chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site exfoliation, Injection site pruritus, Injection site rash
Clinical narrative: Patient reported a rash at the injection site, with itching and skin peeling off. No treatment, the rash was healing.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Irritability, Pyrexia
Clinical narrative: Fever and fussy since 11 PM on 6-3-13. Temp of 103.6 on 6-4-13 at 6:45 AM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pt had a bout of nausea that started shortly after and lasted approx 72 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given a Zoster vaccine instead of a PROQUAD vaccine. There has been no adverse reaction as of today.
Age: 0.75
Sex: M
Vaccine: HEP, HIBV, IPV, PNC13, PPV, TTOX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 months and 30 days old male patient. The registered nurse reported that on 16-MAY-2013 another nurse from the practice inadvertently administered the patient a dose of PNEUMOVAX23 (lot # H012650, expiration date reported as 27-FEB-201) (dose, route, anatomical location unspecified). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II. The reporter stated that on an unknown date the patient had positive titer for mumps and rubella but negative titer for measles. The reporter was unsure if the positive and negative titers were due to the patient having M-M-R II in the past or just due to a natural disease. The outcome of patient was negative for measles was unknown. The causal relationship was not reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 29-MAY-2013 the patient was vaccinated with the first dose of PROQUAD (Merck) (lot number and expiration date not reported) (0.5ml, route not reported). Other suspect therapies included VARIVAX (Merck) (lot number and expiration date not reported) (0.5ml, route not reported). No concomitant therapies were reported. The licensed practical nurse reported that the patient was administered a dose of both VARIVAX (Merck) and PROQUAD (Merck). The patient had not received any varicella vaccinations prior to 29-MAY-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). The physician reported that on an unknown date, the patient experienced shingles after administration of ZOSTAVAX. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Erythema, Local swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a 42 year old male patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number and expiry date was not reported, route was subcutaneous). Concomitant medications were not reported. On an unknown date, the nurse reported that the patient was administered ZOSTAVAX in his abdomen which was other than indicated in the prescribing information and experienced swelling and red mark in the abdomen area and a slight fever. The nurse also confirmed that the patient was 42 years old and was administered ZOSTAVAX which was other than indicated in the prescribing information. There was no lab diagnostics studies performed. On an unknown date, the patient recovered from the reported events. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. On an unknown date, "a long time ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unknown date, the patient experienced shingles following vaccination. The outcome of shingles was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to a patient of unknown age. On 29-MAY-2013 the patient was vaccinated with an expired dose of M-M-R II (lot number 0597AA, expiration date 26-APR-2013) (dose not reported, subcutaneous). Concomitant therapy was not reported. No adverse effect was noted. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient with no pertinent medical history reported. On 29-MAY-2013 the patient was vaccinate with PROQUAD (Merck) (lot number J000198, expiration date 08-JUL-2014) (0.5ml, subcutaneous). Other suspect therapies included the first scheduled dose of VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported). No concomitant medications were reported. The licensed practical nurse reported that the patient received his first scheduled dose of VARIVAX (Merck) and then received a dose of PROQUAD (Merck) on the same day. No adverse effects were reported at this time. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist (who was also the one of the two patients) via company representative refers to the pharmacy technician of unknown age and gender. Approximately on an unknown date in May 2013, the patients were vaccinated with a dose of ZOSTAVAX (lot # J000853, expiry date was 23-APR-2014, route and dose were not reported) that had been accidentally left in the refrigerator for a week. The reporter had enquired about this and was told that it was ok to use this vaccine during the next three months. Approximately on an unknown date in May 2013, (reported as the week of 12-MAY-2013, 3 days after vaccination), the patients broke out in large, painful hives, broke out with rash and welts. One of the patient who was a pharmacy technician had described the pain as being similar to a bee sting. No medical attention was sought. No treatment was provided for the event painful hives. The outcome of all the reported events was unknown. Additional information has been requested. Case 1305USA015472 was split for the pharmacist and the pharmacy technician into case # 1306USA001369.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid exfoliation, Eyelid oedema, Neuralgia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old female patient with no drug reactions/allergies. The patient's medical history included shingles in April 2012. On 22-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000444, expiry date was 11-APR-2014)0.65 milliliter (ml), subcutaneously. Approximately on an unknown date in May 2013, the patient was experiencing above the left eye, tingling, nerve pain, a little swollen and "scaly". Laboratory test performed was none. The patient sought medial attention (had called the pharmacist on 28-MAY-2013). No treatment was provided. The outcome of all the reported events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patient of unknown age. The nurse reported that the patients might have received PROQUAD (Merck) (lot#H015787, exp 24-FEB-2014) that was exposed to 45F for 3 weeks (504 hours). The temperature excursion had been determined to be unsupported by in-house stability data. There were no adverse symptoms reported. Follow up information received which reported that lot number H015787 was verified as valid lot number for PROQUAD (Merck). Follow-up has been received from a healthcare worker, who reported that, on 20-MAY-2013, a patient was administered a dose of PROQUAD (Merck) that had been exposed to 45 F for 3 weeks (504 hours). No adverse symptoms were reported. This is one of three reports from the same source. The other linked reports are: MARRS# 1305USA016986 and MARRS# 1306USA001037. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 24 year old female patient regarding herself. The patient had no pertinent medical history or drug allergies. On 20-MAY-2013, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported) and on the same was found to be 5 months pregnant. Approximate date of last menstrual period was 06-JAN-2013 and estimates date of delivery was on 13-OCT-2013. There was no concomitant medication reported. The patient sought medical attention. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient. On 22-MAY-2009 the patient was vaccinated with the first dose of M-M-R II (strength, dose and frequency were not provided). On 29-MAY-2013 the patient was vaccinated with an expired 2nd dose of M-M-R II (batch # 664546, lot #664546/0906Z, expiration date 09-JUL-2012) (strength, dose and frequency were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered refers to a unknown number of patients of unknown age. Since possibly 17-AUG-2011, the patients may have been vaccinated with a dose of improperly stored VAQTA, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient. In May 2013 (reported as last week, exact date unspecified), the patient was vaccinated with ZOSTAVAX in the arm (dose, route and lot # not reported). The pharmacist reported that the patient (anonymous) developed a rash under her arm at the injection site. On an unspecified date, the patient recovered from rash under her arm at the injection site. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No medical history was reported. The patient was vaccinated with GARDASIL (lot#, expiry not reported) on the following dates: 20-SEP-2010, 30-JUL-2012 and 01-OCT-2012. No adverse effect reported. No concomitant medications were reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 year old male patient. On unspecified dates the patient was vaccinated with three doses of GARDASIL (lot numbers, doses and routes not reported). No adverse effect was noted. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HIBV
Symptoms: Accidental exposure to product, Eye irrigation, Eye irritation, Ocular hyperaemia
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 26 year old female patient (who is a nurse). On 31-MAY-2013, the nurse got PEDVAXHIB, (lot number, expiry date was unknown) in her eyes and was experiencing red and burning eyes following flushing of eyes with water for 5 minutes. Concomitant therapies included LEXAPRO. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 3 year old patient (unknown gender). No medical history was reported. The patient was vaccinated with first dose of VAQTA (lot#, expiry not reported) on 17-JUN-2008 and dose 2 of VAQTA (lot #, expiry not reported) on 07-JUL-2009. No concomitant medications were reported. The nurse reported that the patient received a pediatric dose of VAQTA (Lot # 666030/1397Y, expiry- 27-AUG-2012) instead of RECOMBIVAX HB on 05-MAR-2010. No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered refers to an unknown number of patients of unknown age. Since possibly 17-AUG-2011, the patients may have been vaccinated with a dose of improperly stored GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patient of unknown age. The nurse reported that the patients might have received PROQUAD (Merck) (lot#H015787, exp 24-FEB-2014) that was exposed to 45F for 3 weeks (504 hours). The temperature excursion had been determined to be unsupported by in-house stability data. There were no adverse symptoms reported. Follow up information received which reported that lot number H015787 was verified as valid lot number for PROQUAD (Merck). Follow-up has been received from a healthcare worker, who reported that, on 21-MAY-2013, a patient was administered a dose of PROQUAD (Merck) that had been exposed to 45 F for 3 weeks (504 hours). No adverse symptoms were reported. This is one of three reports from the same source. The other linked reports are: MARRS# 1305USA016986 and MARRS# 1306USA001036. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot # not reported). The physician report that the patient (anonymous) experienced hair loss after receiving the GARDASIL. The patient saw a dermatologist for medical attention. The outcome of hair loss was reported as not recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with no drug reactions/allergies. On 14-MAY-2013 (also reported as an unspecified date in May 2013), the patient was vaccinated with a dose of ZOSTAVAX (lot # j000494, expiry date was 14-APR-2014, route and dose were not reported) in the unspecified arm. On an unknown date in May 2013, the patient was diagnosed with cellulitis in the unspecified arm in which ZOSTAVAX was administered. The patient had sought medical attention for the same. The patient was treated with an unspecified antibiotic. The outcome of cellulitis was unknown. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. On unspecified dates the patient was vaccinated with VARIVAX (Merck) (batch number not provided) doses, 0.5 ml, subcutaneous for prophylaxis. When titers were drawn on an unspecified date the result was equivocal with 0.97 result. The outcome and relatedness were not provided. The patient did not seek medical attention. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative refers to an approximately 80-year-old female patient (reported in her 80's). On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date not reported) subcutaneously. On an unknown date (reported as the following day) the patient experienced "pronounced raised and red reaction" around the injection site. Treatment information and lab diagnostic studies were unspecified by the reporter. It was unspecified whether the patient sought medical attention for the events. The outcome of "pronounced raised and red reaction" around the injection site is unknown. Causality was not reported. Additional information is not expected.
Age: 0.01
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Foetal disorder, Foetal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse for GARDASIL, a pregnancy registry product, refers to a newborn female. The patient's mother is a 17 year old female with asthma, acetaminophen and PERCOCET allergy and seasonal allergy and without any previous pregnancies. The mother was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 18-APR-2012. The mother was vaccinated with dose 2 of GARDASIL (dose, route and lot # not reported) on 21-AUG-2012. Other medications used during the pregnancy were prenatal vitamins (1 tablet oral, daily, during the entire pregnancy), INFLUENZA VIRUS VACCINE (UNSPECIFIED) (strength 0.5 ml, once) on 14-NOV-2012 and ALBUTEROL) (inhaler, as needed). On an unknown date after vaccination with GARDASIL, she was diagnosed to be pregnant (case # 1211USA000348). The patient went to an office visit, and on an unspecified date, a blood pregnancy rest was positive. The last menstrual period was on 02-AUG-2012, and an estimated delivery date: 09-MAY-2013. No adverse effects were reported for the mother. On 05-NOV-2012 a prenatal ultrasound showed a single live fetus, with size and placenta within normal limits. She gave birth to a baby girl (7 lbs, 19 3/4 inches, apgar score: 9.9; head circumference 34.25 cm) at 40 weeks and 3 days gestation (from LMP). There were no congenital anomalies, no complications or abnormalities. Although, it was reported the infant was "not normal". No outcome was reported. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse for GARDASIL, a pregnancy registry product, refers to a newborn female. The patient's mother is a 17 year old female with asthma, acetaminophen and PERCOCET allergy and seasonal allergy and without any previous pregnancies. The mother was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 18-APR-2012. The mother was vaccinated with dose 2 of GARDASIL (dose, route and lot # not reported) on 21-AUG-2012. Other medications used during the pregnancy were prenatal vitamins (1 tablet oral, daily, during the entire pregnancy), INFLUENZA VIRUS VACCINE (UNSPECIFIED) (strength 0.5 ml, once) on 14-NOV-2012 and ALBUTEROL) (inhaler, as needed). On an unknown date after vaccination with GARDASIL, she was diagnosed to be pregnant (case # 1211USA000348). The patient went to an office visit, and on an unspecified date, a blood pregnancy rest was positive. The last menstrual period was on 02-AUG-2012, and an estimated delivery date: 09-MAY-2013. No adverse effects were reported for the mother. On 05-NOV-2012 a prenatal ultrasound showed a single live fetus, with size and placenta within normal limits. She gave birth to a baby girl (7 lbs, 19 3/4 inches, apgar score: 9.9; head circumference 34.25 cm) at 40 weeks and 3 days gestation (from LMP). There were no congenital anomalies, no complications or abnormalities. Although, it was reported the infant was "not normal". No outcome was reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Laboratory test
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013 with additional information received on 29 May 2013. A 24-year-old female subject with no past medical history was found to have acute pericarditis, unspecified 1 days after receiving the following vaccines on 12 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included a normal ECG and an abnormal troponin I of 00.66 ng/ml on 24 February 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013 with additional information received on 29 May 2013. A 24-year-old female subject with no past medical history was found to have acute pericarditis, unspecified 1 days after receiving the following vaccines on 12 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included a normal ECG and an abnormal troponin I of 00.66 ng/ml on 24 February 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Intensive care, Myopericarditis
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, C-reactive protein normal, Chest X-ray normal
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Echocardiogram normal
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Fatigue, Haematocrit decreased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Haemoglobin decreased, Myocarditis, Pericardial effusion, Platelet count normal, Red blood cell count decreased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased, Troponin T normal, White blood cell count increased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest pain, Chills, Dyspnoea
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ST segment elevation, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have acute pericarditis unspecified 20 days after and non-specific myocarditis 22 days after receiving the following vaccines on 14 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013, abnormal troponin I of 12.58 on 03 March 2013 and a normal echocardiogram on 06 March 2013. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: M
Vaccine: MMR, MMR
Symptoms: Communication disorder
Clinical narrative: Information has been received from a consumer (patient's mother) concerning a male patient of an unknown age, who on unknown dates, was vaccinated with three doses of M-M-R II at 2, 6 and 17 month of age (doses, routes and lot #s not reported). It was reported that, on unspecified date, the patient developed subsequent various reactions. After the last dose of M-M-R II, the patient could no longer communicate. At the time of the report, the patient's outcome was unknown. Relatedness for the events was not reported for M-M-R II. Follow up information was received from a health care worker, who mentioned that the patient's mother had a son who with autism. No further information was available. Follow up information was received from the mother: Since receiving the doses of M-M-R II vaccinations, her son experienced "serious breathing episodes" and had an unspecified neurological disorder. The outcome of the "serious breathing episodes" and unspecified neurological disorder was not reported. Serious breathing episodes was determined serious by reporter. Additional information has been requested.
Sex: M
Vaccine: MMR, MMR
Symptoms: Adverse reaction, Communication disorder, Dyspnoea, Nervous system disorder
Clinical narrative: Information has been received from a consumer (patient's mother) concerning a male patient of an unknown age, who on unknown dates, was vaccinated with three doses of M-M-R II at 2, 6 and 17 month of age (doses, routes and lot #s not reported). It was reported that, on unspecified date, the patient developed subsequent various reactions. After the last dose of M-M-R II, the patient could no longer communicate. At the time of the report, the patient's outcome was unknown. Relatedness for the events was not reported for M-M-R II. Follow up information was received from a health care worker, who mentioned that the patient's mother had a son who with autism. No further information was available. Follow up information was received from the mother: Since receiving the doses of M-M-R II vaccinations, her son experienced "serious breathing episodes" and had an unspecified neurological disorder. The outcome of the "serious breathing episodes" and unspecified neurological disorder was not reported. Serious breathing episodes was determined serious by reporter. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: PNC13, RV5, RV5
Symptoms: Faeces discoloured, Irritability, Mucous stools
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 3 month old male patient. on an unknown date, the patient was vaccinated with a dose 1 of oral ROTATEQ (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient developed intussusception after receiving oral ROTATEQ. The patient did not require hospitalization and an actual diagnosis was not made. It was just suspected that he was experiencing intussusception. There was no treatment rendered for the event. The outcome of intussusception was unknown. Additional information is not expected.
Age: 0.25
Sex: M
Vaccine: PNC13, RV5, RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 3 month old male patient. on an unknown date, the patient was vaccinated with a dose 1 of oral ROTATEQ (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient developed intussusception after receiving oral ROTATEQ. The patient did not require hospitalization and an actual diagnosis was not made. It was just suspected that he was experiencing intussusception. There was no treatment rendered for the event. The outcome of intussusception was unknown. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Swelling, redness, pain at injection site left tricep area (vaccine was given SQ, as per manufacturers instructions). Later, had fever to 101, axillary adenopathy. Area of swelling/induration/pain/erythema reached a maximum diameter of ~15 cm before gradually subsiding over the next 5-6 days.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site swelling, Lymph node pain, Oedema peripheral, Pain
Clinical narrative: Swelling, redness, pain at injection site left tricep area (vaccine was given SQ, as per manufacturers instructions). Later, had fever to 101, axillary adenopathy. Area of swelling/induration/pain/erythema reached a maximum diameter of ~15 cm before gradually subsiding over the next 5-6 days.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling, redness, pain at injection site left tricep area (vaccine was given SQ, as per manufacturers instructions). Later, had fever to 101, axillary adenopathy. Area of swelling/induration/pain/erythema reached a maximum diameter of ~15 cm before gradually subsiding over the next 5-6 days.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling, redness, pain at injection site left tricep area (vaccine was given SQ, as per manufacturers instructions). Later, had fever to 101, axillary adenopathy. Area of swelling/induration/pain/erythema reached a maximum diameter of ~15 cm before gradually subsiding over the next 5-6 days.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Albumin globulin ratio, Anion gap, Aspartate aminotransferase normal, Bacterial test negative, Basophil count decreased
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Blood urea normal, Carbon dioxide normal, Chlamydia test negative, Chromaturia, Eosinophil count decreased
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Eosinophil percentage decreased, Erythema, Glomerular filtration rate, Glucose urine absent, Haematocrit normal
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Haemoglobin normal, Haemoglobin urine present, Headache, Human chorionic gonadotropin negative, Injection site erythema
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Mean cell volume increased, Mean platelet volume normal, Monocyte count increased, Monocyte percentage, Nausea
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Neutrophil count decreased, Neutrophil percentage increased, Nitrite urine absent, Oedema peripheral
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Platelet count normal, Protein total normal, Protein urine absent, Red blood cell count decreased
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Red blood cells urine positive, Red cell distribution width normal, Specific gravity urine normal, Type III immune complex mediated reaction, Urinary sediment present
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis abnormal, Urine bilirubin decreased, Urine ketone body present, Urine leukocyte esterase positive, Urobilinogen urine decreased
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased, White blood cells urine negative, pH urine normal
Clinical narrative: Pt awoke this morning with redness and swelling in the upper arm that was vaccinated (left) that progressed throughout the day down to her elbow. She was seen in the ER on 6/2/13 for c/o of HA, nausea, neck pain, and swelling, redness, pain in (L) arm. Dx'd as arthus reaction.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Pt presented 47 hrs after vaccination with redness around injection site.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Pt. had syncopal episode immediately after HPV given. Pt. became pale, non-responsive for 1-2 seconds. No treatment except legs elevated. Syncopal episode reoccurred approximately 20 min. later. Pt. discharged after about 1 hr with stable gait, alert - oriented x 3.
Age: 43.0
Sex: F
Vaccine: ANTH, SMALL, TDAP, TYP
Symptoms: Angina unstable, Electrocardiogram normal, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 43-year-old female subject was found to have angina decubitis 1 day after receiving the following vaccination on 11 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported), Tdap (manufacturer, lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included a normal ECG and normal troponin I on 11 February 2013. Treatments were not reported. Past medical history included eczema. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.