chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR
Symptoms: Accidental overdose, Medication error, Palpitations, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 5-year-old female subject who was vaccinated with PEDIARIX, IPOL. Concurrent vaccination included HIB vaccine and PREVENAR both given on 10 July 2003 and live MMR II given on 6 August 2008. There were no concurrent medications. On 6 August 2008 at 15:00 the subject received unspecified dose (it was noted to be the subjects 5th dose of PEDIARIX at 0.5 ml in the left thigh. Also on 6 August 2008, the subject received 4th dose of unspecified time after vaccination with IPOL, the subject developed fever and heart palpitations. These events resolved within 24 hours of onset, 8 August 2008. The subject also experienced an accidental overdose as she received an extra dose of IPOL. The healthcare professional considered the events were probably related to vaccination with PEDIARIX. When the subject had been asked if she had any previous events with other vaccines, it was reported that the subject developed a fever after receiving 1st dose of PEDIARIX (lot number was 21883B2 or 21881C9) in the left thigh on 10 July 2003. The fever resolved within 24 hours. It was reported that the subject had received both of the lots given above, but the reporter was unsure which one specifically was given for the 1st dose. Follow-up information received on 06 October 2008 indicated that the events resolved and were not considered to be related to treatment with PEDIARIX, but related to inactivated IPOL.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Adverse reaction, Lethargy
Clinical narrative: This case was reported by a physician and described the occurrence of lethargy in a 2-month-old subject of unspecified gender who vaccinated with PEDIARIX. On an unspecified date, the subject received an unspecified dose PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced lethargy. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 06 October 2008 indicated that the subject was a 3 month old. Events of lethargy and adverse reactions (not specified otherwise) were reported to have begun on 10 July 2008 with a resolution date of 11 July 2008. The reporter considered the events to be probably related to the DTap component of the PEDIARIX vaccine. The 0.5 ml dose of PEDIARIX received by the subject was the 1st dose administered.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of injection site hives in a 6-month-old female subject who was vaccinated with PEDIARIX. On an unspecified date, the subject received an unspecified dose of PEDIARIX (unknown). Forty-eight hours after vaccination with PEDIARIX, the subject experienced injection site hives. At an unspecified time after vaccination with PEDIARIX, the subject developed hives all over body. The subject was treated with BENADRYL and the hives resolved after an unspecified period of time. The reporter was an allergist, who was contacted by the subject's physician. Thus, no further information was available on the infant subject.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Apnoea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of apnea in a subject of unspecified age and gender who was vaccinated with PEDIARIX. On an unspecified date, the subject received an unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced apnea. A pharmacist called to check on thimerosal content of PEDIARIX, and stated that she heard of a subject who received PEDIARIX and Experienced apnea. No further information was available at the time of this report. This case was assessed as medically serious. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an unspecified adverse event in a child subject of unspecified gender who was vaccinated with PEDIARIX. On an unspecified date in (2005 and 2006) the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced an unspecified adverse event. The reporter stated that she was contacted by a physician's office because the consumer believed that the thimerosal harmed her baby. Details were not provided. At the time of reporting the outcome of the event was unspecified. The pharmacist wanted to know the thimerosal content of several lot numbers in 2005 and 2006. Two additional lot numbers, in addition to that for PEDIARIX, provided in the report were AC21B033BA and AC14B008AA.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal faeces, Dyspepsia, Nausea, Vomiting, Weight gain poor
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of nausea in a 2-month-old male subject who was vaccinated with PEDIARIX. A physician or other health professional has not verified this report. Concurrent vaccination included HIB and PREVNAR both given on 29 April 2004. There were no concurrent medications. On 20 April 2004 the subject received 1st dose of PEDIARIX at 0.5 ml. On 30 April 2004, 1 day after vaccination with PEDIARIX, the subject experienced nausea and began vomiting. Additionally, his stools were not normal. He continued to vomit after every time he ate. Up to this point, the subject had been normal and followed a normal growth pattern. After receiving PEDIARIX, he stopped gaining weight because he was vomiting so much. This occurred on and off for several months. All vaccinations were stopped at that point. The subject went to see several doctors who could not find any underlying cause. Nausea and vomiting eventually resolved, abnormal stools improved, but the digestion problems continued. The subject was noted to have food allergies (which improved), one of which was a dairy allergy. He also has a sensitivity to wheat. These conditions were not known to cause a severe allergic reaction. This was a systemic reaction. A similar reaction occurred for this subject approximately four years later following vaccination with INFARIX. For information surrounding this report, refer to case number A0742478A.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Pyrexia, White blood cell count abnormal
Clinical narrative: This case reported by a physician, via GSK representative, that described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX. Concurrent vaccinations given on the same date as PEDIARIX included ACTHIB, ROTATEQ oral; and PREVNAR. On an unspecified date On an unspecified date, the subject received the 2nd dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced a high fever, reported to be in the 103 degree Fahrenheit range. At unspecified time after vaccination with PEDIARIX blood was drawn from the subject and the test results showed a white blood count "shift to the left", but no bacteria was detected. The subject was treated with at least one dose of ROCEPHIN. The fever was reported to be resolved within 24 hours, but the outcome of the abnormal white blood cell count was not reported.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Pyrexia, White blood cell count abnormal
Clinical narrative: This case was reported by a physician, via a GSK representative, that described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX. Concurrent vaccinations given on the same date as PEDIARIX included ACTHIB, ROTATEQ, oral and  unspecified PREVNAR unknown. On an unspecified date, the subject received the second dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced a high fever, reported to be in the 103 degree Fahrenheit range. At an unspecified time after vaccination with PEDIARIX, BLOOD was drawn from the subject and the test results showed a white blood count "shift to the left", but no bacteria was detected. The subject was treated with at least one dose of  Rocephin. The fever was reported to be resolved within 24 hours, but the outcome of the abnormal white blood cell count was not reported.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Immediate post-injection reaction
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  On 25 July 2008 the subject received 1st dose of PEDIARIX at 0.5 ml.  Immediately after the injection, on 25 July 2008, the subject began crying uncontrollably and continued to cry throughout the visit.  Approximately 3 hours later, the subject was still crying.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was probably related to vaccination with PEDIARIX.  Follow-up received on 26 August 2008 indicate that the subject cried for 4 hours and then stopped.  The reporter considered the event possibly related to treatment with INFANRIX.
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Contusion, Incorrect route of drug administration
Clinical narrative: This case was reported by a physician and described the occurrence of wrong route of administration in a subject of unspecified age and gender who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccination included HIB vaccine (manufacturer unspecified) given in 2003.  In 2003 the subject received unspecified dose of PEDIARIX in an unknown thigh.  In 2003, at an unspecified time after vaccination with PEDIARIX, the subject experienced purple bruising.  It was reported that PEDIARIX may have possibly been administered subcutaneously.  This would be a wrong route of administration.  At the time of reporting the outcome of the events was unspecified.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, VARCEL
Symptoms: Gait disturbance, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling at the injection site in a 2-year-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included penicillin allergy.  Concurrent vaccination included HIB vaccine, (Merck) and VARICELLA Virus vaccine (Merck) both given on 16 June 2008.  There were no concurrent medications.  On 16 June 2008, at 15:00 - 16:00, the subject received 1st dose of PEDIARIX at 0.5 ml in the left thigh.  On 17 June, 2008, 1 day after vaccination with PEDIARIX, the subject developed a swollen, raised area at the injection site that was warm to the touch and caused the subject to walk with a limp.  The subject was seen in the physician's office for these events.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with PEDIARIX.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site cyst, Injection site discolouration, Injection site mass, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a physician and described the occurrence of a lump on leg at injection site in a 7-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline.  Concurrent vaccinations given on 15 April 2008 included the 3rd dose of ACTHIB, Sanofi; and the 3rd dose of PREVNAR, Wyeth.  Previous vaccinations given on 29 November 2007 and 30 January 2008 included the 1st and 2nd doses of PEDIARIX, GlaxoSmithKline.  On 15 April 2008 at 10:45, the subject received 3rd dose of PEDIARIX (.5 ml, unknown, left thigh).  On 12 May 2008, 27 days after vaccination with PEDIARIX, the subject developed a 1 cm in diameter lump on her left thigh, which was the site of the PEDIARIX injection.  On 18 June 2008, the subject was seen again in the physician's office and the lump was described as being solid, cystic, purplish in color, and more superficial.  The physician stated that the lump had not improved, but had changed since the first time he saw it.  The physician reported that the subject experienced no problem following her two previous PEDIARIX doses.  At the time of reporting, the event was unresolved.  The physician considered the event was probably related to vaccination with PEDIARIX.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of soreness in a 11-year-old male subject who was vaccinated with PEDIARIX.  Concurrent medical conditions included cystic fibrosis. On 05 June 2008, the subject inadvertently received a dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced soreness. This was considered to be vaccination error, as the subject was an inappropriate age for vaccination with PEDIARIX. At the time of reporting, the outcome of the events was unspecified.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 13-month-old female subject who was vaccinated with PEDIARIX. A physician or other health care professional has not verified this report. On  unspecified dates, the subject received the 1st dose, 2nd dose, 3rd dose and 4th doses of PEDIARIX. On unspecified dates, the subject's mother reported that her daughter received the 1st dose of PEDIARIX at 2 months old; the 2nd dose of PEDIARIX at 4 months old; the 3rd dose of PEDIARIX at 6 months old; and the 4th dose of PEDIARIX at 13 months old. At unspecified times following all four doses of PEDIARIX, the subject experienced a fever. An extra (4th) dose of PEDIARIX was inadvertently administered to the subject instead of an intended DTAP vaccine. At the time reporting, the fever was unresolved. The subject's mother refused to provide any further details, as she wanted to leave it up to the physician's office to provide this information. This case is lost to follow-up, as the reporter did not provide any contact information.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass
Clinical narrative: This case was reported by a physician and described the occurrence of a lump at the injection site in a 7-month-old male subject who was vaccinated with PEDIARIX. On 11 April 2008 the subject received 3rd dose of PEDIARIX at 0.5ml in the right thigh. On 14 April 2008, 3 days after vaccination with PEDIARIX, the subject experienced a lump at the injection site. The child's parents noted the lump and reported it to the physician. The lump was described as soft, mobile and the size of a grape. There was no redness. No treatment had been required as of the time of reporting. No reactions were noted following the first two administrations of PEDIARIX. At the time of reporting the event was unresolved.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of excessive screaming in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX, GlaxoSmithKline.  In March 2008, the subject received the 2nd dose of PEDIARIX (.5 ml, unknown, right thigh).  Within one hour after vaccination with PEDIARIX, the subject experienced a screaming reaction, described as "unconsolable non-stop screaming", which lasted for a period of several hours.  At the time of reporting the event was resolved.  The reporting physician considered the event was probably related to vaccination with PEDIARIX.  Follow-up information was received on 23 May 2008 via a registered nurse, who indicated that this case was reported to a Regulatory Agency (VAERS ID # was not reported).  The nurse reported that the subject was a 12-month-old female who was vaccinated with PEDIARIX on 28 March 2008.  The subject's medical history included gastroesophageal reflux.  Concurrent medical conditions included allergic rhinitis.  Concurrent vaccinations given on 28 March 2008 included ACTHIB, manufacturer unspecified; unknown; left thigh; and PREVNAR, manufacturer unspecified; unknown; left thigh.  Concurrent medications included Singulair and Zantac.  In addition to the previously reported excessive screaming, on 28 March 2008, at an unspecified time after vaccination with PEDIARIX, the subject experienced a fever and fussiness.  The subject's fever was reported to range from 102 to 103 degrees Fahrenheit for a period of four days, before resolving on 31 March 2008.  The fussiness and excessive screaming were also reported to last for a period of four days, before resolving on 31 March 2008.  As of 01 April 2008, all of the symptoms were reported to be resolved.  The immunization series with PEDIARIX was discontinued.  The reporting nurse considered the events to be related to vaccination with PEDIARIX.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of excessive screaming in a 2-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (PEDIARIX, GlaxoSmithKline) for prophylaxis. In March 2008, the subject received the 1st dose of PEDIARIX (.5 ml, unknown). Within one hour after vaccination with PEDIARIX, the subject experienced a screaming reaction, described as "unconsolable non-stop screaming", which lasted for a period of several hours. At the time of reporting the event was resolved. The reporting physician considered the event was probably related to vaccination with PEDIARIX. Follow-up information was received on 23 May 2008 via a registered nurse, who indicated that this case was reported to a Regulatory Agency (VAERS I #308873). The nurse reported that the subject was a 2-month-old male who was vaccinated with PEDIARIX on the morning of 08 February 2008. The subject's medical history included increased bilirubin levels. Concurrent medical conditions included gastroesophageal reflux. Concurrent vaccinations given on 08 February 2008 included(ACTHIB, manufacturer unspecified); unknown; left thigh; (ROTATEQ, manufacturer unspecified); oral; and (PREVNAR, manufacturer unspecified); unknown; left thigh. The excessive screaming was reported to the physician's office via a phone call on 08 February 2008 at 14:45. The subject was treated with two doses of Tylenol, four hours apart. The events were reported to be improved, then resolved as of 09 February 2008. The immunization series with PEDIARIX was discontinued. The reporting nurse considered the event to be related to vaccination with PEDIARIX.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: This case was reported by a physician and described the occurrence of generalized petechiae in an infant subject who was vaccinated with PEDIARIX, HIB vaccine and PREVNAR. The subject had no history of bleeding. On an unspecified dates the subject received unspecified dose of PEDIARIX , unspecified dose of HIB vaccine, unspecified dose of PREVNAR for month two and month four vaccines. At an unspecified time after vaccination with PEDIARIX. HIB vaccine and PREVNAR, the subject experienced generalized petechiae that subsisted for a few weeks. Upon drawing blood, a low platelet count was found. All other blood type levels were normal. The petechiae lasted a few weeks longer at which point further blood work-up showed a form of platelet aggregation disorder. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: DTAPHEPBIP, MEN
Symptoms: Dyspnoea, Lip swelling, Urticaria
Clinical narrative: This case was reported by a healthcare professional via a representative and described the occurrence of swollen lips in a child male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccination given on the same date as PEDIARIX included meningitis vaccine (unknown manufacturer).  In 2008 (approximately two months prior to reporting) the subject received 1st dose of PEDIARIX at 0.5 ml.  At an unspecified time after vaccination with PEDIARIX, the subject experienced swollen lips, hives and trouble breathing.  At the time of reporting the events were resolved.  The healthcare professional considered the events were possibly related to vaccination with PEDIARIX.
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Insomnia, Irritability, Screaming
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of irritability in a 16-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent vaccination included MMR vaccine (manufacturer unspecified) and VARICELLA virus vaccine (manufacturer unspecified) both given on 3 March 2008.  Concurrent medications included Multivitamins (Multivitamin).  On 3 March 2008 at 11:00 the subject inadvertently received 4th dose of PEDIARIX (unknown).  On 3 March 2008, 2 hours after vaccination with PEDIARIX, the subject experienced irritability.  He was screaming at 18:00.  The mother reported that her child was not sleeping at night and had been uncontrollable throughout the day.  The subject experienced a systemic reaction.  The 4th dose of PEDIARIX was considered to be a maladministration (asymptomatic/extra dose given) as a 4th dose of PEDIARIX is not indicated.  At the time of reporting the events were improved.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Body temperature increased, Incorrect dose administered, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of high fever in a 17-month-old female subject who was vaccinated with PEDIARIX. A physician has verified this report. Concurrent vaccination included PREVENAR given on 24 January 2008 at 9:30 the subject inadvertently received a 4th dose of PEDIARIX rather than the planned dose of INFANRIX. The 4th dose of PEDIARIX was considered to be an extra dose administered. The subject experienced a systemic reaction. On 24 January 2008, an unspecified amount of time after vaccination with PEDIARIX, the subject experienced a high fever. Days later, on 27 January 2008, the subject experienced restless sleep. The fever remained for a few days (number not specified) and then resolved. At the time of reporting, restless sleep was unresolved. A physician verified this report in follow-up received on 06 March 2008. Follow-up indicated that the subject was seen on 30 January 2008 with rash, therefore, the possibility of Roseola was brought up as a possible explanation for the fever. Fever lasted from 24 January 2008 to 26 January 2008 with rash starting that day. The maximum temperature for the subject was 103 degrees.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of legs in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKlein).  Previous and/or concurrent vaccination included PEDIARIX (GlaxoSmithKlein); unknown given on an unspecified date.  On 27 November 2007, the subject received 3rd dose of PEDIARIX (.5 ml, unknown,left thigh).  On 27 November 2007, less than one day after vaccination with PEDIARIX, the subject developed swelling of legs, pain, and fever that lasted a few days and resolved.  The reporting healthcare professional stated the subject was vaccinated at another site and did not have the information to provide.  The subject did not have these reactions with the two previous PEDIARIX vaccinations.  Teh healthcare professional reported that this was the 3rd immunization in the PEDIARIX series and that would be considered too early at the age of 4-months to have received three vaccinations (inappropriate schedule of vaccine administered).  On 1 December 2007, the events of swelling of legs, pain and fever had resolved.  The healthcare professional considered the events of swelling of legs, pain, and fever as probably related to vaccination with PEDIARIX.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Fontanelle bulging, Pyrexia
Clinical narrative: This case was reported by a physician, via sales representative and described the occurrence of bulging fontalle in a 4-month-old subject of unspecified gender who was vaccinated with combined PEDIARIX. Previous and/or concurrent vaccination included Haemophilus influenzae tetanus conjugate vaccine; Sanofi; unknown given on an unspecified date; combined PEDIARIX; GlaxoSmithKline; unknown given on an unspecified date; Pneumococcal vaccine, unspecified; Wyeth. On an unspecified date the subject received 2nd dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced bulging fontanelle and fever (greater than 103.0). At the time of reporting the outcome of the events were unspecified.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Adverse reaction, Fontanelle bulging, Inappropriate schedule of drug administration, Laboratory test normal, Lumbar puncture normal
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of bulging Fontanelle in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX. Previous and/or concurrent vaccinations given on the same day as PEDIARIX included Haemophilius influenzae type B vaccine, manufacturer unspecified; pneumococcal vaccine, unspecified; manufacturer unspecified. On an unspecified date the subject received 2nd dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced bulging Fontanelle. The subject required medical attention in the physician's office. It was unknown if the bulging Fontanelle was a congenital anomaly / birth defect. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event possibly related to vaccination with PEDIARIX. On 11 February 2008 follow-up was received via the healthcare professional. She reported that the 4 month old male subject received the first dose of PEDRIX on 16 October 2007 and the second dose of PEDIARIX on 07 January 2008. Concurrent vaccinations given on the same day as PEDIARIX included ROTATEQ, oral route, manufacturer unspecified, along with Haemophillus influenzae type B vaccine; manufacturer unspecified, pneumococcal vaccine, unspecified; manufacturer unspecified. On 07 January 2008, the subject experienced an inappropriate schedule of vaccine administered. Three days following vaccination with with PEDIARIX, on 10 January 2008, the subject experienced a bulging Fontanelle and an unspecified adverse reaction. The subject was seen by the physician. A spinal tap and unspecified laboratory tests were performed and all results  were normal. The healthcare professional noted that the events were not serious and she considered that the bulging Fontanelle and unspecified adverse reaction were possibly related to the use of PEDIARIX. The healthcare professional noted that the bulging Fontanelle  was not associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via medicinal product. On an unspecified date, the bulging Fontanelle and unspecified adverse reaction resolved.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Crying
Clinical narrative: This case was reported by a consumer, and subsequently confirmed by a physician, that described the occurrence of prolonged crying in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and (PEDIARIX, GlaxoSmithKline) for prophylaxis. Concurrent vaccinations given on 08 November 2007 included HAEMOPHILIUS INFLUENZAE type B vaccine; manufacturer unspecified; (ROTATEQ, manufacturer unspecified); (PREVNAR, manufacturer unspecified). On 08 November 2007 at 10:00, the subject received the 1st dose of PEDIARIX (dose and route of administration unspecified, unknown thigh). Three hours after vaccination with PEDIARIX, the subject experienced prolonged crying. The child's mother reported that the event resolved after 7.5 hours. Follow-up information was received on 10 March 2008 via a physician, who reported that the subject was treated with Tylenol. At the time of this report, the subject had not received the 2nd dose of PEDIARIX. The reporting physician considered the event to be almost certainly related to vaccination with PEDIARIX.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 6 week-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HIB vaccine (Merck) and PNEUMOCOCCAL vaccine (Wyeth).  On 18 May 2007 and 28 August 2007 the subject received 1st dose and 2nd dose of PEDIARIX (.5 ml, unknown) in the left leg.  On 18 May 2007, less than one day after vaccination with PEDIARIX, the subject experienced crying.  The constant crying lasted for 5 hours after vaccination with PEDIARIX and then resolved.  On 28 August 2007, the subject received the second dose of PEDIARIX and experienced constant crying for five hours after vaccination with PEDIARIX.  Further doses of PEDIARIX were delayed and then discontinued due to these events.  Following a dose of tetanus and diphtheria (unknown manufacturer) on 07 November 2007 there were no reports of crying at the time of this report.  The reporter stated that the physician believed that the crying was caused by the pertussis component of the PEDIARIX.  Medical attention was not required.  At the time of reporting the outcome of the events were resolved.  The healthcare professional considered the crying was probably related to vaccination with PEDIARIX.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with PEDIARIX. On an unspecified time after vaccination with PEDIARIX, the subject experienced fever. At the time of reporting the outcome of the event was unspecified. The reporting physician was speaking with a GSK sales representative about PEDIARIX and mentioned that other physicians using PEDIARIX had complained about fever with the product. No other specifics offered. Following-up was received on 9 November 2007. A nurse from the reporting physician's office noted that this doctor does not prescribe PEDIARIX.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a 60-year-old female subject who was vaccinated with ENGERIX B. On 23 September 2004, the subject received the 3rd dose of ENGERIXB (unknown), to complete the three dose series. The 2nd dose of ENGERIX B (unknown) was given on 25 February 2004. On 12 June 2007, approximately three years after receiving the 3rd dose in the Hepatitis B vaccination series, the subject had a titer drawn that was hepatitis B antibody negative. At the time of reporting the outcome of the events was unspecified.
Age: 0.7
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to a seven-month-old has been received from a physician concerning a seven-month-old male who received FLUMIST on 01-Dec-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. on 16-Dec-2008, 15 days after the patient received FLUMIST, the physician's nurse confirmed that there were no late-occurring adverse events reported.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report administered expired FLUMIST was received from a nurse concerning a four-year-old male. The patient received FLUMIST on 02-Dec-2008. The patient was given FLUMIST that expired in December 2007. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1 customers not discarding product from the previous season and 2 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-APR-2009: product complaint investigation results.
Age: 1.8
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Cough, Nasal congestion, Nasal mucosal discolouration, Pyrexia
Clinical narrative: A spontaneous non serious report of stuffy nose, fever, green mucus coming out of her nose and coughing was received from the patient's mother concerning a 21-month-old female patient subsequent to accidental exposure to FLUMIST. This case in submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included a similar reaction when the mother's roommate received FLUMIST last year. Concomitant medications were not reported. The patient did not receive FLUMIST. On 01-Dec-2008, her father received FLUMIST. Twenty-four hours later, the patient developed stuffy nose, fever, and coughing. On 02-Dec-2008, the patient had green colored mucus coming from her nose. The events of stuffy nose, fever, and coughing were ongoing. Follow-up Information 23-APR-2009: No additional information available. Reported refused to be contacted.
Age: 1.8
Sex: F
Vaccine: FLUN3
Symptoms: Secondary transmission
Clinical narrative: A spontaneous non serious report of stuffy nose, fever, green mucus coming out of her nose and coughing was received from the patient's mother concerning a 21-month-old female patient subsequent to accidental exposure to FLUMIST. This case in submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included a similar reaction when the mother's roommate received FLUMIST last year. Concomitant medications were not reported. The patient did not receive FLUMIST. On 01-Dec-2008, her father received FLUMIST. Twenty-four hours later, the patient developed stuffy nose, fever, and coughing. On 02-Dec-2008, the patient had green colored mucus coming from her nose. The events of stuffy nose, fever, and coughing were ongoing. Follow-up Information 23-APR-2009: No additional information available. Reported refused to be contacted.
Age: 1.59
Sex: M
Vaccine: DTAP, FLUN3, IPV, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious report "given FLUMIST to 19-month-old" was received from a doctor's medical assistant involving a 19-month-old male. On 14-Dec-2008 the patient received FLUMIST. On the same day, the patient received hepatitis B, DTap, PCV, IPV/OPV vaccines. The patient had no relevant medical history. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FLUMIST.
Age: 0.9
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non serious report of "gave FLUMIST to an 11-month-old" has been received from a registered nurse concerning an 11-month-old male. Medical history and concomitant medications were not reported, There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved, This case is admitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 24-Dec-2008 was incorporated into the narrative and included the patient's gender. The reporting nurse confirmed that there were no late-occurring adverse events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired product has been received from a registered nurse concerning a four-year-old male who received FLUMIST on 15-Nov-2008. FLUMIST expired on 12-Nov-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessment's are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. 01/05/09 On 05-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events reported. 01/05/09 Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
Age: 0.6
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non serious, spontaneous report of administration of FLUMIST to a seventh month-old was received from a nurse. There was no adverse event associated with the medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 1.3
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non serious, spontaneous report of gave expired FLUMIST to a three-year-old female patient was received from a medical assistant. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 moths of age for FLUMIST. This is in follow-up to report(s) previously submitted on 12/16/08. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 06-Jan-2009 and incorporated the narrative: no adverse event occurred. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Fatigue, Influenza, Influenza serology positive, Oropharyngeal pain
Clinical narrative: A non serious spontaneous report of influenza A, fatigue, fever, sore throat, and stomach ache has been received from a physician concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance to a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history included an enterovirus on the 04-Nov (year unreported). The patient received FLUMIST 0.2ml intranasally for influenza vaccine on 22-Oct-2008. On 14-Dec-2008, the patient experienced fatigue, fever, a=sore throat, stomach ache, and was positive for Influenza A on 150Dec-2008, when tested with BIONEX rapid Influenza A&B test. On 15-Dec-2008, she had a negative rapid streptococcal test and a urinalysis revealed large ketones. The patient was treated with oseltamivir phosphate and was sent home to be followed up in one week. The events resolved on an unreported date in 2008.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Streptococcal identification test negative, Urine analysis abnormal, Urine ketone body present
Clinical narrative: A non serious spontaneous report of influenza A, fatigue, fever, sore throat, and stomach ache has been received from a physician concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance to a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history included an enterovirus on the 04-Nov (year unreported). The patient received FLUMIST 0.2ml intranasally for influenza vaccine on 22-Oct-2008. On 14-Dec-2008, the patient experienced fatigue, fever, a=sore throat, stomach ache, and was positive for Influenza A on 150Dec-2008, when tested with BIONEX rapid Influenza A&B test. On 15-Dec-2008, she had a negative rapid streptococcal test and a urinalysis revealed large ketones. The patient was treated with oseltamivir phosphate and was sent home to be followed up in one week. The events resolved on an unreported date in 2008.
Age: 1.92
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non serious report of a child under two years of age who received FLUMIST was received from a registered nurse concerning a 23-month-old female. The patient's medical history wand concomitant medications were not reported. On 19-Dec-2008, the child was given FLUMIST. The patient's name was inadvertently entered in the clinic's schedule on 19-DEC-2008 to receive FLUMIST although she was still only 23 months old. The information regarding the patient's age was missed by both the clinic physician and the nurse-in-charge of the immunization. On 20-Dec-2008, the patient was brought back to the clinic for her scheduled baby follow-up. Her physical examinations were all normal and there was also no report of adverse event relating to FLUMIST vaccination. As of 12-Jan-2009, no report of delayed occurring adverse with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 12-Jan-2009 and incorporated in the narrative including the corrected date of FLUMIST vaccination as 19-Dec-2008 as well as reporter's confirmation that there was no delayed occurring adverse event.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non serious report of administered expired FLUMIST was received from a registered nurse concerning a four-year-old female. Medical history and concomitant medications were not reported. On 22-Dec-2008, the patient received FLUMIST that expired on 10-Dec-2008. The physician was made ware of the incident and has decided not to redose FLUMIST. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments, are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month for FLUMIST.  This is in follow-up to report(s) previously submitted on 12/23/2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. On 08-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events. Follow-up information received on 24-MAR-2009 included Product Complaint Investigation results.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Product quality issue
Clinical narrative: A non serious, spontaneous report of administration of expired product was received from a nurse concerning a two year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. There are no events reported after follow-up. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 08-Jan-2009 and incorporated into the narrative follow-up outcome. Follow-up information was received on 07-Apr-2009: Product Complaint Investigation results.
Age: 3.2
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired product was received from a registered nurse concerning a 38-month-old female. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. There was no adverse event associated with medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 10-Mar-2009 that no delayed adverse events resulted from this error. 3/25/2010 Based on the results of the investigation, the root cause fro the medication errors were caused by 1) customers not discarding product from the previous season and  2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009 product complaint investigation results.