for any of the children, because no records of these events were maintained in the office. Since there are no identifiable patients, this report is considered not reportable.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: This report described injection site induration in a 15 month old female. On 05/07/01, the vaccinee received her fourth right thigh dose of DTaP. She subsequently experienced injection site induration, edema and redness (3" X 3" area). The parents contacted the physician within two days of vaccination. On 05/09/01, diphenhydramine hydrochloride was prescribed. As of 05/11/01, the adverse events were resolving.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This report described cellulitis in the injection area in a four year old male who received DTaP. On 06/11/01, the vaccinee received a 0.5 cc IM dose of DTaP; it was not known how many previous doses of DTaP the vaccinee had received. Subsequently, the left arm injection site was red and hot to touch with indurations from the injection site down to elbow. There was "some" swelling but no pus. The vaccinee wad found to have cellulitis. He was treated with amoxicillin trihydrate/clavulanic acid 400 mg/5 ml 1 1/2 teaspoons twice daily for seven days. As of 10/04/01, the outcome of the events was unknown
Age: 1.7
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: This report described possible infection at the injection site in a 20-month-old male who received DTaP. On 05/16/01, the vaccinee a 0.5 IM left deltoid dose of DTaP; it was not known many doses of DTaP the vaccinee had previously received. Subsequently, the vaccinee experienced a "large" swollen area at the injection site (left shjoulder) with pain. He was found to have allergic vs. infection". The vaccinee was treated with amoxicilliin  trihydrarte/clavulanic acid (Zyrtec) 25 mg daily. The reporter stated that the adverse events could possibly be associated with erroneous administration. As of 10/04/01, the outcome of the events was unknown.
Age: 4.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Report 20010134251 described upper arm edema (injection site) in a four year old male who received Infanrix for prevention of diphtheria, tetanus, and pertussis. The vaccinee had no known drug allergies. His medical history included wheezing and eczema (not affecting the arms). On 05/24/2001, the vaccinee received his fifth dose of Infanrix, inactivated poliovirus vaccine, and MMR vaccine. It was not recalled which one of the concomitant vaccines was administered in the same arm as Infanrix. Within 12 hours, on 05/25/2001, the pt developed left upper arm edema. The arm became swollen from distal to the shoulder to just proximal to the elbow. There was mild, diffuse erythema and local warmth, but no induration or crepitus. The circumference of the affected arm was not measured, but subjectively did not appear to be twice that of the contralateral arm. As of 06/04/2001, the event was completely resolved without sequelae.
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: This report described injection site swelling in a 19 month old female who received DTaP. On 05/09/01, the vaccinee received her fourth "5 cc" left leg dose of DTaP. Two days later, on 05/11/01, the mother reported that the vaccinee's left leg was red and swollen hard greater than size of one dollar coin. There was no streaking. The registered nurse instructed the mother to apply warm compress, to administer acetaminophen (Tylenol) for comfort and to call if streaking developed or redness developed. The physician was notified. No return call was received. The reporter stated that the adverse events were moderate in severity and were related to DTaP. As of 07/20/01, the adverse event had resolved
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: This report describes a lump at the injection site of a 4 month old male who received an injection of Infanrix. On 06/04/01, the infant received his first injection of Infanrix. Unspecified concomitant vaccines were administered at "opposite sites" On 06/05/01, one day post-immunization, the infant developed a "large' lump at the Infanrix injection site. The infant was seen by the physician who prescribed paracetamol (Tylenol) 60 mg every four hours. The lump resolved. The reporter considered the event to be mild in intensity and related to Infanrix administration. This is one of three infants from this facility who developed an injection site reaction following receipt of Infanrix lot 992A2.
Sex: F
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: This report describes pertussis in an approximately one year old female who received either DTP (brand unknown) or DTaP (brand unknown). Approximately, "seven year ago" the vaccinee received her first IM leg dose of DTP (brand unknown) or DTaP (brand unknown) Subsequently, "seven year ago", she cried and developed a fever. On an unspeciifed date, the vaccinee received her second IM leg dose of DTP (brand unknown) or DTaP (brand unknown). Subsequently, the vaccines reportedly developed pertussis. On unspecified dates, the vaccine received her third and fourth day IM leg doses of DTP (brand Unknown) or DTaP (brand Unknown). Following dose 4, the vaccinee cried and developed a fever. A doctor visit was required. As of 06/18/01, the outcome of the events was resolved.
Age: 5.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Report 2001015040-1 described swelling at the injection site in a five year old male who received Infanrix. This report was received from an office manager and has been verified by a licensed vocational nurse. The vaccinee is a "well child." Concomitant medications were not specified. The vaccinee had no illness at the time of vaccination. On 06/11/2001, the vaccinee received his fifth 0.5cc IM dose of Infanrix, his fourth SC 0.5cc dose of IPV, and his second SC 0.5cc dose of MMR vaccine. On 06/12/2001, the vaccinee experienced a localized site reaction consisting of redness, slight swelling and warm to touch. Cold pack was applied to deltoid. Ibuprofen 1 1/2 teaspoon every six hours as needed was prescribed. The redness and swelling subsided after 2-3 days with no compromising effects afterwards. Infanrix was discontinued. The reporter stated that the adverse events could not be associated with medical history, other drug, lack of efficacy, or erroneous administration. The reporter stated that the adverse events were mild in intensity and were related to Infanrix. As of 08/15/2001, the adverse events had resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Haematochezia
Clinical narrative: Report 2001015124-1 described blood in the stool of a six month old female who received Infanrix. The vaccinee had a "severe" cow protein allergy, allergic protocolitis, and enterocolitis. These conditions started at three weeks of age. On 06/12/2001, the vaccinee received her first IM anterolateral thigh dose of Infanrix, an IM dose of Prevnar and an IM dos eof Haemophilus influenzae b vaccine. On 06/14/2001, the vaccinee was found to have blood in her stool. No drugs were used to treat the adverse event. As of 06/20/2001, the pt's adverse event was "under control with dietary restriction."
Age: 3.4
Sex: F
Vaccine: DTAP
Symptoms: Drug administration error, Injection site erythema, Injection site oedema
Clinical narrative: Report 2001016272-1 described injection site swelling in a three year old female who received Infanrix. The vaccinee was allergic to Zithromax. She had no medical history. She took no concomitant medications. On 06/29/2001, the vaccinee received her fifth 0.1 ml dose of Infanrix. The dose was inadvertently administered intradermally; the nurse who administered the vaccine thought it was a PPD test. Post-vaccination, on 06/29/2001, the vaccinee experienced "local erythema and swelling, but no fever of fussiness." Medical attention was required at a doctor's office. The reporter indicated that the adverse events were mild in intensity and were related to Infanrix. As of 07/20/2001, the outcome of the adverse events was resolved.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Anaphylactic reaction, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Report 2001016286-1 describes a "mild anaphylactic reaction" in 7 month old female who received an injection of Infanrix. There were no pre-existing medical conditions or concurrent medications. There were no known allergies at the time of the first dose of Infanrix was administered. On 05/03/2001, the infant received her first injection of Infanrix. At that time, she also received her first injection of haemophilus influenzae type b conjugate vaccine and an injection of hep B vaccine. It was not known if she had received previous injections of hep B vaccine. Within 20 mins post-immunization, she developed a facial rash, hives, itching, and redness. She recovered that day,  without treatment. On 06/18/2001, the infant received a second injection of the same Hib vacine. She had no adverse experience. The infant was referred to an allergist on 06/25/2001, at 8 months of age. The allergist performed a skin prick test with Infanrix diluted 1:10. Within 15-20 mins of injecting the diluted Infanrix, the infant developed itching, hives on her neck, and a wheal and flare at the injection site. The allergist made a diagnosis of "mild anaphylactic reaction" and administered 12.5mg Benadryl orally and 0.05mL epinephrine 1:1000. The infant recovered that day. The infant received another injection of the same hep B vaccine on 07/02/2001. She had no adverse experience. On an unspecified date, she received an injection of DT toxoids; she had no adverse experience. The allergist reported that the facial rash, hives, itching, and redness that occurred following receipt of the first Infanrix injection were of moderate intensity and related to Infanrix administration. The allergist reported that the "mild anaphylactic reaction" that occurred following receipt of the second Infanrix injection was of moderate intensity and related to Infanrix administration. The infant will received no further injection of Infanrix. The "mild anaphylactic reaction" is considered medically serious.
Age: 3.4
Sex: F
Vaccine: DTAP
Symptoms: Drug administration error, Gastroenteritis, Injection site induration, Pyrexia, Vomiting
Clinical narrative: Report 2001016305-1 describes induration at the injection site of a 3 year old female who  inadvertently received an intradermal injection of Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no known illness at the time of Infanrix administration. On 06/29/2001, the child inadvertently received an intradermal injection of Infanrix, rather than tuberculosis purified protein derivative (PPD). Later that day, an unspecified time post-injection, she developed a 9mm by 11mm area of induration at the injection site. The induration resolved on an unspecified date. The reporter considered the induration at the injection site to be mild in intensity and related to Infanrix administration. On 07/03/2001, four days following receipt of Infanrix, the child developed a fever of 101 to 102.5 deg F and vomiting. A diagnosis of gastroenteritis was made. The reporter did not assess the relationship between Infanrix administration and the development of gastroenteritis. On an unspecified date, the gastroenteritis resolved.
Age: 1.6
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Report 2001016368-1 described red and swollen injection site in four nineteen month old vaccinees of unspecified gender who received Infanrix. On an unspecified date, four vaccinees received a dose of Infanrix; it was not known whether or not, they had received previous doses of Infanrix. Subsequently, they experienced "very red, swollen thighs." As of 06/28/01, the outcome of the events was unknown. This case is considered not reportable as a pt has not been identified. Follow-up request is being done.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Report 2001016915-1 describes a mass at the injection site of a 4 month old female who received an injection of Infanrix. There was no relevant medical history, concurrent illness, or concurrent medication. On 06/05/2001, the infant received her second injection of Infanrix. Unspecified concomitant vaccines were administered at "opposite sites." Later that day, she developed a 1cm area of erythema and induration and a mass at the Infanrix injection site. The infant was seen by the physician, who prescribed Tylenol 80mg every four hours for pain relief. The erythema, induration and mass resolved. The reporter considered the events to be mild in intensity and related to Infanrix administration. this is one of three infants from this facility who developed an injection site reaction following receipt of Infanrix lot DTPA992A2.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Report 2001016916-1 describes a lump at the injection site of a 2 month old male who received an injection of Infanrix. There was no relevant medical history, concurrent illness, or concurrent medication. The infant had no adverse experiences following prior immunizations. On 06/01/2001, the infant received an injection of Infanrix; number of previous Infanrix injections was not reported. Unspecified concomitant vaccines were administered at "opposite sites." The infant's mother reported that he developed a lump with warmth at the Infanrix injection since later that day. The physician prescribed Tylenol 80mg every four hours for pain relief. The outcome of the lump and warmth was not provided. This is one of three infants from this facility who developed an injection site reaction following receipt of Infanrix lot DTPA992A2.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: This report described limb swelling in a four year old female who received DTaP. On an unspecified date, the vaccinee received the first 0.5 cc IM dose od DTaP, a right thigh dose of IVP and a left  deltoid dose of MMR. Subsequently, the vaccinee experienced "swollen limb". The vaccinees was examined by a health care professional for the reaction.  The swelling did not extend to the nearest joints. The area of swelling/induration was 4.7 x 4 cm. There was no fever. There was tenderness and erythema at the injection site. There was no fluctuance/crepitus or functional impairment. Cold packs and cefalexin monohydrate (Keflex) were prescribed. The reporter stated that these adverse events were of mild intensity. As of 07/30/01, the events had resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: This report describes red splotches in a four month old female received  Infanrix. On 05/10/01, 09:30, the vaccinee received her her second IM right thigh dose of Infanrix, her second IM left leg dose of IPV  and her second IM left leg dose of Haemophilus influenzae type B vaccine. On 05/10/01, in the evening, the vaccinee experienced red splotches at the injection site which ascended the trunk and descended down the left leg. Additionally, she had a temperature of 102.5 degrees F. Symptoms resolved in 24 hours. As of 08/17/01, the outcome of the events were resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Report 2001017818-1 described injection site edema in a four year old male who received Infanrix. The vaccinee was described as a "well child." On 05/09/2001, the vaccinee received the fifth IM left thigh dose of Infanrix, and the fourth SC right thigh dose of IPV. On 05/11/2001, the registered nurse reporter received a telephone call from the mother of the vaccinee: the vaccinee's left leg had a red welted area slightly smaller than a tennis all, and bigger than one dollar coin size. There was no streaking. The registered nurse reported the events to the physician who ordered warm compresses and Tylenol for comfort. The mother was asked to call if streaking developed, redness increased, or symptoms did not resolve. No call back was necessary. The reporter stated that the adverse events were moderate in intensity and were possibly related to Infanrix. As of 07/20/2001, the adverse events had resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Report 2001017844-1 described swollen injection site in a six month old female who received Infanrix. The vaccinee was described as a "well child." No illness at the time of vaccination was reported. On 05/11/2001, the vaccinee received her third 0.5cc left thigh muscle dose of Infanrix, her third right thigh muscle doseof Haemophilus influenzae type B vaccine, and her first right thigh muscle dose of Prevnar. On 05/12/2001, the reporting registered nurse received a phone call from the vaccinee's mother: she reported that the vaccinee's left leg had a red spot 2 x 2inch (3 x 25cent piece size) which started one day ago. There was no streaking. The physician instructed to mother to apply a warm towel and to administer Tylenol. No return call was received. The reporter stated that the adverse events were of moderate intensity and were possibly related to Infanrix. As of 07/20/2001, the adverse events had resolved.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Report 201018310-1 described seizure in a 7 month old female who received Infanrix. Allergies, medical history, and concomitant conditions were not specified. On 06/28/2001, the vaccinee received her first dose of Infanrix. On 06/28/2001 17:50, according to the father, the vaccinee experienced a 'full-body seizure and turned blue." The mother of the vaccinee performed cardiopulmonary resuscitation. The seizure reportedly ended and was replaced by a "half-body seizure." It was unknown whether the pt was treated at the ER or by a physician. Seizure is considered to be medically serious. As of 07/26/2001, the outcome of the event was unknown.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site vesicles, Injection site warmth, Pruritus
Clinical narrative: This report describes at the injection  site in a five year old female who received DTaP. On 07/26/01, the vaccinee received her fourth left thigh dose of Infanrix. "Within Hours" post-vaccination, she developed swelling heat, blisters and itching at the injection site. The vaccinee was seen in the emergency room. The reporter was "not sure if treatment was given". As of 08/02/01, the adverse events had resolverd.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Report 2001018906-1 described injection site hot to touch in a 4 year old male who received Infanrix. The vaccinee was allergic to sulfa. He had no medical history and received no concomitant medications. On 07/31/2001, the vaccinee received his fourth left thigh dose of Infanrix. Subsequently, he developed localized swelling at the injection site. Additionally, the injection site was hot to touch. As of 08/02/2001, the adverse events had resolved.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: On 6/25/01, the vaccinee received his 1st right thigh dose of Infanrix. "Within 24 hours" the vaccinee developed a painful red lump at the injection site which did not resolve. The lump was a palpable mass. On 8/9/01 follow-up, the lump was still there. The physician manipulated the area lightly. On 8/10/01, the mother called and stated that the "lump broke open with greenish/yellowish drainage noted". No treatment was given. As of 8/10/01, the outcome of the events was unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 8/10/01, the vaccinee received a left deltoid dose of Infanrix and an IM 0.5ml dose of IPOL; the vaccinee had received an unspecified number of previous doses of Infanrix. Subsequently, the vaccinee developed a 5-6cm lump in diameter at the injection site which was more diffuse than a palpable mass. It did not extend to the joints. It was "slightly enlarged". The lump was hot to touch. The injection site was painful and the the pain was confined to the injection site. The vaccinee had no fever. There was diffuse erythema not confined to the injection site. The swelling resolved in 5 days after being treated with ice and observed. No drugs were used to treat the adverse event. The vaccinee was treated by a physician. The reporter stated that the adverse events were moderate in severity and were related to Infanrix. The adverse events resolved on 8/16/01. As of 8/28/01, the adverse events had resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, UNK
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: On 8/14/01, the vaccinee received her 5th SC left thigh dose of Infanrix and a left arm SC dose of IPOL and a right leg IM dose of MMR. Twelve hours later, she experienced a red swollen painful area at the injection site. The vaccinee was examined by a healthcare professional for the reaction. The swelling did not extend to the nearest 2 joints. There was no fever. The induration was a palpable mass. The injection site reaction was treated with ice and acetaminophen (Tylenol) as needed. The swelling resolved in 45 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, UNK
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: On 1/7/98, 2/20/98, in 12/98, 8/3/00 and 8/7/01, the vaccinee received her 1st, 2nd, 3rd, 4th and 5th 0.5ml IM doses of Infanrix. Additionally, on 8/7/01, she received a 0.5cc SC right deltoid dose of IPOL and her 2nd 0.5cc SC left dose of MMR. Within 24 hours, post vax, on 8/8/01, the vaccinee experienced an 8cm X 9cm diameter erythema with induration at the injection site. The vaccinee was examined by a healthcare professional on 8/9/01 for the reaction. On 8/10/01, the vaccinee had a 9cm X 9cm erythematous and indurated area which was painful to palpation and was warm to touch. The induration was a palpable mass. On 8/14/01, the vaccinee had a 8mm X 9mm erythematous indurated area of the left upper arm which was warm compared to "other" skin. The vaccinee was treated with cefalexin monohydrate (Keflex) 250mg 2 teaspoons 3 times daily for 10 days for cellulitis and with hydroxyzine hydrochloride (Atarax) 15mg 3 times daily orally from 8/10/01 to 8/18/01 for the allergic reaction. The pt was offered an appointment on 8/17/01 unless symptoms subsided. The pt did not come for the appointment. The reporter stated that the cellulitis and allergic reaction were moderate in intensity, were related to Infanrix and resolved on 8/17/01. The reporter stated that the cellulitis and allergic reaction were related to Infanrix. As of 8/17/01, the symptoms had resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 6/12/01, the vaccinee received his 5th 0.5cc dose of Infanrix, his 4th .5cc SC dose of IPOL and his 2nd 0.5cc SC dose of MMR. On 6/13/01, the vaccinee experienced a "low-grade" site reaction which included redness (2" in diameter), "a small amount" of swelling, and warm to touch. Ibuprofen 1 1/2 teaspoons every 6 hours orally for swelling and pain as needed (6/13/01 to 6/14/01) and cold pack helped to reduce swelling and discomfort. These symptoms then subsided day 2-3 after injection, with no subsequent problems reported since. Infanrix was discontinued. The reporter stated that the adverse events were mild in severity and were related to Infanrix. As of 8/16/01, the adverse events had resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 6/12/01, the vaccinee received his 5th 0.5cc IM dose of Infanrix, his 4th 0.5cc SC dose of IPOL and his 2nd 0.5cc SC dose of MMR. On 6/13/01, he experienced injection site redness with 3" swelling, warm to touch and "low-grade" tenderness (per pt). Ibuprofen 1 1/2 teaspoons orally every 6 hours as needed was administered from 6/13/01 to 6/14/01 for swelling and discomfort as well as cold packs to the site. Redness and swelling subsided after 2-3 days with no compromising effects thereafter. Infanrix was discontinued. The reporter stated that the adverse evens were moderate in severity and were related to Infanrix. As of 8/15/01, the adverse events had resolved.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On an unspecified date, the vaccinee received a dose of Infanrix; it was not known whether the vaccinee had received previous doses of Infanrix. Subsequently, the vaccinee experienced injection site edema and redness. As of 8/21/01, the outcome of the adverse events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On an unspecified date, the vaccinee received a dose of Infanrix; it was not known whether the vaccinee had received previous doses of Infanrix. Subsequently, the vaccinee experienced injection site edema and redness. As of 8/31/01, the outcome of the adverse events was unknown.
Age: 15.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: This report describes hives in a 15 year old female who received Infanrix. It was received from a medical technician and has not been verified by a physician or other healthcare professional. On 08/23/01, the vaccinee received her fourth left thigh dose of Infanrix, a dose of Haemophilus Influenza type b vaccine, and Inactivated Poliovirus vaccine On 08/24/01, the vaccinee developed "hives all over" per the mother. The nurse practitioner administered Benadryl liquid. Symptoms resolved in 24048 hrs. As of 08/28/01, the adverse events had resolved.
Age: 0.7
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous
Clinical narrative: Report 2001021333-1 described rash in an eight month old female who received Infanrix. The vaccinee's allergies, medical history and concomitant medications were not specified. On an unspecified date, the vaccinee received her first dose of Infanrix. One week later, she experienced a raise, red, rash. As of 08/31/2001, the outcome of the event was unknown.
Age: 4.2
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Report 2001021419-1 described swelling at injection site in a four year old female who received Infanrix. This report was received from a medical assistant and has not been verified by a physician or another health care professional. Reportedly, the vaccinee had no allergies, medical history, or concomitant medications. Reportedly, the vaccinee had no illness at the time of vaccination. On 08/03/2001, the vaccinee received a 0.5ml IM dose of Infanrix; it was not known whether the vaccinee had received previous doses of Infanrix. Reportedly, subsequently, she experienced redness at injection site, swelling at injection site and fever. Reportedly, the vacicnee was found to have cellulitis "due to the injection." Reportedly, the vaccinee was treated wtih Keflex 250mg four times daily orally starting on 08/06/2001. Her symptoms resolved. The reporter stated that 'the child has not received any other doses of Infanrix because she is caught up on her vaccations at this time." The reporter stated that the adverse events were mild and were related to Infanrix. As of 10/08/2001, symptoms had resolved.
Age: 5.7
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Report 2001021434-1 describes cellulitis at the injection site of a five year old male who received Infanrix. Medical history included redness and swelling at the injection site and a fever following receipt of an injection of Acel-Imune on 06/28/2001. These events required unspecified treatment in the ER. Concurrent conditions and medications were not specified. On 08/14/2001, the child received an injection of Infanrix. The reporter indicated that the child had received previous injections of Infanrix, but the number of previous injections was not provided. On 08/14/2001, an unspecified time post-immunization, the child experienced redness and swelling at the injection site, and fever. On 08/16/2001, he was seen by the physician, who made a diagnosis of cellulitis and prescribed Keflex 250mg twice daily and Benadryl every four or five hours, as needed. The cellulitis resolved on an unspecified date. The reporter considered the cellulitis to be moderate in intensity and related to Infanrix administration.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Report 2001021437-1 describes cellulitis at the injection site of a five year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 08/29/2001, the child received an injection of Infanrix. The reporter indicated that the child had received previous injections of Infanrix, but the number of previous injections was not provided. On 08/29/2001, an unspecified time post-immunization, the injection site became red, swollen and hot. The child was seen by the physician, who made a diagnosis of cellulitis and prescribed Benadryl every four hours. The cellulitis resolved on 09/01/2001. The reporter considered the cellulitis to be mild in intensity and related to Infanrix administration.
Sex: U
Vaccine: DTAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Report 12001023200-1 described vomiting in a vaccinee of unspecified age and gender who received Infanrix. On an unspecified date, the vaccinee received a dose of Infanrix. It was note known whether the vaccinee hand received previous doses of Infanrix. The vaccinee's mother called the nurse reporter and stated that her child who had received the vaccinee was experencing diarrhea and vomiting. As of 09/27/2001, the outcome of the adverse events was ongoing.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Report 2001023796-1 described probably cellulitis in a 19 month old male who received Infanrix. The  vaccinee's allergies, medical history, and concomitant medications were not specified. There was no illness at the time of vaccination. On 06/04/2001, the vaccinee received a 0.5cc IM right deltoid dose of Infanrix. It was not known how many previous doses of Infanrix he had received. on 06/05/2001, he experienced "proably cellulitis" with a right deltoid 10 x 9cm area of erythema and induration surrounding the injection site. The induration was the size of a 50 cent piece. The area was hot to touch and had irregular borders. The "probable cellulitis" was treated with Augmentin 300mg twice daily for ten days. The reporter indicated that the adverse events could possibly be associated with erroneous administration. As of 10/04/2001, the outcome of the "probable cellulitis" was unknown.
Age: 0.4
Sex: M
Vaccine: DTAP
Symptoms: Drug administration error, Injection site mass
Clinical narrative: Report 2001024387-1 describes a lump at the injection site of a 5 month old male who inadvertently received the fourth injection of Infanrix five weeks, rather than six months, following receipt of the third injection. This report was received from the infant's mother and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the infant received his fourth injection of Infanrix, this injection was administered five weeks, rather than six months, following the administration of the third injection of Infanrix. On 09/25/2001, an unspecified time post-imunization, the infant developed a lump at the injection site. He had not experienced a lump at the injection site following receipt of any other vaccines. The lump persisted as of 10/01/2001.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: Report 2001025056-1 describes an infection at the injection site in an 18 month old male who received an injection of Infanrix. This report was received from the vaccinee's father and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On 10/09/2001, the pt received his first injection of Infanrix. Approximatley sixteen hours post-vaccination, the pt developed a "red nickle-sized circle" on his leg about two inches below the injection site. The next morning, 10/10/2001, the redness increased in size to about 3.5 inches and was "giving off heat." On 10/11/2001, the pt was seen by a physician, who reportedly made a diagnosis of infection at the injection site and prescribed Keflex.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cough, Lethargy, Pyrexia, Somnolence
Clinical narrative: Report 2001025671-1 describes lethargy in a 5.5 year old male who received Infanrix. This report was received from a consumer and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received his fifth injection of Infanrix. Post-vacicnation, the vaccinee became lethargic and slept for three hours. Additionally, he had a fever and a "hacking" cough. As of 10/24/2001, the outcomes of the events were unknown.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Irritability
Clinical narrative: Report 2001025697-1 describes high-pitched screaming in a 2 month old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of vaccination. On 10/17/2001, the infant received his first injection of Infanrix. On that date, he also received his first injections of Haemophilus influenzae type b conjugate vaccine and inactivated poliomyelitis virus vaccine. Later that day, an unspecified time post-immunization, the infant experienced high-pitched screaming that lasted one to two hours. Additionally, he experienced jumpiness and irritability. The irritability was treated with Tylenol from 10/17/2001 to 10/18/2001. The events resolved on 10/17/2001. The reporter considered the events to be of moderate intensity and possibly related to Infanrix administration. The infanrix immunization series was discontinued.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administration error, Eye inflammation, Eye irritation
Clinical narrative: Report 2001027157-1 describes eye burning in a 40 year old female who, while administering an injection of Infanrix, had some of the vaccine squirt into her eye. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/14/2001, a nurse who was administering Infanrix to a vaccinee, had some of the vaccine squirt into one of her eyes. It was not specified which eye was involved. Her eye started to burn. She flushed the eye with water and the burning resolved. The most recent info received on 04/22/2002, indicated that the nurse "had no ill effects."  A 15-day follow up report received 05/28/2003 adds no new info.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site mass, Injection site reaction
Clinical narrative: Report A0355776A describes an injection site reaction in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/27/2001, the vaccinee received his first injection of vaccinee received infections of inactivated poliomyelitis virus vaccine and MMR vaccine. On 11/30/2001, three days after receiving Infanrix, he experienced an injection site reaction at the site of Infanrix administration, characterized by a hard, red, itchy lump measuring 1.5 inches in diameter; the area was hot to the touch. The vaccinee provider considered the events to be mild in severity and were related to Infanrix administration. The events resolved on 12/06/2001.