chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial on 08 March 2017 and follow-up information received on 13 March 2017. A 24 year-old male subject with no significant medical history. The subject received concomitant medication with HPV, Quadravalent on 05 April 2016, Anthrax on 05 April 2016. The subject received a dose of ACAM2000  (lot number and route, site of administration not reported) on 28 April 2016. On 13 May 2016, 15 days after vaccination the subject was diagnosed with I40.8 other acute myocarditis. The lab data included 13 May 2016, Troponin I was 0.04 (abnormal), ECG done on 13 May 2016 was normal Echocardiogram done on 18 May 2016 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 healthy 24-year-old male who developed acute myocarditis with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of HPV and Anthrax vaccine. Acute Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 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 April 2016. On 10 May 2016, 15 days after vaccination the subject was diagnosed with acute pericarditis unspecified and on 11 May 2016, 16 days after vaccination the subject was diagnosed with acute pericarditis. Lab data included: on 10 May 2016, the subject had ECG which was abnormal and on 11 May 2016, the subject had blood test in which Troponin I was abnormal with the highest value of 01.79 ng/ml and also had echocardiogram which was abnormal. The 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 healthy 21-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Acute pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL
Symptoms: Cardiac failure, Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report on 08 March 2017 and follow up information received on 13 March 2017 from an investigator in a trial. A 27 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 15 May 2016. On 26 May 2016, 11 days after vaccination the subject was diagnosed with acute I30.9 acute pericarditis, unspecified and I50.9 heart failure, unspecified. The subject's lab data included, on 26 May 2016, ECG was abnormal, Echocardiogram was normal. Troponin I result, highest value 20.02 ng/Ml was abnormal. 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 healthy 27-year-old male who developed acute pericarditis unspecified and heart failure unspecified with favorable temporal association post vaccination with ACAM2000. Acute pericarditis and heart failure are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Pericarditis, Troponin I
Clinical narrative: Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator in a trial. 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 04 August 2016. On 23 August 2016, 19 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified, and on 15 August 2016, 11 days post vaccination the subject was diagnosed with I40.9 Acute myocarditis, unspecified. The lab data included within 30 days post vaccination, the Troponin I, ECG, 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 healthy 22-year-old male who developed acute myocarditis and acute pericarditis with favorable temporal association post vaccination with ACAM2000. Myopericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Initial solicited report on 08 March 2017 and follow up information received on 13 March 2017 from an investigator in the trial. A 23 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 03 August 2016. On 14 August 2016, 11 days after vaccination the subject was diagnosed with I40.8 Other acute myocarditis/I51.4 Myocarditis, unspecified. The subject's lab data included, ECG was normal done on 14 August 2016, Echocardiogram was normal and Troponin I result, highest value 0.54 ng/Ml was abnormal done on 15 August 2016. 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 healthy 23-year-old male who developed acute myocarditis with favorable temporal association post vaccination with ACAM2000. Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema, Injection site swelling, Nodule
Clinical narrative: Initial unsolicited report received from a physician on 10-MAR-2017. This case involves a female patient (onset age unknown) who was vaccinated with an unknown dose injection of PENTACEL (batch number: C5251AA and expiry date, route and dose in series were not reported) and a dose of PREVNAR (batch number, expiry date, route and dose in series were not reported) in the leg (reported as one vaccine per leg) on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed bilateral swelling, redness, and knot at injection site. The patients Lab data and corrective treatment was reported as unknown. The patient's outcome was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TD, TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) via partner company Pfizer (manufacturer reference Number: 2017083845) on 10-MAR-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TENIVAC and a dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series for both the vaccines were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to tetanus and TENIVAC. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on chest, back, face and legs.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Computerised tomogram head normal, Electrocardiogram normal, Fatigue, Hyporesponsive to stimuli
Clinical narrative: Patient was found down in the bathroom at about 7:15 AM. We called 911. The paramedics described patient as being in a "postictal" state. He was minimally responsive, and very lethargic, or tired, barely able to keep his eyes open. After about 10 minutes, he was able to stand and walk, but was still weak, and not tracking very well. He was taken to hospital by ambulance. Patient reported "waking up" in the ambulance, and did not remember what happened. CT head, EKG, labs, and urine tests were negative. They released patient to go home about 12:00 PM. Patient has had 2 more seizures, occurring on Monday, March 6, and again, on Monday, March 20.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test normal, Lethargy, Postictal state, Seizure
Clinical narrative: Patient was found down in the bathroom at about 7:15 AM. We called 911. The paramedics described patient as being in a "postictal" state. He was minimally responsive, and very lethargic, or tired, barely able to keep his eyes open. After about 10 minutes, he was able to stand and walk, but was still weak, and not tracking very well. He was taken to hospital by ambulance. Patient reported "waking up" in the ambulance, and did not remember what happened. CT head, EKG, labs, and urine tests were negative. They released patient to go home about 12:00 PM. Patient has had 2 more seizures, occurring on Monday, March 6, and again, on Monday, March 20.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX23 (lot #: M032635 with expiration date: 05-MAY-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine had been improperly stored at temperature greater than 32°F but less than 36 °F for 12 hours without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product formulation administered, No adverse event, Product packaging quantity issue, Product quality issue
Clinical narrative: This spontaneous report as received from an office manager who reported confusion with the direction for the preparation of M-M-R II. The office manager reported that as the prescribing information states, the dose of M-M-R II should be 0.5mL, but that that supplied diluent is 0.7mL. Since the prescribing information states to withdraw the entire contents of the diluent to reconstitute, then to withdraw the entire contents of the reconstituted mixture, this would create a possibility of 0.2mL overage. The office manager reported that this causes confusion. No adverse effects reported. PQC filed in 382484. Feedback forward in 382816. Additional information is not expected as there was no consent to contact reporter.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin, Rash, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: This spontaneous report was received from a physician and refers to a 23 month old female patient. The patient had none medical history, concurrent conditions or drug reactions/allergies. There were no significant concomitant medications. On 20-APR-2016, the patient was vaccinated with VARIVAX, (dose, frequency, lot # and expiration date were not reported) subcutaneously for preventive health maintenance.    Around 03-MAR-2017, the patient developed a rash and that day, she was hospitalized. During the hospitalization, the patient was treated with acyclovir 200 mg four times a day and with an antibiotic, cephalexin (KEFLEX) 100 mg, four times a day. Additionally, a punch biopsy of the skin where the rash was located was performed and the result was infected keratinocytes, positive Varicella-Zoster Virus (VZV), herpetic infection (varicella zoster virus infection). The patient was discharged on 08-MAR-2017. The outcome of rash and varicella zoster virus infection was reported as recovering.  The causality between the events and VARIVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a female pharmacist of unknown age who refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending. On unknown date, during the administration of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) to an unspecified patient, a few drops of the reconstituted vaccine came out of the needle and went on her own skin. No adverse symptom was reported. Additional information is not expected because there was no consent to contact the reporter.; Sender's Comments: US-009507513-1703USA008814:
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a bachelor of science in nursing (BSN) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In June 2015, the patient completed four doses of ACTHIB (dose, route of administration, lot # and expiration date were not reported). On 20-MAR-2017, the patient received the fifth dose of Haemophilus influenzae type b (Hib) vaccine as was vaccinated with LIQUID PEDVAXHIB (0.5ml, intramuscularly, lot # M036058, expiration date 19-MAY-2019) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Pericarditis
Clinical narrative: Initial solicited report received from an investigator in the trial on 08 March 2017 and follow-up information received on 13 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 02 August 2016. On 24 August 2016, 22 days after vaccination the subject was diagnosed with I30 acute pericarditis. The lab test for Troponin I was not performed, ECG done on 24 August 2016 was normal; 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 healthy 20-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis and pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Age: 25.0
Sex: F
Vaccine: MMR, MMR
Symptoms: No adverse event
Clinical narrative: No adverse event to report.
Age: 25.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event to report.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Lethargy, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on L arm (still present) w/ similar rash on R arm already resolved, lo grade fever (101 at day care), responding to antipyretics, lethargic for a while but recovered spontaneously.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: REDNESS, SWELLING TO 3 3/4 INCH CIRCLE ON RIGHT ARM. PAIN, ITCHING.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician 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, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M036728 , expiration date 20-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1.5 degrees Celsius, 31 degrees Fahrenheit/ -1 degrees Celsius or colder for 2 hours and 53 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003571:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to multiple unspecified patients. Patients' medical history, concurrent conditions, drug reactions and/ or allergies, and concomitant therapies were not provided. It was reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # M036059 and expiration date 03-JUN-2019  on multiple unspecified dates (the frequency, strength, and route were not provided). No adverse effects were reported. The storage conditions were reported as follows: temperature: 13.7 °C; time: 1 hour; there was no previous temperature excursion and a data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a immunisation official and refers to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (lot # L044056, expiry date: 02-MAY-2017, route of administration not reported). The temperature excursion range was between -14°C to -10°C within 1 hour. Data logger was involved. No adverse effect was noted. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009918: US-009507513-1703USA009917:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L046899, expiration date: 23-FEB-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 2 days. There were no previous temperature excursions reported. Data logger was involved. No adverse reactions were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009938: US-009507513-1703USA009937.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, VARCEL
Symptoms: Ear infection, Rash, Rash vesicular, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, concerning a 61 weeks-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient did not have history of drug reactions or allergies. On 30-JAN-2017, the patient was vaccinated with live VARIVAX (lot #, expiration date, strength, dose, frequency and anatomical location of the injection were not reported), administered subcutaneously for varicella prevention. The patient was also vaccinated with PREVNAR 13 that day. On 10-MAR-2017, the patient was treated for an ear infection with amoxicillin. Then on 11-MAR-2017, he broke out with a chickenpox type rash. It was stated by the reporter that later, on 12-MAR-2017, the patient's medication was switched to azithromycin (ZITHROMAX). On 13-MAR-2017, he was brought into the office with a rash covering his arms, legs, cheeks, chest, and shoulder blades, which was positively diagnosed as chickenpox (Varicella). No other information was provided on this matter. At the reporting time, the patient was recovering from the ear infection and varicella. The relationship between the VARIVAX and PREVNAR 13 with the events was not provided. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009916: US-009507513-1703USA009915:
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, VARCEL
Symptoms: Ear infection, Pharyngeal oedema, Rash generalised
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, concerning a 61 weeks-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient did not have history of drug reactions or allergies. On 30-JAN-2017, the patient was vaccinated with live VARIVAX (lot #, expiration date, strength, dose, frequency and anatomical location of the injection were not reported), administered subcutaneously for varicella prevention. The patient was also vaccinated with PREVNAR 13 that day. On 10-MAR-2017, the patient was treated for an ear infection with amoxicillin. Then on 11-MAR-2017, he broke out with a chickenpox type rash. It was stated by the reporter that later, on 12-MAR-2017, the patient's medication was switched to azithromycin (ZITHROMAX). On 13-MAR-2017, he was brought into the office with a rash covering his arms, legs, cheeks, chest, and shoulder blades, which was positively diagnosed as chickenpox (Varicella). No other information was provided on this matter. At the reporting time, the patient was recovering from the ear infection and varicella. The relationship between the VARIVAX and PREVNAR 13 with the events was not provided. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009916: US-009507513-1703USA009915:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2017 (reported as from 15-FEB-2017 to 15-MAR-2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M038846, expiration date 26-APR-2018, orally; exact doses were not reported). The vaccines were exposed to temperature of 32 to 36 Fahrenheit degrees for 8 hours before administration to the patients. No previous temperature excursion was reported. Digital Data Logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. From 16-FEB-2017 to 16-MAR-2017, a four of improperly stored doses of VAQTA injection (lot # M033611 with expiration date at 02-MAR-2018; dose and route of administration were not reported) were administered to the patients, for prophylaxis. The administered doses of vaccine were exposed to a temperature between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 45 minutes. Data logger was used to track the temperature. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of LIQUID PEDVAXHIB lot# M027883, expiration date 15-APR-2019 or lot # M036058, expiration date 19-MAY-2019 (dose and route of administration were not reported) were administered to the patients for prophylaxis. On unknown dates, the doses were stored in the temperatures between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 284 hours. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported.  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA003536:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-MAR-2017, the patient inadvertently received an expired dose of ZOSTAVAX lot # K008883, expiration date 20-SEP-2015, subcutaneously (dose not provided) that was reconstituted with sterile diluent (manufacturer unknown) lot # M022416 and expiration date 17-DEC-2018. No adverse effects reported. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 weeks old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date at the age of 6 weeks old instead of 2 months of age, the patient was vaccinated with a dose of with LIQUID PEDVAXHIB lot number M027883 with expiration date 15-APR-2019 (dose, anatomical location and route were not reported) for prophylaxis. No adverse effects were reported. 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 immunisation officai and refers to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with incorrect stored VARIVAX (L037565, expiry date: 29-SEP-2017, route of administration not reported). The temperature excursion range was between -14°C to -10°C within 1 hour. Data logger was involved. No adverse effect was noted. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009918: US-009507513-1703USA005609:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a immunisation official and refers to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (M027117, expiry date: 26-JUL-2017 and M037654, expiry date: 29-NOV-2017, route of administration not reported). The temperature excursion range was between -14°C to -10°C within 1 hour. Data logger was involved. No adverse effect was noted. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005609: US-009507513-1703USA009917.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of VAQTA injection (lot# M018767, expiry date 01-FEB-2018; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of RECOMBIVAX HB injection (lot# M013639, expiry date 15-SEP-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008835.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of an unspecified Merck human papillomavirus (HPV) vaccine injection (lot# reported as M033583, expiry date 14-APR-2019; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of PNEUMOVAX 23 injection (lot# M039060, expiry date 22-MAY-2018; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of ROTATEQ oral liquid (lot# M014318, expiry date 30-SEP-2017; exact dose was not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA008835:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M039318, expiration date: 20-SEP-2018, lot # M035142, expiration date: 03-AUG-2018, lot # M028546, expiration date: 07-JUN-2018, lot # M018436, expiration date: 13-APR-2018 or lot # L037559, expiration date: 29-SEP-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 2 days. There were no previous temperature excursions reported. Data logger was involved. No adverse reactions were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006914: US-009507513-1703USA009937.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Muscle tightness, Myalgia, Neuralgia
Clinical narrative: Localized muscle soreness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Pt. arm became red and inflamed.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 08-AUG-2016, the patient was vaccinated subcutaneously with the first dose of GARDASIL (dose and frequency were not reported) lot # M014929 with expiration date of 27-MAY-2017 for prophylaxis. On 12-OCT-2016, the patient was vaccinated subcutaneously with the second dose of GARDASIL (dose and frequency were not reported) lot # M014929 with expiration date of 27-MAY-2017 for prophylaxis. There were no previous temperature excursions occurred for the vaccine. On 27-FEB-2017, the patient went to the nurse's office to receive the third dose of human papillomavirus (HPV) with GARDASIL 9 subcutaneously for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age referring on himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAR-2017, the patient was vaccinated with PNEUMOVAX23 (administered in arm; dose, route of administration, lot # and expiration date were not reported). 4 hours after vaccination, the patient started to experience pain in the muscles in the arm where the vaccine was administered and his arm "hurt". The outcome of the adverse events and causality between the events and PNEUMOVAX23 were not reported. The product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The patient was administered an expired dose of PNEUMOVAX 23 via intramuscular route (lot# reported as L041028, expiration date: 16-FEB-2017, dose was not reported) on 08-MAR-2017. No adverse effects were noted by the reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.    On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M018957, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion between 32 and 35 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009946: US-009507513-1703USA009947: