chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Pericarditis, Productive cough, Rhinorrhoea
Clinical narrative: Initial report received on 19 May 2010 and follow up received on 20 May 2010 from an investigator under the reference number H-406-004. A 22 year-old male subject with no significant medical history received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); TYPHOID vaccine (manufacturer and lot number not  reported); and ANTHRAX vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis (see case 2010-02637 for details) and bronchospasm. Additional symptoms noted on the Emergency Room report include: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. The subject was treated for bronchospasm with albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), ATROVENT (500 mcg) and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of bronchospasm as possibly related to the study product. This is a report of a 22 year-old who experienced pericarditis (described in case 2010-02637) and other symptoms consistent with bronchospasm and possible upper respiratory tract infection within 2 weeks of vaccination with ACAM2000, typhoid vaccine, and BIOTHRAX. Although it is possible that the cardiac event and the pulmonary event may have had an etiological association, it is highly likely that the brochospasm was triggered by a probable upper respiratory tract infection, as evidenced by the productive cough and sputum. The patient was lost to follow-up; recovery status is unknown and further information is not available.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP, SMALL, ANTH, HEP, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging normal, Troponin I
Clinical narrative: This report was received from an investigator of a trial on 20 May 2010. A 46 year-old male subject received the following vaccines on 25 August 2009: ACAM2000 (lot number not reported); anthrax (manufacturer and lot number not reported) and hepatitis B (manufacturer and lot number not reported). Fifteen days after vaccination, on 10 September 2009, the subject was diagnosed with other and unspecified acute myocarditis. The subject had an abnormal electrocardiogram result on 10 September 2009 and a normal echocardiogram on 14 September 2009. The Troponin I result was not available. An MRI of the heart performed on 16 September 2009 was normal. No other information was provided. 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.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Dyspnoea, Dyspnoea exertional, Electrocardiogram abnormal, Pericarditis
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 24 year-old male subject received the following vaccines on 10 September 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Fifteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject's medical history was not available. On Day 13 (23 September 2009), the subject had an electrocardiogram which was abnormal. On Day 15 (25 September), the subject had an echocardiogram which was abnormal and a Troponin I which was normal. 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. List of documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 24 year-old male subject received the following vaccines on 10 September 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Fifteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject's medical history was not available. On Day 13 (23 September 2009), the subject had an electrocardiogram which was abnormal. On Day 15 (25 September), the subject had an echocardiogram which was abnormal and a Troponin I which was normal. 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. List of documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 24 year-old male subject received the following vaccines on 10 September 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Fifteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject's medical history was not available. On Day 13 (23 September 2009), the subject had an electrocardiogram which was abnormal. On Day 15 (25 September), the subject had an echocardiogram which was abnormal and a Troponin I which was normal. 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. List of documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the trial on 20 May 2010. A 36 year-old male subject with no significant medical history received the following vaccines on 14 September 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Twenty-four days after vaccination, the subject was diagnosed with non-specific myocarditis. On Day 9 (23 September 2009), the subject had normal electrocardiogram. On Day 11 (25 September 2009), the subject had a Troponin I of 0.25 (abnormal) and an echocardiogram which was normal. 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. List of documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 20 year-old male subject with a history of eczema received the following vaccines on 24 September 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). The subject had previously received influenza vaccine, split virus (manufacturer unknown and lot number not reported) on 16 September 2009. Thirteen days after receipt of smallpox vaccine, the subject was diagnosed with unspecified disease of the pericardium. The subject was also diagnosed with non-specific myocarditis 14 days after vaccination. On Day 11 (05 October 2009), the subject had an abnormal electrocardiogram and a normal echocardiogram. On Day 13 (07 October 2009), the subject had a Troponin I of 12.3 (abnormal). 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.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Electrocardiogram abnormal, Myalgia, Pyrexia, Troponin increased
Clinical narrative: This report was received from the investigator in the trial on 20 May 2010. 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 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. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the trial on 20 May 2010. 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 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. List of documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: TD, TD
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood electrolytes normal, Fatigue
Clinical narrative: Muscular weakness in both forearms, muscular weakness in calf (both legs), experienced rapid heart beat, some feelings of constriction in arms and legs, general fatigue and some bodily imbalance in walking.
Age: 77.0
Sex: F
Vaccine: TD, TD
Symptoms: Balance disorder, Blood potassium, Blood sodium, Fatigue, Heart rate increased
Clinical narrative: Muscular weakness in both forearms, muscular weakness in calf (both legs), experienced rapid heart beat, some feelings of constriction in arms and legs, general fatigue and some bodily imbalance in walking.
Age: 77.0
Sex: F
Vaccine: TD, TD
Symptoms: Muscle disorder, Muscular weakness, Renal disorder, Vasoconstriction
Clinical narrative: Muscular weakness in both forearms, muscular weakness in calf (both legs), experienced rapid heart beat, some feelings of constriction in arms and legs, general fatigue and some bodily imbalance in walking.
Age: 31.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Diarrhoea, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Nausea, fatigue, and headache followed by diarrhea and sleeplessness for 2 days.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swelling to right deltoid. Lymphadenopathy to Rt. axilla and Rt. neck - cervical lymph node.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Localized reaction, erythema and warm to touch. Supportive care, cool pack and prelone syrup x 3 days. 48 hrs later symptoms 100% resolved.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Left arm red and itchy use ice pack and Ibuprofen prn, can use Benadryl cream, for itch.
Age: 1.71
Sex: F
Vaccine: HEPA, PNC13
Clinical narrative: Went to ER 2 days after injections. Dx. Cellulitis. Treatment-KEFLEX TID x 10 days doing well.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Child apparently limping on left leg. Around noon, leg became very swollen to the whole thigh, down to the knee. Upon evaluation on 5/26/10 at 2:15 pm leg measured at upper thigh is approx 11/2 inches larger on the left than the right, with the edema just at the knee. Leg has some light redness and warm to touch. Appointment made with Dr. to be seen.
Age: 27.0
Sex: M
Vaccine: ANTH, JEVX, SMALL, TYP, ANTH, JEVX, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: This report was received from the investigator on 20 May 2010. A 27 year-old male subject received the following vaccines on 27 October 2009: ACAM2000 (lot number not reported); typhoid Vi CPS (sanofi pasteur, lot number not reported), anthrax (manufacturer and lot number not reported) and Japanese Encephalitis (manufacturer and lot number not reported). The subject was vaccinated with influenza, LIVE intranasal (manufacturer and lot number not reported) three weeks prior. Six days after smallpox vaccination on 02 November 2009, the subject was diagnosed with acute pericarditis unspecified. The subject had an abnormal electrocardiogram on 02 November 2009 and had a normal troponin I test on 13 November 2009. No other information was provided. 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.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator on 20 May 2010. A 20 year-old male subject with medical history significant for dizziness/fainting spells received the following vaccine on 17 October 2009: ACAM2000 (lot number not reported). The subject was vaccinated two weeks prior to that on 03 October 2009 with influenza split virus vaccine (manufacturer and lot number not reported). Nineteen days after vaccination with ACAM2000, on 05 November 2009, the subject was diagnosed with non-specific myocarditis. The subject had an abnormal electrocardiogram result on 30 October 2009 and an abnormal Troponin I result of 7.90 on 30 October 2009. Echocardiogram results were not reported. No further information was provided. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator on 20 May 2010. A 20 year-old male subject with medical history significant for dizziness/fainting spells received the following vaccine on 17 October 2009: ACAM2000 (lot number not reported). The subject was vaccinated two weeks prior to that on 03 October 2009 with influenza split virus vaccine (manufacturer and lot number not reported). Nineteen days after vaccination with ACAM2000, on 05 November 2009, the subject was diagnosed with non-specific myocarditis. The subject had an abnormal electrocardiogram result on 30 October 2009 and an abnormal Troponin I result of 7.90 on 30 October 2009. Echocardiogram results were not reported. No further information was provided. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Atrial fibrillation, Chest pain, Dyspnoea, Palpitations, Tachycardia
Clinical narrative: Chest pain, SOB and palpitations. Condition developed into a chronic Afib condition. see attached full report. Symptoms: Pain, chest NOS(786.50), Palpitations(785.1), Tachycardia NOS (785.0).
Age: 34.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis after H1N1 vaccine:got it at different facility and not hospitalized at our facility. Difficult to report w/o details. Symptoms: Symptoms: 1. Anaphylaxis. Treatment Drugs Used: Mercury, Ammoniated.
Age: 1.28
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: High fever - 104 at E.D. of hospital.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Nuclear magnetic resonance imaging normal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 28 year-old male subject with no relevant medical history received the following vaccines: ACAM2000 (lot number not reported) on 06 January 2010; and TYPHIM VI (lot number not reported), anthrax vaccine (other manufacturer and lot number not reported), and hepatitis B vaccine (other manufacturer and lot number not reported) on 05 January 2010. Sixteen days after receipt of ACAM2000, subject was diagnosed with unspecified disease of the pericardium. On Day 12 (18 January 2010), the subject had a normal Troponin I level. On Day 13 (19 January 2010), the subject had an abnormal electrocardiogram and a normal echocardiogram. On Day 19 (25 January 2010), the subject had an MRI of the heart which was normal. 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. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLUX, IPV, MEN, TD
Symptoms: Dysgeusia, Facial palsy, Guillain-Barre syndrome, Paralysis
Clinical narrative: Receives email Sir/Ma'am, a 30 y/o male presented to the immunization clinic. He was hospitalized x 2 weeks in September of 2003 with GBS with lower extremity paralysis from chest down and Bell's Palsy left-sided facial paralysis with persistent, residual left-sided facial droop, after receiving multiple immunizations on 25APR2003, including: INFLUENZA (IM); TD; IPV and MPSV4. On 02MAY2003 he received HEP A/B TWINRIX #2. He denies any GI sx or URI sx prior to receipt of vaccinations. He endorses a metallic taste in his mouth prior to onset of GBS in Sept of 2003. Since, then, he has received INFLUENZA, Split Virus, IM (21 NOV 2003); INFLUENZA, Split Virus, IM (18 NOV 2005); INFLUENZA, Live, Intranasal (20 JAN 2005); INFLUENZA, Live, Intranasal (04 OCT 2006); Influenza, Live, Intranasal (19 NOV 2007); INFLUENZA, Live, Intranasal (23 OCT 2008); INFLUENZA, Live Intranasal (28 AUG 2009); Oral TYPHOID (25 APR 2006); SMALLPOX (14 JAN 2009); AVA#1 (29 Dec 2008); AVA #2 (14 JAN 2009); AVA #3(02 MAR 2009) and AVA #4 (04 AUG 2009).
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: Unconsolable crying for over 3 hours despite administering Tylenol.
Age: 1.81
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling 6cm x 5 cm around injection site.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Back pain, Injection site induration, Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: WOKE UP WITH DULL ACHY PAIN IN MIDDLE BACK AND LARGE SWOLLEN WARM INDURATION AT VACCINATION SITE.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator on 20 May 2010. A 22 year-old male subject with a history of palpitations/pounding heart without exercise, chest pain, chest pressure, pericarditis and abnormal electrocardiogram, received ACAM2000 (lot number not reported) on 05 August 2009. The subject had previously received anthrax vaccine (other manufacturer and lot number not reported) on 23 July 2009. On Day 7 (12 August 2009), the subject had a normal Troponin I level and an abnormal electrocardiogram. Eight days after receipt of smallpox vaccine, the subject was diagnosed with unspecified disease of the pericardium. 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. List of document held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Laboratory test, Pericardial disease
Clinical narrative: This report was received from the investigator in the trial on 20 May 2010. Additional information was received on 24 May 2010 from the investigator. A 29 year-old male subject whose medical history was not available received the following vaccines: ACAM2000 (lot number not reported) on 18 December 2008; and anthrax vaccine (other manufacturer and lot number not reported), and Hep B vaccine (other manufacturer and lot number not reported) on 09 December 2008. Nine days after receipt of smallpox, the subject was diagnosed with unspecified disease of the pericardium. Results of diagnostic testing were not available. 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.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Diagnostic procedure, Pericardial disease
Clinical narrative: This report was received from the investigator in the trial on 20 May 2010. Additional information was received on 24 May 2010 from the investigator. A 29 year-old male subject whose medical history was not available received the following vaccines: ACAM2000 (lot number not reported) on 18 December 2008; and anthrax vaccine (other manufacturer and lot number not reported), and Hep B vaccine (other manufacturer and lot number not reported) on 09 December 2008. Nine days after receipt of smallpox, the subject was diagnosed with unspecified disease of the pericardium. Results of diagnostic testing were not available. 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.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator of a trial on 20 May 2010. A 26 year-old male subject received the following vaccines on 15 July 2009: ACAM2000 (lot number not reported); TYPHIM VI (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Fourteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of high blood pressure, elevated cholesterol, palpitations/pounding heart without exercise, and headaches. On Day 12 (27 July 2009), the subject had a Troponin I of 2.97 (abnormal) and electrocardiogram and echocardiogram which were both abnormal. 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. List of documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Nuclear magnetic resonance imaging normal, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator of a trial on 20 May 2010. A 30 year-old male subject received the following vaccine on 06 March 2009: ACAM2000 (lot number not reported). Twenty-eight days after vaccination on 03 April 2009, the subject was diagnosed with unspecified disease of the pericardium. The subject had an abnormal Troponin I result of 10.31 (units and reference range not provided) and an abnormal electrocardiogram (results not provided) on 19 March 2009. Normal MRIs of the spinal cord and heart were done on 20 March 2009. 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.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 19 year-old male subject received ACAM2000 (lot number not reported) on 27 January 2009 and TYPHIM VI (lot number not reported and Anthrax vaccine (other manufacturer and lot number not reported) on 26 January 2009. Eighteen days after smallpox vaccination, the subject was diagnosed with acute pericarditis. The subject's medical history was not available. On Day 14 (09 February 2009), the subject had a Troponin I and electrocardiogram which were reported as abnormal and an echocardiogram which was reported as normal. 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-intervention) study. List of documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 19 year-old male subject received ACAM2000 (lot number not reported) on 27 January 2009 and TYPHIM VI (lot number not reported and Anthrax vaccine (other manufacturer and lot number not reported) on 26 January 2009. Eighteen days after smallpox vaccination, the subject was diagnosed with acute pericarditis. The subject's medical history was not available. On Day 14 (09 February 2009), the subject had a Troponin I and electrocardiogram which were reported as abnormal and an echocardiogram which was reported as normal. 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-intervention) study. List of documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: FLUN3, SMALL, FLUN3, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram normal, Pericardial disease
Clinical narrative: This report was received from the investigator in the trial on 20 May 2010. A 24 year-old male subject with no significant medical history received the following vaccines on 25 September 2009: ACAM2000 (lot number not reported) and influenza vaccine live intranasal (other manufacture and lot number not reported). The subject received anthrax vaccine (other manufacturer and lot number not reported) the previous day (24 September 2009). Eleven days after receipt of the ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. On Day 11 (06 October 2009), the subject had an abnormal echocardiogram and a normal electrocardiogram. 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. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myocardial infarction, Pericardial disease
Clinical narrative: This report was received from the investigator of a trial on 20 May 2010. A 22 year-old male subject with a medical history significant for asthma received the following vaccines on 02 September 2009: ACAM2000 (lot number not reported); TYPHIM VI (sanofi pasteur, lot number not reported) and anthrax (manufacturer and lot number not reported). Ten days after vaccination on 12 September 2009, the subject was diagnosed with unspecified disease of the pericardium and on 14 September 2009 was diagnosed with subendocardial infarction. The subject had no reported results that were available. No other information was provided. 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.
Age: 21.0
Sex: F
Vaccine: RAB, YF
Symptoms: Abdominal pain, Abortion spontaneous, Back pain, Blood human chorionic gonadotropin positive, Constipation
Clinical narrative: 21 y/o AD Female reports inadvertent receipt of yellow fever (live virus) and pre-exposure rabies #3 (inactivated virus) vaccines during pregnancy. The SM received the vaccines on 11MAY10 and signed a form saying she was not pregnant at the time, but a urine HCG was not obtained. On 13MAY10 the SM had a + Serum hCG test/ OB Hx: Gravida 1, para 0, aborta 0, stillbirths 0. Was notified and recommended that the SM be seen by OB and notify the Provider of her inadvertent receipt of live virus vaccines during early gestation. Her LMP was 11APR10. The SM also received pre-exposure rabies #1 on 19APR10, pre-exposure rabies #2 on 04-MAY10 and TYPHOID ViCPs on 04MAY10. SM reported experiencing intermittent "random" pelvic cramping initially on 13MAY10 and she thought it might be her menstrual period, as she did not know at the time that she was pregnant. She reported a hx of tobacco use of 1-2 cigarettes daily, decreased from 1ppd x 4 years and ETOH of 3 drinks over weekends prior to + Serum hCG. The SM's OB Nurse Intake Hx was obtained at OB on 17MAY10, at which time the SM's did not report any adverse events following immunization during pregnancy. On 25MAY10 the SM was seen at ED @ 13:40 for "threatened abortion." She reported noticing blood on the toilet tissue when she wiped early that day. She was d/c'd to home and returned to ED @ 0200 on 26MAY10 with increased vaginal bleeding and pelvic cramping. The SM was evaluated at 0801 at OB Clinic on 27MAY10 (EGA 6+4/7weeks) at which time she reported increased cramping, vaginal bleeding and passage of tissue x 8 hours, accompanied by lower back pain, but denied fever, V, diarrhea or dysuria. She also reported some nausea and constipation. A transvaginal US showed a thin endometrial stripe of 4mm, no solitary fetus, a gestational sac was not seen and a yolk sac was not seen. No intraabdominal pregnancy was appreciated and the cul de sac had no fluid present. There were no fetal heart sounds by Doppler. She was Dx as having a SPONTANEOUS ABORTION with indications to follow hCG levels to "0" and to f/u as needed. The SM was given 7 days of convalescent leave and prescribed PERCOCET 5/325 1 tab po q 4 h prn pain not controlled with MOTRIN. Tissue was sent to pathology for exam and Quantitative hCG was ordered.
Age: 21.0
Sex: F
Vaccine: RAB, YF
Symptoms: Drug exposure during pregnancy, Foetal heart rate abnormal, Massage, Nausea, Pathology test
Clinical narrative: 21 y/o AD Female reports inadvertent receipt of yellow fever (live virus) and pre-exposure rabies #3 (inactivated virus) vaccines during pregnancy. The SM received the vaccines on 11MAY10 and signed a form saying she was not pregnant at the time, but a urine HCG was not obtained. On 13MAY10 the SM had a + Serum hCG test/ OB Hx: Gravida 1, para 0, aborta 0, stillbirths 0. Was notified and recommended that the SM be seen by OB and notify the Provider of her inadvertent receipt of live virus vaccines during early gestation. Her LMP was 11APR10. The SM also received pre-exposure rabies #1 on 19APR10, pre-exposure rabies #2 on 04-MAY10 and TYPHOID ViCPs on 04MAY10. SM reported experiencing intermittent "random" pelvic cramping initially on 13MAY10 and she thought it might be her menstrual period, as she did not know at the time that she was pregnant. She reported a hx of tobacco use of 1-2 cigarettes daily, decreased from 1ppd x 4 years and ETOH of 3 drinks over weekends prior to + Serum hCG. The SM's OB Nurse Intake Hx was obtained at OB on 17MAY10, at which time the SM's did not report any adverse events following immunization during pregnancy. On 25MAY10 the SM was seen at ED @ 13:40 for "threatened abortion." She reported noticing blood on the toilet tissue when she wiped early that day. She was d/c'd to home and returned to ED @ 0200 on 26MAY10 with increased vaginal bleeding and pelvic cramping. The SM was evaluated at 0801 at OB Clinic on 27MAY10 (EGA 6+4/7weeks) at which time she reported increased cramping, vaginal bleeding and passage of tissue x 8 hours, accompanied by lower back pain, but denied fever, V, diarrhea or dysuria. She also reported some nausea and constipation. A transvaginal US showed a thin endometrial stripe of 4mm, no solitary fetus, a gestational sac was not seen and a yolk sac was not seen. No intraabdominal pregnancy was appreciated and the cul de sac had no fluid present. There were no fetal heart sounds by Doppler. She was Dx as having a SPONTANEOUS ABORTION with indications to follow hCG levels to "0" and to f/u as needed. The SM was given 7 days of convalescent leave and prescribed PERCOCET 5/325 1 tab po q 4 h prn pain not controlled with MOTRIN. Tissue was sent to pathology for exam and Quantitative hCG was ordered.
Age: 21.0
Sex: F
Vaccine: RAB, YF
Symptoms: Ultrasound Doppler abnormal, Ultrasound antenatal screen abnormal, Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: 21 y/o AD Female reports inadvertent receipt of yellow fever (live virus) and pre-exposure rabies #3 (inactivated virus) vaccines during pregnancy. The SM received the vaccines on 11MAY10 and signed a form saying she was not pregnant at the time, but a urine HCG was not obtained. On 13MAY10 the SM had a + Serum hCG test/ OB Hx: Gravida 1, para 0, aborta 0, stillbirths 0. Was notified and recommended that the SM be seen by OB and notify the Provider of her inadvertent receipt of live virus vaccines during early gestation. Her LMP was 11APR10. The SM also received pre-exposure rabies #1 on 19APR10, pre-exposure rabies #2 on 04-MAY10 and TYPHOID ViCPs on 04MAY10. SM reported experiencing intermittent "random" pelvic cramping initially on 13MAY10 and she thought it might be her menstrual period, as she did not know at the time that she was pregnant. She reported a hx of tobacco use of 1-2 cigarettes daily, decreased from 1ppd x 4 years and ETOH of 3 drinks over weekends prior to + Serum hCG. The SM's OB Nurse Intake Hx was obtained at OB on 17MAY10, at which time the SM's did not report any adverse events following immunization during pregnancy. On 25MAY10 the SM was seen at ED @ 13:40 for "threatened abortion." She reported noticing blood on the toilet tissue when she wiped early that day. She was d/c'd to home and returned to ED @ 0200 on 26MAY10 with increased vaginal bleeding and pelvic cramping. The SM was evaluated at 0801 at OB Clinic on 27MAY10 (EGA 6+4/7weeks) at which time she reported increased cramping, vaginal bleeding and passage of tissue x 8 hours, accompanied by lower back pain, but denied fever, V, diarrhea or dysuria. She also reported some nausea and constipation. A transvaginal US showed a thin endometrial stripe of 4mm, no solitary fetus, a gestational sac was not seen and a yolk sac was not seen. No intraabdominal pregnancy was appreciated and the cul de sac had no fluid present. There were no fetal heart sounds by Doppler. She was Dx as having a SPONTANEOUS ABORTION with indications to follow hCG levels to "0" and to f/u as needed. The SM was given 7 days of convalescent leave and prescribed PERCOCET 5/325 1 tab po q 4 h prn pain not controlled with MOTRIN. Tissue was sent to pathology for exam and Quantitative hCG was ordered.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Radioallergosorbent test negative, Swelling, Urticaria
Clinical narrative: Received H1N1 vaccine in (#2 H1N1 this season) and developed urticaria with swelling of UPT (no resp. distress)-resolved with BENADRYL.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: None. Given PNEUMOVAX instead of PREVNAR.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy at injection site, afebrile x 2d. Use Ice et Hydrocortisone Cr. 1% prn.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Patient developed induration, erythema and pain to left arm-visited PCP, approximately 10d later and treated with steriods.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Body temperature increased, Urticaria
Clinical narrative: At 5:00 pm several hives appeared.  By 6:30 PM hives appeared on chest, back, and face.  Temp 102.  Seen at Emergency Department.  Treated with Benadryl.  Within 20 minutes hives subsided and temperature came down.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching @ site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Area red, swollen (lt. thigh) - Pt's mother states "was running fever" but did not take Pt's temperature.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on neck and face.
Age: 26.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site pain
Clinical narrative: Received GARDSASIL #1 on 5/11/10 in (R) deltoid. Pt returns today with complaints of (R) arm pain at injection site. No redness, swelling, heat or hardness noted.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Redness, swelling and pain at injection site. Headache, malaise and fever of 102F.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Redness, swelling and pain at injection site. Headache, malaise and fever of 102F.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure lasting approx. 2 minutes. Sudden spike in fever while napping.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Erythema, Local swelling
Clinical narrative: Local redness/swelling/discomfort - persisted x 1 week. Responded to ibuprofen.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out at school around 20 hours after vaccine administered.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Induration
Clinical narrative: Redness & induration 3x3cm RL thigh.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis-BENADRYL, PEPCID, ice.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Eczema, Eye swelling, Pruritus, Urticaria
Clinical narrative: Received GARDASIL #2 on 5 20 2010. On 5/21/2010, developed hives, pruritis, periorbital swelling. Pre-existing condition of eczema exacerbation. As of 5/25/2010, no improvement of symptoms. Pt advised to call Dermatologist.
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Back pain, Electromyogram, Impaired work ability, Inflammation, Movement disorder
Clinical narrative: Received tetanus shot. Within a week was in severe pain and barely able to move. Pain in upper back by neck, shoulder and arm. Severe muscles spasms and loss of sensation in arm and hand followed. Given prednisone and referred to neurologist. Diagnosed with brachial neuritis from shot. Being seen by neurologist and orthopedic surgeion for inflammation that has set into shoulder as result. Physical therapy twice a week. On anti-inflammatories, painkillers, nerve pain medication and muscle relaxers. Unable to work at regular job and do regular recreational activities. Unsure if will be permanent.
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Muscle spasms, Musculoskeletal pain, Neurological examination, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Received tetanus shot. Within a week was in severe pain and barely able to move. Pain in upper back by neck, shoulder and arm. Severe muscles spasms and loss of sensation in arm and hand followed. Given prednisone and referred to neurologist. Diagnosed with brachial neuritis from shot. Being seen by neurologist and orthopedic surgeion for inflammation that has set into shoulder as result. Physical therapy twice a week. On anti-inflammatories, painkillers, nerve pain medication and muscle relaxers. Unable to work at regular job and do regular recreational activities. Unsure if will be permanent.
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Pain in extremity, Radiculitis brachial, Sensory loss
Clinical narrative: Received tetanus shot. Within a week was in severe pain and barely able to move. Pain in upper back by neck, shoulder and arm. Severe muscles spasms and loss of sensation in arm and hand followed. Given prednisone and referred to neurologist. Diagnosed with brachial neuritis from shot. Being seen by neurologist and orthopedic surgeion for inflammation that has set into shoulder as result. Physical therapy twice a week. On anti-inflammatories, painkillers, nerve pain medication and muscle relaxers. Unable to work at regular job and do regular recreational activities. Unsure if will be permanent.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Approximately around 8:00PM on 5/25/2010 pt. developed chills, fever, general malaise (with pronounced pain over kidneys), vertigo and lightheadedness. On 5/26/2010 the pt. remained in bed all day due to dizziness, anorexia and continued malaise. Fever of 103 degrees F. lasted 24 hours. On 5/26 pt. remained lightheaded, and weak. Right arm where Tdap was given was red, swollen, warm and painful. Patient took Tylenol and ibuprofen.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Approximately around 8:00PM on 5/25/2010 pt. developed chills, fever, general malaise (with pronounced pain over kidneys), vertigo and lightheadedness. On 5/26/2010 the pt. remained in bed all day due to dizziness, anorexia and continued malaise. Fever of 103 degrees F. lasted 24 hours. On 5/26 pt. remained lightheaded, and weak. Right arm where Tdap was given was red, swollen, warm and painful. Patient took Tylenol and ibuprofen.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Pyrexia, Renal pain, Vertigo
Clinical narrative: Approximately around 8:00PM on 5/25/2010 pt. developed chills, fever, general malaise (with pronounced pain over kidneys), vertigo and lightheadedness. On 5/26/2010 the pt. remained in bed all day due to dizziness, anorexia and continued malaise. Fever of 103 degrees F. lasted 24 hours. On 5/26 pt. remained lightheaded, and weak. Right arm where Tdap was given was red, swollen, warm and painful. Patient took Tylenol and ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: Pt has moderate swollen lymph nodes into her neck on the arm the vaccine was given.  No fever but achy and nauseous.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dizziness, Erythema, Hypoaesthesia, Injection site discomfort
Clinical narrative: 5/18/2010 states she felt dizziness, nausea, vomiting some discomfort L deltoid injection site. 5/19/10 states she has dry heaves, low back pain 10/10, with radiation to upper legs front and back pain 10/10, L deltoid and L arm pain 9.5/10 with numbness L fingers. Examined by Occupational Health Doctor. No treatment. 5/21/10 Denies low back pain 0/10, denies leg pain 0/10. denies nausea, vomiting & dry heaves, states L deltoid still painful 5/10. Has reddened area 40mm X 75mm, warm to touch. States she wants to see her PCP for possible cellulitis treatment. 5/21/10 Started on Amoxicillin 875 mg one BID for 7 days. 5/27/10 States she has no pain L deltoid, reddness has resolved. She will call clinic if has any further or unresolved symptoms.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Retching, Skin warm, Vomiting
Clinical narrative: 5/18/2010 states she felt dizziness, nausea, vomiting some discomfort L deltoid injection site. 5/19/10 states she has dry heaves, low back pain 10/10, with radiation to upper legs front and back pain 10/10, L deltoid and L arm pain 9.5/10 with numbness L fingers. Examined by Occupational Health Doctor. No treatment. 5/21/10 Denies low back pain 0/10, denies leg pain 0/10. denies nausea, vomiting & dry heaves, states L deltoid still painful 5/10. Has reddened area 40mm X 75mm, warm to touch. States she wants to see her PCP for possible cellulitis treatment. 5/21/10 Started on Amoxicillin 875 mg one BID for 7 days. 5/27/10 States she has no pain L deltoid, reddness has resolved. She will call clinic if has any further or unresolved symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth around L deltoid.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Hyperhidrosis, Mobility decreased, Pyrexia
Clinical narrative: High fever - sweating -  tremors headache - unable to sit up - shivering.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: High fever - sweating -  tremors headache - unable to sit up - shivering.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Blood test, Chills, Ear pain, Fatigue, Full blood count normal
Clinical narrative: SORE NECK AND HEADACHE THE NIGHT OF THE VACCINE; STABBING PAINS IN HEAD AND EARS FOR THE NEXT FIVE DAYS ALONG WITH FATIGUE, A MILD TO MODERATE FEVER, CHILLS, AND SENSITIVE SKIN OVER ENTIRE BODY; GENERAL BODY ACHES STARTED ON 05/11/2010 AND EVERY MORNING WOKE UP WITH VERY SORE NECK AND BACK MUSCLES; STABBING HEAD AND EAR PAIN CEASED ON 5/15 BUT ALL OTHER EVENTS PERSISTED UNTIL 5/21.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Headache, Myalgia, Neck pain, Pain, Pyrexia
Clinical narrative: SORE NECK AND HEADACHE THE NIGHT OF THE VACCINE; STABBING PAINS IN HEAD AND EARS FOR THE NEXT FIVE DAYS ALONG WITH FATIGUE, A MILD TO MODERATE FEVER, CHILLS, AND SENSITIVE SKIN OVER ENTIRE BODY; GENERAL BODY ACHES STARTED ON 05/11/2010 AND EVERY MORNING WOKE UP WITH VERY SORE NECK AND BACK MUSCLES; STABBING HEAD AND EAR PAIN CEASED ON 5/15 BUT ALL OTHER EVENTS PERSISTED UNTIL 5/21.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: White blood cell count abnormal
Clinical narrative: SORE NECK AND HEADACHE THE NIGHT OF THE VACCINE; STABBING PAINS IN HEAD AND EARS FOR THE NEXT FIVE DAYS ALONG WITH FATIGUE, A MILD TO MODERATE FEVER, CHILLS, AND SENSITIVE SKIN OVER ENTIRE BODY; GENERAL BODY ACHES STARTED ON 05/11/2010 AND EVERY MORNING WOKE UP WITH VERY SORE NECK AND BACK MUSCLES; STABBING HEAD AND EAR PAIN CEASED ON 5/15 BUT ALL OTHER EVENTS PERSISTED UNTIL 5/21.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Two-three days post-vaccination, patient developed an itching rash on the neck, back and chest. This lasted for roughly a week. After two weeks, rash had cleared.
Age: 51.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 51 yo client received Intranasal Influenza vaccination.
Age: 19.0
Sex: F
Vaccine: HEPAB, MEN, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swelling around injection area the morning after. A red, swollen rash appeared, and continued to grow in size. About 2 1/2 in in diameter. Left Sub Q arm.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Rash papular
Clinical narrative: Moderate erythema at injection site (L) arm with swelling lasting two weeks (3mm induration on 5/26/10); papular erythematous rash developed 2 days after immunization over entire body.