chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of extensive swelling of the vaccinated limb in a 4-year-old male subject who was vaccinated with INFANRIX, AVENTIS. On 12 March 2008 at 12:30 the subject received 5th dose of INFANRIX (unknown, left arm) and the subject received 3rd dose of Polio vaccine (unknown). On 14 March 2008, 2 days after vaccination with INFANRIX and Polio vaccine, the subject experienced severe swelling in left upper arm through elbow. This case was also associated with a pharmaceutical product complaint as the reporter is concerned that something is wrong with these vaccines and that they ar holding on to them to return to GSK if necessary. The lot number for INFANRIX was reported to be AC14606999. The physician considered the events were clinically significant (or requiring intervention). The subject was seen in the physician's office and treated with antibiotics. At the time of reporting the outcome of the severe arm swelling was resolved. The physician considered the extensive swelling of the vaccinated limb was possibly related to vaccination with INFANRIX and Polio vaccine. The physician indicated that she had a second patient with the same issues. See GSK case number A0723483A for details. Follow-up information was received on 09 May 2008 via a physician, who reported that the polio vaccine received was actually the 4th dose in the series, rather than 3rd dose as originally reported. The reporting physician also indicated that the extensive swelling of the vaccinated limb was not related to the Polio vaccine. In addition, the physician stated that the event occurred on 15 March 2008, three days after vaccination with INFANRIX instead of 14 March 2008 as originally reported. The physician stated that the subject was also treated with steroid, in addition to the originally reported antibiotics, and the events resolved. The physician considered the event to be possibly related to the use of INFANRIX, and also listed this particular batch (lot # AC14B069AA) of the vaccine as a possible cause.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP
Symptoms: Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of the left arm in a 4-year-old male subject who was vaccinated with (DTaP, GlaxoSmithKline). Concurrent vaccination included (AVENTIS), MMR (Merck) and VARIVAX (Merck) all given on 18 March 2008. There were no concurrent medications. On 12 March 2008 at 12:30 the subject received 5th dose of DTaP. On 14 March 2008, 2 days after vaccination with DTaP, the subject experienced swelling of the left arm. The subject was treated with prednisone and KEFLEX. At the time of reporting the event was resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of the left arm in a 4-year-old male subject who was vaccinated with (DTaP, GlaxoSmithKline). Concurrent vaccination included (AVENTIS), MMR (Merck) and VARIVAX (Merck) all given on 18 March 2008. There were no concurrent medications. On 12 March 2008 at 12:30 the subject received 5th dose of DTaP. On 14 March 2008, 2 days after vaccination with DTaP, the subject experienced swelling of the left arm. The subject was treated with prednisone and KEFLEX. At the time of reporting the event was resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of the left arm in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included IPOL (Aventis), MMR II (Merck) and VARIVAX (Merck) all given on 18 March 2008. There were no concurrent medications. On 18 March 2008 at 12:30 the subject received 5th dose of INFANRIX. On 20 March 2008, 2 days after vaccination with INFANRIX, the subject experienced swelling of the left arm. The subject was treated with Prednisone and Keflex. At the time of reporting the outcome of the event was unspecified.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inconsolable crying in a 2-month-old male subject who was vaccinated with (INFANRIX). On an unspecified date the subject received 2nd dose of INFANRIX. On 18 October 2007 at 13:50 the subject received 1st dose of INFANRIX at 0.5 ml in the right thigh. At an unspecified time after vaccination with INFANRIX, the subject experienced inconsolable crying. The reporter was not sure if the event occurred following the 1st dose of INFANRIX or the 2nd dose of INFANRIX. At the time of reporting the outcome of the event was not specifically stated, however, the reporter did say that the subject experienced inconsolable crying for 8 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with (INFANRIX, GlaxoSmithKline). Previous and/or concurrent vaccination included seasonal (FLUZONE, non-gsk); Sanofi; right arm given on 20 October 2008. On 20 October 2008 at 14:15, the subject received 5th dose of INFANRIX (.5 ml, unknown left arm). On 22 October 2008, 2 days after vaccination with INFANRIX, the subject experienced swelling injection site. The sales representative was informed that this pediatric subject received INFANRIX and experienced swelling at the injection site. A FLUZONE vaccine was also given in the right arm and not considered a co-suspect vaccine. The subject's mother brought him into clinic. BENADRYL and cold compresses were prescribed. The mother was also told to outline swelling and monitor for increase in size from 3.5 inches to 3.75 inches. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 01 December 2008, via healthcare professional who reported the subject's events occurred on 22 October 2008 and resolved on 24 October 2008. The reporting healthcare professional considered the events related to vaccination with INFANRIX.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with (INFANRIX, GlaxoSmithKline). Previous and /or concurrent vaccination included (IPOL, non-gsk); Sanofi; right arm given on 14 October 2008. On 14 October 2008, the subject received 3rd dose of INFANRIX (.5 ml, unknown left arm). On 16 October 2008, 2 days after vaccination with INFANRIX, the subject experienced swelling injection site and injection site redness. The sales representative was informed that this pediatric subject received INFANRIX and experienced redness and swelling at the injection site. An IPOL vaccine was also given in the right arm and not considered a co-suspect vaccine. The subject's mother called the clinic to report the findings. The immunization series was delayed. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 01 December 2008 via healthcare professional; who reported the subject's events started one day after vaccination with INFANRIX on 15 October 2008 and resolved on 17 October 2008. The reporting healthcare professional considered the events related to vaccination with INFANRIX.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Generalised non-convulsive epilepsy, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 14 year old female with a history of premature birth (36 weeks) on 03-SEP-2008 was vaccinated into the left arm with GARDASIL (lot # 659184/0843X). Concomitant therapy included MENACTRA. Approximately two weeks after the patient got the 1st GARDASIL she started having seizures. The patient had no family history of seizures (also reported as has family history of seizures in paternal aunt) and had always been a healthy person. She was now on medication to help control the seizures (KEPPRA) 500 mg in the morning and 1000 mg at night. On 08-APR-2009 neuroconsults received which was dated from 30-DEC-2008 and 20-JAN-2009. The patient was for evaluation of seizures following multiple episodes of shaking of left arm, staring and unresponsiveness. Episodes first began in late summer 2008 which consisted of just arm shaking lasting less than a minute. In November 2008 the patient complained of headache and the parents noticed the patient with left arm a shaking, dropped the object which the patient was holding, staring and unresponsive. The patient had awareness of event but was unable to speak. And it was resolved after approximately 1 minute. In early December 2008 the patient was found apparently sleeping on bathroom floor and slept two hours after event. The patient was sent for EEG (electroencephalography) which was abnormal and c/w non-convulsive primary generalized epilepsy. Brain MRI (magnetic resonance imaging) was within normal limits. Head CT (computed axial tomography) was within normal limits. Follow up on 20-JAN-2009 with continued episodes. In addition, the patient again found on bath room floor apparently sleeping. So the patient started on KEPPRA although unclear if episodes were seizures. Generalised non-convulsive epilepsy, staring, headache, speech disorder, tremor and unresponsive to stimuli was considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 659184/0843X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. The VAERS ID # is 343494.  Follow-up: Pt is still currently taking medication to control her seizure's. 05/12/10 Follow up: Patient is still currently taking medication to control her seizures.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging normal, Speech disorder, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 14 year old female with a history of premature birth (36 weeks) on 03-SEP-2008 was vaccinated into the left arm with GARDASIL (lot # 659184/0843X). Concomitant therapy included MENACTRA. Approximately two weeks after the patient got the 1st GARDASIL she started having seizures. The patient had no family history of seizures (also reported as has family history of seizures in paternal aunt) and had always been a healthy person. She was now on medication to help control the seizures (KEPPRA) 500 mg in the morning and 1000 mg at night. On 08-APR-2009 neuroconsults received which was dated from 30-DEC-2008 and 20-JAN-2009. The patient was for evaluation of seizures following multiple episodes of shaking of left arm, staring and unresponsiveness. Episodes first began in late summer 2008 which consisted of just arm shaking lasting less than a minute. In November 2008 the patient complained of headache and the parents noticed the patient with left arm a shaking, dropped the object which the patient was holding, staring and unresponsive. The patient had awareness of event but was unable to speak. And it was resolved after approximately 1 minute. In early December 2008 the patient was found apparently sleeping on bathroom floor and slept two hours after event. The patient was sent for EEG (electroencephalography) which was abnormal and c/w non-convulsive primary generalized epilepsy. Brain MRI (magnetic resonance imaging) was within normal limits. Head CT (computed axial tomography) was within normal limits. Follow up on 20-JAN-2009 with continued episodes. In addition, the patient again found on bath room floor apparently sleeping. So the patient started on KEPPRA although unclear if episodes were seizures. Generalised non-convulsive epilepsy, staring, headache, speech disorder, tremor and unresponsive to stimuli was considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 659184/0843X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. The VAERS ID # is 343494.  Follow-up: Pt is still currently taking medication to control her seizure's. 05/12/10 Follow up: Patient is still currently taking medication to control her seizures.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Immunology test abnormal, Inappropriate schedule of drug administration, Incorrect dose administered, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of swelling at the injection site in a 5-year-old male subject who was vaccinated with DTAP, unknown manufacturer. A physician or other health care professional has not verified this report. In April 2006, the subject 5th dose of DTAP at the age of 3 years and 3 months following two bouts of pneumonia and an immunology screen showing depressed tetanus immunity. This was considered to be a decreased therapeutic response. The dates of previous DTAP administrations were not provided. This was considered to be an inappropriate schedule of drug administration as the 5th dose of DTAP was given too soon. No adverse events from that administration were reported. On 25 March 2008, the subject received a 6th dose of DTAP and an unknown amount of time later developed swelling at the injection site, injection site redness, injection site pruritus and low grade fever. On the evening of administration of the 6th dose of DTAP was considered to be an extra dose. At the time of reporting the outcome of the events was unspecified. Follow-up information received via the subjects mother on 28 March 2008 indicated that according to the child's physician, the child had received a different DTAP vaccine and not INFANRIX as was previously reported. Above details have been changed accordingly.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia, Therapeutic response decreased
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of swelling at the injection site in a 5-year-old male subject who was vaccinated with DTAP, unknown manufacturer. A physician or other health care professional has not verified this report. In April 2006, the subject 5th dose of DTAP at the age of 3 years and 3 months following two bouts of pneumonia and an immunology screen showing depressed tetanus immunity. This was considered to be a decreased therapeutic response. The dates of previous DTAP administrations were not provided. This was considered to be an inappropriate schedule of drug administration as the 5th dose of DTAP was given too soon. No adverse events from that administration were reported. On 25 March 2008, the subject received a 6th dose of DTAP and an unknown amount of time later developed swelling at the injection site, injection site redness, injection site pruritus and low grade fever. On the evening of administration of the 6th dose of DTAP was considered to be an extra dose. At the time of reporting the outcome of the events was unspecified. Follow-up information received via the subjects mother on 28 March 2008 indicated that according to the child's physician, the child had received a different DTAP vaccine and not INFANRIX as was previously reported. Above details have been changed accordingly.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by an other manufacturer via a nurse and described the occurrence of nausea in a female subject who was vaccinated with (Dtpa, manufacturer unspecified). On an unspecified date the subject received unspecified dose of Dtpa (unknown). At an unspecified time after vaccination with Dtpa, the subject experienced nausea and vomiting. Medical attention was sought.  At the time of reporting the events were resolved. Follow-up information was received on 21 April 2008, via nurse, who reported the 61-year-old subject's events lasted a couple of days and resolved. The reporting nurse questioned if the events were related to erroneous administration. The subject received a concomitant vaccination of ZOSTAVAX on 25 March 2008.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccinated with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. This case, A0722975A, serves as the master case. The other case numbers are A0722979A, A0722980A and A0722981A. Follow-up information was received on 25 April 2008, via physician, who reported the 2-month old female subject received 1st dose INFANRIX and COMVAX on 02 April 2008. On 3 April 2008, 1 day after vaccination with INFANRIX, the subject experienced swelling of the entire thigh. At the time of reporting the event was improved. The physician considered the event was related to vaccination with INFANRIX. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFANRIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who reported the 2-month-old subject experienced limb swelling. The physician believed there was a problem with this particular lot of INFANRIX.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered at inappropriate site, Lymphadenopathy, Product quality issue, Pyrexia, Swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. Case A0722975A serves as the master case. The other case numbers are A0722979, A0722980A and A0722981A. Follow-up information was received on 25 April 2008, via physician , who reported the 4-year-old male subject was vaccinated with INFANRIX, (GlaxoSmithKline). On 19 March 2008 the subject received 5th dose of INFANRIX (unknown, unknown gluteal). On 19 March 2008, as a result of vaccination with INFANRIX, in the "buttock", the subject experienced vaccine administered at inappropriate site. On 20 March 2008, 1 day after vaccination with INFANRIX, the subject experienced swelling in considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFANRIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who believed there was a problem with this particular lot of INFANRIX.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site swelling, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. Case A0722975A serves as the master case. The other case numbers are A0722979A, A0722980A, A0722981A. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFANRIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who reported limb swelling in a 2-year-old subject. The physician believed there was a problem with this particular lot of INFANRIX.
Age: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKilne). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. Case A0722975A serves as the master case. The other case numbers are A0722979A, A0722980A and A0722981A. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFNARIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who reported limb swelling in a 6-month-old subject. The physician believed there was a problem with this particular lot of INFANRIX.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of extensive swelling of vaccinated limb in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of INFANRIX (unknown).  At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling in the upper arm where the vaccine was received.  This case was also associated with a pharmaceutical product complaint as the reporter is concerned that something is wrong with these vaccines and that they are holding on to them to return to agency if necessary.  At the time of reporting the outcome of the extensive swelling of the vaccinated limb was unspecified.  The reporter stated that this same event occurred in another subject.  See agency case number A0723454A for details.  Follow-up information was received on 09 May 2008 via a physician, who reported that the subject was a 4 year-old male, who received the 5th dose of INFANRIX on 18 March 2008.  Co-suspect vaccine administered on 18 March 2008 included the 4th dose of IPOL (Sanofi-Aventis).  Approximately two days after vaccination with INFANRIX and IPOL, the subject experienced severe swelling in his left upper arm through his elbow.  The reporting physician considered the event to have jeopardized the patient or required intervention.  The physician indicated that the subject received unspecified treatment and the event resolved.  The physician considered the event to be possibly related to the use of INFANRIX, and also listed this particular batch (lot #AC14B069AA) of the vaccine as a possible cause.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site nodule, Oedema peripheral, Pain, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of legs in a subject of unspecified age and gender who was vaccinated with (INFANRIX, GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of INFANRIX (.5 ml, unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter could not recall any other details, but strongly felt there was a quality issue with INFANRIX. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events probably related to vaccination with INFANRIX.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Oedema peripheral, Pain, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of legs in a subject of unspecified age and gender who was vaccinated with (INFANRIX, GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of INFANRIX (.5 ml, unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter could not recall other details, but strongly felt there was a quality issue with INFANRIX because she has not seen there events occur so often over the last four years she has worked within the practice. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events probably related to vaccination with INFANRIX.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Local swelling, Product quality issue
Clinical narrative: This case was reported by a physician and described the occurrence of swollen buttocks in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included IPV; Sanofi Pasteur MSD; unknown; unknown given on 25 March 2008. On 25 March 2008, the subject received 5th dose of INFANRIX (.5 ml, unknown). On 26 March 2008, 1 day after vaccination with INFANRIX, the subject experienced swollen buttocks. The physician believed there was a problem with this particular lot of INFANRIX. At the time of reporting the outcome of the events was unspecified.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, UNK
Symptoms: Erythema, Incorrect dose administered, Lymph node pain, Lymphadenopathy, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen axillary nodes in a 5-year-old male subject who was vaccinated with INFANRIX, MMR II (Merck). Concurrent vaccination included IPOL and unspecified vaccine PPD both given on 7 May 2008. On 7 May 2008 at 09:45 the subject received 5th booster dose of INFANRIX at 0.5 ml, intramuscularly in the left arm and 2nd dose of MMR II vaccine at 0.5 ml subcutaneously in the right tricep. Approximately 12 to 24 hours later, on 8 May 2008, the subject experienced swollen axillary nodes, erythema, swelling and itching. Also reported was pain in axillary node and a warm axillary node. Erythema, swelling and itching resolved at an unspecified time. Swelling of the axillary node was unresolved. The outcome of the axillary node tenderness and warm axillary node was not specified. While being seen for these events in the physician's office, it was noted that the subject received a 4th dose of INFANRIX intramuscularly in the left deltoid on 30 March 2007. According to the reporter, this dose of INFANRIX was not needed. This was considered to be an extra dose administered. The healthcare professional considered the events of swollen axillary node, erythema, swelling and itching to be probably related to vaccination with INFANRIX and MMR II vaccine. Follow-up information received on 16 June 2008 indicated that the events were unresolved and possibly related to treatment with INFANRIX. The subject's mother reportedly called the reporter on 23 May 2008 and stated that her daughter's axillary node was still enlarged. She also mentioned that it was not tender. Swollen axillary gland was documented in follow-up.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, UNK
Symptoms: Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen axillary nodes in a 5-year-old male subject who was vaccinated with INFANRIX, MMR II (Merck). Concurrent vaccination included IPOL and unspecified vaccine PPD both given on 7 May 2008. On 7 May 2008 at 09:45 the subject received 5th booster dose of INFANRIX at 0.5 ml, intramuscularly in the left arm and 2nd dose of MMR II vaccine at 0.5 ml subcutaneously in the right tricep. Approximately 12 to 24 hours later, on 8 May 2008, the subject experienced swollen axillary nodes, erythema, swelling and itching. Also reported was pain in axillary node and a warm axillary node. Erythema, swelling and itching resolved at an unspecified time. Swelling of the axillary node was unresolved. The outcome of the axillary node tenderness and warm axillary node was not specified. While being seen for these events in the physician's office, it was noted that the subject received a 4th dose of INFANRIX intramuscularly in the left deltoid on 30 March 2007. According to the reporter, this dose of INFANRIX was not needed. This was considered to be an extra dose administered. The healthcare professional considered the events of swollen axillary node, erythema, swelling and itching to be probably related to vaccination with INFANRIX and MMR II vaccine. Follow-up information received on 16 June 2008 indicated that the events were unresolved and possibly related to treatment with INFANRIX. The subject's mother reportedly called the reporter on 23 May 2008 and stated that her daughter's axillary node was still enlarged. She also mentioned that it was not tender. Swollen axillary gland was documented in follow-up.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of erythema in a child subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received 5th or 4th dose of INFANRIX. At an unspecified time after vaccination with INFANRIX, the subject experienced erythema and swelling. At the time of reporting the outcome of the events was unspecified. It was reported that "the practice" has seen an increase in redness and swelling with the use of INFANRIX used for the 4th and 5th doses. The reporter stated that is more redness and swelling with the INFANRIX pre-filled syringe than compared to using the "Sanofi DTaP vaccine in a vial. The reporter speculated that he increase in redness and swelling with INFANRIX may by due to the air bubble in the INFANRIX pre-filled syringe. The extent of the redness and swelling was not reported, therefore, it is unknown if the redness and swelling is at the injection site location or is more systemic in nature. The number of subjects involved was not known.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of swelling in legs in a subject of unspecified age and gender who was vaccinated with DTaP (manufacturer unspecified), IPV. On an unspecified date the subject received unspecified dose of DTaP (unknown, unknown thigh) and unspecified dose of IPV (unknown, unknown thigh). At an unspecified time after vaccination with DTaP and IPV, the subject experienced swelling of legs. At the time of reporting the event was resolved. The reporter stated that this event happened years ago when they used unknown DTaP vaccine with separate IPV vaccine, injected into the same leg. An unknown number of subjects experienced limb (leg) swelling. When they switched to administering the DTaP in one leg and the IPV in the other leg, the limb (leg) swelling no longer occurred. The event was associated with giving both DTaP and IPV in the same leg.
Sex: U
Vaccine: DTAP
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of nonspecific reaction in a subject of unspecified age and gender who was vaccinated with DTP (A or W not known) vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of DTP (A or W not known) (unknown). At an unspecified time after vaccination with DTP (A or W not known), the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified. This event was reported because the reporter would like to give BOOSTRIX to the subject who experienced an unspecified moderate reaction to a DTaP or DTwP vaccine approximately 10 years ago. Event reported as above.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Nausea, Nonspecific reaction, Vomiting
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of nausea in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. Following vaccination with PEDIARIX in April 2004, the subject experienced nausea, vomiting, abnormal stools, digestive problems, inability to gain weight and food allergies including diary and wheat sensitivities. On 05 August 2008 at 15:45, the subject received 1st dose of INFANRIX at 0.5 ml in the left arm. In the morning of the day following vaccination with INFANRIX, on 06 August 2008, the subject experienced nausea and began vomiting. This was a systemic reaction. The event were unresolved at the time of reporting. The subject has a history of a similar reaction following vaccination with PEDIARIX in April 2004. For information surrounding this report, refer to case number A0742470A.
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced an unspecified (localized) injection site reaction. At the time of reporting the outcome of the event was unspecified. The reporter stated this event occurred in as many as 10 subjects. Other vaccines given at this facility include ADACEL (Sanofi), MMR and VARIVAX. The site was trying to rule out the source. No concurrent vaccines were mentioned in this report.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a physician, via a GSK sales representative, that described the occurrence of swelling at the injection site in an unspecified number of 4-year-old subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date(s) the subjects received the 5th dose of INFANRIX (.5 ml, unknown). At an unspecified time after vaccination with INFANRIX, the subjects experienced swelling at the injection site and injection site redness. A physician reported to a GSK sales representative that she has noticed an increase in injection site swelling and redness in 4-year-olds vaccinated with INFANRIX. The representative reported that the events were primarily occurring in an unspecified number of 4-year-old subjects, but the children of other ages were possibly involved. No other patient specific identifiers were provided for the vaccination subjects. The physician inquired if the formulation of INFANRIX had changed, since she had been using the vaccine for a long period of time and this was a new development. A product complaint was lodged for this report, but no lot number was provided. At the time of reporting the outcome of the events was unspecified. The GSK sales representative noted that there was a pertussis outbreak in the reporting region, but did not know if any of the subjects vaccinated with INFANRIX had been exposed to or diagnosed with pertussis.
Age: 1.6
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in an 18-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline).  Concurrent vaccinations given on 19 August 2008 included the 1st dose of VARIVAX (Merck);  unknown.  On 19 August 2008, the subject received the 4th dose of INFANRIX (.5 ml, unknown, left thigh).  On 21 August 2008, 2 days after vaccination with INFANRIX, the subject experienced swelling at the injection site and injection site redness.  The reporter indicated that medical attention was required at the physician's office.  The reporter stated that the INFANRIX vaccination series was neither discontinued, nor delayed.  At the time of reporting, the outcome of the events was unspecified.  Follow-up information was received on 12 September 2008 via a nurse, which conflicted with the initial information received on this subject.  The nurse indicated that the onset of the events occurred on 19 August 2008, which was the same say that the subject received the INFANRIX vaccination.  After an unspecified period of time, the events were resolved.  The healthcare professional considered the events to be related to vaccination with INFANRIX, but indicated that she did not consider the events to be serious.  The healthcare professional also indicated that the INFANRIX vaccination series was neither discontinued, nor delayed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of injection site in a 5-year-old female subject who was vaccinated INFANRIX (GlaxoSmithKline). Concurrent vaccinations given on 19 August 2008 included the 1st dose of FLUMIST; MedImmune; intranasal; and poliomyelitis virus vaccine; Sanofi Pasteur; unknown. Concurrent medications included TYLENOL. On 19 August 2008, the subject received the 5th dose of INFANRIX (.5 ml, unknown, left arm). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling at the injection site and injection site redness. The reporter indicated that medical attention was required at the physician's office. The reporter stated that the INFANRIX vaccination series was neither discontinued, nor delayed. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 12 September 2008 via a nurse, who reported that the onset of the events occurred on 19 August 2008, on the same day the subject received the INFANRIX vaccination. After an unspecified period of time, the events were resolved. The healthcare professional considered the events to be related to vaccination with INFANRIX, but indicated that she did not consider the events to be serious. The healthcare professional also indicated that the INFANRIX vaccination series was neither discontinued, nor delayed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent medical conditions included allergies and eczema. Concurrent vaccinations given on 20 August 2008 included the 1st dose of FLUMIST MedImmune; intranasal; and IPOL; Sanofi Pasteur; unknown. On 20 August 2008, the subject received the 5th dose of INFANRIX (.5 ml, unknown, left arm). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling at the injection site and injection site redness. The reporter indicated that medical attention was required at the physician's office. The reporter stated that the INFANRIX vaccination series was neither discontinued, nor delayed. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 12 September 2008 via a nurse, who reported that the onset of the events occurred on 22 August 2008, two days after vaccination with INFANRIX. After an unspecified period of time, the events were resolved. The healthcare professional considered the events to be related to vaccination with INFANRIX, but indicated that she did not consider the events to be serious. The healthcare professional also indicated that the INFANRIX vaccination series was neither discontinued, nor delayed.
Sex: U
Vaccine: DTAP
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 INFANRIX, GlaxoSmithKline. On an unspecified date in (2005 and 2006) the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced an unspecified adverse event. The reporter believed that the thimerosal harmed her baby. Details were not provided. At the time of reporting the outcome of the event unspecified. The Pharmacist wanted to know the thimerosal content of several lot numbers of GSK vaccine given in 2005 and 2006. Two additional lot numbers, in addition to that for INFANRIX, provided in the report were AC21B047BA and AC21B033BA.
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 4-month-old male subject who was vaccinated with Dtap (manufacturer unspecified).  On an unspecified date the subject received a dose of Dtap (unknown manufacturer).  At an unspecified time after vaccination with Dtap, the subject experienced crying.  The reporter was not sure if the vaccine given was INFANRIX or another manufacturer's Dtap.  At the time of reporting the outcome of the event was not known.
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the event was unspecified. This event occurred in 7 patients. Linked cases include A0746425A, A0746426A, A0746427, A0746428A, A074629A and A0746430A. Follow-up identified a product complaint number. It was additional reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on November 2008 from GSK and stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse event were recorded."
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746426A, A0746427, A0746428A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
Sex: U
Vaccine: DTAP
Symptoms: Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746427, A0746428A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."