chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX, lot number M005972, expiration date 02-FEB-2018, lot number M031970, expiration date 30-JUN-2018, by subcutaneous route, (anatomical location and dose number were not reported), for prophylaxis. The vaccines were reconstituted with sterile diluent (lot number as reported K015799, expiration date 19-JUL-2017), however the sterile diluent was stored within the recommended storage range. The VARIVAX was between 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) during a time frame of 15 minutes. The VARIVAX had a previous temperature excursion. The digital data logger was not involved. No product quality complain was involved. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA007563.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD, lot number M001150, expiration date 05-JUL-2017, lot number M022400, expiration date 01-NOV-2017, by subcutaneous route, (anatomical locationa and dose number were not reported), for prophylaxis. The vaccines were reconstituted with sterile diluent (lot number as reported K015799, expiration date 19-JUL-2017), however the sterile diluent was stored within the recommended storage range. The PROQUAD was between 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) during a time frame of 15 minutes. The PROQUAD had a previous temperature excursion. The digital data logger was not involved. No product quality complain was involved. No adverse effects were reported.  This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007501:
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unspecified gender. On 13-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L009213 exp date 17-MAR-2017) (dose and route not reported). The temperature of excursion was 47 °F to 77 °F with a highest temperature of 55.1 °F for 15 minutes. There was no previous temperature excursion. A data logger issue was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006936:
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited pregnancy report received from a non-health care professional on 03-MAR-2017. This case involves a 28 years old female patient who was vaccinated intramuscularly with an unknown dose of ADACEL (batch number: U5604AA expiry date: 17-MAR-2019, dose, dose in series were not reported) in the right deltoid on 02-MAR-2017 while she was pregnant. The patient's last menstrual period and estimated conception period was not reported and expected delivery date was reported on 16-MAY-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as patient is pregnant and Illness at the time of vaccination was reported as reporter denied. Any other vaccinations within four weeks of vaccinations were also reported as unknown. The patient had not reported any medical history and comment regarding the mother's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco drugs) was reported none per reporter. The patient had not reported any concomitant medications. On 03-MAR-2017, one day following the vaccination, the patient had developed pain and limited movement of right arm and exposure during pregnancy. The patient did not reported emergency room (ER) or doctor visit. The event outcome was reported as unknown. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging abnormal, Pericardial disease
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 22-year-old male subject with no significant medical history reported. The subject received concomitant medication with Japanese Encephalitis on 2 November 2015, Influenza on 15 October 2015 and Anthrax 02 November 2015. The subject received a dose of ACAM2000, (lot number and site of administration not reported) on 09 November 2015. On 18 November 2015, 09 days after vaccination the subject was diagnosed with pericardium, unspecified. On 24 November 2015, 15 days after vaccination the subject was diagnosed with Myocarditis, unspecified. And on 02 December 2015, 24 days after vaccination the subject was diagnosed with acute myocarditis, unspecified. The lab data included 19 November 2015, the Troponin I was 00.27, on 18 November 2015, ECG was abnormal, on 19 November 2015, Echocardiogram were normal, on 01 December 2015 MRI (heart) was abnormal, MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study; Sender's Comments: This case involves a 22-year-old male who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM200. Subject had other confounding factors as multiple concomitant administrations of vaccines including Japanese encephalitis, influenza and anthrax vaccines. Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine cannot be ruled out.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 22-year-old male subject with no significant medical history reported. The subject received concomitant medication with Japanese Encephalitis on 2 November 2015, Influenza on 15 October 2015 and Anthrax 02 November 2015. The subject received a dose of ACAM2000, (lot number and site of administration not reported) on 09 November 2015. On 18 November 2015, 09 days after vaccination the subject was diagnosed with pericardium, unspecified. On 24 November 2015, 15 days after vaccination the subject was diagnosed with Myocarditis, unspecified. And on 02 December 2015, 24 days after vaccination the subject was diagnosed with acute myocarditis, unspecified. The lab data included 19 November 2015, the Troponin I was 00.27, on 18 November 2015, ECG was abnormal, on 19 November 2015, Echocardiogram were normal, on 01 December 2015 MRI (heart) was abnormal, MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study; Sender's Comments: This case involves a 22-year-old male who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM200. Subject had other confounding factors as multiple concomitant administrations of vaccines including Japanese encephalitis, influenza and anthrax vaccines. Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine cannot be ruled out.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pericardial disease
Clinical narrative: Initial solicited report received on 02 March 2017 and follow up information received on 07 March 2017 from an investigator in a trial. A 22-year-old male subject with no significant medical history reported. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 06 January 2016. On 18 January 2016, 12 days after vaccination the subject was diagnosed with I21.3 ST-elevation (stemi) myocardial infarction of unspecified site, I30.9 acute pericarditis, unspecified and I31.9 disease of pericardium, unspecified. The lab data included 18 January 2016 within 30 days post vaccination, the Troponin I was 0.69 ng/ml (abnormal), ECG was abnormal, Echocardiogram was normal while MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 22-year-old male who developed acute pericarditis, unspecified and ST segment elevation myocardial infarction with favorable temporal association post vaccination with ACAM2000. Pericarditis and myocardial infarctions are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine can not be ruled out.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 02 March 2017 and follow up information received on 07 March 2017 from an investigator in a trial. A 22-year-old male subject with no significant medical history reported. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 06 January 2016. On 18 January 2016, 12 days after vaccination the subject was diagnosed with I21.3 ST-elevation (stemi) myocardial infarction of unspecified site, I30.9 acute pericarditis, unspecified and I31.9 disease of pericardium, unspecified. The lab data included 18 January 2016 within 30 days post vaccination, the Troponin I was 0.69 ng/ml (abnormal), ECG was abnormal, Echocardiogram was normal while MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 22-year-old male who developed acute pericarditis, unspecified and ST segment elevation myocardial infarction with favorable temporal association post vaccination with ACAM2000. Pericarditis and myocardial infarctions are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine can not be ruled out.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I normal
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 26 year-old male subject with no significant medical history. The subject received concomitant medication with Influenza Vaccine on 29 January 2016. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 01 February 2016. On 24 February 2016, 23 days after vaccination the subject was diagnosed with myocarditis, unspecified. The lab data included on 24 February 2016, the Troponin I was normal, on 25 February 2016, ECG was abnormal, on 26 February 2016, Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 26-year-old male subject who had unspecified myocardtis with favorable temporal association post vaccination with ACAM2000. Myocarditis is a listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine can not be ruled out.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Pericardial disease, Troponin I
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 23-year-old male subject had medical history of chest pain, Abnormal ECG (electrocardiogram), 3 Dizziness/Fainting Spells The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 29 January 2016. On 08 February 2016, 10 days after vaccination the subject was diagnosed with disease of pericardium, unspecified. The lab data included Troponin I, ECG and Echocardiogram were not available, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 23-year-old male who developed disease of pericardium; unspecified with favorable temporal association post vaccination with ACAM2000. Pericarditis is listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. The company has assessed the event as possibly related to study vaccine.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 22 January 2016. On 22 February 2016, 31 days after vaccination the subject was diagnosed with Disease of pericardium, unspecified. On 08 February 2016, 17 days after vaccination the subject was diagnosed with acute myocarditis, unspecified. The lab data included 05 February 2016, the Troponin I was 1.45 (abnormal), on 02 February 2016, ECG was abnormal, on 03 February 2016 Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 22-year-old male who developed Disease of pericardium; unspecified and acute myocarditis, unspecified with favorable temporal association post vaccination with ACAM2000. Pericarditis and myocarditis are listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. The company has assessed the event as possibly related to study vaccine.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 25 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 25 February 2016. On 06 March 2016, 10 days after vaccination the subject was diagnosed with acute pericarditis unspecified. The lab data included 06 March 2016, the Troponin I was 1.0 (abnormal), ECG and Echocardiogram were not available, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 25-year-old male who developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Pericarditis is listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines.The company has assessed the event as possibly related to study vaccine.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Angina pectoris, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator in a trial on 02 March 2017. A 20-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 20 April 2016. On 10 May 2016, 22 days after vaccination the subject was diagnosed with angina pectoris. On 29 April 2016, 09 days after vaccination the subject was diagnosed with Non-ST elevation (NSTEMI) myocardial infarction. The lab data included on 29 April 2016, the Troponin I was 0.06 (abnormal) and ECG was abnormal, Echocardiogram, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 20-year-old male who developed angina pectoris and Non-ST elevation (NSTEMI) myocardial infarction with favorable temporal association post vaccination with ACAM2000. Myocardial infarction is listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. The company has assessed the event as possibly related to study vaccine.
Age: 11.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MEN, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient was back in the office with sibling and was noted to have a 3.5" x 3" red area on right deltoid area at vaccine site. Patient stated it was itchy but no other complaints.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Arthralgia, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, pain in her throat, stomach pain. On 03/16/2017: pain in her legs, pan in her knees.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: IMMEDIATELY AFTER RECEIVING PREVNAR SWELLING AND REDNESS LT UPPER ARM, MYALGIAS, FEVER, DROWSINESS/WEAKNESS, NECK DISCOMFORT POSTERIORLY.  MINIMAL COUTH, NO THROAT SWELLING NOR GI SYMPTOMS.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Musculoskeletal discomfort, Myalgia, Pyrexia, Somnolence
Clinical narrative: IMMEDIATELY AFTER RECEIVING PREVNAR SWELLING AND REDNESS LT UPPER ARM, MYALGIAS, FEVER, DROWSINESS/WEAKNESS, NECK DISCOMFORT POSTERIORLY.  MINIMAL COUTH, NO THROAT SWELLING NOR GI SYMPTOMS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pain
Clinical narrative: 2 DAYS AFTER RECEIVING PREVNAR, LUMP NOTED AT SITE OF INJECTION.  NEXT DAY PINK PATCH DISTAL TO INJECTION SITE AND PAIN TOP OF LEFT SHOULDER ON ABDUCTION.  NO ORAL SX, FEVER, ARTHRALGIAS/MYALGIAS ELSEWHERE.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Skin irritation
Clinical narrative: IRRITATION SAME NIGHT OF INJECTION. REDNESS AND SWELLING AT INJECTION SITE. NO FEVER, CHILLS.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: IRRITATION SAME NIGHT OF INJECTION. REDNESS AND SWELLING AT INJECTION SITE. NO FEVER, CHILLS.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Neck pain
Clinical narrative: Deep muscle pain in the left shoulder, radiating up neck, radiating down the bicep, wrist pain and numb hand.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: SMALL REDDENED, WARM AREA TO UPPER LEFT ARM ON 03/16/2017 THAT HAS PROGRESSED TO A LARGE LINEAR REDDENED, WARM, PAINFUL AREA THAT EXTENDS FROM DELTOID MUSCLE ON LEFT ARM WRAPPING AROUND TO LEFT BICEP WITH PAIN RADIATING INTO ARMPIT.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Aphonia, Body temperature increased, Chills, Insomnia, Laryngitis
Clinical narrative: Pneumococcal Polysaccharide Vaccine administered Monday afternoon Respiratory discomfort Tues. evening. Deep cough with phlegm Wed. morning Temp of 100.2 with chills and worsening cough Wed. evening; ibuprofen taken at bedtime Worse cough with phlegm, chills, temp on Thurs; ibuprofen taken morning & evening - difficulty sleeping due to cough Fri - worse cough, loss of voice, minor chills; ibuprofen taken in morning at time of this report filing Similar reaction when the same vaccine was received 10/10/2011; laryngitis with complete loss of voice for one week. No similar symptoms encountered over the intervening years.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Painful respiration, Productive cough
Clinical narrative: Pneumococcal Polysaccharide Vaccine administered Monday afternoon Respiratory discomfort Tues. evening. Deep cough with phlegm Wed. morning Temp of 100.2 with chills and worsening cough Wed. evening; ibuprofen taken at bedtime Worse cough with phlegm, chills, temp on Thurs; ibuprofen taken morning & evening - difficulty sleeping due to cough Fri - worse cough, loss of voice, minor chills; ibuprofen taken in morning at time of this report filing Similar reaction when the same vaccine was received 10/10/2011; laryngitis with complete loss of voice for one week. No similar symptoms encountered over the intervening years.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 03-NOV-2013, the patients were vaccinated with 19 improperly stored doses of ZOSTAVAX lot# J006832, expiration date 14-SEP-2014 (dose and route of administration were not reported). There was no adverse effect reported. Data logger was not involved. There were no information about previous excursions reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007724:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was referring to himself. There was no information about the patent's concomitant therapies or medical history provided. In approximately 2012, reported as 'about five years ago', the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, lot# and expiry date were unknown) for prophylaxis. On an unknown date, reported as 'a few years ago', the patient experienced shingles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Product quality complaint (PQC) was not involved. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-FEB-2017, the patient was vaccinated with a dose ZOSTAVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient returned to the pharmacy on 15-FEB-2017, because he/she experienced huge red rash at the injection site. The outcome of the events were unknown. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored PROQUAD (lot # M021428, expiration date 29-OCT-2017; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, duration of temperature excursion): 26-NOV-2016, 6 degree Fahrenheit (F), 6 min 26-NOV-2016, 7 F, 6 min 26-NOV-2016, 8 F, 6 min 26-NOV-2016, 9 F, 9 min 26-NOV-2016, 10 F, 4 min 25-NOV-2016, 6 F, 10 min 24-NOV-2016, 6 F, 8 min 24-NOV-2016, 7 F, 6 min 13-NOV-2016, 7 F, 8 min 13-NOV-2016, 6 F, 7 min 12-NOV-2016, 6 F, 10 min 12-NOV-2016, 7 F, 7 min 12-NOV-2016, 8 F, 10 min 06-NOV-2016, 6 F, 8 min 06-NOV-2016, 7 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 7 F, 6 min 04-NOV-2016, 8 F, 7 min 04-NOV-2016, 6 F, 6 min Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063:
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patient was vaccinated with first and second dose of GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient was vaccinated inadvertently with an expired third dose of GARDASIL lot #K001500 with an expiration date 06-NOV-2016 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not reported.      Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The medical assistant reported that an improperly stored dose of ROTATEQ 2 mL orally (lot # M038209, expiration date 23-APR-2018) was administered to a patient on 06-MAR-2017. No adverse effects reported. Information received was not because of a data logger. No previous temperature excursion. Temperature: between 0°C to 2°C; Time frame: 2 hours. No further information to report. Follow-up information was received from a medical assistant on 06-MAR-2017 concerning a patient of unknown age and gender. The medical assistant reported than an improperly stored dose of ROTATEQ (lot #M038209, expiration date 23-APR-2018) was administered since the previous excursion. Temperature: 1°C; Time frame: 1 hour. Previous temperature excursion: 0°C to 2°C for 2 hours. Clarification (16-MAR-2017): It was noted that the patient received only one dose of the improperly stored ROTATEQ on 06-MAR-2017. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Lupus-like syndrome
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced lupus-like syndrome. The outcome of lupus-like syndrome was not reported. No product quality complain was reported. Upon internal review, the event lupus-like syndrome was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 03-NOV-2013, the patients were vaccinated with 9 improperly stored doses of VARIVAX, expiration date 27-MAR-2015 (dose, route of administration and lot# were not reported). There was no adverse effect reported. Data logger was not involved. There were no information about previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007805.
Sex: M
Vaccine: PNC13
Symptoms: Clumsiness, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for himself. This male patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The day after receiving the vaccine he feel a bit "clumsy" and after a few days he was diagnosed with pneumonia. The outcome of the events was unknown. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of unspecified age and race/ethnicity received PREVNAR 13 (Lot# lot R33240), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient broke out with rash all over her body on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site reaction, Rash papular
Clinical narrative: In-duration 2x2cm. Paplovesicles 2-3. Right thigh.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mother noticed that patient had a rectal temp of 102.4 on the evening of 03/16/2017. On 03/17/2017 a phone call was made to our practice requesting an appointment for 03/17/2017 with the covering physician due to rash and fever. Upon examination by Dr.it was determined that both the rash and fever were possibly related to the MMR or varicella vaccination given 11 days ago. Patient is expected to recover fully.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Headache
Clinical narrative: Chills, Red around arm, joint pain, headache. Muscle pain, decreased appetite.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Myalgia
Clinical narrative: Chills, Red around arm, joint pain, headache. Muscle pain, decreased appetite.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram normal, Injection site pain, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Within two weeks of vaccination with hep b this pt developed weakness and pain in the arm where the shot was given.
Age: 42.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Client states onset of symptoms began "2-3 days after the injections". She complained of soreness and swelling to area of injection that extends to elbow. Client presented to the Health Department 03/15/17 (6 days post injection).
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Persistent and increasing shoulder pain since vaccination. Has been seen in clinic twice for this.
Age: 20.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Monoplegia, Muscular weakness, Pain in extremity
Clinical narrative: Within two weeks of hep b vaccine pt developed pain, weakness, and then paralysis in her left arm.
Age: 20.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Blood test, Computerised tomogram, Electromyogram, Injection site reaction, Monoplegia
Clinical narrative: Within two weeks of hep b vaccine pt developed pain, weakness, and then paralysis in her left arm.
Age: 20.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Within two weeks of hep b vaccine pt developed pain, weakness, and then paralysis in her left arm.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right arm and hand tingling and numb going on threes days as of today 03/17/2017.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy
Clinical narrative: This spontaneous report has been received from a pharmacist regarding a 69-year-old female patient. Concurrent conditions included asthma and hypertension. The patient's concomitant therapies and drug reaction/allergies were unknown. On 14-FEB-2017, the patient was vaccinated with PNEUMOVAX23 intramuscularly on the left arm deltoid (lot # M004318 with expiration date 12-OCT-2017) (dose was not reported) for pneumococcal prevention. On the same date, after the vaccination, the patient reported increased redness (Erythema) and warmth (Feeling hot) that extended from the left shoulder to the left elbow and swelling in lymph nodes under the left arm (Lymphadenopathy). The patient did not receive any treatment for the events and no diagnostic laboratories were performed. At the time of this report, the patient had not recovered from the events. There was no product quality complaint (PQC) involved. It was also reported that on 16-FEB-2017, the patient had a surgery on her gums. The causality assessment between erythema, feeling hot, and lymphadenopathy with PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Blood test, Decreased appetite, Gastric disorder, Stool analysis
Clinical narrative: This spontaneous report as received from a pharmacist (also the patient's father) refers to a 14 year old female patient. She had known penicillin allergy. The patient did not have any other pertinent medical history and the patient did not take concomitant medications. In December 2016, the patient received second dose of either GARDASIL or GARDASIL 9 (Pharmacist was unsure)(dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, the patient experienced stomach issues after eating and at the time of the reporting she still had them. In January 2017, the patient experienced lack of appetite. The patient was seen by an unspecified gastroenterologist in approximately January 2017 (reported as "about a month ago") for the above reported symptoms. Unspecified blood work and "stool samples" were performed on unspecified dates, results were not provided (also reported as "all tests were no"). The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and suspect therapy was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient in her 80's, with a preexisting illness in which she was passing out a few times daily. No information regarding the patient's concomitant medications, drug reactions, or allergies was provided. On an unknown date in 2017 (reported as "within the last two weeks"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided). On an unknown date in 2017, after receipt the vaccine, the patient passed out while in the pharmacy. She did not seek medical attention. It was reported that no measures were taken. No treatment was given for the adverse event. On the same day, shortly after passing out, the patient woke up and went home (outcome: resolved). The relatedness between the adverse event and ZOSTAVAX was not provided. Upon internal review, the adverse event of passing out was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61-year-old female patient. The patient's concurrent conditions included hepatitis A and hepatitis B. Her concomitant medications included unspecified treatments to treat those diseases. She did not have pertinent medical history, nor known drug reactions or allergies. On 14-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX intramuscularly (exact dose, lot # and expiry date were not reported). Subsequently, on an unknown date in 2017, the patient experienced redness, soreness and swelling at the injection site. She had no lab diagnostics studies performed and did not receive any treatment for the events. Product quality complaint was not involved. The outcome of the events and causality between the events and ZOSTAVAX vaccination was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 11-SEP-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB for prophylaxis (route, lot # and expiration date were not reported). It was reported that the patient received the second dose of RECOMBIVAX HB for prophylaxis (route, lot # and expiration date were not reported) on 15-NOV-2016. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Peroneal nerve palsy
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. Pertinent medical history included leukemia, lymphoma and "another unspecified immune compromised disease". Concomitant medications were unknown by the reporter. On an unspecified date, the physician administered ZOSTAVAX to a patient for prevention of shingles (route and lot # not provided). On an unspecified date, the patient developed shingles and dropped foot from nerve damage in an upper leg. The causality was not provided. The outcome of the events was unknown. The physician told the company representative that the patient had asked him "if he should sue". Additional information is not expected as the physician did not provide consent to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, aches. Treat at home with NSAIDS, push fluids, and rest.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 5 red spots, the size of fingerprints around the site of injection.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Choking, Drooling, Full blood count normal, Hypotonia
Clinical narrative: Received MMR vaccine 3/15/17. Woke with 99.7 temp next morning. After nap woke very lethargic/limp. No LOC. Attempted to eat and had excessive drooling and choking vomiting. Mild drooling continued. Recent viral illness. Brought to office. Resolved as of 3/16/17 evening.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Streptococcus test negative, Viral infection, Vomiting
Clinical narrative: Received MMR vaccine 3/15/17. Woke with 99.7 temp next morning. After nap woke very lethargic/limp. No LOC. Attempted to eat and had excessive drooling and choking vomiting. Mild drooling continued. Recent viral illness. Brought to office. Resolved as of 3/16/17 evening.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 36 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JAN-2017 (at an unspecified hospital), the patient was vaccinated with M-M-R II (dose, frequency, route of administration, therapy type, lot # and expiration date were not reported) for prophylaxis. On 03-MAR-2017, the patient was given an additional booster of M-M-R II recombinant human albumin (rHA), lot # M017346, expiration date 06-APR-2018 (formulation, dose, frequency and route of administration were not reported) for an prophylaxis (at the reporter's office). No adverse effect was reported. The product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to a unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored second dose of PROQUAD Lot number M009746, expiration date 23-AUG-2017 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of >-10 C but <8 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008048: US-009507513-1703USA008046: US-009507513-1703USA008051: US-009507513-1703USA008050: US-009507513-1703USA008049: US-009507513-1703USA008047: US-009507513-1703USA008052:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 63-year-old female patient who refers to herself. The patient's concurrent conditions, medical history, known allergies and concomitant therapies were not reported. In 2014, the patient received a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for "treatment of shingles". In March 2017, the patient experienced shingles. She sought medical attention via office visit and received treatment with cream for the shingles symptoms on an unknown date, in March 2017. The outcome of shingles was not recovered at the time of reporting. The causality was not reported. Additional information is not expected as there was no consent for further contact.
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Guillain-Barre syndrome, Pneumonia, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a 67 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 11-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (route and site of administration, dose, lot number and expiration date were not reported) for prophylaxis. Since 11-JAN-2017 (reported as "for a week"), the patient was experiencing cough, chills and fever. She complained of these symptoms when she came into the reporter's office on 18-JAN-2017. The patient was treated with albuterol sulfate (PROVENTIL) and betamethasone (CELESTONE), which was reported as an intervention to prevent serious criteria. In February 2017 (reported as "in February"), the patient was diagnosed with pneumonia and Guillain-Barre syndrome. No lab diagnostic studies were performed. Product quality complaint was not involved. The outcome of pneumonia and Guillain-Barre syndrome was reported as not recovered. The relatedness between the events and the vaccination with PNEUMOVAX23 was not reported. No additional information was provided. Upon internal review, pneumonia and Guillain-Barre syndrome were determined to be medically significant. Additional information has been requested.