chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Anuria, Blood immunoglobulin M increased, Full blood count, Lymphocyte count increased, Pyrexia
Clinical narrative: On 03/05/2012 developed small, flat red spots all over body, concentrated on back of neck but present all over. On 03/07/2012 went 15 hours without urination and developed a fever of 101-102 degrees F.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Rash macular
Clinical narrative: On 03/05/2012 developed small, flat red spots all over body, concentrated on back of neck but present all over. On 03/07/2012 went 15 hours without urination and developed a fever of 101-102 degrees F.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, warmth, induration, tender to touch, and pain localized to the site of injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site swelling, Pain
Clinical narrative: Swelling noted on left thigh, got gradually worse and worse . Red hot tender painful seen by MD 3/9/12 and diagnosed with cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Tenderness
Clinical narrative: Swelling noted on left thigh, got gradually worse and worse . Red hot tender painful seen by MD 3/9/12 and diagnosed with cellulitis.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Unsure as to when other than he got a rash. It was reported 2 1/2 months after it happened.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Injection site swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Swelling at the site and it spread to a larger area on my arm, fever, weakness, pain, throbbing shooting pain.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Musculoskeletal pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: I experienced intense pain (left arm) in the middle of the night after the injection. The intense pain did subside after 2 days. Since that time it is still very painful in the left shoulder area with limited mobility. I also experience shooting nerve pain down the arm into elbow and fingers, up my shoulder into neck and through the middle of my back on left side. I have been taking ibuprofen which really doesn't seem to do anything to relieve pain. I did see my physician at the two week mark and he suggested an EMG and prescribed Vicodin as needed for sleep which I have not needed. I may pursue EMG at a later time also looking into some physical therapy.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Confusional state, Diarrhoea, Disorientation, Hallucination, visual, Headache
Clinical narrative: Patient became extremely disoriented and confused. Described visual hallucinations when he closed his eyes - swirling fragments of colored maps. Did not recognize our street when we were driving on it. Mild sweating. Headache. Nausea. Three bouts of diarrhea in a 4 hour period. Symptoms began to clear up at noon, and he seems himself again now (3:00 PM, same day).
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Patient became extremely disoriented and confused. Described visual hallucinations when he closed his eyes - swirling fragments of colored maps. Did not recognize our street when we were driving on it. Mild sweating. Headache. Nausea. Three bouts of diarrhea in a 4 hour period. Symptoms began to clear up at noon, and he seems himself again now (3:00 PM, same day).
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Confusional state, Disorientation, Hallucination, visual
Clinical narrative: Patient became extremely disoriented and confused. Described visual hallucinations when he closed his eyes - swirling fragments of colored maps. Did not recognize our street when we were driving on it. Mild sweating. Headache. Nausea. Three bouts of diarrhea in a 4 hour period. Symptoms began to clear up at noon, and he seems himself again now (3:00 PM, same day).
Age: 8.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abnormal behaviour, Crying, Depression, Emotional disorder, Headache
Clinical narrative: Child was suddenly and very uncharacteristically depressed, emotional and (in her words), "grumpy."  She could not give a reason why she would suddenly start crying...Also reported having a bad headache. This behavior is *extremely* unusual in this child. Given how her brother and mother reacted at the same time, I thought it was worth reporting.
Age: 54.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site swelling, Insomnia, Oedema peripheral, Pain
Clinical narrative: Patient walked in the next day reporting pain at last after the injection.  Unable to sleep. Took Motrin for the pain. Next day report swelling of arm. Walked into clinic approxmiately 1500.  Patient presented with minimal edema from right shoulder to elbow.  Edema from elbow to wrist and slight edema in fingers. Right arm warm to touch. Patient complained of itchiness. Some very faint areas of redness around elbow area. Advised patient to utilize ice on the arm and take Benadryl.
Age: 54.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pruritus, Skin warm
Clinical narrative: Patient walked in the next day reporting pain at last after the injection.  Unable to sleep. Took Motrin for the pain. Next day report swelling of arm. Walked into clinic approxmiately 1500.  Patient presented with minimal edema from right shoulder to elbow.  Edema from elbow to wrist and slight edema in fingers. Right arm warm to touch. Patient complained of itchiness. Some very faint areas of redness around elbow area. Advised patient to utilize ice on the arm and take Benadryl.
Age: 38.0
Sex: F
Vaccine: TYP, YF
Symptoms: Depression, Fatigue, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Depression/malaise. Woke up in tears. Burst into tears several times throughout the day for no reason. Really bad headache. Slight nausea. Extreme fatigue. Stiff neck. Still feeling like this now (3:00 PM).
Age: 38.0
Sex: F
Vaccine: TYP, YF
Symptoms: Nausea, Tearfulness
Clinical narrative: Depression/malaise. Woke up in tears. Burst into tears several times throughout the day for no reason. Really bad headache. Slight nausea. Extreme fatigue. Stiff neck. Still feeling like this now (3:00 PM).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Feeling hot, Injection site pruritus, Injection site swelling
Clinical narrative: 3 HOURS AFTER VACCINATION PT FELT HOT, PRURITUS AND SWELLING OVER INJECTION SITE.  HE WAS SEEN THE NEXT DAY AND TREATED WITH BENADRYL.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: AREA OF INJECTION GOT RED, HOT AND PRURITIC.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Nuclear magnetic resonance imaging, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 39-year-old male subject had received an injection of ACAM2000 (lot number not reported) on 10 March 2011. The subject had a normal troponin I on 10 March 2011. The subject's ECG, echocardiogram and MRI of the heart results were not available. The subject was diagnosed with other, chest pain on 10 March 2011. Medical history was not available. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012. A 23 year-old male subject with a past medical history of chest pain, an abnormal ECG, dizziness/fainting spells, myocarditis and pericarditis was found to have "other, chest pain" 12 days after the subject had received the following vaccines on 07 May 2010: an injection of ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory tests included an abnormal ECG on 19 May 2010. Troponin I and echocardiogram results were not available. A Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 24-year-old male subject had received the following vaccinations: On 24 November 2011, an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and an injection of HEPATITIS A - HEPATITIS B (manufacturer and lot number not reported). The subject's troponin I, ECG, echocardiogram, MRI (brain, spinal cord and heart) and lumbar puncture results were not available. The subject was diagnosed with other, chest pain on 05 December 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging brain, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 24-year-old male subject had received the following vaccinations: On 24 November 2011, an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and an injection of HEPATITIS A - HEPATITIS B (manufacturer and lot number not reported). The subject's troponin I, ECG, echocardiogram, MRI (brain, spinal cord and heart) and lumbar puncture results were not available. The subject was diagnosed with other, chest pain on 05 December 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram normal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 21-year-old female subject had received the following vaccinations: On 04 November 2009, an injection of ACAM2000 (lot number not reported). On 03 November 2009, an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), an injection of ANTHRAX (manufacturer and lot number not reported) and Influenza (manufacturer and lot number not reported). The subject's troponin I result was not available. The subject had a normal ECG on 12 November 2009. The subject was diagnosed with other, chest pain on 13 November 2009. The subject had a medical history of dizziness/fainting spells and notes that were not available on an abnormal ECG and eczema. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Troponin I, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 29-year-old male subject had received the following vaccinations: On 04 November 2009, an injection of ACAM2000 (lot number not reported). On 03 November 2009, an injection of ANTHRAX (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and TYPHIM VI, sanofi pasteur SA (lot number not reported). The subject had an abnormal troponin I on 13 November 2009, a normal echocardiogram on 14 November 2009 and an abnormal ECG on 15 November 2009. The subject was diagnosed with chest pain, unspecified on 13 November 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardiac enzymes normal, Catheterisation cardiac normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 29-year-old male subject had received the following vaccinations: On 04 November 2009, an injection of ACAM2000 (lot number not reported). On 03 November 2009, an injection of ANTHRAX (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and TYPHIM VI, sanofi pasteur SA (lot number not reported). The subject had an abnormal troponin I on 13 November 2009, a normal echocardiogram on 14 November 2009 and an abnormal ECG on 15 November 2009. The subject was diagnosed with chest pain, unspecified on 13 November 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 29-year-old male subject had received the following vaccinations: On 04 November 2009, an injection of ACAM2000 (lot number not reported). On 03 November 2009, an injection of ANTHRAX (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and TYPHIM VI, sanofi pasteur SA (lot number not reported). The subject had an abnormal troponin I on 13 November 2009, a normal echocardiogram on 14 November 2009 and an abnormal ECG on 15 November 2009. The subject was diagnosed with chest pain, unspecified on 13 November 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Angina unstable, Cardiac enzymes normal, Cardiac stress test normal, Chest X-ray normal, Chest pain
Clinical narrative: This study case was received from the investigator in ae trial on 22 February 2012. A 36 year-old male subject whose family history included a parent with CAD and a grandparent that had a bypass at the age of 40 was found to have on 28 August 2009 other, chest pain 19 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported). On 22 July 2009, the subject received ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). The subject arrived by ambulance and presented with L (left) substernal, sharp CP (chest pain) which was reported as 5/10 and SOB (shortness of breath). The subject's pain resolved after the first dose of NG (nitroglycerin). Relevant diagnostic testing revealed: serial ECGs and enzymes are negative, CXR- no PE, no effusion. The subject was admitted to the hospital for continued monitoring (dates not reported). The ER (emergency room) summary included: "IMPRESSION: CP; unstable angina, cardiac rub". Diagnostic testing included: ECG1 : 19days post vaccination Abnormal ECG, possible inferior MI; ECG2 : 19days post vaccination after NG given, no CP, NSR, no stenosis; ECG3: 20days post vaccination NSR (normal sinus rhythm), pain free; ECG4: 20days post vaccination NSR with sinus arrhythmia, pain free; ECG5: 20days post vaccination NSR, subject sleeping, pain free, normal ECG; ECG6: 20days post vaccination NSR, CP 1/10, with mild dyspnea, normal ECG; ECG7: 20days post vaccination NSR with sinus arrhythmia, CP 3/10, normal ECG; ECG8: 20days post vaccination after NG given, no CP, no SOB, no STEMI, Sinus bradycardia, otherwise normal ECG; inpatient stress test 20days post vaccination maximum HR of 166bpm (90.2%). No significant ST segment elevation, normal stress test. Laboratory data included: Troponin I "12:59 19days post vaccination negative; 16:02 19days post vaccination negative; 00:45 20days post vaccination negative. The subject remained on AD (active duty). Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Electrocardiogram ST segment normal, Electrocardiogram abnormal, Pericardial rub, Sinus bradycardia
Clinical narrative: This study case was received from the investigator in ae trial on 22 February 2012. A 36 year-old male subject whose family history included a parent with CAD and a grandparent that had a bypass at the age of 40 was found to have on 28 August 2009 other, chest pain 19 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported). On 22 July 2009, the subject received ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). The subject arrived by ambulance and presented with L (left) substernal, sharp CP (chest pain) which was reported as 5/10 and SOB (shortness of breath). The subject's pain resolved after the first dose of NG (nitroglycerin). Relevant diagnostic testing revealed: serial ECGs and enzymes are negative, CXR- no PE, no effusion. The subject was admitted to the hospital for continued monitoring (dates not reported). The ER (emergency room) summary included: "IMPRESSION: CP; unstable angina, cardiac rub". Diagnostic testing included: ECG1 : 19days post vaccination Abnormal ECG, possible inferior MI; ECG2 : 19days post vaccination after NG given, no CP, NSR, no stenosis; ECG3: 20days post vaccination NSR (normal sinus rhythm), pain free; ECG4: 20days post vaccination NSR with sinus arrhythmia, pain free; ECG5: 20days post vaccination NSR, subject sleeping, pain free, normal ECG; ECG6: 20days post vaccination NSR, CP 1/10, with mild dyspnea, normal ECG; ECG7: 20days post vaccination NSR with sinus arrhythmia, CP 3/10, normal ECG; ECG8: 20days post vaccination after NG given, no CP, no SOB, no STEMI, Sinus bradycardia, otherwise normal ECG; inpatient stress test 20days post vaccination maximum HR of 166bpm (90.2%). No significant ST segment elevation, normal stress test. Laboratory data included: Troponin I "12:59 19days post vaccination negative; 16:02 19days post vaccination negative; 00:45 20days post vaccination negative. The subject remained on AD (active duty). Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in ae trial on 22 February 2012. A 36 year-old male subject whose family history included a parent with CAD and a grandparent that had a bypass at the age of 40 was found to have on 28 August 2009 other, chest pain 19 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported). On 22 July 2009, the subject received ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). The subject arrived by ambulance and presented with L (left) substernal, sharp CP (chest pain) which was reported as 5/10 and SOB (shortness of breath). The subject's pain resolved after the first dose of NG (nitroglycerin). Relevant diagnostic testing revealed: serial ECGs and enzymes are negative, CXR- no PE, no effusion. The subject was admitted to the hospital for continued monitoring (dates not reported). The ER (emergency room) summary included: "IMPRESSION: CP; unstable angina, cardiac rub". Diagnostic testing included: ECG1 : 19days post vaccination Abnormal ECG, possible inferior MI; ECG2 : 19days post vaccination after NG given, no CP, NSR, no stenosis; ECG3: 20days post vaccination NSR (normal sinus rhythm), pain free; ECG4: 20days post vaccination NSR with sinus arrhythmia, pain free; ECG5: 20days post vaccination NSR, subject sleeping, pain free, normal ECG; ECG6: 20days post vaccination NSR, CP 1/10, with mild dyspnea, normal ECG; ECG7: 20days post vaccination NSR with sinus arrhythmia, CP 3/10, normal ECG; ECG8: 20days post vaccination after NG given, no CP, no SOB, no STEMI, Sinus bradycardia, otherwise normal ECG; inpatient stress test 20days post vaccination maximum HR of 166bpm (90.2%). No significant ST segment elevation, normal stress test. Laboratory data included: Troponin I "12:59 19days post vaccination negative; 16:02 19days post vaccination negative; 00:45 20days post vaccination negative. The subject remained on AD (active duty). Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Post-tussive vomiting
Clinical narrative: Initial report received on 23 February 2012 from the investigator in a study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3731AA received on 10 January 2011, lot number C3731AA received on 10 March 2011 and lot number C3872AB received on 17 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 11 October 2011, almost 4 months after the last dose. On 15 October 2011, the subject developed a paroxysmal cough with a 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 18 October 2011 for 5 days. The subject was hospitalized for 2 days. At the time of final contact on 27 October 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 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: 0.6
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder, Vaccination failure
Clinical narrative: Initial report received on 23 February 2012 from the investigator in a study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3731AA received on 10 January 2011, lot number C3731AA received on 10 March 2011 and lot number C3872AB received on 17 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 11 October 2011, almost 4 months after the last dose. On 15 October 2011, the subject developed a paroxysmal cough with a 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 18 October 2011 for 5 days. The subject was hospitalized for 2 days. At the time of final contact on 27 October 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 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: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Endometrial hypertrophy, Human chorionic gonadotropin, Maternal exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Initial report received from a healthcare professional on 08 September 2011. A 28-year-old pregnant female patient had received a dose of ADACEL (lot number C39385AA) on 26 August 2011. The exact date of the last menstrual period was reported as an unknown day in July 2011 with estimated date of delivery on an unknown date in April 2011. The patient had no known risk factors, and does not use alcohol or tobacco, and denied any use of recreational drugs. The patient has not experienced any adverse events since being vaccinated with ADACEL on 26 August 2011. Follow-up information was received from a health care professional on 05 March 2012. Based upon the new information provided, this case has been upgraded to serious. The patient's last menstrual period was 20 July 2011. The patient experienced a miscarriage on 08 September 2011, approximately 2 weeks after Tdap. On 08 September 2011, the patient had an ultrasound that showed thickened endometrial lining with no intrauterine pregnancy (IUP) and the patient's beta human chorionic gonadotropin (BHCG) was 84. The patient had no illness at the time of vaccination and no adverse events to prior vaccinations. The patient had no family history of congenital abnormalities. The patient's concomitant medications included prenatal vitamins. The patient's outcome was not reported. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Cough, Dry skin, Dyspnoea, Gastroenteritis viral, Increased upper airway secretion
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of Tdap. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. An 11-year-old male patient had received a 0.5 mL dose 5 injection of Tdap (manufacturer, lot number, route and site of administration not reported) on 05 September 2005. The patient was 4-years-old at the time. On 07 September 2005, the patient received a 0.5 mL dose 4 injection of IPV, a 0.5 mL dose 2 injection of MMR and a 0.5 mL dose 1 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 09 January 2012 with complaints of cough for the last month, fits of cough, can't catch his breath, brings up mucus and a low grade fever. The patient's sister and dad have the same cough. The previous weekend the patient was vomiting with the stomach flu. Upon examination, the patient had erythema on tonsils, no cervical lymphadenopathy, good air movement with no crackles or wheezes, sandpapery feeling skin with colored papules on back. The physician's assessment was cough and pharyngitis. A rapid strep test was done and results were negative. The patient's sister tested positive for pertussis so the patient was treated for pertussis as well with azithromycin. No laboratory testing was done for the patient to confirm pertussis. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of headache and unspecified disorder of male genital organs. The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0356CA on 13 March 2001, lot number U0378AA on 25 May 2001, lot number U0532DA on 17 August 2001 and lot number U0549AA on 26 July 2002. The patient was up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Laboratory test normal, Pertussis, Pharyngeal erythema, Pharyngitis, Pyrexia
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of Tdap. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. An 11-year-old male patient had received a 0.5 mL dose 5 injection of Tdap (manufacturer, lot number, route and site of administration not reported) on 05 September 2005. The patient was 4-years-old at the time. On 07 September 2005, the patient received a 0.5 mL dose 4 injection of IPV, a 0.5 mL dose 2 injection of MMR and a 0.5 mL dose 1 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 09 January 2012 with complaints of cough for the last month, fits of cough, can't catch his breath, brings up mucus and a low grade fever. The patient's sister and dad have the same cough. The previous weekend the patient was vomiting with the stomach flu. Upon examination, the patient had erythema on tonsils, no cervical lymphadenopathy, good air movement with no crackles or wheezes, sandpapery feeling skin with colored papules on back. The physician's assessment was cough and pharyngitis. A rapid strep test was done and results were negative. The patient's sister tested positive for pertussis so the patient was treated for pertussis as well with azithromycin. No laboratory testing was done for the patient to confirm pertussis. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of headache and unspecified disorder of male genital organs. The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0356CA on 13 March 2001, lot number U0378AA on 25 May 2001, lot number U0532DA on 17 August 2001 and lot number U0549AA on 26 July 2002. The patient was up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Rash papular, Streptococcus test, Vomiting
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of Tdap. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. An 11-year-old male patient had received a 0.5 mL dose 5 injection of Tdap (manufacturer, lot number, route and site of administration not reported) on 05 September 2005. The patient was 4-years-old at the time. On 07 September 2005, the patient received a 0.5 mL dose 4 injection of IPV, a 0.5 mL dose 2 injection of MMR and a 0.5 mL dose 1 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 09 January 2012 with complaints of cough for the last month, fits of cough, can't catch his breath, brings up mucus and a low grade fever. The patient's sister and dad have the same cough. The previous weekend the patient was vomiting with the stomach flu. Upon examination, the patient had erythema on tonsils, no cervical lymphadenopathy, good air movement with no crackles or wheezes, sandpapery feeling skin with colored papules on back. The physician's assessment was cough and pharyngitis. A rapid strep test was done and results were negative. The patient's sister tested positive for pertussis so the patient was treated for pertussis as well with azithromycin. No laboratory testing was done for the patient to confirm pertussis. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of headache and unspecified disorder of male genital organs. The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0356CA on 13 March 2001, lot number U0378AA on 25 May 2001, lot number U0532DA on 17 August 2001 and lot number U0549AA on 26 July 2002. The patient was up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Bordetella test positive, Cough, Decreased appetite, Nasal congestion, Oral mucosal erythema
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 4-year-old male patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of PEDIARIX, GlaxoSmithKline, received on 12 September 2007, 16 November 2007, 18 January 2008 and 14 November 2008 (routes and sites not reported). The patient had received a 0.5ml injection of DTaP (lot number, manufacturer, route and site not reported) on 19 August 2011. On the same date, the patient also received a 0.5ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR and a 0.5 ml dose 2 injection of Varicella (manufacturer, lot number, route and site not reported). The patient was seen on 23 January 2012 with complaints of cough for a week, almost a whoop, vomiting after cough, fever, sore throat, runny nose, congestion and appetite decreased. Upon examination, the patient had nasal congestion, oral erythema, lungs were clear to auscultation bilaterally with no wheeze or crackles and skin-colored papules with sandpaper feel on back. The physician's assessment was cough and rash. A nasopharyngeal swab and rapid strep test was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella parapertussis DNA detected. Negative for Bordetella pertussis DNA." The patient was treated with azithromycin. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of torticollis, PE tubes, frequent strep, tonsils and adenoids removed, constipation, wheeze, speech delay and possible upper extremity strength issue. The patient's father had a medical history of weight problems. The patient's mother had a medical history of migraines/headaches and weight problems. The patient's paternal grandmother had a medical history of high blood pressure, maternal grandfather had a medical history of cancer, maternal grandmother had a medical history of weight problems and paternal uncle had a medical history of migraines/headaches. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oropharyngeal pain, Papule, Polymerase chain reaction, Post-tussive vomiting, Pyrexia
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 4-year-old male patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of PEDIARIX, GlaxoSmithKline, received on 12 September 2007, 16 November 2007, 18 January 2008 and 14 November 2008 (routes and sites not reported). The patient had received a 0.5ml injection of DTaP (lot number, manufacturer, route and site not reported) on 19 August 2011. On the same date, the patient also received a 0.5ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR and a 0.5 ml dose 2 injection of Varicella (manufacturer, lot number, route and site not reported). The patient was seen on 23 January 2012 with complaints of cough for a week, almost a whoop, vomiting after cough, fever, sore throat, runny nose, congestion and appetite decreased. Upon examination, the patient had nasal congestion, oral erythema, lungs were clear to auscultation bilaterally with no wheeze or crackles and skin-colored papules with sandpaper feel on back. The physician's assessment was cough and rash. A nasopharyngeal swab and rapid strep test was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella parapertussis DNA detected. Negative for Bordetella pertussis DNA." The patient was treated with azithromycin. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of torticollis, PE tubes, frequent strep, tonsils and adenoids removed, constipation, wheeze, speech delay and possible upper extremity strength issue. The patient's father had a medical history of weight problems. The patient's mother had a medical history of migraines/headaches and weight problems. The patient's paternal grandmother had a medical history of high blood pressure, maternal grandfather had a medical history of cancer, maternal grandmother had a medical history of weight problems and paternal uncle had a medical history of migraines/headaches. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Respiratory tract congestion, Rhinorrhoea, Streptococcus test
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 4-year-old male patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of PEDIARIX, GlaxoSmithKline, received on 12 September 2007, 16 November 2007, 18 January 2008 and 14 November 2008 (routes and sites not reported). The patient had received a 0.5ml injection of DTaP (lot number, manufacturer, route and site not reported) on 19 August 2011. On the same date, the patient also received a 0.5ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR and a 0.5 ml dose 2 injection of Varicella (manufacturer, lot number, route and site not reported). The patient was seen on 23 January 2012 with complaints of cough for a week, almost a whoop, vomiting after cough, fever, sore throat, runny nose, congestion and appetite decreased. Upon examination, the patient had nasal congestion, oral erythema, lungs were clear to auscultation bilaterally with no wheeze or crackles and skin-colored papules with sandpaper feel on back. The physician's assessment was cough and rash. A nasopharyngeal swab and rapid strep test was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella parapertussis DNA detected. Negative for Bordetella pertussis DNA." The patient was treated with azithromycin. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of torticollis, PE tubes, frequent strep, tonsils and adenoids removed, constipation, wheeze, speech delay and possible upper extremity strength issue. The patient's father had a medical history of weight problems. The patient's mother had a medical history of migraines/headaches and weight problems. The patient's paternal grandmother had a medical history of high blood pressure, maternal grandfather had a medical history of cancer, maternal grandmother had a medical history of weight problems and paternal uncle had a medical history of migraines/headaches. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Asthma, Bordetella test positive, Bronchial hyperreactivity, Bronchitis, Cough
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02350. Initial report was received from a health care professional on 24 February 2012. A 10-year-old female patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of DTaP (manufacturers, lot numbers, routes and sites not reported) on 28 August 2001, 25 November 2001, 13 December 2001 and 26 December 2002. The patient had received a 0.5ml dose 5 injection of DTaP (manufacturer, lot number, route and site not reported) on 15 May 2006. On the same date, the patient also received a 0.5ml dose 4 injection of IPV and a 0.5ml dose 2 injection of MMR (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 24 January 2012 with complaints of coughing fits for over a week, congestion only at nose, bringing up mucus with cough, feels nauseous after cough, shortness of breath (SOB), sore throat, achy, dizzy, ear pain, headache, poor appetite, diarrhea, croup and asthma. Upon examination, the patient had nasal congestion and lungs were clear to auscultation bilaterally with no wheeze or crackles. The physician's assessment was bronchitis, cough, reactive airways disease (RAD) and diarrhea. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, FLOVENT and albuterol. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of MRSA, refractive error, infantile asthma, influenza, allergic rhinitis, strep, otitis media (OM), vomiting, breast milk allergy and soy allergy. The patient was up-to-date with HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father had a medical history of environmental allergies, asthma and sinus infections. The patient's mother had a medical history of sinus infections, environmental allergies and eczema. The patient's brother had a medical history of asthma. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Croup infectious, Decreased appetite, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02350. Initial report was received from a health care professional on 24 February 2012. A 10-year-old female patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of DTaP (manufacturers, lot numbers, routes and sites not reported) on 28 August 2001, 25 November 2001, 13 December 2001 and 26 December 2002. The patient had received a 0.5ml dose 5 injection of DTaP (manufacturer, lot number, route and site not reported) on 15 May 2006. On the same date, the patient also received a 0.5ml dose 4 injection of IPV and a 0.5ml dose 2 injection of MMR (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 24 January 2012 with complaints of coughing fits for over a week, congestion only at nose, bringing up mucus with cough, feels nauseous after cough, shortness of breath (SOB), sore throat, achy, dizzy, ear pain, headache, poor appetite, diarrhea, croup and asthma. Upon examination, the patient had nasal congestion and lungs were clear to auscultation bilaterally with no wheeze or crackles. The physician's assessment was bronchitis, cough, reactive airways disease (RAD) and diarrhea. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, FLOVENT and albuterol. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of MRSA, refractive error, infantile asthma, influenza, allergic rhinitis, strep, otitis media (OM), vomiting, breast milk allergy and soy allergy. The patient was up-to-date with HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father had a medical history of environmental allergies, asthma and sinus infections. The patient's mother had a medical history of sinus infections, environmental allergies and eczema. The patient's brother had a medical history of asthma. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.