chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Oedema peripheral, Rash, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient was vaccinated with the first dose of GARDASIL (Lot # 670049/1261AA) into the left arm on 25-FEB-2012. Other suspect therapy included the first dose of MENACTRA (Lot# U3850AA) given into the left arm on 25-FEB-2012. No concomitant medications were reported. On 25-FEB-2012 the patient experienced (L) arm rash, swollen and felt warm. Patient was given BENADRYL and KENALOG. The outcome of the events were unknown. The original reporting source was not provided. The VAERS ID# is 451356-1.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Feeling hot, Oedema peripheral, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient was vaccinated with the first dose of GARDASIL (Lot # 670049/1261AA) into the left arm on 25-FEB-2012. Other suspect therapy included the first dose of MENACTRA (Lot# U3850AA) given into the left arm on 25-FEB-2012. No concomitant medications were reported. On 25-FEB-2012 the patient experienced (L) arm rash, swollen and felt warm. Patient was given BENADRYL and KENALOG. The outcome of the events were unknown. The original reporting source was not provided. The VAERS ID# is 451356-1.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with asthma and no illness at time of vaccination. The patient was vaccinated into right arm with lot # (671006/1291AA) dose 2 GARDASIL on 04-APR-2012. The patient was also vaccinated into right arm with lot # (AC52B074CA) dose 1 BOOSTRIX and into left arm with lot # (M11065) dose 1 MENVEO. Concomitant medications included SINGULAIR, QVAR, BENADRYL and VENTOLIN. On 04-APR-2012 the patient became dizzy and fell face first to the floor. He was checked by our physician assistant and left in stable condition. The outcome of the events was unknown. The original reporting source was not provided. The VAERS ID # is 453094-1. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with asthma and no illness at time of vaccination. The patient was vaccinated into right arm with lot # (671006/1291AA) dose 2 GARDASIL on 04-APR-2012. The patient was also vaccinated into right arm with lot # (AC52B074CA) dose 1 BOOSTRIX and into left arm with lot # (M11065) dose 1 MENVEO. Concomitant medications included SINGULAIR, QVAR, BENADRYL and VENTOLIN. On 04-APR-2012 the patient became dizzy and fell face first to the floor. He was checked by our physician assistant and left in stable condition. The outcome of the events was unknown. The original reporting source was not provided. The VAERS ID # is 453094-1. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Cardiac monitoring normal, Palpitations
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient with no pertinent medical history and no pre-existing illness on 08-NOV-2011, was vaccinated IM in the right arm with a dose of GARDASIL (lot# 669795/1317AA, 13-OCT-2013). Concomitant vaccine given on the same day included a dose of MENVEO (lot# A10131) given IM in the right arm. On 09-NOV-2011, one day post vaccinations, the patient experienced heart palpitations. The patient was still in process of evaluations. Event monitor was normal so far seeing pediatric. At the time of the report, the patient had not recovered. The patient sought medical attention. ER visit was required. This report was considered non serious by the Agency. The original reporting source was not provided. The VAERS ID# is 453642-1. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old male patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated in the right arm with dose 1 of GARDASIL (lot #, dose and route not reported) on 30-APR-2012. No other co-suspects and no concomitant medications were reported. The day after injection on 01-MAY-2012, the patient started having a headache. He later had a fever of 102, around 9:00pm. He started taking ADVIL for the fever. The following day 02-MAY-2012 he was still running a fever between 100-102. He was also experiencing aches and entire body pains with severe headache. The 3rd day after injection on 03-MAY-2012, the patient went back to the doctor, a flu test was done that came back negative. That night the fever continued to run as high as 102 with aches and severe headache. The patient was going to return to the doctor if the fever persisted the next day. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 454950-1. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV2, HPV2
Symptoms: Altered state of consciousness, Dizziness, Fall
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of passed out in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Medical history included allergic rhinitis, a rash on her right thigh and vesicoureteral reflux on the left side. Past medical history include acute sinusitis. Concurrent medications included desonide, LOTRIMIN cream and ZYRTEC. On 12 June 2012 at 14:30 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On 12 June 2012, immediately after vaccination with CERVARIX, the subject experienced a drop in blood pressure. One minute following vaccination, the subject went limp, but did not completely lose consciousness. The subject's blood pressure dropped to 68/48 after vaccination with CERVARIX on 12 June 2012. The subject was monitored for 15 to 20 minutes and her blood pressure rose to 122/78. The subject was doing well and no further treatment was administered. The events resolved. It was noted that the dose of CERVARIX administered was the subject's 3rd dose in "the series", but was her 1st dose of CERVARIX. Follow-up information was received on 10 July 2012 via healthcare professional who reported additional medical conditions included allergy to BACTRIM. The concurrent condition of rash on thighs that started on 07 June 2012 was noted to be getting better on 12 June 2012. The healthcare professional clarified this was the subject's last dose of CERVARIX. Reporting healthcare professional attributed the events to anxiety. The events resolved on 12 June 2012.
Age: 11.0
Sex: F
Vaccine: HPV2, HPV2
Symptoms: Blood pressure decreased, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of passed out in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Medical history included allergic rhinitis, a rash on her right thigh and vesicoureteral reflux on the left side. Past medical history include acute sinusitis. Concurrent medications included desonide, LOTRIMIN cream and ZYRTEC. On 12 June 2012 at 14:30 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On 12 June 2012, immediately after vaccination with CERVARIX, the subject experienced a drop in blood pressure. One minute following vaccination, the subject went limp, but did not completely lose consciousness. The subject's blood pressure dropped to 68/48 after vaccination with CERVARIX on 12 June 2012. The subject was monitored for 15 to 20 minutes and her blood pressure rose to 122/78. The subject was doing well and no further treatment was administered. The events resolved. It was noted that the dose of CERVARIX administered was the subject's 3rd dose in "the series", but was her 1st dose of CERVARIX. Follow-up information was received on 10 July 2012 via healthcare professional who reported additional medical conditions included allergy to BACTRIM. The concurrent condition of rash on thighs that started on 07 June 2012 was noted to be getting better on 12 June 2012. The healthcare professional clarified this was the subject's last dose of CERVARIX. Reporting healthcare professional attributed the events to anxiety. The events resolved on 12 June 2012.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster
Clinical narrative: Patient had severe pain in upper back, right side. Pain persisted for next few days and after a week soaring case of shingle complete with blister up and down my right arm. He still have pain but it is abting as of 07/12/2012.
Age: 15.0
Sex: F
Vaccine: HPV2, HPV2
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a consumer (subject's grandmother) and described the occurrence of headache in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 26 June 2012 at 10:30 the subject received 1st dose of CERVARIX (unknown route, left arm). On 26 June 2012, approximately 2 hours after vaccination with CERVARIX, the subject experienced headache, nausea, stomach pain and diarrhea. The subject's grandmother reported that the events started "a couple of hours later" after vaccination. The subject's grandmother called the physician's office due to the events. She stated the subject "did not throw up, but is still nauseated". At the time of reporting the events were unresolved.
Age: 15.0
Sex: F
Vaccine: HPV2, HPV2
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: This case was reported by a consumer (subject's grandmother) and described the occurrence of headache in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 26 June 2012 at 10:30 the subject received 1st dose of CERVARIX (unknown route, left arm). On 26 June 2012, approximately 2 hours after vaccination with CERVARIX, the subject experienced headache, nausea, stomach pain and diarrhea. The subject's grandmother reported that the events started "a couple of hours later" after vaccination. The subject's grandmother called the physician's office due to the events. She stated the subject "did not throw up, but is still nauseated". At the time of reporting the events were unresolved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Subsequently, four days after vaccination, on an unknown date, the patient experienced injection site rash. The patient told pharmacist that she had shingles before and it looked like shingles. The patient came and was seen at the pharmacy. Treatment given for AE included BENADRYL. At the time of the report the patient's outcome was unknown. Follow up information has been received from pharmacist refers to a 61 year old female patient with a history of chickenpox, who on 21-MAY-2012 at 15:00 was vaccinated in left arm with a 0.5 ml dose of ZOSTAVAX (route not reported), (Lot #671004/0729AA). On 21-MAY-2012 at 20:00 the patient experienced site rash for 2 days (patient recovered from adverse event on 23-MAY-2012). The herpes zoster presented pain (severity 1). The patient received BENADRYL every 6 hours. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Subsequently, four days after vaccination, on an unknown date, the patient experienced injection site rash. The patient told pharmacist that she had shingles before and it looked like shingles. The patient came and was seen at the pharmacy. Treatment given for AE included BENADRYL. At the time of the report the patient's outcome was unknown. Follow up information has been received from pharmacist refers to a 61 year old female patient with a history of chickenpox, who on 21-MAY-2012 at 15:00 was vaccinated in left arm with a 0.5 ml dose of ZOSTAVAX (route not reported), (Lot #671004/0729AA). On 21-MAY-2012 at 20:00 the patient experienced site rash for 2 days (patient recovered from adverse event on 23-MAY-2012). The herpes zoster presented pain (severity 1). The patient received BENADRYL every 6 hours. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthma, Cough, Dysphonia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 years old male patient with asthma. The patient was vaccinated with the first dose GARDASIL (lot # 672233/1561AA) on 18-APR-2012, and the second dose (lot# 673256/0629AE) on 26-JUL-2012. Vaccination routes were unspecified. It was reported that the patient had a mild exacerbation of his asthma after his first vaccination with GARDASIL, and another exacerbation of his asthma after his second dose of GARDASIL. The exacerbations, including coughing, occurred a couple hours after vaccination. Albuterol and other unspecified asthma medications were given for the events. The outcome of patient was unspecified. The patient sought medical attention via seeing in office. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthma, Condition aggravated, Cough
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 years old male patient with asthma. The patient was vaccinated with the first dose GARDASIL (lot # 672233/1561AA) on 18-APR-2012, and the second dose (lot# 673256/0629AE) on 26-JUL-2012. Vaccination routes were unspecified. It was reported that the patient had a mild exacerbation of his asthma after his first vaccination with GARDASIL, and another exacerbation of his asthma after his second dose of GARDASIL. The exacerbations, including coughing, occurred a couple hours after vaccination. Albuterol and other unspecified asthma medications were given for the events. The outcome of patient was unspecified. The patient sought medical attention via seeing in office. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Autism, Immediate post-injection reaction, Intensive care, Lumbar puncture normal, Oxygen saturation decreased
Clinical narrative: Patient was born with an APGAR of 8.5 by C-section at about 10:00 PM March 7, 2001. Around 4:00 am March 7, I called for them to bring him to nurse. They administered a Hep-B shot and he had an oxygen desat incident immediately and ended up in the ICU for 4 days. A spinal tap showed nothing. He was perfectly healthy until he got the Hep B shot. Now he has autism.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site necrosis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with either PNEUMOVAX 23 or flu vaccine (manufacturer unspecified)(Lot #, dose/frequency and route unspecified) on an unknown date. No concomitant medications were reported. The pharmacist reported that she had heard that the patient had developed necrosis at the injection site after getting vaccinated with either PNEUMOVAX 23 or flu vaccine (manufacturer unspecified). It was unknown which vaccine of these vaccines the patient had been given. It was unspecified whether the patient had sought medical attention. No treatment information was reported. The outcome was unknown at reporting. Upon internal review, necrosis at the injection site was determined to be medically significant. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Hypotension, Syncope
Clinical narrative: Syncope with hypotension; tx elevate lower extremities, cool cloth to forehead, orange juice, crackers.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope, Visual impairment
Clinical narrative: Patient received 4 vaccines at apprx 11:40 AM. At apprx 11:50 AM patient had a syncopal episode in the office, complaining just prior to that he began seeing gray spots.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: CSF protein increased, Guillain-Barre syndrome
Clinical narrative: Guillain Barre diagnosed 7/26/12. Received Pneumonia vaccine 7/13/12.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swollen, red, painful, warm to touch approximately 24hrs. after Varicella vaccine administered. ER administered prednisolone 15mg/5ml (42.99mg) and went patient home with Rx for prednisolone and famotidine.
Age: 1.41
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3498AA received on 14 December 2009, lot number C3545AB received on 16 February 2010, lot number C3545AB received on 08 April 2010 and lot number C3855AB received on 08 March 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms with cough on 31 May 2012, approximately 14 months after the last dose. On 07 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 11 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 11 June 2012 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 14 June 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: 1.41
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3498AA received on 14 December 2009, lot number C3545AB received on 16 February 2010, lot number C3545AB received on 08 April 2010 and lot number C3855AB received on 08 March 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms with cough on 31 May 2012, approximately 14 months after the last dose. On 07 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 11 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 11 June 2012 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 14 June 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: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received a first dose of TRIPEDIA, lot number U2397BA on 06 October 2008; a second and third dose of PENTACEL, lot number C2881AA on 19 December 2008 and 17 February 2009; and a dose of DAPTACEL, lot number C3191AA on 08 February 2010 (routes and sites administration not reported). The subject developed a cough on 02 July 2012, approximately 28 months after the last dose. On 11 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 on 18 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of Azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 23 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: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received a first dose of TRIPEDIA, lot number U2397BA on 06 October 2008; a second and third dose of PENTACEL, lot number C2881AA on 19 December 2008 and 17 February 2009; and a dose of DAPTACEL, lot number C3191AA on 08 February 2010 (routes and sites administration not reported). The subject developed a cough on 02 July 2012, approximately 28 months after the last dose. On 11 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 on 18 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of Azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 23 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: 1.55
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Sleep disorder
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a three-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 3 doses of PENTACEL; lot number C3242AA received on 20 January 2009, lot number C3276AA received on 23 March 2009, lot number C3276AA received on 22 May 2009 and one dose of DAPTACEL, lot number C3380AA received on 08 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms with cough on 18 June 2012, approximately 24 months after the last dose. On 25 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 19 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 19 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case and was outbreak related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Post-tussive vomiting
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3428AB received on 07 October 2009, lot number C3470AA received on 15 December 2009, lot number C3573AB received on 17 February 2010 and one dose of DAPTACEL, lot number C3473AA received on 06 January 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 19 June 2012, approximately 17 months after the last dose. On 26 June 2012, the subject developed a cough. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 28 June 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiological linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3428AB received on 07 October 2009, lot number C3470AA received on 15 December 2009, lot number C3573AB received on 17 February 2010 and one dose of DAPTACEL, lot number C3473AA received on 06 January 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 19 June 2012, approximately 17 months after the last dose. On 26 June 2012, the subject developed a cough. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 28 June 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiological linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 02 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3929AA received on 16 June 2011, lot number C3980AA received on 15 August 2011 and lot number C4044AB received on 14 October 2011 (routes and sites of administration not reported). The subject developed cough on 07 July 2012, approximately eight months after the last dose. On 09 July 2012, the subject developed cold-like symptoms. The subject also experienced paroxysmal cough without a whoop and sleep disturbance. Laboratory testing included positive PCR on 11 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 10 July 2012 for five days. The subjects was not hospitalized. At the time of final contact on 27 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. According to the investigator, this case was epidemiological linked to a laboratory confirmed case and was OB (outbreak) related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 02 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3929AA received on 16 June 2011, lot number C3980AA received on 15 August 2011 and lot number C4044AB received on 14 October 2011 (routes and sites of administration not reported). The subject developed cough on 07 July 2012, approximately eight months after the last dose. On 09 July 2012, the subject developed cold-like symptoms. The subject also experienced paroxysmal cough without a whoop and sleep disturbance. Laboratory testing included positive PCR on 11 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 10 July 2012 for five days. The subjects was not hospitalized. At the time of final contact on 27 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. According to the investigator, this case was epidemiological linked to a laboratory confirmed case and was OB (outbreak) related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.65
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 02 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3879AA received on 26 July 2011, lot number C3913AB received on 11 October 2011 and lot number C4045AA received on 06 January 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 July 2012, approximately five months after the last dose. On 12 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 16 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 16 July 2012 for five days. The subjects was not hospitalized. At the time of final contact on 18 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.65
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 02 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3879AA received on 26 July 2011, lot number C3913AB received on 11 October 2011 and lot number C4045AA received on 06 January 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 July 2012, approximately five months after the last dose. On 12 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 16 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 16 July 2012 for five days. The subjects was not hospitalized. At the time of final contact on 18 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Oedema peripheral, Pain in extremity
Clinical narrative: Arm in which injection was given (left arm) became swollen and sore. There was a small rash around the injection site-she had taken Ibuprofen and was feeling better the next day.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Depressed level of consciousness, Hyporesponsive to stimuli
Clinical narrative: Hyporesponsive episode. Deep sleep shortly after vaccine. Baby in deep sleep. Mom could not arouse him until after 10 minutes. No color change. Pulse present.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Varicella post vaccine
Clinical narrative: Child previously immunized with 2 doses of VARIVAX developed varicella. Seen in office on 7/27/12.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site papule
Clinical narrative: Few red papules at vaccine site right thigh with some induration.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Erythema, Headache, Oedema peripheral, Pain
Clinical narrative: Middle of that night felt pain in that arm with some redness.  Next day, pt felt some sob and had swollen right arm down to fingers.  Following day felt aches, pains, HA in back and arm pain was getting worse.  Redness progressing every day.  Pt also felt her face "blew up".
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling face
Clinical narrative: Middle of that night felt pain in that arm with some redness.  Next day, pt felt some sob and had swollen right arm down to fingers.  Following day felt aches, pains, HA in back and arm pain was getting worse.  Redness progressing every day.  Pt also felt her face "blew up".
Age: 25.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity
Clinical narrative: Staff returned to facility 48h after vaccines to read PPDs administered. Nursing Director reported to staff the patient had an allergic reaction to the PN vaccine which resulted in her being hospitalized.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Pyrexia
Clinical narrative: General malaise, fever greater than 101.6.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: 8/8/12 received telephone call from mom stating child's arm swollen, hot, and red from elbow to shoulder.  States looks "burned" has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took child to ER 8/8/12. Diagnoses with cellulitis vs arteritis reaction.  Given antibiotics, steroid cream, and Benadryl.  8/9/12 Nurse spoke with mom who states am not any better. Informed may take 2-3 days to improve. Mom states will follow up with phone call to report child's status.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: 8/8/12 received telephone call from mom stating child's arm swollen, hot, and red from elbow to shoulder.  States looks "burned" has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took child to ER 8/8/12. Diagnoses with cellulitis vs arteritis reaction.  Given antibiotics, steroid cream, and Benadryl.  8/9/12 Nurse spoke with mom who states am not any better. Informed may take 2-3 days to improve. Mom states will follow up with phone call to report child's status.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: 8/8/12 received telephone call from mom stating child's arm swollen, hot, and red from elbow to shoulder.  States looks "burned" has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took child to ER 8/8/12. Diagnoses with cellulitis vs arteritis reaction.  Given antibiotics, steroid cream, and Benadryl.  8/9/12 Nurse spoke with mom who states am not any better. Informed may take 2-3 days to improve. Mom states will follow up with phone call to report child's status.
Age: 44.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Left arm became red and swollen.  Progressed for a day to the point where in involved upper arm to the elbow, left shoulder into the pectoralis muscle.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling cold, Pyrexia
Clinical narrative: Felt dizzy, cold, had calicus on both hands, and had fever. Took Tylenol. Went to the emergency room to get checked out. Doctor stated adverse reaction to the meningitis immunization. The doctor gave Motrin.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Skin lesion
Clinical narrative: Awaken with multiple lesions to upper arms, 1 on back and 1 on face, has progressed since then and now covering most of body.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large red swollen area over most of left upper arm, centered around injection mark. The area is warm to touch and a bot tender. Symptomatic care discussed such as ice, Tylenol, and Benadryl suggested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Eye discharge, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: Welts under arms, fever, runny nose & eyes.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, and swelling bilaterally in deltoid areas. Started the day after immunization. 2 days before visit to MC. Treatment - Ibuprofen 400mg and ice.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Injection site pain, Pain in extremity, Ultrasound scan
Clinical narrative: PAIN RADIATING DOWN LEFT ARM OVER TO CHEST AREA. SORENESS AT INJECTION SITE.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: Developed Chicken Pox, mild case.  Taking Benadryl and using Calamine lotion.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Developed Chicken Pox, mild case.  Taking Benadryl and using Calamine lotion.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Muscular weakness, Myalgia, Oedema peripheral, Pruritus
Clinical narrative: Upper arm swelling, itching, and redness around site of vaccine, with muscle tenderness and weakness. Progressive swelling of arm to forearm over 3 days.  Still has erythema of forearm, and muscle soreness of upper arm.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 12x13 large red tender and itchy area centered on the injection site on the left arm. It is also slightly raised and warm to touch.
Age: 1.86
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Developed rash/urticaria.  Went to ER.  ER treated with steroids and Benadryl.  Patient improved significantly after treatment was initiated.  Still had mild urticaria this a.m. at office visit.
Age: 13.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Convulsion, Head injury, Syncope
Clinical narrative: Fainted, seizure 30 seconds after shot. Hit head on floor.  He laid down for 20 mins. after.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: On 8-9-12 pt had blackout spell while getting GARDASIL. Pt stayed in office for 30 min after shot lying down. BP was WNL.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Left deltoid reported to be red, warm to touch about 20 hours after vaccines received. At 25 hrs after vaccines mother reported possible shortness of breath, referred to ER for eval. ER eval shows mild light pink erythmoid with no tenderness. Diagnosed with local drug reaction at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local swelling, Oedema peripheral, Rash pruritic
Clinical narrative: Localized swelling within minutes of vaccine.  Ice pack applied. Upper arm swollen and sore for 24 hours.  Itchy rash began to appear on left forearm within 24 hours and has persisted for 7 days with slow resolution.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Client became 'faint' in elevator after receiving vaccine.  Client had not eaten breakfast.  Placed in reclining position and given juice.  After 5 minutes, no longer voiced dizziness or feeling faint.  Walking without difficulty.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Asthenia, Blood test normal, Choking, Confusional state, Cyanosis
Clinical narrative: Started throwing up, then choking.  Stopped breathing completely, lips turning blue, eyes glassy, could not hold self up.  After breathing resumed, was unresponsive and couldn't stay awake until she received oxygen in the ambulance.  Remained unresponsive and confused for about an hour.  Tylenol was administered, fever came down and symptoms subsided.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Laboratory test normal, Pyrexia, Respiratory arrest, Somnolence, Staring
Clinical narrative: Started throwing up, then choking.  Stopped breathing completely, lips turning blue, eyes glassy, could not hold self up.  After breathing resumed, was unresponsive and couldn't stay awake until she received oxygen in the ambulance.  Remained unresponsive and confused for about an hour.  Tylenol was administered, fever came down and symptoms subsided.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Started throwing up, then choking.  Stopped breathing completely, lips turning blue, eyes glassy, could not hold self up.  After breathing resumed, was unresponsive and couldn't stay awake until she received oxygen in the ambulance.  Remained unresponsive and confused for about an hour.  Tylenol was administered, fever came down and symptoms subsided.
Age: 38.0
Sex: F
Vaccine: ANTH, SMALL, TDAP, TYP
Symptoms: Feeling hot, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Red, raised rash that started on left arm (near injection site) rash spread entire body.  Rash itches and feels hot.
Age: 1.14
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS, SWELLING, AND ITCHY ON VACCINE ADMINISTRATION SITE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash vesicular
Clinical narrative: Developed shingles-like rash on chest and back.  Next day developed the same rash on right arm.  Two days later, developed more shingles-like rashes on other areas of chest and back.  Had headache on 8/3/2012 & on 8/4/2012 prior to developing a rash.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Burning sensation at injection site at approximately 1:30pm.  Raised, red, 2inch by 2inch itchy and painful bump at injection site noticed about 3:30pm. Fine red rash covering injected arm noticed at 5:15pm.  Swollen glands noted on neck and throat at 5:15pm.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash erythematous
Clinical narrative: Burning sensation at injection site at approximately 1:30pm.  Raised, red, 2inch by 2inch itchy and painful bump at injection site noticed about 3:30pm. Fine red rash covering injected arm noticed at 5:15pm.  Swollen glands noted on neck and throat at 5:15pm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Diarrhoea, Headache, Nausea
Clinical narrative: Elevated temp 103 for 2 days. Symptom free until 08/07/2012, then headache, nausea, diarrhea. Mother reports patient raising eyebrows when he talks.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Patient reported signs of erythema, and swelling in right arm upon waking the morning following injection. She had been monitoring throughout the day and reports the swelling and redness has reduced throughout the day and arm is still tender. She reports not having had any rash, itching, or swelling in or around her throat, face, and trunk area. She had not had any difficulity in breathing.
Age: 36.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Sore rt arm and difficulty raising arm because of pain.  Fever.  Tmax 102.
Age: 12.0
Sex: F
Vaccine: DTAP, HPVX, MEN
Symptoms: Abnormal behaviour, Altered state of consciousness, Blood test normal, Crying, Speech disorder
Clinical narrative: During soccer practice exhibited erratic behavior. Crying, unaware of surrounding or people, saying random statements, wide eyes and staring, also closed eyes and motionless.
Age: 12.0
Sex: F
Vaccine: DTAP, HPVX, MEN
Symptoms: Staring, Urine analysis normal
Clinical narrative: During soccer practice exhibited erratic behavior. Crying, unaware of surrounding or people, saying random statements, wide eyes and staring, also closed eyes and motionless.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body ache.