chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Bradycardia, Gaze palsy, Hypotonia, Pallor, Vaccination site pain
Clinical narrative: Two months old male a full term, previously healthy baby, presenting with pale and limp episodes x 2 for about 15-20 seconds and 10 second pt. was bradycardic after vaccination (about 10 minutes after vaccine). His eyes was open but kind of rolled up and partly bradycardic for 10-20 seconds. Pt. back to normal color and HR: 140, RR 24, no apnea, no cyanosis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Breath sounds abnormal, Cough, Erythema, Heart rate increased, Oxygen saturation decreased
Clinical narrative: Respiratory distress; red in face & coughing. Sats 80's & HR 180's. EPI Jr Pen IM administered. Breath sounds tight. Albuterol and racepinephrine nebulizer given. 12.6 mg Dexamethasone IM given. Breath sounds clear. HR 130's Sats 96-97% BENADRYL 25mg po given itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Pruritus, Respiratory distress
Clinical narrative: Respiratory distress; red in face & coughing. Sats 80's & HR 180's. EPI Jr Pen IM administered. Breath sounds tight. Albuterol and racepinephrine nebulizer given. 12.6 mg Dexamethasone IM given. Breath sounds clear. HR 130's Sats 96-97% BENADRYL 25mg po given itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Respiratory distress, Tachycardia, Urticaria
Clinical narrative: Respiratory distress; red in face & coughing. Sats 80's & HR 180's. EPI Jr Pen IM administered. Breath sounds tight. Albuterol and racepinephrine nebulizer given. 12.6 mg Dexamethasone IM given. Breath sounds clear. HR 130's Sats 96-97% BENADRYL 25mg po given itching.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Urticaria within 2 hours of administration.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site pain, Injection site vesicles
Clinical narrative: First day after patient received vaccination his arm was sore. He did not look at it at the time. The next day his arm felt like it was on fire (red, inflamed down to elbow & black in the center). He put ice on it & waited for it to get better. It formed blister & pus. Patient popped blister to reduce pressure. He contacted the doctor even though he thought it's getting better, (on 6/21/11). Doctor asked him to come in & patient was given SEPTRA DS.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Purulent discharge
Clinical narrative: First day after patient received vaccination his arm was sore. He did not look at it at the time. The next day his arm felt like it was on fire (red, inflamed down to elbow & black in the center). He put ice on it & waited for it to get better. It formed blister & pus. Patient popped blister to reduce pressure. He contacted the doctor even though he thought it's getting better, (on 6/21/11). Doctor asked him to come in & patient was given SEPTRA DS.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: (R) arm 5 cm in diameter, erythematous 10 cm. Slightly warm & tender to touch.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin swelling, Skin warm
Clinical narrative: Pink, raised area about 2-3 inches in diameter. Warm to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid redness (L) upper arm swollen & red. Today decreased redness continued (L) upper arm swollen. TYLENOL, ice packs, CLARITIN.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Nervousness, Pyrexia
Clinical narrative: After several hours after receiving vaccine pt said he felt feverish and shaky. He then went to emergency rm.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Autopsy, Death, Encephalopathy, Pathology test, Rett's disorder
Clinical narrative: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16-month-old male, who died from the congenital anomaly static encephalopathy while enrolled in a study. The subject received four doses of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ACTHIB, lot number UE237AA (Sanofi Pasteur SA lot number X0672); a dose MMR II (manufacturer Merck), lot number 0181N and a dose of PREVNAR (manufacturer Lederle), lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2005 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. Follow-up information was received on 12 April 2011 from an investigator involved in the study. According to the investigator, the first acellular pertussis dose cannot be confirmed as DAPTACEL because the vaccine was given at an out-of-network facility and the lot number was not available. It was therefore impossible to determine the correct vaccine group for analysis purposes and the subject will not be included in the listings for the final Clinical Study Report.  List of additional information available in source documents: Death certificate.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction
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 9 month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance. The subject's vaccine history included 3 doses of PENTACEL: lot number C3496AA received on 25 January 2010, lot number C3555AA received on 01 April 2010, and lot number C3608AA received on 07 June 2010 (route and site of administration not reported). Approximately 3 months after the last dose, on 03 September 2010, the subject developed a cough. Two days later, the subject developed a paroxysmal cough. The subject also experienced posttussive vomiting, cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 09 September 2010. Corrective treatment consisted of azithromycin for 5 days starting on 10 September 2010. At the time of final contact on 04 November 2010, the subject's cough had resolved. The duration of cough was reported at that time as 35 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: 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 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 9 month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance. The subject's vaccine history included 3 doses of PENTACEL: lot number C3496AA received on 25 January 2010, lot number C3555AA received on 01 April 2010, and lot number C3608AA received on 07 June 2010 (route and site of administration not reported). Approximately 3 months after the last dose, on 03 September 2010, the subject developed a cough. Two days later, the subject developed a paroxysmal cough. The subject also experienced posttussive vomiting, cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 09 September 2010. Corrective treatment consisted of azithromycin for 5 days starting on 10 September 2010. At the time of final contact on 04 November 2010, the subject's cough had resolved. The duration of cough was reported at that time as 35 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: 0.54
Sex: M
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 a study under the reference number M5A16. This is one 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 a 8 month old, male subject (initials not collected) was identified by the investigator based on review of data from a surveillance system. The subject's vaccine history included 3 doses of PENTACEL: lot number C3545AA received on 10 December 2009, lot number C3451AA received on 12 March 2010, and lot number C3588AA received on 26 April 2010 (route and site of administration not reported). Approximately 2 months after the last dose, the subject developed a cough on 26 June 2010. Four days later, the subject developed a paroxysmal cough with whoop and posttussive vomiting. The subject also experienced symptoms of cold-like illness and sleep disturbance (dates not reported). Laboratory testing included positive PCR on 30 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of a single dose of azithromycin on 30 June 2010. The subject was not hospitalized. At the time of final contact on 05 August 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 20 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. Documents held by sender: None.
Age: 0.54
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 a study under the reference number M5A16. This is one 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 a 8 month old, male subject (initials not collected) was identified by the investigator based on review of data from a surveillance system. The subject's vaccine history included 3 doses of PENTACEL: lot number C3545AA received on 10 December 2009, lot number C3451AA received on 12 March 2010, and lot number C3588AA received on 26 April 2010 (route and site of administration not reported). Approximately 2 months after the last dose, the subject developed a cough on 26 June 2010. Four days later, the subject developed a paroxysmal cough with whoop and posttussive vomiting. The subject also experienced symptoms of cold-like illness and sleep disturbance (dates not reported). Laboratory testing included positive PCR on 30 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of a single dose of azithromycin on 30 June 2010. The subject was not hospitalized. At the time of final contact on 05 August 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 20 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. Documents held by sender: None.
Age: 0.5
Sex: M
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 above-mentioned 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 (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (WEDSS). 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: 0.5
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 above-mentioned 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 (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (WEDSS). 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. 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 State Electronic Disease 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. 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. 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 State Electronic Disease 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. 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 a post-marketing observation surveillance study. 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 from the State Electronic Disease Surveillance System. 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. 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 a post-marketing observation surveillance study. 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 from the State Electronic Disease Surveillance System. 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. 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 a post-marketing observation surveillance study. 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 from the State Electronic Disease Surveillance System. 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. 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 a post-marketing observation surveillance study. 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 from the State Electronic Disease Surveillance System. 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. 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 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 12 month 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 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: 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 16 month 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 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 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: 1.26
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Pertussis, 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 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 Electronic Disease Surveillance 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 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: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in a 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 surveillance system. The subject's vaccine history included 4 doses of PENTACEL: lot number C3295AA received on 21 August 2009, 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 (route and site 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: Initial report received on 11 January 2011 from the Investigator participating in a 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 surveillance system. The subject's vaccine history included 4 doses of PENTACEL: lot number C3295AA received on 21 August 2009, 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 (route and site 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: Initial report received on 11 January 2011 from the Investigator participating in a 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 a surveillance system. The subject's vaccine history included 4 doses of DAPTACEL; 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 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. Company Comment: No vaccine protects 100% of individuals against infection. Therefore, it is 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 of was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in a 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 a surveillance system. The subject's vaccine history included 4 doses of DAPTACEL; 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 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. Company Comment: No vaccine protects 100% of individuals against infection. Therefore, it is 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 of was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. 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: Initial report received on 11 January 2011 from the investigator 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 was identified by the investigator based on data from the 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 C2553A 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 testing included positive PCR on 04 October 2010. Chest x-ray findings were negative for pneumonia. Corrective 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: Initial report received on 11 January 2011 from the investigator 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 was identified by the investigator based on data from the 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 C2553A 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 testing included positive PCR on 04 October 2010. Chest x-ray findings were negative for pneumonia. Corrective 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: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in a post-marketing observational surveillance study. 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 3-year-old, female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in a post-marketing observational surveillance study. 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 3-year-old, female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in a post-marketing observational surveillance study. 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 3-year-old, female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in a post-marketing observational surveillance study. 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 3-year-old, female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of TRIPEDIA: lot number U1751BA received on 20 April 2007, lot number U1751BA received on 20 June 2007, lot number U2290BA received on 21 August 2007, and lot number U2470BA received on 10 March 2009 (route and site of administration not reported). Approximately 21 months after the last dose, the subject developed a paroxysmal cough on 25 November 2010. The subject also developed symptoms of cold-like illness, posttussive vomiting, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 07 December 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 December 2010. The subject was not hospitalized. At the time of final contact on 20 December 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.