chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid is warm, pink, itchy, swollen.  Still has full range of motion but with discomfort.  Denies HA, blurry vision, lightheadedness, dizziness, cp, sob, abdominal pain, nausea, vomiting, diarrhea, weakness.  Pt took Benadryl and Tylenol earlier today that helped a little bit.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid is warm, pink, itchy, swollen.  Still has full range of motion but with discomfort.  Denies HA, blurry vision, lightheadedness, dizziness, cp, sob, abdominal pain, nausea, vomiting, diarrhea, weakness.  Pt took Benadryl and Tylenol earlier today that helped a little bit.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a doctor's office manager refers to an 18 years old male patient with no pertinent medical history and no drug reaction or allergies. The patient was vaccinated with a first 0.5 ml dose of VARIVAX (Merck) lot # (630037/0312J expiration date 17-FEB-2000) SQ on 14-MAY-1999, and with a second 0.5 ml dose of VARIVAX (Merck) (lot # 656576/0446U expiration date 09-MAR-2009) SQ on 25-MAY-2007. No other co-suspects were reported. There were no concomitant medications. The manager reported that on 23-JUL-2012, the patient experienced shingles. The patient was treated with ZOVIRAX ointment. There were no lab diagnosis or studies performed. The outcome of shingles was unknown. Additional information has been requested,
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Cyanosis, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old male patient with eczema and nuts allergy. The patient was vaccinated with the first dose of VARIVAX and the first dose of MMR II on 20-MAR-2009 and had no symptoms at that time. Other suspect therapies included KINRIX. No concomitant medication was reported. The patient was received the second dose of VARIVAX (Lot#0360AE, exp 15-FEB-2014) 0.5ml Subcutaneously, the second dose of MMR II (Lot# 0426AE, exp 27-FEB-2014) and KINRIX on 06-AUG-2012 and developed an allergic reaction. Approximately 5 to 10 minutes after administration of all 3 vaccines the patient experienced coughing, shortness of breath, vomiting, wheezing and blue lips. There were redness and swelling of both legs. The patient had an oxygen stat of "88". The patient was administered an EPIPEN, oxygen, XOPENEX, BENADRYL I.M. and SOLU-MEDROL while in the office. The patient was then transported to the emergency room and admitted to the hospital. The patient was released from the hospital on 07-AUG-2012. The outcome of the events were reported as recovering at time of the report. The events were considered to be other important medical events and life threatening by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Oxygen saturation decreased, Pallor, Vomiting, Wheezing
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old male patient with eczema and nuts allergy. The patient was vaccinated with the first dose of VARIVAX and the first dose of MMR II on 20-MAR-2009 and had no symptoms at that time. Other suspect therapies included KINRIX. No concomitant medication was reported. The patient was received the second dose of VARIVAX (Lot#0360AE, exp 15-FEB-2014) 0.5ml Subcutaneously, the second dose of MMR II (Lot# 0426AE, exp 27-FEB-2014) and KINRIX on 06-AUG-2012 and developed an allergic reaction. Approximately 5 to 10 minutes after administration of all 3 vaccines the patient experienced coughing, shortness of breath, vomiting, wheezing and blue lips. There were redness and swelling of both legs. The patient had an oxygen stat of "88". The patient was administered an EPIPEN, oxygen, XOPENEX, BENADRYL I.M. and SOLU-MEDROL while in the office. The patient was then transported to the emergency room and admitted to the hospital. The patient was released from the hospital on 07-AUG-2012. The outcome of the events were reported as recovering at time of the report. The events were considered to be other important medical events and life threatening by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Cyanosis, Dyspnoea, Erythema, Hypersensitivity
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old male patient with eczema and nuts allergy. The patient was vaccinated with the first dose of VARIVAX and the first dose of MMR II on 20-MAR-2009 and had no symptoms at that time. Other suspect therapies included KINRIX. No concomitant medication was reported. The patient was received the second dose of VARIVAX (Lot#0360AE, exp 15-FEB-2014) 0.5ml Subcutaneously, the second dose of MMR II (Lot# 0426AE, exp 27-FEB-2014) and KINRIX on 06-AUG-2012 and developed an allergic reaction. Approximately 5 to 10 minutes after administration of all 3 vaccines the patient experienced coughing, shortness of breath, vomiting, wheezing and blue lips. There were redness and swelling of both legs. The patient had an oxygen stat of "88". The patient was administered an EPIPEN, oxygen, XOPENEX, BENADRYL I.M. and SOLU-MEDROL while in the office. The patient was then transported to the emergency room and admitted to the hospital. The patient was released from the hospital on 07-AUG-2012. The outcome of the events were reported as recovering at time of the report. The events were considered to be other important medical events and life threatening by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Oedema peripheral, Oxygen saturation decreased, Vomiting, Wheezing
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old male patient with eczema and nuts allergy. The patient was vaccinated with the first dose of VARIVAX and the first dose of MMR II on 20-MAR-2009 and had no symptoms at that time. Other suspect therapies included KINRIX. No concomitant medication was reported. The patient was received the second dose of VARIVAX (Lot#0360AE, exp 15-FEB-2014) 0.5ml Subcutaneously, the second dose of MMR II (Lot# 0426AE, exp 27-FEB-2014) and KINRIX on 06-AUG-2012 and developed an allergic reaction. Approximately 5 to 10 minutes after administration of all 3 vaccines the patient experienced coughing, shortness of breath, vomiting, wheezing and blue lips. There were redness and swelling of both legs. The patient had an oxygen stat of "88". The patient was administered an EPIPEN, oxygen, XOPENEX, BENADRYL I.M. and SOLU-MEDROL while in the office. The patient was then transported to the emergency room and admitted to the hospital. The patient was released from the hospital on 07-AUG-2012. The outcome of the events were reported as recovering at time of the report. The events were considered to be other important medical events and life threatening by the reporter. Additional information has been requested.
Sex: M
Vaccine: TD
Symptoms: Nausea, Palpitations, Pyrexia
Clinical narrative: Fever up to 101.2 the day after the vaccine - resolved after several hours. Also nausea & racing heart.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Inflammation & tenderness to (R) deltoid area. Seen 8/9/12 vaccine admin. 8/7/12.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pruritus, Skin warm
Clinical narrative: 8/13/2012 Patient assessed by RN: 2 cm (width) x 1 cm (length) x 0.2 cm pink/red raised area from dermus. Warm to the touch.  Patient reports itching at site. Dr. assesed patient.  Cool compresses ordered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 15 minutes after vaccine was administered, pt experienced redness, itchiness, and swelling at site of injection. Pharmacist recommended oral antihistamine to relieve symptoms. Pharmacist called pt to f/u 8/14/12; pt stated the swelling and itchiness had not decreased, but she was not concerned or bothered by it anymore.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Nodule, Pruritus, Swelling
Clinical narrative: LARGE (2 INCH DIAMETER) RAISED SWOLLEN KNOT, EXTREME ITCHING/BURNING, RED PATCH. TREATMENT WITH ICE PACKS SEVERAL TIMES. THREE DAYS OUT, STILL USING ICE, CONDITION IS RESOLVING.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Pt. reported throat tightening and lip tingling. No lip/tongue swelling/dysphonia/wheezing or vital sign instability, including stable oxygen saturation measured.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 08 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a six-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4145AA received on 23 February and 25 April 2012, and lot number C4230AA received on 26 June 2012 (routes and sites of administration not reported). The subject developed a cough on 12 July 2012, 16 days after receiving the last dose. On 20 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 23 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough was still persisting. The duration of the cough was reported at the time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 08 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a six-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4145AA received on 23 February and 25 April 2012, and lot number C4230AA received on 26 June 2012 (routes and sites of administration not reported). The subject developed a cough on 12 July 2012, 16 days after receiving the last dose. On 20 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 23 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough was still persisting. The duration of the cough was reported at the 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
Symptoms: Chest X-ray normal, Cough, Culture negative, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a six-month-old female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C4143AA received on 27 February 2012, lot number C4080AB received on 10 May 2012 and lot number C3080AB received on 09 July 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, five days  after the last dose. On 16 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR  and negative culture on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a six-month-old female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C4143AA received on 27 February 2012, lot number C4080AB received on 10 May 2012 and lot number C3080AB received on 09 July 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, five days  after the last dose. On 16 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR  and negative culture on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 06 August 2012 from the investigator participating in a post-marketing observation surveillance study under the reference number MSA16. A case of pertussis disease in a eight-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received 3 doses of PENTACEL; received on 09 January 2012, 09 March 2012 and 10 May 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough and had cold-like symptoms on 19 July 2012, approximately two months after the last dose. On 24 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 25 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 06 August 2012 from the investigator participating in a post-marketing observation surveillance study under the reference number MSA16. A case of pertussis disease in a eight-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received 3 doses of PENTACEL; received on 09 January 2012, 09 March 2012 and 10 May 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough and had cold-like symptoms on 19 July 2012, approximately two months after the last dose. On 24 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 25 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cardiac monitoring, Cellulitis, Computerised tomogram abdomen, Electrocardiogram
Clinical narrative: Acute cellulitis (L) arm below injection site w/ in 4 hrs of injection. Hospitalized 24 hrs later for 3 days. Treatment included IV antibiotics, prednisone, bloodwork, breathing treatments, abdominal CT. Run of tachycardia, monitoring, follow up visits.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Tachycardia
Clinical narrative: Acute cellulitis (L) arm below injection site w/ in 4 hrs of injection. Hospitalized 24 hrs later for 3 days. Treatment included IV antibiotics, prednisone, bloodwork, breathing treatments, abdominal CT. Run of tachycardia, monitoring, follow up visits.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Apnoea, Convulsion, Loss of consciousness, Pulse absent
Clinical narrative: Pt seized lost consciousness, became apneic and was without a pulse, ambu bagged pt. 0.4 mg epi given & pt regained pulse & consciousness. A&Ox3. Paramedics came. Pt did not hit his head. HR: 100 BP: 116/70 when paramedics arrived. Total seizure length: 1.5 minutes.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Eyelid oedema, Flushing, Glossodynia, Lip swelling
Clinical narrative: Begin to have burning of tongue within 20 min after vaccine, progressed to swelling of lips & eyelids with flushing chest up. Stable BP. Pulse oximetry 94%, given EPI x2 & DEPO MEDROL with improvement, admitted to hospital.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Alopecia, Irritability, Pyrexia, Rash papular, Vaccination complication
Clinical narrative: Mother reported vaccine reaction to our practice 8-8-12, first visit to office. Reported fussy, fever 100 degrees within 1 hr of vaccine up to 100.7-102.1 (R), vomiting some on first day. To ER at midnight on 4-25-12. Mother reports admitted, fever, hair fell out, mother reports hospitalized x 3 day. Took 1 week before back to normal - ER diagnoses viral vs vaccine reaction.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Viral infection, Viral rash, Vomiting
Clinical narrative: Mother reported vaccine reaction to our practice 8-8-12, first visit to office. Reported fussy, fever 100 degrees within 1 hr of vaccine up to 100.7-102.1 (R), vomiting some on first day. To ER at midnight on 4-25-12. Mother reports admitted, fever, hair fell out, mother reports hospitalized x 3 day. Took 1 week before back to normal - ER diagnoses viral vs vaccine reaction.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 08 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received three doses of PENTACEL; lot number C3338AA received on 11 January 2010, lot number C3404AA received on 09 March 2010 and lot number C3494AA received on 11 May 2010; and one dose of TRIPEDIA; lot number U3497BA received on 15 November 2011 (routes and sites of administration not reported). The subject developed a cough on 05 July 2012, approximately seven months after the last dose of pertussis vaccine. On 07 July 2012, the subject developed cold-like symptoms and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 08 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 08 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received three doses of PENTACEL; lot number C3338AA received on 11 January 2010, lot number C3404AA received on 09 March 2010 and lot number C3494AA received on 11 May 2010; and one dose of TRIPEDIA; lot number U3497BA received on 15 November 2011 (routes and sites of administration not reported). The subject developed a cough on 05 July 2012, approximately seven months after the last dose of pertussis vaccine. On 07 July 2012, the subject developed cold-like symptoms and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 08 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3545AB received on 27 January 2010, lot number number C3555AA received on 08 April 2010 and lot number C3602AB received on 28 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 06 July 2012, approximately two years after the last dose. On 15 July 2012, the subject developed a cough and paroxysms began on 23 July 2012. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3545AB received on 27 January 2010, lot number number C3555AA received on 08 April 2010 and lot number C3602AB received on 28 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 06 July 2012, approximately two years after the last dose. On 15 July 2012, the subject developed a cough and paroxysms began on 23 July 2012. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3545AA received on 01 December 2009, lot number C3579AA received on 01 March 2010 and lot number C3573AB received on 03 May 2010 (routes and sites of administration not reported). On 06 May 2012, the subject developed a cough, approximately two years after the last dose. On 13 May 2012, the subject developed paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 19 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3545AA received on 01 December 2009, lot number C3579AA received on 01 March 2010 and lot number C3573AB received on 03 May 2010 (routes and sites of administration not reported). On 06 May 2012, the subject developed a cough, approximately two years after the last dose. On 13 May 2012, the subject developed paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 19 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 15-month-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; received on 06 May 2011, 01 July 2011 and 26 September 2011 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 06 June 2012, approximately eight months after the last dose. On 20 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 21 June 2012. Corrective treatments consisted of azithromycin starting on 21 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 15-month-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; received on 06 May 2011, 01 July 2011 and 26 September 2011 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 06 June 2012, approximately eight months after the last dose. On 20 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 21 June 2012. Corrective treatments consisted of azithromycin starting on 21 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: Fever up to 101, both legs swollen, tight painful when touched, slight redness, pt. very fussy.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia, Skin tightness
Clinical narrative: Fever up to 101, both legs swollen, tight painful when touched, slight redness, pt. very fussy.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Oropharyngeal pain, Pain in extremity, Pruritus, Rash
Clinical narrative: 6/22/12 after 1 pm tetanus shot was given to me on upper left arm. Arm mildly sore, after administration, Sunday lips on and off numb, Monday chest area; rash and sensitive Tuesday broke out in a severe rash, chest, neck & face. Hands and arms itch, with slight sore throat.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Rash, Rash erythematous, Rash pruritic, Vulvovaginal pain
Clinical narrative: No temperature. Given vaccine 7-16-12. Developed skin rash 7-26-12 developed skin rash around left eyes, under right breast, right thigh & vagina. Rash was slightly raised, red & itched. No pain associated with rash except vaginally.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient has 5" x 6" erythemic, swollen, warm. Painful area around injection site, entire (L) upper arm is swollen.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Disorientation, Dizziness, Nausea, Syncope
Clinical narrative: Pt received ADACEL injection, after 7 minutes felt sick to his stomach. Nauseated, light-headed and collapsed to floor. Was conscious, but slightly disoriented Pt was given H2O & chair to sit on until EMR team came, took pt to ER - given IV's to stabilized BP, pt is doing well now.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Headache, Injection site erythema, Rash erythematous, Rash generalised
Clinical narrative: Pt was well at time of physical. 1 1/2 hrs later developed red and blotchy rash all over body. No breathing issue. Rash started to resolve over before getting BENADRYL. Rash gone by next AM, but then got headache and temp to 103. Also a red mark where shot was given that was not there right before.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Rash macular
Clinical narrative: Pt was well at time of physical. 1 1/2 hrs later developed red and blotchy rash all over body. No breathing issue. Rash started to resolve over before getting BENADRYL. Rash gone by next AM, but then got headache and temp to 103. Also a red mark where shot was given that was not there right before.
Age: 30.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Injection site rash, Pyrexia, Vomiting
Clinical narrative: The patient presents with complaints of fever to 102.4 and a rash. He was given a tetanus shot and a pneumonia shot 2 days ago. The fever started yesterday. The rash is in the area of his shots. He started throwing up today x2. He always has abdominal pain and there does not appear to be any difference now than usual. He denies sinus pressure, ST, cough, sputum, hemoptysis, diarrhea, BRBPR, melena, dysuria, hematuria.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 1 dose of DAPTACEL; lot number C2951BA received on 23 June 2008 and 3 doses of PENTACEL; lot number C3176AA received on 16 September 2008, lot number C3176AA received on 12 November 2008 and lot number C3497AA received on 06 November 2009 (routes and sites of administration not reported). On 08 July 2012, the subject developed a cough, approximately 2 years and 8 months after the last dose. On 14 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting
Clinical narrative: Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 1 dose of DAPTACEL; lot number C2951BA received on 23 June 2008 and 3 doses of PENTACEL; lot number C3176AA received on 16 September 2008, lot number C3176AA received on 12 November 2008 and lot number C3497AA received on 06 November 2009 (routes and sites of administration not reported). On 08 July 2012, the subject developed a cough, approximately 2 years and 8 months after the last dose. On 14 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Pain in extremity
Clinical narrative: Please see attached report -. HPV #2 (lot # H009746 with exp. date 11JAN15) vaccine was administered at 10:25 per MD order. There was immediate bleeding lasting less than 5 seconds upon removal of the needle. Bleeding was stopped with compression. A quarter sized hematoma was noted at the vaccine site with redness spreading t half dollar size. Patient complained of soreness and numbness all over her left arm at 10:30am. MD was notified and ordered a cold compression dressing and 400mg of ibuprofen, which was administered orally at 10:35 am. Patient began itching all over left arm at 10:45 am. BENADRYL 25 mg was given orally at 10:47 am per MD order. At 11:32am, a pressure dressing was applied and the cold pack was removed per MD order. The patient was released from our care in good condition. Mother and patient were instructed to continue 400mg of ibuprofen every six hours for the next 48 hours. Mother was advised of the possibility of bruising and swelling. Patient was instructed to follow up with any concerns.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Vaccination site haematoma
Clinical narrative: Please see attached report -. HPV #2 (lot # H009746 with exp. date 11JAN15) vaccine was administered at 10:25 per MD order. There was immediate bleeding lasting less than 5 seconds upon removal of the needle. Bleeding was stopped with compression. A quarter sized hematoma was noted at the vaccine site with redness spreading t half dollar size. Patient complained of soreness and numbness all over her left arm at 10:30am. MD was notified and ordered a cold compression dressing and 400mg of ibuprofen, which was administered orally at 10:35 am. Patient began itching all over left arm at 10:45 am. BENADRYL 25 mg was given orally at 10:47 am per MD order. At 11:32am, a pressure dressing was applied and the cold pack was removed per MD order. The patient was released from our care in good condition. Mother and patient were instructed to continue 400mg of ibuprofen every six hours for the next 48 hours. Mother was advised of the possibility of bruising and swelling. Patient was instructed to follow up with any concerns.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea haemorrhagic, Irritability, Pyrexia, Rotavirus test
Clinical narrative: 10 episodes of diarrhea with tinge of blood, fussy & fever of 100.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Dehydration, Headache, Leukopenia, Liver function test abnormal, Pain
Clinical narrative: Likely serum sickness. Fever, body aches, headache vomiting, dehydration, leukopenia, elevated liver function tests.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Serum sickness, Vomiting
Clinical narrative: Likely serum sickness. Fever, body aches, headache vomiting, dehydration, leukopenia, elevated liver function tests.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyskinesia
Clinical narrative: Pt felt faint with jerking movements.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Gait disturbance, Headache, Hypersomnia
Clinical narrative: Duration - 5 days - c/o fatigue, excessive sleepiness, gait abnormalities, dizziness, LLE weakness, HA.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness
Clinical narrative: Duration - 5 days - c/o fatigue, excessive sleepiness, gait abnormalities, dizziness, LLE weakness, HA.
Age: 30.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash covering entire torso & legs, 2 days following vaccination.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Developed fever on 7/21/12 at 0100 which lasted 3 days. In addition, vomiting x 2 on 7/21/12 severe headache on 7/21/12.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Started feeling really tired and dizzy around noon time on 8/11/12.  Felt sick to my stomach; NO VOMITING OR DIARRHEA.  Symptoms continued on Sunday 8/12 as well.  Symptoms finally went away on Sunday evening.  I took a total of 1 dramamine during the symptoms to try and relieve the dizziness which helped only slightly.
Age: 0.12
Sex: F
Vaccine: DTAPHEPBIP, HEP, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Duplicate Hepatits B vaccine in error.
Age: 1.26
Sex: F
Vaccine: HIBV, PPV, HIBV, PNC
Symptoms: Crying, Injection site urticaria, Poor quality sleep, Vomiting
Clinical narrative: Vomited one time, emptying stomach content.  Restless sleep all night, constant crying.  Woke up at 7:00 am with hives on her left leg, same location as the shot.
Age: 1.26
Sex: F
Vaccine: HIBV, PPV, HIBV, PNC
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Vomited one time, emptying stomach content.  Restless sleep all night, constant crying.  Woke up at 7:00 am with hives on her left leg, same location as the shot.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Chondropathy, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Skeletal injury, Surgery
Clinical narrative: Significant shoulder pain which worsened over subsequent days.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Abdominal pain, Amenorrhoea, Blood test, Burning sensation, Contusion
Clinical narrative: Within several hours of vaccination, began having pain in upper left leg and tingling in left leg.  Shot was administered in upper left arm.  Days following vaccination: pain in left leg, left side below ribcage felt sore and bruised; developed rashes on legs and burning sensation in arms and hands that would come and go; large bruises on legs and arms began showing up for no reason; extreme exhaustion day of vaccination and for several days afterwards.  3 days after vaccination: extreme abdominal pain lasting several hours. For 2 weeks following vaccination: left arm pain and left shoulder painful and difficult to use; could not lift anything with that arm and had to use heat packs on arm, finally began to get better but still have pain from time to time in my left shoulder.  Blood work performed on 6/18 showed rise in Eosinophils (642) normal range is 15-500.  Did not have a menstrual cycle following vaccination until 58 days later.  Last period ended on May 29, 2012.  Vaccinated June 4th.  Did not have another period until July 28, 2012. Went to doctor on 6/18 and reported complaints, doctor ordered the blood work.  I do not have insurance so I could not afford to make several visits.  I am to return for blood work and follow up appointment with doctor, which I plan to do this week, August 2012.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Eosinophil count increased, Fatigue, Flank pain, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Within several hours of vaccination, began having pain in upper left leg and tingling in left leg.  Shot was administered in upper left arm.  Days following vaccination: pain in left leg, left side below ribcage felt sore and bruised; developed rashes on legs and burning sensation in arms and hands that would come and go; large bruises on legs and arms began showing up for no reason; extreme exhaustion day of vaccination and for several days afterwards.  3 days after vaccination: extreme abdominal pain lasting several hours. For 2 weeks following vaccination: left arm pain and left shoulder painful and difficult to use; could not lift anything with that arm and had to use heat packs on arm, finally began to get better but still have pain from time to time in my left shoulder.  Blood work performed on 6/18 showed rise in Eosinophils (642) normal range is 15-500.  Did not have a menstrual cycle following vaccination until 58 days later.  Last period ended on May 29, 2012.  Vaccinated June 4th.  Did not have another period until July 28, 2012. Went to doctor on 6/18 and reported complaints, doctor ordered the blood work.  I do not have insurance so I could not afford to make several visits.  I am to return for blood work and follow up appointment with doctor, which I plan to do this week, August 2012.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain in extremity, Paraesthesia, Rash
Clinical narrative: Within several hours of vaccination, began having pain in upper left leg and tingling in left leg.  Shot was administered in upper left arm.  Days following vaccination: pain in left leg, left side below ribcage felt sore and bruised; developed rashes on legs and burning sensation in arms and hands that would come and go; large bruises on legs and arms began showing up for no reason; extreme exhaustion day of vaccination and for several days afterwards.  3 days after vaccination: extreme abdominal pain lasting several hours. For 2 weeks following vaccination: left arm pain and left shoulder painful and difficult to use; could not lift anything with that arm and had to use heat packs on arm, finally began to get better but still have pain from time to time in my left shoulder.  Blood work performed on 6/18 showed rise in Eosinophils (642) normal range is 15-500.  Did not have a menstrual cycle following vaccination until 58 days later.  Last period ended on May 29, 2012.  Vaccinated June 4th.  Did not have another period until July 28, 2012. Went to doctor on 6/18 and reported complaints, doctor ordered the blood work.  I do not have insurance so I could not afford to make several visits.  I am to return for blood work and follow up appointment with doctor, which I plan to do this week, August 2012.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Malaise
Clinical narrative: Client describes a numbness inside her body; a feeling of being unwell.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Injection area inflammed, red area got very big and hard. Lasted about 3 days. She took some Allegra tablets.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Minimal left upper extremity swelling and minimal erythema in the medial biceps and forearm area for 4 days.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Genital herpes, Headache, Rash vesicular
Clinical narrative: Scattered vesicular eruption, headache, eruptions genital herpes.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Dizziness, Genital herpes, Headache, Rash papular
Clinical narrative: Scattered vesicular eruption, headache, eruptions genital herpes.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin lesion, Varicella virus test
Clinical narrative: Scattered vesicular eruption, headache, eruptions genital herpes.