chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.61
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 21 January 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the system. The subject's vaccine history included 2 doses of TRIPEDIA; lot number U1891BA received on 06 September 2006 and lot number U1813BA received on 01 November 2006; and 2 doses of DAPTACEL; lot number C2552AA received on 12 January 2007 and lot number C2799AA received on 13 February 2008 (route and sites of administration not reported). The subject developed cold-like symptoms, and on 21 August 2010, approximately 30 minutes after the last dose, she developed a paroxysmal cough without whoop or posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 03 September 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 03 September 2010. The subject was not hospitalized. At the time of final contact on 01 November 2010, the subject's cough had been resolved. The duration of the cough was reported at that time as 53 days. Investigator causality assessment is not reported as per protocol. Documents held by sender: None.
Age: 1.61
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 21 January 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the system. The subject's vaccine history included 2 doses of TRIPEDIA; lot number U1891BA received on 06 September 2006 and lot number U1813BA received on 01 November 2006; and 2 doses of DAPTACEL; lot number C2552AA received on 12 January 2007 and lot number C2799AA received on 13 February 2008 (route and sites of administration not reported). The subject developed cold-like symptoms, and on 21 August 2010, approximately 30 minutes after the last dose, she developed a paroxysmal cough without whoop or posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 03 September 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 03 September 2010. The subject was not hospitalized. At the time of final contact on 01 November 2010, the subject's cough had been resolved. The duration of the cough was reported at that time as 53 days. Investigator causality assessment is not reported as per protocol. Documents held by sender: None.
Age: 1.61
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 21 January 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the system. The subject's vaccine history included 2 doses of TRIPEDIA; lot number U1891BA received on 06 September 2006 and lot number U1813BA received on 01 November 2006; and 2 doses of DAPTACEL; lot number C2552AA received on 12 January 2007 and lot number C2799AA received on 13 February 2008 (route and sites of administration not reported). The subject developed cold-like symptoms, and on 21 August 2010, approximately 30 minutes after the last dose, she developed a paroxysmal cough without whoop or posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 03 September 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 03 September 2010. The subject was not hospitalized. At the time of final contact on 01 November 2010, the subject's cough had been resolved. The duration of the cough was reported at that time as 53 days. Investigator causality assessment is not reported as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one of 13 cases received during the surveillance period from 01 January 2010 to 23 February 2011. Initial report received on 23 February 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the system. The subject's vaccine history included 3 doses of PENTACEL; lot number C3541AA received on 23 February 2010, lot number C3579AA received on 23 April 2010, and lot number C3633AA received on 22 June 2010 (routes and sites of administration not reported). On 13 August 2010, 52 days after the last dose, she developed a cough. On 16 August 2010, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 August 2010 for five days. The subject was not hospitalized. At the time of final contact on 14 September 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 28 days. Laboratory testing for PCR was not reported. However, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Pertussis, Sleep disorder
Clinical narrative: This is one of 13 cases received during the surveillance period from 01 January 2010 to 23 February 2011. Initial report received on 23 February 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the system. The subject's vaccine history included 3 doses of PENTACEL; lot number C3541AA received on 23 February 2010, lot number C3579AA received on 23 April 2010, and lot number C3633AA received on 22 June 2010 (routes and sites of administration not reported). On 13 August 2010, 52 days after the last dose, she developed a cough. On 16 August 2010, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 August 2010 for five days. The subject was not hospitalized. At the time of final contact on 14 September 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 28 days. Laboratory testing for PCR was not reported. However, 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: 1.35
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Pertussis, Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: This is one case out of a cumulative total of 14 pertussis cases received during the surveillance period from 01 January 2010 to 10 March 2011. Initial report received on 10 March 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included four doses of DAPTACEL, lot number C2799AA received on 14 March 2008, lot number C2933AB received on 15 May 2008, lot number C2934AA received on 16 July 2008 and lot number C2956AA received on 30 April 2009 (routes and sites of administration not reported). On 17 February 2011, approximately 21 months after the last dose, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 March 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin starting on 17 February 2011 for 10 days. The subject was not hospitalized. At the time of final contact on 03 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.35
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 14 pertussis cases received during the surveillance period from 01 January 2010 to 10 March 2011. Initial report received on 10 March 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included four doses of DAPTACEL, lot number C2799AA received on 14 March 2008, lot number C2933AB received on 15 May 2008, lot number C2934AA received on 16 July 2008 and lot number C2956AA received on 30 April 2009 (routes and sites of administration not reported). On 17 February 2011, approximately 21 months after the last dose, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 March 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin starting on 17 February 2011 for 10 days. The subject was not hospitalized. At the time of final contact on 03 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.35
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 14 pertussis cases received during the surveillance period from 01 January 2010 to 10 March 2011. Initial report received on 10 March 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included four doses of DAPTACEL, lot number C2799AA received on 14 March 2008, lot number C2933AB received on 15 May 2008, lot number C2934AA received on 16 July 2008 and lot number C2956AA received on 30 April 2009 (routes and sites of administration not reported). On 17 February 2011, approximately 21 months after the last dose, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 March 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin starting on 17 February 2011 for 10 days. The subject was not hospitalized. At the time of final contact on 03 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.35
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 14 pertussis cases received during the surveillance period from 01 January 2010 to 10 March 2011. Initial report received on 10 March 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included four doses of DAPTACEL, lot number C2799AA received on 14 March 2008, lot number C2933AB received on 15 May 2008, lot number C2934AA received on 16 July 2008 and lot number C2956AA received on 30 April 2009 (routes and sites of administration not reported). On 17 February 2011, approximately 21 months after the last dose, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 March 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin starting on 17 February 2011 for 10 days. The subject was not hospitalized. At the time of final contact on 03 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sick relative, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA/C3623AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and approximately five months after the last dose, developed a cough on 08 February 2011. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 28 February 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unspecified number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. The subject had a twin sibling who also developed pertussis (captured in case number 2011-01492). Sponsor 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 11 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 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA/C3623AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and approximately five months after the last dose, developed a cough on 08 February 2011. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 28 February 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unspecified number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. The subject had a twin sibling who also developed pertussis (captured in case number 2011-01492). Sponsor 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: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Rash erythematous, Rash macular, Screaming
Clinical narrative: Rash red & splotchy, pt screaming uncontrollably. Rash appeared on left leg.
Age: 46.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Initial report was received 15 June 2011 from a health care professional. This case represents one of a cluster of three patients who experienced adverse events after receiving ADACEL, lot number C3898BA. The other two patients have been captured in case numbers 2011-03461 and 2011-03462. A 46-year-old male patient who had a history of hypertension and allergy to penicillin, had received a first dose intramuscular left deltoid injection of ADACEL, lot number C3898BA and an intramuscular right deltoid injection of Hepatitis B vaccine (manufacturer GlaxoSmithKline, lot number AHBUB944BB) on 01 June 2011, and one day later, he developed a reddened, warm to touch area that was approximately the size of a grapefruit. He was evaluated by a health care professional who diagnosed the symptoms as cellulitis. Corrective treatments were not reported. The patient had not received any other vaccinations within four weeks prior to receiving ADACEL and Hepatitis B vaccines. At the time of the report, the event was not completely resolved. Outcome was not recovered. The reporter for this case is the same as case number 2011-03460.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Allergy to vaccine, Ear infection, Screaming
Clinical narrative: Vaccines given at 0949, mom called stating pt is screaming. Did eat & nap after vaccines. Came back to clinic at 2pm. Doctor dx with allergy to Pertussis and ear infection.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Skin lesion, Varicella
Clinical narrative: Child dx with varicella uncomplicated 3 lesions in different stages.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: 1105--pt c/o nausea (no vomiting), shortness of breath, chest tightness, diaphoretic, c/o jaw pain, shaky---Assessed by Dr and had pt drink 4 cups of water. 1115--BP 119/77 P 83 R 20; feeling very tired, less chest pain, less nauseated, jaw pain gone, still a little shaky. 1130--BP 120/75 P 80--feeling some pressure in forehead, sore neck, seeing bubbles, nausea and pain gone. 1135--ambulated in hall, steady on feet, bubbles going away. 1140--left clinic, going home.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Nausea, Neck pain, Pain in jaw, Tremor
Clinical narrative: 1105--pt c/o nausea (no vomiting), shortness of breath, chest tightness, diaphoretic, c/o jaw pain, shaky---Assessed by Dr and had pt drink 4 cups of water. 1115--BP 119/77 P 83 R 20; feeling very tired, less chest pain, less nauseated, jaw pain gone, still a little shaky. 1130--BP 120/75 P 80--feeling some pressure in forehead, sore neck, seeing bubbles, nausea and pain gone. 1135--ambulated in hall, steady on feet, bubbles going away. 1140--left clinic, going home.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: 1105--pt c/o nausea (no vomiting), shortness of breath, chest tightness, diaphoretic, c/o jaw pain, shaky---Assessed by Dr and had pt drink 4 cups of water. 1115--BP 119/77 P 83 R 20; feeling very tired, less chest pain, less nauseated, jaw pain gone, still a little shaky. 1130--BP 120/75 P 80--feeling some pressure in forehead, sore neck, seeing bubbles, nausea and pain gone. 1135--ambulated in hall, steady on feet, bubbles going away. 1140--left clinic, going home.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Patient received PNEUMOVAX 23 on 3/29/2011. Patient called the clinic the next morning complaining of redness and swelling around the injection site. Patient instructed to apply ice to the area and take MELOXICAM or ibuprofen. The patient called again on 3/31/2011 stating that his arm was getting worse. Patient was told to come in to be evaluated. It was confirmed that patient had an allergic reaction to the vaccine and was treated with PREDNISONE taper and CLARITIN. Improvement was noted on 4/1/2011.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiparesis, Injected limb mobility decreased, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction after 3rd injection of GARDASIL HPV vaccination on left side arm. The subject's arm swelled from the shoulder to the elbow. The swelling was hot to touch. The injection left a dime sized bruise around the site. Swelling lasted greater than three days. The subject has difficulty moving limb. The entire left side of body is weak.
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: Urticaria, respiratory distress, tachycardia
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Pruritus, Respiratory distress
Clinical narrative: Urticaria, respiratory distress, tachycardia
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Respiratory distress, Tachycardia, Urticaria
Clinical narrative: Urticaria, respiratory distress, tachycardia
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Alpha 1 foetoprotein normal, Blood test normal, Caesarean section, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot# 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of Tdap and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric bloodworks were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetopreotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams via C-section due to failure to progress. The baby's Apgar score was 8/9. Upon internal overview, C-section/ failure to progress was determined to be an other important medical event. Additional information had been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot# 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of Tdap and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric bloodworks were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetopreotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams via C-section due to failure to progress. The baby's Apgar score was 8/9. Upon internal overview, C-section/ failure to progress was determined to be an other important medical event. Additional information had been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Drug exposure during pregnancy, Failed trial of labour, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot# 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of Tdap and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric bloodworks were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetopreotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams via C-section due to failure to progress. The baby's Apgar score was 8/9. Upon internal overview, C-section/ failure to progress was determined to be an other important medical event. Additional information had been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Ultrasound antenatal screen normal, Ultrasound foetal, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot# 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of Tdap and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric bloodworks were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetopreotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams via C-section due to failure to progress. The baby's Apgar score was 8/9. Upon internal overview, C-section/ failure to progress was determined to be an other important medical event. Additional information had been requested.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Developed a fever shortly after immunization and had a seizure on 06/22/2011 & was taken to Hospital.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Tunnel vision
Clinical narrative: After receiving vaccine pt became dizzy, had nausea, became pale, & had tunnel vision. Pt also became diaphoretic. Vitals were checked, pt was laid down & was given juice. After 20 minutes vitals were stable, she was able to walk @ the room with no dizziness & vision had returned to normal.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Death
Clinical narrative: Initial report received on 18 May 2010 from an investigator participating in the above-mentioned trial under the reference number M5A11. A 3-month-old male subject died 28 days after he received a first dose injection of PENTACEL, lot number C3385AA on 12 November 2009. The subject also received the following vaccines on the same date: a first dose of PREVNAR (lot number D74804), a second dose of RECOMBIVAX HB (lot number AHBVB761CA), and a first dose of ROTATEQ (Lot number 0088Y). The subject was last seen on 12 November 2009 for normal well baby care which was unremarkable. The subject died on 10 December 2009. The reporter had no additional information pertaining to the cause or description of death; therefore the "Event Start Date (Date of onset of symptoms)" was reported as unknown. At the time of the report, the county coroner's bureau confirmed the death but would not provide preliminary information. The bureau did indicate that the manner of death was determined to be natural causes and autopsy results would be available as soon as they were considered final. According to the investigator, the event was not related to PENTACEL.
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt received Immunization and developed hives & itching 2 hrs later. BENADRYL 50mg was given IM at the time. Symptoms resolved.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pruritus, Rash
Clinical narrative: "Body aches, rash, itching". Tx with OTC meds.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Local reaction, Nodule, Pruritus
Clinical narrative: Developed nodule and pruritic patch under injected arm which still had large local reaction. Likely reactive inflammation from large local rx. 1 week following this she developed pruritic scattered patches on extremities and face. Likely unrelated, re-enactment of childhood atopic dermatitis, perhaps due to immune stimulation of vaccination.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: Patient developed Herpes zoster (L) side chest.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella-like rash.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 34-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (multiple other childhood vaccines - manufacturer unspecified) given on the same date as INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with INFANRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with INFANRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subjects have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 17-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (multiple other childhood vaccines - manufacturer unspecified) given on the same date as INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with INFANRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with INFANRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subjects have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.
Age: 1.36
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Small round welt beside vaccine administration site and leg red around welt and vaccine injection site on both legs.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Lip swelling, Lymphadenopathy, Rash
Clinical narrative: Rash on trunk.  Rash on trunk subsiding and rasn on arms and buttock. Swelling of glands and lips noted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye pruritus, Lacrimation increased, Swelling face, Wheezing
Clinical narrative: Pt with swelling on L side of face also with itchy watery eyes wheezing also heard in lungs pt given Benadryl 25 mg followed by Epi Pen Jr