chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in an 11 month old, male subject was identified by the investigator based on review of data from the Agency. The subject's vaccine history included 3 doses of PENTACEL received on 12 August 2009, 22 October 2009, and 23 December 2009 (route, site of administration, and lot numbers were not reported). Approximately 6 months after the last dose, on 15 June 2010, he developed a paroxysmal cough. He also experienced symptoms of cold-like illness, posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 17 June 2010. Chest X-ray findings were negative for pneumonia. Corrective treatment consisted of AZITHROMYCIN for 5 days starting on 17 June 2010. The subject was not hospitalized. At the time of final contact on 04 July 2010, the subject's cough had been resolved. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None.
Age: 0.47
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject was identified by the investigator based on review of data from the surveillance system. The subject's vaccine history included 3 doses of PENTACEL received on 13 May 2009, 09 July 2009, and 09 September 2009 (route, site of administration, and lot numbers were not reported). Approximately 9 months after the last dose, on 17 June 2010, the subject developed paroxysmal cough with whoop. Other symptoms included cold-like symptoms and posttussive vomiting. Laboratory testing included positive PCR on 24 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 24 June 2010. The subject was not hospitalized. At the time of final contact on 02 July 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company comment: No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive a booster, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Age: 0.47
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject was identified by the investigator based on review of data from the surveillance system. The subject's vaccine history included 3 doses of PENTACEL received on 13 May 2009, 09 July 2009, and 09 September 2009 (route, site of administration, and lot numbers were not reported). Approximately 9 months after the last dose, on 17 June 2010, the subject developed paroxysmal cough with whoop. Other symptoms included cold-like symptoms and posttussive vomiting. Laboratory testing included positive PCR on 24 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 24 June 2010. The subject was not hospitalized. At the time of final contact on 02 July 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company comment: No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive a booster, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report was received on 11 January 2011 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject (initials not collected) was identified by the investigator based on review of data. The subject's vaccine history included one dose of DAPTACEL (lot number not reported) received on 21 January 2009, and dose one of PENTACEL (lot number C2999AA) received on 23 March 2009, and the second dose of PENTACEL (lot number not reported) received on 08 May 2009 (route and sites of administration not reported). Nearly 9 months after the last dose, on 28 January 2010, the subject developed a cough. Six days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 05 February 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment was not reported. The subject was not hospitalized. At the time of final contact on 12 February 2010, the subject's cough was still persisting after 15 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As nearly 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive her booster dose, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report was received on 11 January 2011 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject (initials not collected) was identified by the investigator based on review of data. The subject's vaccine history included one dose of DAPTACEL (lot number not reported) received on 21 January 2009, and dose one of PENTACEL (lot number C2999AA) received on 23 March 2009, and the second dose of PENTACEL (lot number not reported) received on 08 May 2009 (route and sites of administration not reported). Nearly 9 months after the last dose, on 28 January 2010, the subject developed a cough. Six days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 05 February 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment was not reported. The subject was not hospitalized. At the time of final contact on 12 February 2010, the subject's cough was still persisting after 15 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As nearly 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive her booster dose, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report was received on 11 January 2011 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject (initials not collected) was identified by the investigator based on review of data. The subject's vaccine history included one dose of DAPTACEL (lot number not reported) received on 21 January 2009, and dose one of PENTACEL (lot number C2999AA) received on 23 March 2009, and the second dose of PENTACEL (lot number not reported) received on 08 May 2009 (route and sites of administration not reported). Nearly 9 months after the last dose, on 28 January 2010, the subject developed a cough. Six days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 05 February 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment was not reported. The subject was not hospitalized. At the time of final contact on 12 February 2010, the subject's cough was still persisting after 15 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As nearly 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive her booster dose, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Initial report was received on 11 January 2011 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject (initials not collected) was identified by the investigator based on review of data. The subject's vaccine history included one dose of DAPTACEL (lot number not reported) received on 21 January 2009, and dose one of PENTACEL (lot number C2999AA) received on 23 March 2009, and the second dose of PENTACEL (lot number not reported) received on 08 May 2009 (route and sites of administration not reported). Nearly 9 months after the last dose, on 28 January 2010, the subject developed a cough. Six days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 05 February 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment was not reported. The subject was not hospitalized. At the time of final contact on 12 February 2010, the subject's cough was still persisting after 15 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As nearly 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive her booster dose, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Post-tussive vomiting
Clinical narrative: Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 12 month old male subject (initial not collected), was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL: lot number C3469AA received on 23 November 2009, lot number C3502AA received on 18 January 2010, and unknown lot number received on 23 March 2010 (route and site of administration not reported). Approximately 6 months after the last dose, on 05 October 2010, the subject developed cough. Other symptoms included cold-like symptoms and posttussive vomiting. Chest x-ray findings were negative for pneumonia. Corrective treatment  consisted of azithromycin started on 27 October 2010. The subject was not hospitalized. At the time of final contact on 27 October 2010, the subject's cough had been ongoing for 23 days (also reported as 20 days) and was still persisting. It is unclear if PCR testing was conducted. However, it was reported that this case was epidemiologically linked to a laboratory confirmed case. The subject had not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Surveillance for Rates of Pertussis Disease Among persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 16 month old, male subject (initials not collected) was identified by the investigator based on review of data from the system. The subject's vaccine history included 4 doses of PENTACEL: lot number C3362AA received on 29 June 2009, lot number C3362AA received on 26 August 2009, lot number C3469AA received on 26 October 2009, and lot number C3662AA received on 26 July 2010 (route and site of administration not reported). Approximately 4 weeks after the last dose, on 22 August 2010, the subject developed paroxysmal cough with whoop. The subject also experienced cold-like symptoms, posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 24 August 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 25 August 2010. The subject was not hospitalized. At the time of final contact on 15 September 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigation, 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: 1.26
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Surveillance for Rates of Pertussis Disease Among persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 16 month old, male subject (initials not collected) was identified by the investigator based on review of data from the system. The subject's vaccine history included 4 doses of PENTACEL: lot number C3362AA received on 29 June 2009, lot number C3362AA received on 26 August 2009, lot number C3469AA received on 26 October 2009, and lot number C3662AA received on 26 July 2010 (route and site of administration not reported). Approximately 4 weeks after the last dose, on 22 August 2010, the subject developed paroxysmal cough with whoop. The subject also experienced cold-like symptoms, posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 24 August 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 25 August 2010. The subject was not hospitalized. At the time of final contact on 15 September 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigation, 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: 1.32
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving Pentacel or Other Pertussis Vaccines. Initial report was received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 16 month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (WEDSS). The subject's vaccination history included 4 doses of PENTACEL: lot number C3295AA received on 21 August 2010, lot number C3378AA received on 08 October 2009, lot number C3470AA received on 22 January 2010,  and lot number C3625AC received on 30 September 2010 (routes and sites of administration not reported). Approximately 1 week after the last dose on 07 October 2010, the subject developed cold-like symptoms and a cough. Six days later, the subject developed a paroxysmal cough without whoop or posttussive vomiting. Laboratory testing included positive PCR on 26 October 2010. Chest x-ray findings were negative. Corrective treatment consisted of azithromycin started on 27 October 2010. The subject was not hospitalized. At the time of final contact on 27 October 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 20 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: 1.32
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving Pentacel or Other Pertussis Vaccines. Initial report was received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 16 month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (WEDSS). The subject's vaccination history included 4 doses of PENTACEL: lot number C3295AA received on 21 August 2010, lot number C3378AA received on 08 October 2009, lot number C3470AA received on 22 January 2010,  and lot number C3625AC received on 30 September 2010 (routes and sites of administration not reported). Approximately 1 week after the last dose on 07 October 2010, the subject developed cold-like symptoms and a cough. Six days later, the subject developed a paroxysmal cough without whoop or posttussive vomiting. Laboratory testing included positive PCR on 26 October 2010. Chest x-ray findings were negative. Corrective treatment consisted of azithromycin started on 27 October 2010. The subject was not hospitalized. At the time of final contact on 27 October 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 20 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: 1.25
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines. Subject ID # 411455. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 Pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of Pertussis disease in a 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of DAPACEL; lot number CT06AA received on 19 May 2006, lot number CT06AA received on 21 July 2006, lot number C2649AA on 15 September 2006, and lot number C62651AA on 15 June 2007. On 16 July 2010, approximately three years after the last dose, the subject developed a paroxysmal cough. She also experienced symptoms of posttussive vomiting and sleep disturbance (onset dates not reported). It is unknown if she experienced symptoms of catarrhal illness. Laboratory testing included positive PCR (date not reported). Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AZITHROMYCIN starting on 04 August 2010 ( stop date not reported). The subject was not hospitalized. At the time of final contact on 14 September 2010, the subject's cough had been resolved. The total duration of the cough was reported at that time as 46 days. Investigator causality assessment not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines. Subject ID # 411455. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 Pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of Pertussis disease in a 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of DAPACEL; lot number CT06AA received on 19 May 2006, lot number CT06AA received on 21 July 2006, lot number C2649AA on 15 September 2006, and lot number C62651AA on 15 June 2007. On 16 July 2010, approximately three years after the last dose, the subject developed a paroxysmal cough. She also experienced symptoms of posttussive vomiting and sleep disturbance (onset dates not reported). It is unknown if she experienced symptoms of catarrhal illness. Laboratory testing included positive PCR (date not reported). Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AZITHROMYCIN starting on 04 August 2010 ( stop date not reported). The subject was not hospitalized. At the time of final contact on 14 September 2010, the subject's cough had been resolved. The total duration of the cough was reported at that time as 46 days. Investigator causality assessment not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Received PENTACEL or Other Pertussis Vaccines. Subject ID: 436559. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 PERTUSSIS cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of PERTUSSIS disease in a 4-year-old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of DAPTACEL: lot number C2405AA received on 08 February 2006, lot number C2396AA received on 04 April 2006, lot number C2432AA received on 06 July 2006, and lot number C2553AA received on 21 March 2007 (route and site of administration not reported). More than 3 years after the last dose, on 26 September 2010, the subject developed a cough. Six days later, he developed paroxysmal cough with whoop. He also developed cold-like symptoms and sleep disturbance (start dates not reported). Laboratory treatment consisted of AZITHROMYCIN for 5 days which started on 05 October 2010. The subject was not hospitalized. At the time of final contact on 11 October 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Received PENTACEL or Other Pertussis Vaccines. Subject ID: 436559. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 PERTUSSIS cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of PERTUSSIS disease in a 4-year-old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of DAPTACEL: lot number C2405AA received on 08 February 2006, lot number C2396AA received on 04 April 2006, lot number C2432AA received on 06 July 2006, and lot number C2553AA received on 21 March 2007 (route and site of administration not reported). More than 3 years after the last dose, on 26 September 2010, the subject developed a cough. Six days later, he developed paroxysmal cough with whoop. He also developed cold-like symptoms and sleep disturbance (start dates not reported). Laboratory treatment consisted of AZITHROMYCIN for 5 days which started on 05 October 2010. The subject was not hospitalized. At the time of final contact on 11 October 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Meningococcal infection, Neisseria test positive, Pneumonia
Clinical narrative: Initial report received from a lay press reporter on 14 January 2011.  A patient (sex and age not provided) received 3 years ago (date not provided) an injection (route and site not provided) of MENACTRA, lot number not reported.  In September 2010, the patient was first diagnosed with acute pneumonia, not meningitis.  But after the pneumonia patient was released from the hospital, blood tests revealed the presence of Neisseria meningitidis serotype Y.  The patient had received the meningitis vaccine three years before becoming infected.  The outcome was not reported.  This case has the same reporter as case 2011- 00232.  Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bronchitis, Contusion, Increased upper airway secretion, Productive cough
Clinical narrative: Initial report was received on 18 January 2011 from a health care professional.  This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE No Preservative 2010-2011 on different dates.  One patient was hospitalized.  Information regarding the patient who was hospitalized is reported in case number 2010-01674; and information regarding the last 2 patients are reported in cases 2011-00303 , and 2011-00252.  A 71-year-old female patient had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE No Preservative 2010-2011 (lot number U3605BA) on 25 October 2010.  That evening after receiving the vaccination, the patient experienced a productive cough with yellowish thick phlegm.  She had bruising on the left side of her ribs, which the patient felt was due to coughing.  It was not mentioned that the patient required an emergency room visit, however the patient was seen in the clinic 1 week later on 02 November 2011 and was treated with antibiotics for bronchitis.  Past medical history includes: actinic keratosis, atrial fibrillation, chronic systolic CHF (congestive heart failure), nocturnal leg cramps, DJD (degenerative joint disease) of the knee, hypothyroidism, glossopharyngeal neuralgia, obesity, osteopenia, allergic rhinitis (NDS), "spells" (Not specified), vitamin B12 deficiency, and is positive for long term use of anticoagulants and high risk medication.  Concurrent medications at time of vaccination included: Lanoxin, Levothyroxine, Metoprolol, Omeprazole, Sertraline, and warfarin.  Per the reporter, it is unknown if the patient recovered.  Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Bronchitis, Contusion, Dizziness, Increased upper airway secretion
Clinical narrative: Initial report was received on 18 January 2011 from a health care professional.  This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE No Preservative 2010-2011 on different dates.  One patient was hospitalized.  Information regarding the patient who was hospitalized is reported in case number 2010-01674; and information regarding the last 2 patients are reported in cases 2011-00303 , and 2011-00252.  A 71-year-old female patient had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE No Preservative 2010-2011 (lot number U3605BA) on 25 October 2010.  That evening after receiving the vaccination, the patient experienced a productive cough with yellowish thick phlegm.  She had bruising on the left side of her ribs, which the patient felt was due to coughing.  It was not mentioned that the patient required an emergency room visit, however the patient was seen in the clinic 1 week later on 02 November 2011 and was treated with antibiotics for bronchitis.  Past medical history includes: actinic keratosis, atrial fibrillation, chronic systolic CHF (congestive heart failure), nocturnal leg cramps, DJD (degenerative joint disease) of the knee, hypothyroidism, glossopharyngeal neuralgia, obesity, osteopenia, allergic rhinitis (NDS), "spells" (Not specified), vitamin B12 deficiency, and is positive for long term use of anticoagulants and high risk medication.  Concurrent medications at time of vaccination included: Lanoxin, Levothyroxine, Metoprolol, Omeprazole, Sertraline, and warfarin.  Per the reporter, it is unknown if the patient recovered.  Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Productive cough
Clinical narrative: Initial report was received on 18 January 2011 from a health care professional.  This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE No Preservative 2010-2011 on different dates.  One patient was hospitalized.  Information regarding the patient who was hospitalized is reported in case number 2010-01674; and information regarding the last 2 patients are reported in cases 2011-00303 , and 2011-00252.  A 71-year-old female patient had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE No Preservative 2010-2011 (lot number U3605BA) on 25 October 2010.  That evening after receiving the vaccination, the patient experienced a productive cough with yellowish thick phlegm.  She had bruising on the left side of her ribs, which the patient felt was due to coughing.  It was not mentioned that the patient required an emergency room visit, however the patient was seen in the clinic 1 week later on 02 November 2011 and was treated with antibiotics for bronchitis.  Past medical history includes: actinic keratosis, atrial fibrillation, chronic systolic CHF (congestive heart failure), nocturnal leg cramps, DJD (degenerative joint disease) of the knee, hypothyroidism, glossopharyngeal neuralgia, obesity, osteopenia, allergic rhinitis (NDS), "spells" (Not specified), vitamin B12 deficiency, and is positive for long term use of anticoagulants and high risk medication.  Concurrent medications at time of vaccination included: Lanoxin, Levothyroxine, Metoprolol, Omeprazole, Sertraline, and warfarin.  Per the reporter, it is unknown if the patient recovered.  Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pyrexia
Clinical narrative: Per patient report: 12/24/2010 a fever to 103 degrees.  On December 28 she again had a fever to 100 degrees.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Severe pain in the upper left arm (especially around injection site)began within hours.  I had difficulty moving my left arm without serious pain, bruising began next morning and was not totally gone for three weeks.  Took Advil for pain relief with only minimal results.  It is now nearly 10 weeks later and I still have serious disability in the left arm.  It is marginally better than in the first 2 days after the injection, but only marginally.  I still cannot lift my arm over my head without pain, can't sleep on my left side, can't carry things with my left hand without either serious discomfort or outright pain.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Dizziness, Injected limb mobility decreased, Injection site swelling
Clinical narrative: swelling of arm at sight on injection - no use of left arm - fever over 103 - dizziness - chills and cold sweats - went to be seen at Hospital the evening of 12/11/2010 and was treated with antibiotic for possible infection and vicodin for pain
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: swelling of arm at sight on injection - no use of left arm - fever over 103 - dizziness - chills and cold sweats - went to be seen at Hospital the evening of 12/11/2010 and was treated with antibiotic for possible infection and vicodin for pain
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Dysphonia, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: A short time after receiving the immunizations patient started having bilateral redness and swelling in both legs. This started at the sites of the injections. A short time later his cries changed from normal in sound to hoarse in nature. A short time later he had hives that were spreading from the site of the injections.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Computerised tomogram head, Deafness unilateral, Dizziness, Nasal dryness
Clinical narrative: Woke up feeling nausous, vertigo, dizzy and could not hear out right ear.  Used over the counter ear drops with no relief.  On 11/6/2010 went to a walk in medical clinic.  Was disgnosed with severe sinus infection and given mucinex, antibiotic and tramadol shot for pain.  On 11/9/10 was family doctor.  He also diagnosed a sinus infection and got another pain shot.  On 11/11/10 went to see an ENT specialist.  He diagnosed a viral infection and prescribed predinsone and famcicolzor.  11/22/10 saw family doctor and diagnosed total right hearing loss.  11/30/10 patient started taking pseudophed.  Quit the next day due to excessive nasal dryness.  Then 11/22/10 was told to order tinnitis formula.  Started taking medication on 12/1/10.  On 12/7/10 was ENT again and he told her that it would just take time to regain hearing.  Next appointment is scheduled for 5/4/2011.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Sinusitis, Vertigo, Viral infection
Clinical narrative: Woke up feeling nausous, vertigo, dizzy and could not hear out right ear.  Used over the counter ear drops with no relief.  On 11/6/2010 went to a walk in medical clinic.  Was disgnosed with severe sinus infection and given mucinex, antibiotic and tramadol shot for pain.  On 11/9/10 was family doctor.  He also diagnosed a sinus infection and got another pain shot.  On 11/11/10 went to see an ENT specialist.  He diagnosed a viral infection and prescribed predinsone and famcicolzor.  11/22/10 saw family doctor and diagnosed total right hearing loss.  11/30/10 patient started taking pseudophed.  Quit the next day due to excessive nasal dryness.  Then 11/22/10 was told to order tinnitis formula.  Started taking medication on 12/1/10.  On 12/7/10 was ENT again and he told her that it would just take time to regain hearing.  Next appointment is scheduled for 5/4/2011.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Blood magnesium, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: Became dizzy in shower, felt heart racing and shortness of breath.  Went to urgent care medical office for evaluation, saw cardiologist and neurologist.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Metabolic function test, Palpitations
Clinical narrative: Became dizzy in shower, felt heart racing and shortness of breath.  Went to urgent care medical office for evaluation, saw cardiologist and neurologist.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chills, Cough, Discomfort, Lymph node pain
Clinical narrative: 5 hours after receiving Fluzone HD 2010-11 PFS (SAN) I had back pain, chills & shivering, cough, general body discomfort particularly in lymph nodes, mild fever, muscle aches.  These symptoms reached a peak at 02:00 AM 01/26/2011 and then began to subside noticeably.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: 5 hours after receiving Fluzone HD 2010-11 PFS (SAN) I had back pain, chills & shivering, cough, general body discomfort particularly in lymph nodes, mild fever, muscle aches.  These symptoms reached a peak at 02:00 AM 01/26/2011 and then began to subside noticeably.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Skin warm, Urticaria
Clinical narrative: Sore arm at injection site of flu vaccine, red, welts, warm to touch, with symptoms increasing in severity
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Injection site erythema, Nausea, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Began with nausea on the evening of 01/24/11. Felt worse on the day and evening of 01/25/11 and developed a low grade fever. At 4:00 AM-6:00 AM 01/26/11 patient had a fever of 103'F p.o. She took 3 Ibuprofen and called the nurse at 10:33 AM. She was scheduled in Urgent Care. Her fever was down to 99.2'F p.o. and her Rt arm was visibly swollen with warmth, tenderness and localized red patches on upper Rt arm and very painful to move Rt arm.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Began with nausea on the evening of 01/24/11. Felt worse on the day and evening of 01/25/11 and developed a low grade fever. At 4:00 AM-6:00 AM 01/26/11 patient had a fever of 103'F p.o. She took 3 Ibuprofen and called the nurse at 10:33 AM. She was scheduled in Urgent Care. Her fever was down to 99.2'F p.o. and her Rt arm was visibly swollen with warmth, tenderness and localized red patches on upper Rt arm and very painful to move Rt arm.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Began with nausea on the evening of 01/24/11. Felt worse on the day and evening of 01/25/11 and developed a low grade fever. At 4:00 AM-6:00 AM 01/26/11 patient had a fever of 103'F p.o. She took 3 Ibuprofen and called the nurse at 10:33 AM. She was scheduled in Urgent Care. Her fever was down to 99.2'F p.o. and her Rt arm was visibly swollen with warmth, tenderness and localized red patches on upper Rt arm and very painful to move Rt arm.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Rash macular
Clinical narrative: Began with nausea on the evening of 01/24/11. Felt worse on the day and evening of 01/25/11 and developed a low grade fever. At 4:00 AM-6:00 AM 01/26/11 patient had a fever of 103'F p.o. She took 3 Ibuprofen and called the nurse at 10:33 AM. She was scheduled in Urgent Care. Her fever was down to 99.2'F p.o. and her Rt arm was visibly swollen with warmth, tenderness and localized red patches on upper Rt arm and very painful to move Rt arm.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Atonic seizures, Blood test, Electroencephalogram, Hypotonia, Myoclonic epilepsy
Clinical narrative: STARTED HAVING SEIZURES-ATONIC & MYOCLONIC (LOSING MUSCLE TONE IN THE UPPER BODY) AFTER GIVEN HIS 6 MONTHS VACCINES & 1ST FLU SHOT. WAS HAVING THEM 20+/DAY. HAS SINCE HAD SEVERAL DR VISITS, EEG, MRI. IS ON ZONOGRAN TO CONTROL THEM. NO OTHER KNOWN CAUSE.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: STARTED HAVING SEIZURES-ATONIC & MYOCLONIC (LOSING MUSCLE TONE IN THE UPPER BODY) AFTER GIVEN HIS 6 MONTHS VACCINES & 1ST FLU SHOT. WAS HAVING THEM 20+/DAY. HAS SINCE HAD SEVERAL DR VISITS, EEG, MRI. IS ON ZONOGRAN TO CONTROL THEM. NO OTHER KNOWN CAUSE.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Full blood count normal, Headache, Laboratory test normal
Clinical narrative: Pruritic rash on arms, chest, back, and scalp. Non-pustule, no blisters. Non-urticarial. Could see and feel rash tactile. Nausea starting on 1/20/2011. Intermittent headache starting 1/20/2011.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Metabolic function test, Nausea, Rash, Rash pruritic
Clinical narrative: Pruritic rash on arms, chest, back, and scalp. Non-pustule, no blisters. Non-urticarial. Could see and feel rash tactile. Nausea starting on 1/20/2011. Intermittent headache starting 1/20/2011.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Hypersensitivity
Clinical narrative: PT CALLED STATES HE GOT A PNEUMOVAX INJECTION YESTERDAY, STATES ON HIS WAY HOME HE STARTED HAVING CHEST PAIN, SOB, FELT LIKE SOMEONE WAS STABBING HIM WITH A KNIFE.  SAYS HIS CHEST IS REALLY SORE NOW, FELT LIKE HE WAS HAVING AN MI SAYS  THE ENTIRE THING ONLY LASTED A COUPLE OF MINUTES. STATES HE IS FINE TODAY EXCEPT FOR THE SORENESS IN HIS CHEST.  Pt probably had allergic type reaction. Will have pt come pick up medrol dose pak and get EKG.
Age: 0.48
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Infant flu vaccine given to child age 5mo 22days
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Formication, Pain in extremity, Pyrexia
Clinical narrative: fever and leg pain; chest pressure and felt "like a spider on my face"
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Wheezing
Age: 1.61
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting, diarrhea
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Pain, Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: First developed rash (blisters) across face, which spread over body.  Chest, abdomen and back, shoulders, neck, face.  Some along arms and legs.  This occurred approximately 2 days later, accompanied by a fever (101F) extreme body aches and chills.  Day 3, the 26th of January, the rash has intensified and spread more along neck, scalp.  No fever noticed, but moderate aches and chills are noticed.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: FEVER OF 102.0 RECTALLY. FUSSY. DECREASED APPETITE.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Erythema, Pain
Clinical narrative: Local redness and soreness, triaged over the telephone, told to ice and take NSAID's.  Two hours later pt reported to ED with chest tightness.