chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 10 year old male patient. No information regarding the patient's medical history and concurrent conditions was reported. On 21-APR-2016 at 16:59, the patient was vaccinated at the private doctor's/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the right arm, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 VAQTA lot # L017757, expiration date: 08-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with doses of M-M-R II (strength, dose number, anatomical location, lot number and expiration date were not provided) intramuscularly instead of subcutaneously. Concomitant therapies were not provided. No adverse events reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-JUN-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency, route of administration and indication were not reported, lot # L039095 with expiration date: 08-JAN-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.8 degrees Fahrenheit for 5 hours 30 minutes. Data logger was involved. Administered vaccine also experienced previous temperature excursion of 9.1 degrees Fahrenheit for 1 hour 15 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot # L017145 with expiration date: 13-MAY-2017 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a site coordinator refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L024993 exp date 17-OCT-2017) (dose and route not reported). No adverse events were reported. This is one of several reports received from the same source. 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 nurse and refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 21-JUN-2016, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency, route of administration and indication were not reported, lot # L048464 with expiration date: 02-DEC-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.8 degrees Fahrenheit for 5 hours 30 minutes. Data logger was involved. Administered vaccine also experienced previous temperature excursion of 9.1 degrees Fahrenheit for 1 hour 15 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated intramuscularly with improperly stored doses of VARIVAX lot # L020002, expiry date 02-JUN-2017, lot # L046887, expiry date 23-NOV-2017 and Lot# reported as M000757, expiry date 06-JAN-2018, frequency reported as once (dose not reported). No adverse events were reported. The therapy was not discontinued. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX23 (lot# L003188 with expiration date 06-JUL-2016; lot# L003227 with expiration date 13-OCT-2016; lot# L024132 with expiration date 27-JAN-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: This solicited report was received from the mother of the patient, a 14 year old female as part of a Market Research. The patient's current conditions, medical history and concomitant medications were not reported. In March 2015 (also reported as spring 2015), the patient was vaccinated with GARDASIL 9 (strength 70 mg, frequency reported as 3 doses over 6 months)(lot number and expiration date not reported). It was reported that the patient received only 2 of the 3 recommended doses. The second dose GARDASIL 9 was administered on an unspecified date between spring and summer 2015. However, at the time of reporting, the third dose has not been administered yet. 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 medical assistant regarding 8 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a non-pregnant female patient of unknown age with Hashimoto's thyroiditis (reported as "condi hashimoga thyroiditis". It was reported that the patient felt hot all over body every time she received a shot. On 22-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX one time vaccination, subcutaneously for prevention of shingles (dose, lot # and expiration date were not reported). On the same day after receiving the ZOSTAVAX vaccine, she felt hot all over body for 4 days. The patient took ibuprofen for the treatment. No lab diagnostics studies were performed. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 PEDVAXHIB lot # L051123, expiration date 13-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 dose of GARDASIL 9 lot # L024993 with expiration date 17-OCT-2017, lot # L045700 with expiration date: 22-FEB-2018 (dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, lot # L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours and on 20-MAY-2016 5.9 degrees F for 5.5 hours. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. 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 certified medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD lot # L019996 with expiration date: 02-DEC-2016 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 4 month old (at the time of the report the patient was 6 month old) male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 28-APR-2016 at 11:28, a the age of 4 month old, the patient was vaccinated with his first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2017, orally, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be a valid lot number for ROTATEQ. Additional information is not expected as all required correspondence has been received.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 4 month old (at the time of the report the patient was 6 month old) female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 27-APR-2016 at 10:21, at the age of 4 month old, the patient was vaccinated with her first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2107, orally, dose was not reported). The temperature excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be a valid lot number for ROTATEQ. Additional information is not expected as all required correspondence has been received.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-MAY-2-16, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, lot # L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours and on 20-MAY-2016 5.9 degrees F for 5.5 hours. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ZOSTAVAX lot # L029482 with expiration date: 06-NOV-2016 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 22-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K023622, expiration date: 20-FEB-2016 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 70 days (reported as 70 days +) since 22-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 07-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K023622, expiration date: 20-FEB-2016 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 70 days (reported as 70 days +) since 22-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, albumin status recombinant human albumin (rHA), lot # L027434, expiry date 22-JUL-2017 (does, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours, on 20-MAY-2016 5.9 degrees F for 5.5 hours, on 08-JUN-2016 6.9 degrees F for 3 hours 50 minutes, on 09-JUN-2016 8.2 degrees F for 9 hours 50 minutes and on 10-JUN-2016 6.6 degrees F for 1 hour 50 minutes. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 11 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 28-APR-2016 at 10:26, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the left arm. On unspecified date, the vaccine that was administered to the patient has been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at time of vaccination. This is one of the several reports received from the same source. Additional information is not expected as all available information was obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern regarding 6 patients of unknown demographics. There was no information about concurrent condition and historical medication. On one of the following dates 14-MAY-2016, 01-JUN-2016, 08-JUN-2016, 09-JUN-2016, 22-JUN-2016 and 05-JUL-2016 the patients were vaccinated with improperly stored ZOSTAVAX 19400 PFU lot # L044530/ expiration date-09-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 GARDASIL 9 lot # L018351 with expiration date 11-AUG-2017, lot # L024993 with expiration date 17-OCT-2017, lot # reported as L037554 with expiration date 25-DEC-2017, lot # reported as M009116 with expiration date: 13-JUN-2018 (dose and route of administration were not reported). It was also reported that sterile diluent (lot # reported 00006430900; expiration date and exact dose were not provided) was used. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 13 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 22-APR-2016 at 15:14, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the right arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient has no illnesses at time of vaccination. This is one of several reports received from the same sources. Additional information is not expected as all available information was obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a site coordinator refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L024993 exp date 17-OCT-2017) (dose and route not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of GARDASIL (lot # K010215 and expiration date 05-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a unspecified number of patients of unknown age and gender. In approximately 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency and route were not reported, lot # M004116 with expiration date: 12-OCT-2017). No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.5 degrees Fahrenheit for 2 minutes on 10-MAY-2016. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of unspecified patients. On unknown dates starting on or after 12-MAY-2016 the patients were vaccinated with ROTATEQ lot # L039298 (expiration date 27-JUN-2017) which was improperly stored at 31.4 F for 1000 minutes. There was no previous temperature excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of unspecified patients. On unknown dates starting on or after 12-MAY-2016 the patients were vaccinated with VARIVAX lot # L049536 (expiration date 08-DEC-2017), which was improperly stored at 14 F for 1400 minutes. There was no previous temperature excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No concomitant medication, pertinent medical history or drug/allergies were reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route, lot number and expiration date were not reported). On an unknown date, the patient developed menstruation changes and disruption. The outcome of the event was unknown. The relatedness between the event and GARDASIL injection was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies were reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (also reported as sterile diluent/vaccine) lot # M005714, expiration date 03-OCT-2017, intramuscularly (dose and anatomical location were not reported) after the vaccines went through a temperature excursion (of going up to 49.4 degrees Fahrenheit for 40 minutes), which was other than indicated in the Prescribing Information. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (also reported as a sterile diluent/vaccine) lot # L042836 with expiration date 24-AUG-2018 and lot # M001813 with expiration date 14-OCT-2018, intramuscularly (dose and anatomical location were not reported) after the vaccines went through a temperature excursion (of going up to 49.4 degrees Fahrenheit for 40 minutes), which was other than indicated in the Prescribing Information. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 16-JUN-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K008198 with expiration date 05-JUN-2016, dose, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information was received from a registered nurse referring to a 5 year old male patient. The patient had no medical history or known drug allergy. At 12 months of age, the patient received M-M-R II and VARIVAX (capture into MARRS# 1607USA000541). On 10-JUN-2016 the patient received 1 dose of PROQUAD (lot # M010477, expired 01-SEP-2017, human serum albumin (HSA)) subcutaneously in the left arm. There was no concomitant therapy. ON 17-JUN-2016 the patient developed a localized rash on the left arm at the injection site. The rash was about 2.5 to 3 inches in diameter and was painful and itchy. The patient had sought medical attention via office visit. No treatment was given for the events. No lab diagnosis was performed. The patient still not recovered from the events at the time of the report. The causality was not reported. This is one of 2 reports for the same patient. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unknown number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDISAL 9 (lot # M005714, expiration date: 03-OCT-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 21 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of the two reports received from the same 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 physician and refers to an unknown number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # L039638, expiration date: 23-AUG-2017; dose not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 21 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored ROTATEQ, following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored PNEUMOVAX23 following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored GARDASIL 9, following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 29-JUN-2016, the patient inadvertently received a dose of GARDASIL, lot# K011492, expiration date: 22-JUN-2016 (expired product administered), dose unknown, intramuscularly. 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 as received from a medical assistant 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 VAQTA lot # reported as M011116, expiration date: 17-JUN-2017 and lot # reported as M022541 with expiration date: 23-FEB-2018 (dose and route of administration were not reported). It was also reported that sterile diluent (lot # reported as 00006430900; expiration date and exact dose were not provided) was used. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 11 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 16-APR-2016 at 12:00 PM, the patient was vaccinated with GARDASIL 9 (lot # L044475, expiration date: 12-MAY-2017) dose 1, intramuscular in the left arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all available information was obtained.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Electrocardiogram normal, Syncope
Clinical narrative: This spontaneous report was received from a physician regarding a 17 year old non-pregnant female patient. The patient did not have pertinent medical history nor drug reactions or allergies. The patient's concomitant therapies were not reported. On 08-FEB-2016, the patient was vaccinated with the second dose of GARDASIL (via intramuscular route in the left upper arm, lot # K010215, expiration date 05-MAY-2017). On the same day, the patient was vaccinated with a dose of VAQTA (dose, route, lot # and expiration date were not reported) and a dose of MENACTRA (dose, route, lot # and expiration date were not reported). The patient experienced light headedness and brief syncope after receiving the dose of GARDASIL. The patient was immediately treated in the office by giving her juice to drink and had patient sit down for an unknown amount of time as the patient did not eat breakfast or lunch. On the same day, the patient went to an unknown emergency room (ER) for further evaluation and did no receive any treatment. Electrocardiogram was performed on ER and a result was normal. The patient's outcome was unknown. The relatedness between the events and the therapy with GARDASIL and was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 ROTATEQ orally, lot # L033693 with expiration date 31-MAY-2017, lot # L039638 with expiration date: 23-AUG-2017, lot # reported as L046319 with expiration date: 28-SEP-2017 (exact dose was not reported). It was also reported that sterile diluent (lot # reported as 00006430900; expiration date and exact dose were not provided) was used. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored VAQTA, following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On multiple unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB, following a temperature excursion (48 hours at 0 Celsius degree) that occurred in February 2015. A digital data logger (DDL) was used to track the temperature. No previous temperature excursion occurred. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 02-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K023622, expiration date: 20-FEB-2016 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 70 days (reported as 70 days +) since 22-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 15 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 02-MAY-2016 at 16:12, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the right arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all available information was obtained.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Certified Medical Assistant (CMA)) refers to a 12 month old patient. On 05-JUL-2016 the patient inadvertently received an "extra" dose of ROTATEQ, oral (dose was not reported, unspecified lot/unspecified expiration). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of VAQTA lot, dosing details unknown. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HIB lot, dosing details unknown. No adverse effects were reported. Product quality complaint  (PQC) was not filed. This is one of the four reports received from the same reporter. 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 pharmacy intern regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On one of the following dates 14-MAY-2016, 28-MAY-2016 and 26-JUN-2016 the patients were vaccinated with improperly stored VARIVAX lot # L024255/ expiration date-01-JUL-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot, dosing details unknown. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 # M005286 with expiration date: 08-OCT-2017, lot # L038522 with expiration date: 11-AUG-2017 (dose and route of administration were not reported). It was also reported that sterile diluent (lot # reported as 00006430900; expiration date and exact dose were not provided) was used. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 RECOMBIVAX HB lot # L048236 with expiration date 31-MAR-2018, lot # L048848 with expiration date: 09-AUG-2018, lot # M022077 with expiration date 10-MAR2019 (dose and route of administration were not reported). It was reported that sterile diluent (STERILE DILUENT) (lot # reported as 00006430900; expiration date and exact dose were not provided) was used. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit. This is one of several reports received from the same 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 medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored dose of ROTATEQ (lot # L020865, expiry date 09-FEB-2017) dosing details unknown. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of four reports received from the same reporter. Additional information has been requested.