chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Acute myocardial infarction, Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 367474. A 21 year old male patient received the following vaccines on 02 November 2009: a percutaneous injection of ACAM2000 (lot number W04-003) and an intramuscular injection of BIOTHRAX (Emergent Biosolutions, lot number FAV219). The sites of administration were not reported. Eleven days post-vaccination, the patient developed chest pain, low grade fever and myalgias. Troponin level and electrocardiogram were reported as abnormal. The outcome was not reported. No additional information was provided. Follow-up information was received from the agency on 17 May 2011, which identified this patient as a subject in a study. The event was previously captured separately as part of the study in case number 2010-02880, and is a duplicate of that case; 2010-02880 will be deleted from the database. This report was received from the investigator in a trial. A 21 year-old male subject with no significant medical history received the following vaccines on 02 November 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Twelve days after vaccination, the subject was diagnosed with other and unspecified acute myocarditis. On Day 12 (14 November 2009), the subject had a Troponin I of 16.2 (abnormal) and an electrocardiogram and echocardiogram which were both abnormal. The subject was hospitalized (dates not reported) and discharged with a diagnosis of acute ST elevation acute myocardial infarction. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 09 August 2010 via a QScan search on the VAERS database, and included reference number 389479. No additional new information was reported. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myalgia, Myocarditis, Pyrexia, Troponin I increased, Troponin increased
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 367474. A 21 year old male patient received the following vaccines on 02 November 2009: a percutaneous injection of ACAM2000 (lot number W04-003) and an intramuscular injection of BIOTHRAX (Emergent Biosolutions, lot number FAV219). The sites of administration were not reported. Eleven days post-vaccination, the patient developed chest pain, low grade fever and myalgias. Troponin level and electrocardiogram were reported as abnormal. The outcome was not reported. No additional information was provided. Follow-up information was received from the agency on 17 May 2011, which identified this patient as a subject in a study. The event was previously captured separately as part of the study in case number 2010-02880, and is a duplicate of that case; 2010-02880 will be deleted from the database. This report was received from the investigator in a trial. A 21 year-old male subject with no significant medical history received the following vaccines on 02 November 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Twelve days after vaccination, the subject was diagnosed with other and unspecified acute myocarditis. On Day 12 (14 November 2009), the subject had a Troponin I of 16.2 (abnormal) and an electrocardiogram and echocardiogram which were both abnormal. The subject was hospitalized (dates not reported) and discharged with a diagnosis of acute ST elevation acute myocardial infarction. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 09 August 2010 via a QScan search on the VAERS database, and included reference number 389479. No additional new information was reported. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: Initial report was received on 25 May 2011 from a consumer who is also the patient. A male patient with no reported past medical history had received in November of 2009 a left arm injection of DTAP (manufacturer, lot number, route and exact date of administration not reported) and an unspecified amount of time later developed permanent pain and damage in the left arm near the injection site. According to the patient his physician states he has suffered "nerve damage". Treatment included therapy and Gabapentin. Concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome is not recovered. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Angiogram abnormal, Atrial natriuretic peptide increased, Back pain, Blood creatine phosphokinase, Blood creatine phosphokinase MB
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 398508. A 22-year-old male patient received ACAM2000 (lot number VV04003A) on 24 August 2010. No medical history or concurrent illness was reported. On 04 September 2010, also reported as 02 September 2010, the patient began experiencing chest pain. He awoke at 0200 with severe chest pain, shortness of breath, mid-back pain, and dizziness. He went to the emergency department at 0800, and was transferred to another facility and admitted to the intensive care unit. An angiogram was abnormal, atrial natriuretic peptide was increased, and blood phosphorus was increased. He also underwent additional testing, including creatine phosphokinase, creatine phosphokinase MB, cardiac catheterization, computerized tomogram, echocardiogram, electrocardiogram, nuclear magnetic resonance imaging, and Troponin I; results of this testing was not reported. The patient was diagnosed with a congenital coronary artery malformation, however it was not noted if this was a new finding. The events subsequently resolved on an unspecified date. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Follow-up information was received from the agency on 17 May 2011, which identified this patient as a subject in study. The event was previously captured separately as part of the study in case number 2011-02573, and is a duplicate of that case; 2011-02573 will be deleted from the database. This study case was received from the investigator. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal Troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information has been requested from the investigator.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Blood phosphorus increased, Catheterisation cardiac, Chest pain, Computerised tomogram, Congenital coronary artery malformation
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 398508. A 22-year-old male patient received ACAM2000 (lot number VV04003A) on 24 August 2010. No medical history or concurrent illness was reported. On 04 September 2010, also reported as 02 September 2010, the patient began experiencing chest pain. He awoke at 0200 with severe chest pain, shortness of breath, mid-back pain, and dizziness. He went to the emergency department at 0800, and was transferred to another facility and admitted to the intensive care unit. An angiogram was abnormal, atrial natriuretic peptide was increased, and blood phosphorus was increased. He also underwent additional testing, including creatine phosphokinase, creatine phosphokinase MB, cardiac catheterization, computerized tomogram, echocardiogram, electrocardiogram, nuclear magnetic resonance imaging, and Troponin I; results of this testing was not reported. The patient was diagnosed with a congenital coronary artery malformation, however it was not noted if this was a new finding. The events subsequently resolved on an unspecified date. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Follow-up information was received from the agency on 17 May 2011, which identified this patient as a subject in study. The event was previously captured separately as part of the study in case number 2011-02573, and is a duplicate of that case; 2011-02573 will be deleted from the database. This study case was received from the investigator. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal Troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information has been requested from the investigator.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram abnormal, Intensive care
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 398508. A 22-year-old male patient received ACAM2000 (lot number VV04003A) on 24 August 2010. No medical history or concurrent illness was reported. On 04 September 2010, also reported as 02 September 2010, the patient began experiencing chest pain. He awoke at 0200 with severe chest pain, shortness of breath, mid-back pain, and dizziness. He went to the emergency department at 0800, and was transferred to another facility and admitted to the intensive care unit. An angiogram was abnormal, atrial natriuretic peptide was increased, and blood phosphorus was increased. He also underwent additional testing, including creatine phosphokinase, creatine phosphokinase MB, cardiac catheterization, computerized tomogram, echocardiogram, electrocardiogram, nuclear magnetic resonance imaging, and Troponin I; results of this testing was not reported. The patient was diagnosed with a congenital coronary artery malformation, however it was not noted if this was a new finding. The events subsequently resolved on an unspecified date. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Follow-up information was received from the agency on 17 May 2011, which identified this patient as a subject in study. The event was previously captured separately as part of the study in case number 2011-02573, and is a duplicate of that case; 2011-02573 will be deleted from the database. This study case was received from the investigator. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal Troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information has been requested from the investigator.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Pericarditis, Troponin I increased
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 398508. A 22-year-old male patient received ACAM2000 (lot number VV04003A) on 24 August 2010. No medical history or concurrent illness was reported. On 04 September 2010, also reported as 02 September 2010, the patient began experiencing chest pain. He awoke at 0200 with severe chest pain, shortness of breath, mid-back pain, and dizziness. He went to the emergency department at 0800, and was transferred to another facility and admitted to the intensive care unit. An angiogram was abnormal, atrial natriuretic peptide was increased, and blood phosphorus was increased. He also underwent additional testing, including creatine phosphokinase, creatine phosphokinase MB, cardiac catheterization, computerized tomogram, echocardiogram, electrocardiogram, nuclear magnetic resonance imaging, and Troponin I; results of this testing was not reported. The patient was diagnosed with a congenital coronary artery malformation, however it was not noted if this was a new finding. The events subsequently resolved on an unspecified date. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Follow-up information was received from the agency on 17 May 2011, which identified this patient as a subject in study. The event was previously captured separately as part of the study in case number 2011-02573, and is a duplicate of that case; 2011-02573 will be deleted from the database. This study case was received from the investigator. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal Troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information has been requested from the investigator.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP, TYP, HEPA, TDAP, TYP
Symptoms: Paralysis, Radiculitis brachial
Clinical narrative: Initial report received from a health care professional on 26 May 2011. A 12-year-old male patient with a history of shoulder dystocia with upper brachial plexia at birth which resolved, received an intramuscular left deltoid injection of ADACEL, sanofi pasteur lot number C3837BA, a right deltoid injection TYPHIM VI, sanofi pasteur lot number B1288-1, and a left deltoid injection VAQTA, Merck lot number 0140AA on 30 Apr 2011. The patient had no known allergies, no illness at the time of vaccination, no other vaccines within 4 weeks and took no concomitant medications. On 01 May 2011 the patient experienced numbness and weakness of the left shoulder area which progressed over the next few weeks. The patient was diagnosed with brachial neuritis. The outcome was reported as not recovered. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP, TYP, HEPA, TDAP, TYP
Symptoms: Asthenia, Hypoaesthesia, Radiculitis brachial
Clinical narrative: Initial report received from a health care professional on 26 May 2011. A 12-year-old male patient with a history of shoulder dystocia with upper brachial plexia at birth which resolved, received an intramuscular left deltoid injection of ADACEL, sanofi pasteur lot number C3837BA, a right deltoid injection TYPHIM VI, sanofi pasteur lot number B1288-1, and a left deltoid injection VAQTA, Merck lot number 0140AA on 30 Apr 2011. The patient had no known allergies, no illness at the time of vaccination, no other vaccines within 4 weeks and took no concomitant medications. On 01 May 2011 the patient experienced numbness and weakness of the left shoulder area which progressed over the next few weeks. The patient was diagnosed with brachial neuritis. The outcome was reported as not recovered. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Mass, Pain, Paraesthesia, Skin tightness
Clinical narrative: Red bump increasing in size, by 6/1/2011, increased to the size of half dollar, painful to move arm, tingling, tightness in arm, swelling. Went back to clinic and was prescribed 875 mg of Augmentin 2x day and told to take 800 mg of Motrin 2x day.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Swelling
Clinical narrative: Red bump increasing in size, by 6/1/2011, increased to the size of half dollar, painful to move arm, tingling, tightness in arm, swelling. Went back to clinic and was prescribed 875 mg of Augmentin 2x day and told to take 800 mg of Motrin 2x day.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). The physician reported that the patient had developed recurrent episodes of pneumococcal meningitis and the patient might have had a splenectomy after receiving PNEUMOVAX 23 and was hospitalized (location and length unspecified). At the time of the report, the status of the patient was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning an about 24 year old female patient who on 13-FEB-2011 was intramuscularly vaccinated with 0.5 mL of the first dose of GARDASIL (lot # and expiration not reported) and on 17-MAY-2011 2011 was intramuscularly vaccinated in the left arm with 0.5 mL of the second dose of GARDASIL (lot # and expiration not reported). Nurse reported that within one or two days after the second dose (on approximately 18-MAY-2011 or 19-MAY-2011) the patient developed pain in the shoulder and difficulty lifting the left arm. The patient was seen on 22-MAY-2011 or 23-MAY-2011 in the clinic and it was determined the vaccination was given about 1/2 inch higher than the deltoid, in the shoulder joint. The patient's condition as of today had not improved. There were no reports of adverse effects following the first dose of GARDASIL. No laboratories were performed. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. The registered nurse considered pain in the shoulder and difficulty lifting the left arm to be disabling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Information has been received from a registered nurse concerning an about 24 year old female patient who on 13-FEB-2011 was intramuscularly vaccinated with 0.5 mL of the first dose of GARDASIL (lot # and expiration not reported) and on 17-MAY-2011 2011 was intramuscularly vaccinated in the left arm with 0.5 mL of the second dose of GARDASIL (lot # and expiration not reported). Nurse reported that within one or two days after the second dose (on approximately 18-MAY-2011 or 19-MAY-2011) the patient developed pain in the shoulder and difficulty lifting the left arm. The patient was seen on 22-MAY-2011 or 23-MAY-2011 in the clinic and it was determined the vaccination was given about 1/2 inch higher than the deltoid, in the shoulder joint. The patient's condition as of today had not improved. There were no reports of adverse effects following the first dose of GARDASIL. No laboratories were performed. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. The registered nurse considered pain in the shoulder and difficulty lifting the left arm to be disabling. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Started having breathing problems, bad coughing and fever. On Saturday night I took him to emergency room, because breathing was getting worse. They said it was a reaction to one of his shots. He had 3 shots MMR, chicken pox and Prevnar. I think it was Prevnar because this has happened 2 other times after shots and Prevnar was the shot that he has had before, the other 2 were new shots. He was put on steroids and it is helping. Not sure if he's over this yet.
Age: 1.29
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Started having breathing problems, bad coughing and fever. On Saturday night I took him to emergency room, because breathing was getting worse. They said it was a reaction to one of his shots. He had 3 shots MMR, chicken pox and Prevnar. I think it was Prevnar because this has happened 2 other times after shots and Prevnar was the shot that he has had before, the other 2 were new shots. He was put on steroids and it is helping. Not sure if he's over this yet.
Age: 1.29
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: Started having breathing problems, bad coughing and fever. On Saturday night I took him to emergency room, because breathing was getting worse. They said it was a reaction to one of his shots. He had 3 shots MMR, chicken pox and Prevnar. I think it was Prevnar because this has happened 2 other times after shots and Prevnar was the shot that he has had before, the other 2 were new shots. He was put on steroids and it is helping. Not sure if he's over this yet.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Accidental exposure
Clinical narrative: inadvertent inoculation of left arm
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: inadvertent inoculation of left arm
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Pyrexia, Rash
Clinical narrative: on 5/28/11 developed fever of 101 degrees Fahrenheit that lasted 1 day, on the evening of 06/06/11 first noticed mild rash on face that spread to trunk and back
Age: 35.0
Sex: F
Vaccine: HEPAB, IPV, YF
Symptoms: Flushing, Throat irritation
Clinical narrative: c/o burning in her throat and her face became very flushed
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or Med Watch report may indicate in the appropriate field that it is an initial report. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced cellulitis. The patient received a dose on an unspecified date. The patient experienced a cellulitis like reaction and a low grade fever that lasted a few days. The patient was taken to the Emergency Room and antibiotics and received antibiotics. Cellulitis was diagnosed. Outcome was unknown. No additional information was available at the time of this report. Follow-up (25May2011): New information received from a contactable healthcare professional: The patient recovered. Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Computerised tomogram head, Computerised tomogram normal, Facial paresis, Fatigue
Clinical narrative: Initial report was received 25 May 2011 from a health care professional. A 29-year-old male patient who had no past medical history, had received a first dose intramuscular left arm injection of ADACEL, lot number U3872BA (sanofi pasteur, Ltd lot number C3827) on 10 May 2011 as part of wound management treatment for a head injury. On 13 May 2011, three days after vaccination, the patient developed right sided facial numbness and tingling, with numbness and tingling of the right hand, and fingers of his right hand. He also experienced fatigue. On an unspecified date, the numbness, tingling and weakness then spread to the left side of his face, and to his left hand and foot. The patient received a neurological consult with negative exam findings. A CT scan of the head was negative. On 25 May 2011, his symptoms were beginning to resolve (also reported as subsiding) and had mostly disappeared. The patient had no concurrent illness and he had not received any other vaccinations within four weeks of ADACEL. At the time of the report, outcome was not recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Muscular weakness, Neurological examination normal, Paraesthesia
Clinical narrative: Initial report was received 25 May 2011 from a health care professional. A 29-year-old male patient who had no past medical history, had received a first dose intramuscular left arm injection of ADACEL, lot number U3872BA (sanofi pasteur, Ltd lot number C3827) on 10 May 2011 as part of wound management treatment for a head injury. On 13 May 2011, three days after vaccination, the patient developed right sided facial numbness and tingling, with numbness and tingling of the right hand, and fingers of his right hand. He also experienced fatigue. On an unspecified date, the numbness, tingling and weakness then spread to the left side of his face, and to his left hand and foot. The patient received a neurological consult with negative exam findings. A CT scan of the head was negative. On 25 May 2011, his symptoms were beginning to resolve (also reported as subsiding) and had mostly disappeared. The patient had no concurrent illness and he had not received any other vaccinations within four weeks of ADACEL. At the time of the report, outcome was not recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Cervical myelopathy, Computerised tomogram head, Computerised tomogram normal, Ear discomfort, Electromyogram normal
Clinical narrative: Initial report was received 25 May 2011 from a health care professional. A 29-year-old male patient who had no past medical history, had received a first dose intramuscular left arm injection of ADACEL, lot number U3872BA (sanofi pasteur, Ltd lot number C3827) on 10 May 2011 as part of wound management treatment for a head injury. On 13 May 2011, three days after vaccination, the patient developed right sided facial numbness and tingling, with numbness and tingling of the right hand, and fingers of his right hand. He also experienced fatigue. On an unspecified date, the numbness, tingling and weakness then spread to the left side of his face, and to his left hand and foot. The patient received a neurological consult with negative exam findings. A CT scan of the head was negative. On 25 May 2011, his symptoms were beginning to resolve (also reported as subsiding) and had mostly disappeared. The patient had no concurrent illness and he had not received any other vaccinations within four weeks of ADACEL. At the time of the report, outcome was not recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Initial report was received 25 May 2011 from a health care professional. A 29-year-old male patient who had no past medical history, had received a first dose intramuscular left arm injection of ADACEL, lot number U3872BA (sanofi pasteur, Ltd lot number C3827) on 10 May 2011 as part of wound management treatment for a head injury. On 13 May 2011, three days after vaccination, the patient developed right sided facial numbness and tingling, with numbness and tingling of the right hand, and fingers of his right hand. He also experienced fatigue. On an unspecified date, the numbness, tingling and weakness then spread to the left side of his face, and to his left hand and foot. The patient received a neurological consult with negative exam findings. A CT scan of the head was negative. On 25 May 2011, his symptoms were beginning to resolve (also reported as subsiding) and had mostly disappeared. The patient had no concurrent illness and he had not received any other vaccinations within four weeks of ADACEL. At the time of the report, outcome was not recovered. Documents held by sender: None.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fall, Hearing impaired, Hyperhidrosis, Presyncope
Clinical narrative: Pt. (pre-syncopal) episode in lobby s/p vaccinations felt dizzy, hearing & vision blurred, fell to floor, caught by father, no head trauma, no LOC, alert, oriented, (+) diaphoresis, BP 98/69.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Vision blurred
Clinical narrative: Pt. (pre-syncopal) episode in lobby s/p vaccinations felt dizzy, hearing & vision blurred, fell to floor, caught by father, no head trauma, no LOC, alert, oriented, (+) diaphoresis, BP 98/69.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Culture positive, Injection site erythema, Injection site reaction, Injection site swelling, Rash
Clinical narrative: Vaccines given on 5/25/11 - mom noticed swelling and redness in (R) thigh on 5/28/11 and then red rash "spots" on face then arms, legs & feet on 5/29/11.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash erythematous
Clinical narrative: Vaccines given on 5/25/11 - mom noticed swelling and redness in (R) thigh on 5/28/11 and then red rash "spots" on face then arms, legs & feet on 5/29/11.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Bed rest, Dizziness
Clinical narrative: Within 2 minutes of receiving vaccine, pt stated she felt faint. Periodic bedrest x 20" BP 120/80 P 88 R 18.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Child fainted about 30 seconds after receiving vaccine. Child came to quickly and was given H2O and sugar. BP 110/68 P-68. Child had not eaten breakfast this am.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Pt reports that 5 days after receiving vaccines, he began experiencing, generalized itching. Two days after itching began he developed generalized hives. No respiratory distress.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm - upper arm - warm erythema on 5/18/11. Meds told to give CLARITIN 10mg am, ZYRTEC 10mg pm.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site rash
Clinical narrative: Bumps in legs/thighs due to vaccine at injection site x 3 days.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Contusion, Mouth ulceration, Rash papular, Rash pustular, Rash vesicular
Clinical narrative: Diffuse papular/vesicular/pustular and scab lesions to body. Ulcers to oral mucosa.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Scab, Ulcer
Clinical narrative: Diffuse papular/vesicular/pustular and scab lesions to body. Ulcers to oral mucosa.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site haematoma, Injection site induration, Injection site pustule, Injection site warmth
Clinical narrative: 5/9/11. Patient administered 4 vaccines on this date, 2 vaccines on each thigh, anterior, lateral vastus lateralis. On 5/19/11 patient here for OV to evaluate left thigh (+) cellulitis 1.5 by 2 cm, warm, firm, slightly bruised, slight pustule at center (PREVNAR 13 area).
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Erythema, Skin mass, Skin warm, Tenderness
Clinical narrative: Knot under skin, small dime size red mark, warm & tender to the touch.
Age: 0.34
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Irritability, Screaming, Staring
Clinical narrative: As per mom the night of shots child staring/blank episode lasting hours & the screaming & crying the entire night & fussy for a wk. No ER visit or med care sought.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling abnormal, Pruritus, Throat tightness
Clinical narrative: Received CPX vaccine (L) arm in 10 minutes entire arm was itching, in 10 more minutes - felt tightness in throat while driving - felt like she was moving when stopping at Stop sign. Health Dept MD advised BENADRYL 25-50mg PO every 4-6 hr. Go to ER if worsens to welts or swelling of lips - tongue.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: On 4-26-11 pt was given PENTACEL & varicella vaccines. On 5-6-11 mother noticed redness & a few bumps on right lateral thigh. Brought to ER 5-7-11 to have a Dr. look at. Advised Ibuprofen children no distress.
Age: 0.51
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave a VARIVAX to a 6 month old. Only indicated for 12 months and older.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Sleep disorder
Clinical narrative: Child received vaccines Friday had fever and fine rash all over body Friday night. Friday fever 104, Saturday 99. No fever Sunday or today, child still has a fine rash all over body - itches - cannot sleep for itching. No fever. No other problems 5/11 & 5/20 left messages phone calls not returned.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on stomach, back and legs - about an hour after vaccine given - provider advised to give BENADRYL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash erythematous
Clinical narrative: About a week ago small, red bumps appeared on arm. The bumps have since gotten slightly larger accompanied by surrounding redness. There is no pain or itch associated with reaction and no other part of body involved.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash pustular, Scab
Clinical narrative: VZV given 5/17/11. On 5/20/11 pt. developed pustules on face. Had 9 pox total - crusted over - resolved. Mild fever resolved .
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Day after vaccine received itching was experienced around waist and legs at edges of undergarment. No visible rash present and it lasted for about 3 days time.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count normal, Headache, Nausea, Oedema peripheral
Clinical narrative: Patient called on 5/12/11, complained of left arm being swollen, red & painful, stated at appnt on 5/13/11 ran a fever as high as 104 degrees, nausea & H/A. Temperature in office was 99 degrees. Patient was given MEDROL Dose pk & KEFLEX.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient called on 5/12/11, complained of left arm being swollen, red & painful, stated at appnt on 5/13/11 ran a fever as high as 104 degrees, nausea & H/A. Temperature in office was 99 degrees. Patient was given MEDROL Dose pk & KEFLEX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymphadenopathy, Oedema peripheral
Clinical narrative: Injection site redness & swelling of upper arm. Enlargement of arm lymph nodes.
Age: 30.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Generalized papulovesicular rash face, neck, torso, arms 1 day after vaccine administered.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 5-19-11 - vaccination. 5-20-11 - raised red area, tender noted. 5-24-11 - raised red area increased to 4 cm diameter with tender erythematous area 11 x 16 cm - started prednisone taper.
Age: 0.45
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash locally on both anterolateral aspect of the thigh - on 6/1/2011, gradually getting better. Mother gave only TYLENOL for fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Child collapsed, dizzy, syncope.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema
Clinical narrative: (L) arm - erythema possible side effect from DTAP/Polio combined.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Injection site pain, Injection site swelling, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: EXCRUCIATING PAIN IN LEFT DELTOID, THREE RAISED PLAQUES ON BICEP, SWELLING AT THE INJECTION SITE WAS APPROX 3" IN DIAMETER AND 1" IN HEIGHT, LOSS OF STRENGTH DUE TO PAIN IN DELTOID, LOSS OF RANGE OF MOTION DUE TO PAIN, AND UNABLE TO SLEEP ON BACK, SIDE, AND STOMACH DUE TO PAIN IN SHOULDER.  SYMPTOMS LASTED THREE DAYS.  TREATMENT WAS INTENSELY PAINFUL STRETCHING, HEAT THERAPY, AND NSAIDS.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Skin plaque, Sleep disorder
Clinical narrative: EXCRUCIATING PAIN IN LEFT DELTOID, THREE RAISED PLAQUES ON BICEP, SWELLING AT THE INJECTION SITE WAS APPROX 3" IN DIAMETER AND 1" IN HEIGHT, LOSS OF STRENGTH DUE TO PAIN IN DELTOID, LOSS OF RANGE OF MOTION DUE TO PAIN, AND UNABLE TO SLEEP ON BACK, SIDE, AND STOMACH DUE TO PAIN IN SHOULDER.  SYMPTOMS LASTED THREE DAYS.  TREATMENT WAS INTENSELY PAINFUL STRETCHING, HEAT THERAPY, AND NSAIDS.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Loss of consciousness
Clinical narrative: pt passed out 10 mins after the vaccine was given
Age: 17.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Asthenia, Loss of consciousness, Nausea, Pallor, Somnolence
Clinical narrative: After vaccines were given patient was getting off of the examination table she began to feel weak and then passed out. Pallor in color once we brought her to the floor she began to wake up. Vital signs were stable at that time....patient became alert few seconds after event did not recall what happened.  Cold compresses applied to patients forehead.  Patient kept stating "I just want to sleep".  After approx 1 hour patient was alert and oriented but still drowsy...water was given.  Patient stated she didn't eat anything for breakfast we attempted to give her some crackers.  Finally without any intake of crackers patient began to feel nausea and was trying to vomit without success.  At that time Dr. advised for patient to be brought to the ER for evaluation.  EMS called and patient brought to ER via ambulance with parent following in her own car.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Left Deltoid is red, swollen, and warm to touch. Under the left arm it is red, swollen, and warm to touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Left Deltoid is red, swollen, and warm to touch. Under the left arm it is red, swollen, and warm to touch.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Scratch, Urticaria
Clinical narrative: Woke up with severe rash, hives.  Extreme itching with welts appearing as she was scratching them.  Tried over the counter itch relief cream, no relief. Took her to ER at app 9:30 pm.  Benadryl prescribed. Got relief in the early hours of Sun 5/29/2011.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: itchy rash on sight of injection for 1 week, swollen, red, painful, 8cm*10 cm
Age: 6.0
Sex: M
Vaccine: DTP, IPV
Symptoms: Cough, Erythema, Lip swelling, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: Ears and buttocks started itching; small hives and redness developed from neck to armpits to below navel and stopped at upper thighs; chin became itchy and bottom lip swollen; he started coughing and clearing throat and had some redness a swelling in throat.
Age: 6.0
Sex: M
Vaccine: DTP, IPV
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Ears and buttocks started itching; small hives and redness developed from neck to armpits to below navel and stopped at upper thighs; chin became itchy and bottom lip swollen; he started coughing and clearing throat and had some redness a swelling in throat.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Decreased appetite, Irritability, Pyrexia, Vomiting
Clinical narrative: Irritability, loss of appetite, fussiness, vomiting, low grade fever
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Decreased appetite, Injection site swelling
Clinical narrative: Crying for more than 3hrs. Not eating. Swelling at injection site ((R) thigh). Tx: TYLENOL & cool compress.
Age: 0.39
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There were no side effects, per CDC we do have to repeat dose when he reaches appropriate age, right now he needs (DTa-IPV-hep B).
Age: 0.64
Sex: M
Vaccine: HIBV, IPV, PNC13
Symptoms: Cough, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Developed local red tiny bumps non vesicular non tender non painful B/L at site of shots AL thighs. Developed 101 fever next day of shot lasting 2 days. Cough next day too.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient administered ZOSTAVAX vaccine on 5/24/2011 in patients left upper posterolateral arm - presented herself to us on 5/28/11 with reddened erythema, swollen, hot, 2 inch red blister on left arm - suggested oral BENADRYL & to call Dr .
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Lt arm red swollen 30 cm (Tdap area) 1 hr after inj. Came in on 5/24/11 BENADRYL 25 mg 1-6 hrs #60.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Grandmother called states Lt thigh red swollen quarter to 50 cent size (DTA area) put cortisone cream (called BENADRYL 125mg 3ML every 6 hrs 4 oz).
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Lt thigh red swollen 9" x 6" (DTA area) was given BENADRYL (12.5 mg) 1-6 hrs - 6oz on 4/22/11 2:30pm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site infection, Staphylococcal infection
Clinical narrative: HUGE RED HOT SWOLLEN SPOT AT INJECTION SITE-UN-RESPONSIVENESS-CONSTANT CRYING-TREMORS FOR 10 WEEKS CONTINUOUSLY-BLOWN BLOOD VESSELS IN EYES-AND ALL THESE THINGS CONTINUE-FALLING DOWN-POSSIBLE SEIZURES-ABNORMAL GAIT-MUCUS AND BLOOD IN STOOL-PERSONALITY CHANGE-DEPRESSED MOOD-INABILITY TO SLEEP DUE TO THE CONSTANT JERKING
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Computerised tomogram, Crying, Depressed mood, Dyskinesia, Electroencephalogram
Clinical narrative: HUGE RED HOT SWOLLEN SPOT AT INJECTION SITE-UN-RESPONSIVENESS-CONSTANT CRYING-TREMORS FOR 10 WEEKS CONTINUOUSLY-BLOWN BLOOD VESSELS IN EYES-AND ALL THESE THINGS CONTINUE-FALLING DOWN-POSSIBLE SEIZURES-ABNORMAL GAIT-MUCUS AND BLOOD IN STOOL-PERSONALITY CHANGE-DEPRESSED MOOD-INABILITY TO SLEEP DUE TO THE CONSTANT JERKING
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Eye haemorrhage, Fall, Gait disturbance, Haematochezia, Injection site erythema
Clinical narrative: HUGE RED HOT SWOLLEN SPOT AT INJECTION SITE-UN-RESPONSIVENESS-CONSTANT CRYING-TREMORS FOR 10 WEEKS CONTINUOUSLY-BLOWN BLOOD VESSELS IN EYES-AND ALL THESE THINGS CONTINUE-FALLING DOWN-POSSIBLE SEIZURES-ABNORMAL GAIT-MUCUS AND BLOOD IN STOOL-PERSONALITY CHANGE-DEPRESSED MOOD-INABILITY TO SLEEP DUE TO THE CONSTANT JERKING
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Mucous stools, Nuclear magnetic resonance imaging
Clinical narrative: HUGE RED HOT SWOLLEN SPOT AT INJECTION SITE-UN-RESPONSIVENESS-CONSTANT CRYING-TREMORS FOR 10 WEEKS CONTINUOUSLY-BLOWN BLOOD VESSELS IN EYES-AND ALL THESE THINGS CONTINUE-FALLING DOWN-POSSIBLE SEIZURES-ABNORMAL GAIT-MUCUS AND BLOOD IN STOOL-PERSONALITY CHANGE-DEPRESSED MOOD-INABILITY TO SLEEP DUE TO THE CONSTANT JERKING
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Personality change, Tremor, Unresponsive to stimuli
Clinical narrative: HUGE RED HOT SWOLLEN SPOT AT INJECTION SITE-UN-RESPONSIVENESS-CONSTANT CRYING-TREMORS FOR 10 WEEKS CONTINUOUSLY-BLOWN BLOOD VESSELS IN EYES-AND ALL THESE THINGS CONTINUE-FALLING DOWN-POSSIBLE SEIZURES-ABNORMAL GAIT-MUCUS AND BLOOD IN STOOL-PERSONALITY CHANGE-DEPRESSED MOOD-INABILITY TO SLEEP DUE TO THE CONSTANT JERKING
Age: 24.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Chills, Fatigue, Incontinence, Pyrexia
Clinical narrative: 15 hr after shot given woke up severe muscle aches & weakness - restless night. In morning after voided - as walked up stairs had involuntary releases of urine, felt "emotional" seen in office 5/20/11 - neuro exam normal.
Age: 24.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Asthenia, Emotional disorder, Myalgia, Restlessness, Urinary incontinence
Clinical narrative: 15 hr after shot given woke up severe muscle aches & weakness - restless night. In morning after voided - as walked up stairs had involuntary releases of urine, felt "emotional" seen in office 5/20/11 - neuro exam normal.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Weakness and severe pain in arm where injection was given. Ongoing weakness and pain in arm, 6 months later.
Age: 0.07
Sex: M
Vaccine: HEP
Symptoms: Dyskinesia, Muscle twitching
Clinical narrative: TWITCHING-JERKING OF SHOULDER, ARM, LEG, FOOT FOR A TOTAL OF 15 MINUTES IT LASTED AND EVERY 10 SEC BABY WOULD GIVE 4 TWITCHES OF SHOULDER, ARM, LEG FOOT
Age: 1.04
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: Child was given initial dose of Varicella on 05-21-03 was seen in office on 06-01-11 and diagnosed with chicken pox. Child had vesicular rash on face, arms and legs. Pt. has not had booster dose of Varicella yet.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reports on June 3 2011 that since his injection in his left deltoid he has pain in his arm mostly with movement, repots that if he moves it around the pain resloves some.  Taking NSAIDS to help with the pain.  Has not been evaluated by a physician for the symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling around site of vaccination, tenderness and redness at site.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Blood test, Fatigue, Gait disturbance
Clinical narrative: The first Hep B shot 5/6/11 - by 5/9/11 achy, tired, swollen throat - 5/20 I had a hard time walking around. Very tired joints hurt - 5/23 I went to the hospital - spent the night. Weakness over entire body, joints hurt. I told the doctor about the shot - with no acknowledgement. I was sent home. Still no better. Very weak, pale, exhausted all the time, headaches.