chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, HEPAB, SMALL, TYP
Symptoms: Asthma, Blood cholesterol normal, Blood creatine phosphokinase MB normal, Blood pressure increased, Blood triglycerides normal
Clinical narrative: This case was received on 02 February 2009 via a search of the VAERS database (reference number 333440).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 36 year-old patient received the following vaccinations on 31 October 2008:  SMALLPOX (ACAM2000, lot number not reported), TYPHIM VI, lot number not reported), BIOTHRAX, manufacturer Bioport Corporation, lot number not reported), TWINRIX, manufacturer GSK, lot number not reported), and FLUMIST, manufacturer MedImmune, lot number not reported).  On 11 November 2008 the patient complained of chest pain with radiation to the left arm associated with diaphoresis and elevated blood pressure, light headache and difficulty taking a deep breath.  The chest pain was worse in the morning on 13 November 2008.  The pain was worse when lying flat, with cough, or deep breath but not associated with exertion and was non-prandial.  The patient was treated with MOTRIN at a local clinic during his visit on 14 November 2008.  On 14 November 2008 the patient had positive cardiac enzymes.  The patient was referred to the hospital on 18 November 2008 and was admitted.  The patient's chest pain lasted about one week, was constant for three days, then became intermittent.  Lab work included:  a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.  Since this episode he had cold like symptoms including runny nose and a cough but he was without chest pain.  He performed activities of daily living without chest pain, tightness or shortness of breath.  The patient's final diagnosis was non-cardiac chest pain, asthma, and tobacco use disorder.  The patient was discharged on 19 November 2008.  The patient recovered from the events.  List of Documents held by Sender:  None.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, HEPAB, SMALL, TYP
Symptoms: Cardiac function test normal, Cardiac stress test normal, Chest X-ray normal, Chest pain, Cough
Clinical narrative: This case was received on 02 February 2009 via a search of the VAERS database (reference number 333440).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 36 year-old patient received the following vaccinations on 31 October 2008:  SMALLPOX (ACAM2000, lot number not reported), TYPHIM VI, lot number not reported), BIOTHRAX, manufacturer Bioport Corporation, lot number not reported), TWINRIX, manufacturer GSK, lot number not reported), and FLUMIST, manufacturer MedImmune, lot number not reported).  On 11 November 2008 the patient complained of chest pain with radiation to the left arm associated with diaphoresis and elevated blood pressure, light headache and difficulty taking a deep breath.  The chest pain was worse in the morning on 13 November 2008.  The pain was worse when lying flat, with cough, or deep breath but not associated with exertion and was non-prandial.  The patient was treated with MOTRIN at a local clinic during his visit on 14 November 2008.  On 14 November 2008 the patient had positive cardiac enzymes.  The patient was referred to the hospital on 18 November 2008 and was admitted.  The patient's chest pain lasted about one week, was constant for three days, then became intermittent.  Lab work included:  a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.  Since this episode he had cold like symptoms including runny nose and a cough but he was without chest pain.  He performed activities of daily living without chest pain, tightness or shortness of breath.  The patient's final diagnosis was non-cardiac chest pain, asthma, and tobacco use disorder.  The patient was discharged on 19 November 2008.  The patient recovered from the events.  List of Documents held by Sender:  None.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, HEPAB, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram normal, Ejection fraction decreased, Electrocardiogram normal, Full blood count normal
Clinical narrative: This case was received on 02 February 2009 via a search of the VAERS database (reference number 333440).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 36 year-old patient received the following vaccinations on 31 October 2008:  SMALLPOX (ACAM2000, lot number not reported), TYPHIM VI, lot number not reported), BIOTHRAX, manufacturer Bioport Corporation, lot number not reported), TWINRIX, manufacturer GSK, lot number not reported), and FLUMIST, manufacturer MedImmune, lot number not reported).  On 11 November 2008 the patient complained of chest pain with radiation to the left arm associated with diaphoresis and elevated blood pressure, light headache and difficulty taking a deep breath.  The chest pain was worse in the morning on 13 November 2008.  The pain was worse when lying flat, with cough, or deep breath but not associated with exertion and was non-prandial.  The patient was treated with MOTRIN at a local clinic during his visit on 14 November 2008.  On 14 November 2008 the patient had positive cardiac enzymes.  The patient was referred to the hospital on 18 November 2008 and was admitted.  The patient's chest pain lasted about one week, was constant for three days, then became intermittent.  Lab work included:  a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.  Since this episode he had cold like symptoms including runny nose and a cough but he was without chest pain.  He performed activities of daily living without chest pain, tightness or shortness of breath.  The patient's final diagnosis was non-cardiac chest pain, asthma, and tobacco use disorder.  The patient was discharged on 19 November 2008.  The patient recovered from the events.  List of Documents held by Sender:  None.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, HEPAB, SMALL, TYP
Symptoms: Headache, High density lipoprotein normal, Hyperhidrosis, Nasopharyngitis, Non-cardiac chest pain
Clinical narrative: This case was received on 02 February 2009 via a search of the VAERS database (reference number 333440).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 36 year-old patient received the following vaccinations on 31 October 2008:  SMALLPOX (ACAM2000, lot number not reported), TYPHIM VI, lot number not reported), BIOTHRAX, manufacturer Bioport Corporation, lot number not reported), TWINRIX, manufacturer GSK, lot number not reported), and FLUMIST, manufacturer MedImmune, lot number not reported).  On 11 November 2008 the patient complained of chest pain with radiation to the left arm associated with diaphoresis and elevated blood pressure, light headache and difficulty taking a deep breath.  The chest pain was worse in the morning on 13 November 2008.  The pain was worse when lying flat, with cough, or deep breath but not associated with exertion and was non-prandial.  The patient was treated with MOTRIN at a local clinic during his visit on 14 November 2008.  On 14 November 2008 the patient had positive cardiac enzymes.  The patient was referred to the hospital on 18 November 2008 and was admitted.  The patient's chest pain lasted about one week, was constant for three days, then became intermittent.  Lab work included:  a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.  Since this episode he had cold like symptoms including runny nose and a cough but he was without chest pain.  He performed activities of daily living without chest pain, tightness or shortness of breath.  The patient's final diagnosis was non-cardiac chest pain, asthma, and tobacco use disorder.  The patient was discharged on 19 November 2008.  The patient recovered from the events.  List of Documents held by Sender:  None.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, HEPAB, SMALL, TYP
Symptoms: Rhinorrhoea, Tobacco abuse, Troponin increased
Clinical narrative: This case was received on 02 February 2009 via a search of the VAERS database (reference number 333440).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 36 year-old patient received the following vaccinations on 31 October 2008:  SMALLPOX (ACAM2000, lot number not reported), TYPHIM VI, lot number not reported), BIOTHRAX, manufacturer Bioport Corporation, lot number not reported), TWINRIX, manufacturer GSK, lot number not reported), and FLUMIST, manufacturer MedImmune, lot number not reported).  On 11 November 2008 the patient complained of chest pain with radiation to the left arm associated with diaphoresis and elevated blood pressure, light headache and difficulty taking a deep breath.  The chest pain was worse in the morning on 13 November 2008.  The pain was worse when lying flat, with cough, or deep breath but not associated with exertion and was non-prandial.  The patient was treated with MOTRIN at a local clinic during his visit on 14 November 2008.  On 14 November 2008 the patient had positive cardiac enzymes.  The patient was referred to the hospital on 18 November 2008 and was admitted.  The patient's chest pain lasted about one week, was constant for three days, then became intermittent.  Lab work included:  a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.  Since this episode he had cold like symptoms including runny nose and a cough but he was without chest pain.  He performed activities of daily living without chest pain, tightness or shortness of breath.  The patient's final diagnosis was non-cardiac chest pain, asthma, and tobacco use disorder.  The patient was discharged on 19 November 2008.  The patient recovered from the events.  List of Documents held by Sender:  None.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Beta haemolytic streptococcal infection, Cellulitis, Eschar, Induration, Injection site streaking
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 333723. A 49-year-old male patient, whose medical history was not reported, received the following vaccinations on 21 November 2008: smallpox (trade name and manufacturer unknown, lot number not reported) and anthrax (trade name and manufacturer unknown, lot number not reported). The patient received the smallpox vaccine in the left deltoid. On 29 November 2008, eight days post-vaccination, the patient went to the emergency room. He reported that her had scratched the vaccination site with his right hand and he developed induration with eschar formation on his right thumb. The eschar was similar in appearance to the left deltoid innoculation site eschar. The patient also reported that he bit his fingernails. He had a right thumb paronychia with cellulitis and lymphatic streaking proximally to the right forearm and "B/L" axillary and inguinal "LAD". The clinical diagnosis was right thumb autoinoculation with paronychia/cellulitis presumed to be "GAS". The patient was treated with intramuscular ceftriaxone and oral clindamycin. The patient's outcome was not reported. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Lymphadenopathy, Paronychia, Skin striae
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 333723. A 49-year-old male patient, whose medical history was not reported, received the following vaccinations on 21 November 2008: smallpox (trade name and manufacturer unknown, lot number not reported) and anthrax (trade name and manufacturer unknown, lot number not reported). The patient received the smallpox vaccine in the left deltoid. On 29 November 2008, eight days post-vaccination, the patient went to the emergency room. He reported that her had scratched the vaccination site with his right hand and he developed induration with eschar formation on his right thumb. The eschar was similar in appearance to the left deltoid innoculation site eschar. The patient also reported that he bit his fingernails. He had a right thumb paronychia with cellulitis and lymphatic streaking proximally to the right forearm and "B/L" axillary and inguinal "LAD". The clinical diagnosis was right thumb autoinoculation with paronychia/cellulitis presumed to be "GAS". The patient was treated with intramuscular ceftriaxone and oral clindamycin. The patient's outcome was not reported. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: C-reactive protein increased, Cardiac enzymes increased, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 333758. A 22 year-old male patient, whose medical history was not reported, received the following vaccinations on 25 November 2008: SMALLPOX (trade name and manufacturer unknown, lot number not reported) and ANTHRAX (trade name and manufacturer unknown, lot number not reported). On 02 December 2008, seven days post vaccination, the patient experienced fatigue, shortness of breath and chest discomfort during a run. That day, the patient went to the emergency room with atypical chest pain, breathing difficulty while running and upper respiratory infection. The patient was reported to have been hospitalized (date not reported). The diagnosis was myopericarditis. Symptoms included sub-sternal chest pain, dyspnoea on exertion, fatigue and malaise < 60 days. Laboratory and diagnostic test results included the following : Elevated cardiac enzymes; troponin peaked at 1.03; CRP 6; ST segment elevation in I, aVF, V3, V4, V5, and V6; PR segment depressed II, III, V3, and V4. Corrective treatment and the patient's outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Dyspnoea exertional, Electrocardiogram PR shortened, Electrocardiogram ST segment elevation, Fatigue, Malaise
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 333758. A 22 year-old male patient, whose medical history was not reported, received the following vaccinations on 25 November 2008: SMALLPOX (trade name and manufacturer unknown, lot number not reported) and ANTHRAX (trade name and manufacturer unknown, lot number not reported). On 02 December 2008, seven days post vaccination, the patient experienced fatigue, shortness of breath and chest discomfort during a run. That day, the patient went to the emergency room with atypical chest pain, breathing difficulty while running and upper respiratory infection. The patient was reported to have been hospitalized (date not reported). The diagnosis was myopericarditis. Symptoms included sub-sternal chest pain, dyspnoea on exertion, fatigue and malaise < 60 days. Laboratory and diagnostic test results included the following : Elevated cardiac enzymes; troponin peaked at 1.03; CRP 6; ST segment elevation in I, aVF, V3, V4, V5, and V6; PR segment depressed II, III, V3, and V4. Corrective treatment and the patient's outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myopericarditis, Troponin increased, Upper respiratory tract infection
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 333758. A 22 year-old male patient, whose medical history was not reported, received the following vaccinations on 25 November 2008: SMALLPOX (trade name and manufacturer unknown, lot number not reported) and ANTHRAX (trade name and manufacturer unknown, lot number not reported). On 02 December 2008, seven days post vaccination, the patient experienced fatigue, shortness of breath and chest discomfort during a run. That day, the patient went to the emergency room with atypical chest pain, breathing difficulty while running and upper respiratory infection. The patient was reported to have been hospitalized (date not reported). The diagnosis was myopericarditis. Symptoms included sub-sternal chest pain, dyspnoea on exertion, fatigue and malaise < 60 days. Laboratory and diagnostic test results included the following : Elevated cardiac enzymes; troponin peaked at 1.03; CRP 6; ST segment elevation in I, aVF, V3, V4, V5, and V6; PR segment depressed II, III, V3, and V4. Corrective treatment and the patient's outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Convulsion, Muscle contracture, Syncope
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under  reference number 334199. A 20-year-old male patient, whose medical history was not reported, received the following vaccinations on 08 December 2008: ACAM2000 (lot number W04003A), TYPHIM VI (lot number B0347), and a second dose of BIOTHRAX (Emergent Biosolutions, lot number FAV175). The ACAM2000 was administered last and afterward, the patient had a syncope with seizure activity and bilateral forearm contractures. His respiratory rate was normal. The patient had an emergency room or doctor visit. Corrective treatment was not reported. The patient recovered after an unspecified amount of time.
Age: 22.0
Sex: U
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: This case was received on 23 February 2009 via a QScan search on the VAERS database, under reference number 334265.  A 22-year-old patient (gender unknown), whose medical history was not reported, received the following vaccinations on 28 October 2008: SMALLPOX (trade name and manufacturer unknown, lot number VV04003A), ANTHRAX (trade name and manufacturer unknown, lot number FAV149) and FLUMIST (Medimmune Vaccines, lot number 500556P).  On 29 October 2008, one day post-vaccination, the patient developed nausea, vomiting, a headache, and myalgias.  The patient went to the emergency room and was seen in the medical treatment facility for 2 days.  The patient was given symptomatic treatment and the symptoms resolved.  NOTE:  Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.
Age: 18.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Cardiac enzymes increased, Chest pain, Cough, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: This case was received on 23 February 2009 via a QScan search on the VAERS database, under reference number 334621. An 18-year-old male patient, whose medical history was not reported, received the following vaccinations on 31 October 2008: SMALLPOX vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), ANTHRAX vaccine (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number 500549P). On an unspecified date, the patient developed the following symptoms: nausea with vomiting, chest pain, flu-like illness, mild headache, cough, sore throat and general body achiness. After an unspecified amount of time, he felt well, but the symptoms returned and included chest pain on 26 November 2008. On 29 November 2008, 29 days post-vaccination, the patient was hospitalized with flu-like symptoms and chest pain. The diagnosis was acute myopericarditis. Laboratory and diagnostic test results included the following: ejection fraction, decreased; troponin, increased; cardiac enzymes, increased; echocardiogram, abnormal; electrocardiogram, ST-T change. Corrective treatment and outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.
Age: 18.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Electrocardiogram ST-T change, Headache, Influenza like illness, Myopericarditis, Nausea
Clinical narrative: This case was received on 23 February 2009 via a QScan search on the VAERS database, under reference number 334621. An 18-year-old male patient, whose medical history was not reported, received the following vaccinations on 31 October 2008: SMALLPOX vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), ANTHRAX vaccine (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number 500549P). On an unspecified date, the patient developed the following symptoms: nausea with vomiting, chest pain, flu-like illness, mild headache, cough, sore throat and general body achiness. After an unspecified amount of time, he felt well, but the symptoms returned and included chest pain on 26 November 2008. On 29 November 2008, 29 days post-vaccination, the patient was hospitalized with flu-like symptoms and chest pain. The diagnosis was acute myopericarditis. Laboratory and diagnostic test results included the following: ejection fraction, decreased; troponin, increased; cardiac enzymes, increased; echocardiogram, abnormal; electrocardiogram, ST-T change. Corrective treatment and outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.
Age: 18.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Oropharyngeal pain, Pain, Troponin increased, Vomiting
Clinical narrative: This case was received on 23 February 2009 via a QScan search on the VAERS database, under reference number 334621. An 18-year-old male patient, whose medical history was not reported, received the following vaccinations on 31 October 2008: SMALLPOX vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), ANTHRAX vaccine (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number 500549P). On an unspecified date, the patient developed the following symptoms: nausea with vomiting, chest pain, flu-like illness, mild headache, cough, sore throat and general body achiness. After an unspecified amount of time, he felt well, but the symptoms returned and included chest pain on 26 November 2008. On 29 November 2008, 29 days post-vaccination, the patient was hospitalized with flu-like symptoms and chest pain. The diagnosis was acute myopericarditis. Laboratory and diagnostic test results included the following: ejection fraction, decreased; troponin, increased; cardiac enzymes, increased; echocardiogram, abnormal; electrocardiogram, ST-T change. Corrective treatment and outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.
Age: 19.0
Sex: M
Vaccine: FLUX, HEPA, SMALL, TYP
Symptoms: Axillary pain, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, Chest pain, Erythema
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 334666. A 19-year-old patient, whose medical history was not reported, received the following vaccinations on 21 November 2008: Smallpox vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), influenza vaccine (trade name and manufacturer unknown, lot number not reported), and HAVRIX (GSK, lot number AHAVB195AB). On 26 November 2008, five days post-vaccination, the patient was referred to an emergency room by his primary care physician for evaluation of smallpox vaccine inoculation site concerns and left axillary pain. The patient's symptoms included the following: flu-like symptoms less than 96 hours, chest pain, pain, erythema and pruritis. Lab test results were normal: Troponin, negative; CPK, normal; CPK-MB, negative; CBC, normal. Corrective treatment and recovery status were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 19.0
Sex: M
Vaccine: FLUX, HEPA, SMALL, TYP
Symptoms: Full blood count normal, Influenza like illness, Pain, Pruritus, Troponin
Clinical narrative: This case was received on 23 February 2009 via a search on the VAERS database, under reference number 334666. A 19-year-old patient, whose medical history was not reported, received the following vaccinations on 21 November 2008: Smallpox vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), influenza vaccine (trade name and manufacturer unknown, lot number not reported), and HAVRIX (GSK, lot number AHAVB195AB). On 26 November 2008, five days post-vaccination, the patient was referred to an emergency room by his primary care physician for evaluation of smallpox vaccine inoculation site concerns and left axillary pain. The patient's symptoms included the following: flu-like symptoms less than 96 hours, chest pain, pain, erythema and pruritis. Lab test results were normal: Troponin, negative; CPK, normal; CPK-MB, negative; CBC, normal. Corrective treatment and recovery status were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPA, SMALL
Symptoms: Folliculitis, Immunisation reaction, Rash erythematous
Clinical narrative: This case was received on 23 February 2009 via a Qscan search on the VAERS database, under reference number 334901. A 20-year-old male patient, whose medical history was not reported, received the following vaccinations on 13 November 2008: ACAM2000 (lot number VV04003ACA), Biothrax (Emergent Bio Solutions, lot number FAV149) and HAVRIX (GSK, lot number AHAV322413A). The patient developed a symptomatic red spots on the upper trunk nine to ten days post-vaccination. On 24 November 2008, 11 days post vaccination, the patient consulted a dermatologist and was diagnosed with folliculitis - sterile follicular based vaccine reaction to smallpox, well described. Corrective treatment was not reported. The patient was reported to have recovered. 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.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Hypokinesia, Injection site inflammation, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a registered nurse, an office manager and a medical assistant, concerning a 23 year old female with no known drug reaction/allergies and a history of a staphylococcal skin infection in abdomen (3 years ago), who on 13-NOV-2008 was vaccinated with the third dose of GARDASIL in the left arm. Subsequently, the patient experienced cellulitis in her arm. The office manager (based on patient's account and medical records) reported that the patient's first visit to ER was on 13-NOV-2008. The patient was admitted to the hospital from 16 to 19-DEC-2008. As inpatient, she received treatment with VANCOMYCIN IV and Clindamycin. The patient had a CT scan of the upper left extremity in December 2008, followed by MRIs of the left upper arm on 16-DEC-2008 (abnormal with increased inflammation), February 2009 (showed improvement) and 17-APR-2009 (increased inflammation). There was no additional information in their records regarding dates, sites and lot numbers for GARDASIL doses or any concomitant vaccines. The medical assistant reported that by the moment the patient was admitted to the hospital, her movements were "very restricted". The registered nurse reported that the patient had been a dietary intern at a hospital. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Type 1 diabetes mellitus, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 10-SEP-2008 a 13 year old female patient with acne was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X) intramuscularly into her left arm. Concomitant therapy on the same date included MENACTRA (Lot # U2661AA) (Sanofi Pasteur) intramuscularly into her right arm. Mom was requesting VAERS done one month after receiving MENACTRA and the first dose of GARDASIL on 10-SEP-2008. The patient had blurred vision. Three months later was diagnosed with type 1 diabetes. On 16-MAR-2009 a Magnetic Resonance was received from the primary care provider including endocrine consult. On 10-SEP-2008 the patient was seen for WCC (well child check up). The assessment: the patient was healthy; physical examination was within normal limits after the vaccines were given. The patient was seen by an ophthalmologist for intermittent blurry vision with visual acuity OK. On 29-JAN-2009 the patient was seen with complain of onset excessive thirst, recent weight loss and increased urinary output. It was reported that the patient was feeling tired. The patient was diagnosed with new onset diabetes type 1 after laboratories performed. The patient was referred to endocrine and was diagnosed with Insulin-Dependent Diabetes Mellitus (IDDM). A fasting glucose was performed: 247, Urinalysis (+) for glucose and mod ketones. Hgb A1C 11.1%. Standard lot check investigations were performed on lot # 659184/0843X. All in-process quality checks for the lot numbers in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the research center and were released. The original reporting source was not provided. The VAERS ID # is 341638. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood glucose increased, Fatigue, Glucose urine, Glycosylated haemoglobin increased, Thirst
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 10-SEP-2008 a 13 year old female patient with acne was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X) intramuscularly into her left arm. Concomitant therapy on the same date included MENACTRA (Lot # U2661AA) (Sanofi Pasteur) intramuscularly into her right arm. Mom was requesting VAERS done one month after receiving MENACTRA and the first dose of GARDASIL on 10-SEP-2008. The patient had blurred vision. Three months later was diagnosed with type 1 diabetes. On 16-MAR-2009 a Magnetic Resonance was received from the primary care provider including endocrine consult. On 10-SEP-2008 the patient was seen for WCC (well child check up). The assessment: the patient was healthy; physical examination was within normal limits after the vaccines were given. The patient was seen by an ophthalmologist for intermittent blurry vision with visual acuity OK. On 29-JAN-2009 the patient was seen with complain of onset excessive thirst, recent weight loss and increased urinary output. It was reported that the patient was feeling tired. The patient was diagnosed with new onset diabetes type 1 after laboratories performed. The patient was referred to endocrine and was diagnosed with Insulin-Dependent Diabetes Mellitus (IDDM). A fasting glucose was performed: 247, Urinalysis (+) for glucose and mod ketones. Hgb A1C 11.1%. Standard lot check investigations were performed on lot # 659184/0843X. All in-process quality checks for the lot numbers in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the research center and were released. The original reporting source was not provided. The VAERS ID # is 341638. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Type 1 diabetes mellitus, Urine analysis abnormal, Urine ketone body present, Urine output increased, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 10-SEP-2008 a 13 year old female patient with acne was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X) intramuscularly into her left arm. Concomitant therapy on the same date included MENACTRA (Lot # U2661AA) (Sanofi Pasteur) intramuscularly into her right arm. Mom was requesting VAERS done one month after receiving MENACTRA and the first dose of GARDASIL on 10-SEP-2008. The patient had blurred vision. Three months later was diagnosed with type 1 diabetes. On 16-MAR-2009 a Magnetic Resonance was received from the primary care provider including endocrine consult. On 10-SEP-2008 the patient was seen for WCC (well child check up). The assessment: the patient was healthy; physical examination was within normal limits after the vaccines were given. The patient was seen by an ophthalmologist for intermittent blurry vision with visual acuity OK. On 29-JAN-2009 the patient was seen with complain of onset excessive thirst, recent weight loss and increased urinary output. It was reported that the patient was feeling tired. The patient was diagnosed with new onset diabetes type 1 after laboratories performed. The patient was referred to endocrine and was diagnosed with Insulin-Dependent Diabetes Mellitus (IDDM). A fasting glucose was performed: 247, Urinalysis (+) for glucose and mod ketones. Hgb A1C 11.1%. Standard lot check investigations were performed on lot # 659184/0843X. All in-process quality checks for the lot numbers in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the research center and were released. The original reporting source was not provided. The VAERS ID # is 341638. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Weight decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 10-SEP-2008 a 13 year old female patient with acne was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X) intramuscularly into her left arm. Concomitant therapy on the same date included MENACTRA (Lot # U2661AA) (Sanofi Pasteur) intramuscularly into her right arm. Mom was requesting VAERS done one month after receiving MENACTRA and the first dose of GARDASIL on 10-SEP-2008. The patient had blurred vision. Three months later was diagnosed with type 1 diabetes. On 16-MAR-2009 a Magnetic Resonance was received from the primary care provider including endocrine consult. On 10-SEP-2008 the patient was seen for WCC (well child check up). The assessment: the patient was healthy; physical examination was within normal limits after the vaccines were given. The patient was seen by an ophthalmologist for intermittent blurry vision with visual acuity OK. On 29-JAN-2009 the patient was seen with complain of onset excessive thirst, recent weight loss and increased urinary output. It was reported that the patient was feeling tired. The patient was diagnosed with new onset diabetes type 1 after laboratories performed. The patient was referred to endocrine and was diagnosed with Insulin-Dependent Diabetes Mellitus (IDDM). A fasting glucose was performed: 247, Urinalysis (+) for glucose and mod ketones. Hgb A1C 11.1%. Standard lot check investigations were performed on lot # 659184/0843X. All in-process quality checks for the lot numbers in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the research center and were released. The original reporting source was not provided. The VAERS ID # is 341638. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Breath sounds abnormal, Change in sustained attention, Crying, Depressed level of consciousness, Dyspnoea
Clinical narrative: 1) Fever of 102.5 starting 4-6 hours after vaccines and lasting for several days. 2) Generalized rash. 3) Episode of unresponsiveness at home.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Hypophagia, Infection, Irritability, Laboratory test normal, Pallor
Clinical narrative: 1) Fever of 102.5 starting 4-6 hours after vaccines and lasting for several days. 2) Generalized rash. 3) Episode of unresponsiveness at home.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Pyrexia, Rash, Rash generalised, Somnolence, Staring
Clinical narrative: 1) Fever of 102.5 starting 4-6 hours after vaccines and lasting for several days. 2) Generalized rash. 3) Episode of unresponsiveness at home.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Influenza serology negative, Pyrexia
Clinical narrative: 1) Fever of 102.5 starting 4-6 hours after vaccines and lasting for several days. 2) Generalized rash. 3) Episode of unresponsiveness at home.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Rash generalised, Unresponsive to stimuli
Clinical narrative: 1) Fever of 102.5 starting 4-6 hours after vaccines and lasting for several days. 2) Generalized rash. 3) Episode of unresponsiveness at home.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Diarrhoea, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Fever, L arm, swelling, redness, warmth, tenderness x 2 day.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Pyrexia, Skin warm, Vomiting
Clinical narrative: Fever, L arm, swelling, redness, warmth, tenderness x 2 day.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm, Tenderness
Clinical narrative: Fever, L arm, swelling, redness, warmth, tenderness x 2 day.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Rhinorrhoea, Vomiting
Clinical narrative: Information has been received from a 45 year old female nurse who on 16-APR-2009 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot number not available) to prevent herself from getting shingles since her husband had shingles recently and she had weak immune system. She had a breast cancer 3 years ago and had chemotherapy. Concomitant therapy included ARIMIDEX, simvastatin (MSD), vitamin D (unspecified), and calcium (unspecified). On 17-APR-2009 the patient experienced runny nose, headache, tiredness, chills and was vomiting after receiving ZOSTAVAX (Merck). The patient was recovering at time of reporting. The patient sought unspecified medical attention. The reporter considered her experiences runny nose, headache, tiredness, chills and vomiting to be other important medical events. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Autism, Body temperature increased, Condition aggravated, Developmental delay, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his now 5 year old son with developmental delays, who at the age of 18 months was vaccinated with a dose of MMR II (approximately October 2005). There was no concomitant medication. A day or two after receiving MMR II the patient developed a 104 degree fever. The patient was taken to the emergency room which he was there for a few hours, but he was not admitted. The consumer reported that before receiving MMR II the patient was having some developmental delay but after receiving MMR II the developmental delays were getting worse. The patient was diagnosed with autism when he was 2 1/2 years old. The patient had improved due to therapy. The patient saw physician for medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HEP, HIBV, PNC
Symptoms: Abnormal behaviour, Autism spectrum disorder, Speech disorder developmental, Staring, Unresponsive to stimuli
Clinical narrative: Information has been received from a consumer concerning her approximately 12 month old male with food allergies and no pertinent medical history who in approximately 2005 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Secondary suspect therapy included a dose of PEDVAXHIB (OMPC) (manufacturer unknown).  Concomitant therapy included a dose of INFLUENZA virus vaccine (unspecified) (manufacturer unknown), a dose of DTAP+HEPB+IPV (manufacturer unknown) and a dose of PREVNAR.  All the vaccines were given in his first year of birth.  After receiving the vaccines the patient did not respond to his name, stared at the fan, delayed speech and flapping.  Unspecified medical attention was sought and unspecified lab work was performed but no results provided.  The consumer reported that at 26 months of age the patient was diagnosed in the autism spectrum, but the patient had improved.  Follow up information was received from a receptionist who indicated that the responsible physician retired about 6 years ago.  Upon internal review, autism spectrum was determined to be an other important medical event.  Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: ANTH, FLU3, TYP
Symptoms: Laboratory test, Rash generalised
Clinical narrative: Reaction to small pox lot number VV04003A. Pt. Developed rash covering entire body 6 days after vaccination. Pox fully formed then reaction occurred. Rash is still ongoing pt on day 2 receiving care.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oropharyngeal pain, Rash erythematous, Rash generalised, Skin irritation
Clinical narrative: PT PRESENTS WIH SKIN IRRITATION AND RED SPOTS ALL OVER BODY SINCE 25 APR 2009 PT SEEN PROVIDER ON 26 SPR 2009. PT ALSO STATED HE RECEIVED LORTAB 7.5, IBUPROFEN 800MG, AND AMOXIL FOR 7 DAYS BY DENTAL SECTION.  PT FIRST NOTED RASH ON WRIST AND HAS SPREADING.  NO FEVER, CHILLS, SWEATS AND HEADACHE.  ONSET OF A SORE THROAT, "NOT BAD ", THAT MORNING  RECEIVED SMALLPOX INOCULATION ON OR ABOUT 15 APRIL 2009.  PT WAS ISSUED HYDROXYZINE 25 MG AND MEDROL 4 MG.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oropharyngeal pain, Rash erythematous, Skin irritation
Clinical narrative: PT PRESENTS WIH SKIN IRRITATION AND RED SPOTS ALL OVER BODY SINCE 25 APR 2009 PT SEEN PROVIDER ON 26 SPR 2009. PT ALSO STATED HE RECEIVED LORTAB 7.5, IBUPROFEN 800MG, AND AMOXIL FOR 7 DAYS BY DENTAL SECTION.  PT FIRST NOTED RASH ON WRIST AND HAS SPREADING.  NO FEVER, CHILLS, SWEATS AND HEADACHE.  ONSET OF A SORE THROAT, "NOT BAD ", THAT MORNING  RECEIVED SMALLPOX INOCULATION ON OR ABOUT 15 APRIL 2009.  PT WAS ISSUED HYDROXYZINE 25 MG AND MEDROL 4 MG.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Pt received TD vaccination 18 April 09.  C/O increased pain over right deltoid muscle on 19 April. Pt states that pain has been stable for the past week.  Denies any C/O radiation of pain, Paresthesia of right arm.  States that pain disturbes sleep but does not interfere with work.  Denies presence of any lump or bump over injection site.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Clumsiness, Headache, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Mom states son ran high fever (102 to 103) starting "about an hour after the shots" for most of weekend. Developed severe headache and "walked into a wall." Child seen in ER. All lab work and lumbar puncture were unremarkable. Mom kept son home from school today. He is fever free and feeling better.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mom states son ran high fever (102 to 103) starting "about an hour after the shots" for most of weekend. Developed severe headache and "walked into a wall." Child seen in ER. All lab work and lumbar puncture were unremarkable. Mom kept son home from school today. He is fever free and feeling better.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site.  Redness, swelling heat and hardness extending from injection site at left deltoid to just aboce the elbow.  Injection administered on 4/24/09 @ 1445 and symptoms presented on Saturday morning, 4/25 accompanied by intermittent fever of approximately 102 F according to patient.  Patient self treating with Acetaminophen 500mg, 2 tabs p.o q 4 hrs.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Local reaction at injection site.  Redness, swelling heat and hardness extending from injection site at left deltoid to just aboce the elbow.  Injection administered on 4/24/09 @ 1445 and symptoms presented on Saturday morning, 4/25 accompanied by intermittent fever of approximately 102 F according to patient.  Patient self treating with Acetaminophen 500mg, 2 tabs p.o q 4 hrs.
Age: 10.0
Sex: M
Vaccine: HEPA, IPV, MNQ, VARCEL
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: SWELLING RIGHT ARM FROM DELTOID AROUND UNDER ARM PIT DOWN TO WRIST, STARTED 4/24/09
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: CLIENT GIVEN TDAP AND MENACTRA AND FAINTED FOR A 15 SEC AND VERBALIZED FEELING DIZZY. PT. LAID ON THE FLOOR AND COLD COMPRESSES APPLIED TO HEAD AND NECK AREA. PT. REGAINED COLOR AND STATED THAT SHE WAS NO LONGER DIZZY AFTER A SNACK. REMAINING 2 VACCINES GIVEN, HEPA AND VARICELLA, CLIENT BECAME DIZZY AGAIN AND PALE. SAME TREATMENT GIVEN. CLIENT RECOVERED. PT. RELEASED HOME WITH DAD WITHOUT SIGNS AND SYMPTOMS NOTED.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pyrexia
Clinical narrative: Headache and fever reported on 4/3/09 via a phone call to the LPN working at the outpatient clinic.  No treatment noted.