chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3176AA received on 17 October 2008, lot number C3200AA received on 22 December 2008 and lot number C3228AA received on 23 February 2009; and one dose of DAPTACEL; lot number C3139AA received on 08 December 2009 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 01 June 2012, approximately two years and six months after the last dose. On 04 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive apnea. Laboratory testing included positive PCR on 12 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3176AA received on 17 October 2008, lot number C3200AA received on 22 December 2008 and lot number C3228AA received on 23 February 2009; and one dose of DAPTACEL; lot number C3139AA received on 08 December 2009 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 01 June 2012, approximately two years and six months after the last dose. On 04 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive apnea. Laboratory testing included positive PCR on 12 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Contusion, Fall, Syncope
Clinical narrative: Pt received HPV vaccine appeared fine while sibling received vaccine, pt fainted. Fell to floor. Responded almost immediately, bruised arm, no other injuries noted. BP, pulse stable. Released after 15 mins.
Age: 1.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 4 doses of PENTACEL; lot number C3498AA received on 03 December 2009, lot number C3579AA received on 02 February 2010, lot number C3608AA received on 09 April 2010 and lot number C3801AA received on 22 April 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 08 June 2012, approximately one year and two months after the last dose. On 10 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 15 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 15 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 4 doses of PENTACEL; lot number C3498AA received on 03 December 2009, lot number C3579AA received on 02 February 2010, lot number C3608AA received on 09 April 2010 and lot number C3801AA received on 22 April 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 08 June 2012, approximately one year and two months after the last dose. On 10 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 15 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 15 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3324AA received on 01 March 2010, lot number C3404AA received on 04 May 2010 and lot number C3451AA received on 12 July 2010 and one dose of DAPTACEL; lot number C3473AA received on 12 April 2011 (routes and sites of administration not reported). On 07 June 2012, the subject developed a paroxysmal cough with a whoop, approximately one year and two months after the last dose. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3324AA received on 01 March 2010, lot number C3404AA received on 04 May 2010 and lot number C3451AA received on 12 July 2010 and one dose of DAPTACEL; lot number C3473AA received on 12 April 2011 (routes and sites of administration not reported). On 07 June 2012, the subject developed a paroxysmal cough with a whoop, approximately one year and two months after the last dose. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Culture positive, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 15-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3872AB received on 16 May 2011, lot number C3911AA received on 25 July 2011 and lot number C3926AC received on 12 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough with a whoop on 16 June 2012, approximately nine months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and positive culture on 20 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 15-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3872AB received on 16 May 2011, lot number C3911AA received on 25 July 2011 and lot number C3926AC received on 12 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough with a whoop on 16 June 2012, approximately nine months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and positive culture on 20 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report was received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of TRIPEDIA: lot number U2289CA on 21 August 2007, lot number U2291BA on 20 November 2007, lot number U2291BA on 22 January 2008 and a dose of DAPTACEL, lot number C2953AA, on 29 September 2008 (route and site of administration not reported). The subject developed catarrhal illness on 12 May 2012, nearly 4 years after the last dose. On 14 May 2012, the subject developed a paroxysmal cough (without whoop). The subject also experienced posttusive vomiting. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for five days. The subject was not hospitalized. At the time of final contact on 04 June 2012, the subject's cough was still persisting. The duration of the cough reported at that time was 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report was received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of TRIPEDIA: lot number U2289CA on 21 August 2007, lot number U2291BA on 20 November 2007, lot number U2291BA on 22 January 2008 and a dose of DAPTACEL, lot number C2953AA, on 29 September 2008 (route and site of administration not reported). The subject developed catarrhal illness on 12 May 2012, nearly 4 years after the last dose. On 14 May 2012, the subject developed a paroxysmal cough (without whoop). The subject also experienced posttusive vomiting. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for five days. The subject was not hospitalized. At the time of final contact on 04 June 2012, the subject's cough was still persisting. The duration of the cough reported at that time was 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an eight-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3980AB received on 23 November 2011, lot number C4045AA received on 23 January 2012 and lot number C4131AA received on 21 March 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 22 May 2012, approximately two months after the last dose. On 23 May 2012, the subject developed a cough and on 25 May 2012 he developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 40 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an eight-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3980AB received on 23 November 2011, lot number C4045AA received on 23 January 2012 and lot number C4131AA received on 21 March 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 22 May 2012, approximately two months after the last dose. On 23 May 2012, the subject developed a cough and on 25 May 2012 he developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 40 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.63
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Culture negative, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 16-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3801AA received on 01 April 2011, lot number C3911AA received on 02 June 2011 and lot number C3926AC received on 09 August 2011 (routes and sites of administration not reported). On 18 May 2012, the subject developed a cough, approximately nine months after the last dose. A paroxysmal cough (without whoop) began on 22 May 2012. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and negative culture on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.63
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 16-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3801AA received on 01 April 2011, lot number C3911AA received on 02 June 2011 and lot number C3926AC received on 09 August 2011 (routes and sites of administration not reported). On 18 May 2012, the subject developed a cough, approximately nine months after the last dose. A paroxysmal cough (without whoop) began on 22 May 2012. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and negative culture on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4081AA received on 19 January 2012, lot number C4163AA received on 21 March 2012 and lot number C4231AA received on 21 May 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 26 May 2012, five days after the last dose. On 27 May 2012, the subject developed a paroxysmal cough (without a whoop). The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 28 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4081AA received on 19 January 2012, lot number C4163AA received on 21 March 2012 and lot number C4231AA received on 21 May 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 26 May 2012, five days after the last dose. On 27 May 2012, the subject developed a paroxysmal cough (without a whoop). The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 28 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Computerised tomogram normal, Crying, Dyskinesia, Hypertonia, Laboratory test normal
Clinical narrative: Pt woke up around 9pm crying. Parents tried to comfort her & she became tonic for about 1 min then had left arm & head jerking x 2 min. No evidence of post ictal state afterward. She was seen in the ER & had a CT scan & lab & everything was normal. Concern for reaction to pertussis.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Vaccination complication
Clinical narrative: Pt woke up around 9pm crying. Parents tried to comfort her & she became tonic for about 1 min then had left arm & head jerking x 2 min. No evidence of post ictal state afterward. She was seen in the ER & had a CT scan & lab & everything was normal. Concern for reaction to pertussis.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative, Vomiting
Clinical narrative: Vomiting next day after VARIVAX.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthritis, Autoimmune disorder, Cerebral disorder, Cerebral hypoperfusion
Clinical narrative: This case was reported by a lawyer and described the occurrence of autoimmune disorder in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 26 April 1999 and 27 May 1999. On 27 April 2000 the subject received the 3rd dose of LYMERIX (unknown). In 2009, nine years after the third vaccination with LYMERIX, unspecified testing revealed moderate decrease in cerebral cortical perfusion in a heterogeneous pattern. Based upon the same testing, the subject was also "potentially diagnosed" with white matter changes of the brain. In 2010, he was diagnosed with "post Lyme vaccination autoimmune syndrome". The complaint alleged that the subject had been "misdiagnosed by a multitude of physicians on multiple occasions" until 2010 when his physician "drew a connection between his condition and the LYMERIX vaccine". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Cerebral small vessel ischaemic disease, Impaired work ability, Laboratory test abnormal, Pain, Post vaccination syndrome
Clinical narrative: This case was reported by a lawyer and described the occurrence of autoimmune disorder in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 26 April 1999 and 27 May 1999. On 27 April 2000 the subject received the 3rd dose of LYMERIX (unknown). In 2009, nine years after the third vaccination with LYMERIX, unspecified testing revealed moderate decrease in cerebral cortical perfusion in a heterogeneous pattern. Based upon the same testing, the subject was also "potentially diagnosed" with white matter changes of the brain. In 2010, he was diagnosed with "post Lyme vaccination autoimmune syndrome". The complaint alleged that the subject had been "misdiagnosed by a multitude of physicians on multiple occasions" until 2010 when his physician "drew a connection between his condition and the LYMERIX vaccine". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Quality of life decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of autoimmune disorder in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 26 April 1999 and 27 May 1999. On 27 April 2000 the subject received the 3rd dose of LYMERIX (unknown). In 2009, nine years after the third vaccination with LYMERIX, unspecified testing revealed moderate decrease in cerebral cortical perfusion in a heterogeneous pattern. Based upon the same testing, the subject was also "potentially diagnosed" with white matter changes of the brain. In 2010, he was diagnosed with "post Lyme vaccination autoimmune syndrome". The complaint alleged that the subject had been "misdiagnosed by a multitude of physicians on multiple occasions" until 2010 when his physician "drew a connection between his condition and the LYMERIX vaccine". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: LYME
Symptoms: Activities of daily living impaired, Anxiety, Arthritis, Autoimmune disorder, Cerebral small vessel ischaemic disease
Clinical narrative: This case was reported by a lawyer and described the occurrence of autoimmune disorder in a subject of unspecified age and gender who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 08 June 1999 and 14 July 1999. On 13 July 2000 the subject received the 3rd dose of LYMERIX (unknown). On 23 September 2010, ten years after the third vaccination with LYMERIX and based upon unspecified testing, the subject was potentially diagnosed with demyelinating disease. Based upon testing on 15 October 2010, the subject was diagnosed with white matter changes of the brain. On or after 15 October 2010, the patient was diagnosed with "post Lyme vaccination autoimmune syndrome". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: LYME
Symptoms: Demyelination, Impaired work ability, Laboratory test abnormal, Pain, Post vaccination syndrome
Clinical narrative: This case was reported by a lawyer and described the occurrence of autoimmune disorder in a subject of unspecified age and gender who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 08 June 1999 and 14 July 1999. On 13 July 2000 the subject received the 3rd dose of LYMERIX (unknown). On 23 September 2010, ten years after the third vaccination with LYMERIX and based upon unspecified testing, the subject was potentially diagnosed with demyelinating disease. Based upon testing on 15 October 2010, the subject was diagnosed with white matter changes of the brain. On or after 15 October 2010, the patient was diagnosed with "post Lyme vaccination autoimmune syndrome". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: LYME
Symptoms: Quality of life decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of autoimmune disorder in a subject of unspecified age and gender who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 08 June 1999 and 14 July 1999. On 13 July 2000 the subject received the 3rd dose of LYMERIX (unknown). On 23 September 2010, ten years after the third vaccination with LYMERIX and based upon unspecified testing, the subject was potentially diagnosed with demyelinating disease. Based upon testing on 15 October 2010, the subject was diagnosed with white matter changes of the brain. On or after 15 October 2010, the patient was diagnosed with "post Lyme vaccination autoimmune syndrome". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Dizziness, Mumps antibody test negative, Nausea
Clinical narrative: Temperature 101, dizziness, nausea.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site erythema
Clinical narrative: Lt. thigh redness at inj. site.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Target lesion red on red around the site of MMR. Swelling, redness, warm to the touch.
Sex: M
Vaccine: HEPA
Symptoms: Bone pain, Discomfort, Food allergy, Headache, Latex allergy
Clinical narrative: Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as : hepatitis B vaccine (Recombinant)(30-AUG-2006, 25-OCT-2006, 03-JAN-2007,04-JUN-2007), haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(25-OCT-2006, 03-JAN-2007), rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (25-OCT-2006), poliovirus vaccine inactivated (unspecified)(25-OCT-2006, 03-JAN-2007, 04-JUN-2007, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck)(09-OCT-2007), VAQTA(07-OCT-2007, 19-AUG-2008, 09-OCT-2007), MMR II (09-OCT-2007), H1N1 (09-OCT02007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headaches, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with z-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information regarding ROTATEQ, MARRS# 1207USA00433. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Milk allergy, Nasopharyngitis, Perfume sensitivity, Pharyngeal inflammation, Photophobia
Clinical narrative: Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as : hepatitis B vaccine (Recombinant)(30-AUG-2006, 25-OCT-2006, 03-JAN-2007,04-JUN-2007), haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(25-OCT-2006, 03-JAN-2007), rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (25-OCT-2006), poliovirus vaccine inactivated (unspecified)(25-OCT-2006, 03-JAN-2007, 04-JUN-2007, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck)(09-OCT-2007), VAQTA(07-OCT-2007, 19-AUG-2008, 09-OCT-2007), MMR II (09-OCT-2007), H1N1 (09-OCT02007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headaches, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with z-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information regarding ROTATEQ, MARRS# 1207USA00433. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Photosensitivity reaction, Skin burning sensation, Skin discomfort, Trichotillomania
Clinical narrative: Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as : hepatitis B vaccine (Recombinant)(30-AUG-2006, 25-OCT-2006, 03-JAN-2007,04-JUN-2007), haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(25-OCT-2006, 03-JAN-2007), rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (25-OCT-2006), poliovirus vaccine inactivated (unspecified)(25-OCT-2006, 03-JAN-2007, 04-JUN-2007, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck)(09-OCT-2007), VAQTA(07-OCT-2007, 19-AUG-2008, 09-OCT-2007), MMR II (09-OCT-2007), H1N1 (09-OCT02007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headaches, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with z-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information regarding ROTATEQ, MARRS# 1207USA00433. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Aphagia, Injection site erythema, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Patient complained of pain in jaw, arm - nausea couldn't eat because of pain in jaw - arm was red & sore at injection sight went to PCP stated poisoning from Tdap???
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Vaccination complication
Clinical narrative: Patient complained of pain in jaw, arm - nausea couldn't eat because of pain in jaw - arm was red & sore at injection sight went to PCP stated poisoning from Tdap???
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Bed rest, Cellulitis, Chills, Erythema, Inflammation
Clinical narrative: Patient complained of arm hurting-redness-inflammation-chills-fever-nausea-went her PCP was told it was cellulitis.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of arm hurting-redness-inflammation-chills-fever-nausea-went her PCP was told it was cellulitis.
Age: 21.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Aphagia, Discomfort, Headache, Pain, Pyrexia
Clinical narrative: Can't eat, headache, fever, total body aches.  States feels signs and symptoms have her feeling she is an "8" in discomfort on zero to 10 pain scale. Patient is seeing Open Door on Friday, 7/27/12 on a separate issue.  Will discuss.
Age: 35.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient was seated during Tdap and Hep A vaccine administration.  Approx 5 minutes after administration, patient lost consciousness for less than 1 minute.  Initially patient was held in chair, then lowered to the floor.  Patient was conscious and remained on floor approx 20 minutes.  Patient then remained seated approx 10 more minutes before leaving facility.  Called patient on 7/27/12 to verify patient did not have additional problems.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Grossly bloody stools with mucus for 14-15 hours prior to seeing in office. Did not have stool 07/26 am. No vomiting. Urinating normally. Slept normally.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Fever, chills, local pain at injection site and a rash at injection site.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Deep vein thrombosis, Guillain-Barre syndrome, Immunoglobulin therapy, Maternal exposure during pregnancy
Clinical narrative: Progressive upper and lower extremity weakness felt to be Guillain Barre Syndrome. Please note patient is pregnant. Given IVIG, found to have DVTs left lower extremities, now receiving Gamunex (different type of IVIG) with full dose Lovenox. Slight improvement in upper extremity strength but patient extremely weak in lower extremities 3/5 strength at hips.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness
Clinical narrative: Progressive upper and lower extremity weakness felt to be Guillain Barre Syndrome. Please note patient is pregnant. Given IVIG, found to have DVTs left lower extremities, now receiving Gamunex (different type of IVIG) with full dose Lovenox. Slight improvement in upper extremity strength but patient extremely weak in lower extremities 3/5 strength at hips.
Age: 26.0
Sex: M
Vaccine: HIBV, PPV, TDAP
Symptoms: Blood culture, C-reactive protein, CSF culture, Computerised tomogram head, Full blood count
Clinical narrative: Severe myalgias, malaise, headache and fever.
Age: 26.0
Sex: M
Vaccine: HIBV, PPV, TDAP
Symptoms: Headache, Lumbar puncture, Malaise, Metabolic function test, Myalgia
Clinical narrative: Severe myalgias, malaise, headache and fever.
Age: 26.0
Sex: M
Vaccine: HIBV, PPV, TDAP
Symptoms: Polymerase chain reaction, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Severe myalgias, malaise, headache and fever.
Age: 0.21
Sex: M
Vaccine: DTPHEP, HIBV, PPV, RVX
Symptoms: Choking, Hypotonia, Moaning, Pain, Pallor
Clinical narrative: Baby gagging, choking, and not breathing, went limp, pale - this lasted about 5 minutes.  After this he started moaning as if in pain and this lasted over an hour.  Baby seemed dazed as if in a trance lasting on into the evening. I had no way to the hospital and was sure he would get better as the doctor assured me these vaccines were safe.  He was given 6 shots at one time.
Age: 0.21
Sex: M
Vaccine: DTPHEP, HIBV, PPV, RVX
Symptoms: Respiratory arrest, Retching, Trance
Clinical narrative: Baby gagging, choking, and not breathing, went limp, pale - this lasted about 5 minutes.  After this he started moaning as if in pain and this lasted over an hour.  Baby seemed dazed as if in a trance lasting on into the evening. I had no way to the hospital and was sure he would get better as the doctor assured me these vaccines were safe.  He was given 6 shots at one time.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Redness, pain and itching tracking down entire upper arm.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site anaesthesia
Clinical narrative: Quarter size numbness around injection site.
Age: 44.0
Sex: F
Vaccine: HEPA, IPV, YF
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site urticaria, Pyrexia
Clinical narrative: Large area little bigger than a quarter size welt/hive at area of vaccination that was red and hot and itchy first noticed 5 1/2 days after vaccination of yellow fever. Had felt tired/feverish for 3 days after vaccination. (but had polio, yellow fever and Hep A #1 same day).
Age: 44.0
Sex: F
Vaccine: HEPA, IPV, YF
Symptoms: Vaccination site warmth
Clinical narrative: Large area little bigger than a quarter size welt/hive at area of vaccination that was red and hot and itchy first noticed 5 1/2 days after vaccination of yellow fever. Had felt tired/feverish for 3 days after vaccination. (but had polio, yellow fever and Hep A #1 same day).
Age: 11.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Received Pneumovax 23 and meningoccocal conjugate (Menactra) vaccinations on Tuesday 7/24/2012 and developed a rash at the site of injection and associated with Fever (102F).
Age: 23.0
Sex: M
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: SYNCOPE.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia, Decreased appetite, Dehydration, Lethargy, Pyrexia
Clinical narrative: Fever, lethargy, & wheezing with decreased appetite & dehydration starting the morning after receiving immunizations.  Parents also believe that patient stopped speaking at that time and has developed profound speech delay.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Speech disorder developmental, Wheezing
Clinical narrative: Fever, lethargy, & wheezing with decreased appetite & dehydration starting the morning after receiving immunizations.  Parents also believe that patient stopped speaking at that time and has developed profound speech delay.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: 1 hour past vaccine, onset of symptoms are as followed and continue to now day 4: generalized fatigue, nausea, sever headache, flu-like symptoms decrease appetite, continuous headache that wakes me up at night. Notified facility that administered vaccine.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Poor quality sleep
Clinical narrative: 1 hour past vaccine, onset of symptoms are as followed and continue to now day 4: generalized fatigue, nausea, sever headache, flu-like symptoms decrease appetite, continuous headache that wakes me up at night. Notified facility that administered vaccine.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Malaise, Myalgia
Clinical narrative: Myalgia & Malaise.