chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown gender and age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004890, expiration date 10-NOV-2017, oral; dose was unknown). No adverse effects were reported. The reporter stated that the vaccines were exposed to 52 Fahrenheit degree for 15 hours and then they backed in range. There were no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 17-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with doses of an unidentified Merck HPV vaccine (name, lot number, dose, route, anatomical site of injection and frequency were not reported). It was reported that, on unknown dates, the patients experienced injection site pain. No product quality complain (PQC) was involved. At the reporting time, the outcome of the event was unknown. The reporter did not provide a causality assessment between the event and the unidentified Merck HPV vaccine. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical, history, concomitant medications, drug reactions or allergies was provided. On 11-OCT-2016, the patient was vaccinated with an expired dose of PROQUAD injection, 0.5 ml, expiration date 01-OCT-2016 (route of administration and lot # were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown gender and age. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L038501, expiration date 16-AUG-2018, lot # L051124, expiration date 14-OCT-2018; dose and route were unknown). No adverse effects were reported. The reporter stated that the vaccines were exposed to 52 Fahrenheit degree for 15 hours and then they backed in range. There were no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 17-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown gender and age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K010215, expiration date 05-MAY-2017, lot # M014929, expiration date 27-MAY-2017; dose and route were unknown). No adverse effects were reported. The reporter stated that the vaccines were exposed to 52 Fahrenheit degree for 15 hours and then they backed in range. There were no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 17-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Age: 24.0
Sex: F
Vaccine: HPV9, PPV
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning to a 24 year old female patient. This was a prospective pregnancy report. The patient's medical history included: asthma, bulimia nervosa, migraine and tobacco abuse. Concurrent conditions and concomitant therapy were not reported. On 26-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L016428, expiration date: 30-JUL-2017, injection. Strength and route of administration were not provided. The same day the patient was also vaccinated with PNEUMOVAX 23 lot# L048265, expiration date: 10-JUN-2017, injection. Strength and route of administration were not reported. On 03-OCT-2016 the patient returned to the office and was administered an unspecified pregnancy test, which exhibited a positive result. Registered Nurse stated the patient was found to be 5 weeks pregnant that day. Initial exposure to GARDASIL 9 and PNEUMOVAX 23, was at 4 weeks (first trimester). No adverse effect was reported. The patient became pregnant with last menstrual period (LMP) of 28-AUG-2016, estimated date of conception of 11-SEP-2016 and estimated date of delivery (EDD) of 04-JUN-2017. It was the patient's first pregnancy. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # was reported as M031568, expiration date 24-DEC-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at -5.6 Celsius (C) for 1 hour and was then back in range. Prior temperature excursions included -12.4 C for 30 minutes and -12.7 C for 26 minutes. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician via a company representative referring to 3 patients of unknown gender, each of them was under age of 65 years old. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route, lot # and expiration date not reported) at a pharmacy. Each patient was under the age of 65 years old and did not have an underlying medical condition. Additional information is not expected as no consent to contact the physician.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Pruritus generalised, Rash generalised, Wheezing
Clinical narrative: Woke up with rash on 10-12-16. Started on legs and spread to most of body, Itch, tx with BENADRYL. Office visit with provider that day- 10/12/16 Office visit 10-13-13, Rash, itchy over most of body. SOB, wheeze, treated with BENADRYL, PO and albuterol neb treatment.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's concomitant medication, pertinent medical history, drug reactions or allergies was reported. On 26-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot# K019386, expiration date: 09-JUN-2016, one shot, once, intramuscularly in an arm. The vaccine was expired. No adverse events were reported. 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 528 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-SEP-2016, the patient was inadvertently vaccinated with a pediatric dose of VAQTA Lot# K026529, expiration date: 02-JUN-2016, 0.5 ml by an unspecified route (accidental underdose). There were no concomitant medications and adverse effects reported. No product quality complain was involved. 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 480 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.), concerning an unspecified number of patients of unknown ages and genders. The patients pertinent medical history and concurrent conditions were not informed. It was reported that on unspecified dates, the patients were administered doses of improperly stored VARIVAX, lot # L018001, expiration date 19-MAY-2017, (dosage and therapy route were not provided). No adverse effects were reported. Concomitant therapies were not informed. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1609USA014852). 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 2352 hours. The type of excursion was refrigerator and the vaccine status in excursion. The concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown dates were vaccinated with an improperly stored doses of RECOMBIVAX HB (Lot No. L044694, exp. not reported), 5 microgram (route not reported). The doses were part of an excursion with temperature of 35F for 1 hour. There was no previous temperature excursion. The reporter did not know if any adverse effect were reported. This is one of several report from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date, the patient was vaccinated with ZOSTAVAX injection (dosage, route, lot number, expiration date and site of injection were not reported). On an unspecified date, the patient experienced shingles for an unspecified reason. At the time of the report the outcome of shingles was unknown. The relationship between the event and ZOSTAVAX was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date, the patient was vaccinated with ZOSTAVAX injection (dosage, route, lot number, expiration date and site of injection were not reported). On an unspecified date, the patient experienced shingles for an unspecified reason. At the time of the report the outcome of shingles was unknown. The relationship between the event and ZOSTAVAX was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown dates were vaccinated with an improperly stored doses of GARDASIL 9 (Lot No. M016193, exp. 28-APR-2018) (route and dose not reported). The doses were part of an excursion with temperature of 35F for 1 hour. There was no previous temperature excursion. The reporter did not know if any adverse effects were reported. This is one of several reports from the same source. 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 physician via company representatives and an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 260 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Received vaccine 10/12/16. Injection site red, warm to touch, painful and itchy. Symptoms started 10/13/16. Redness aprx 4inx2in. Treated with Ibuprofen, KEFLEX BID x 7 days, steroid crm, cool compresses and BENADRYL.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 72 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1032 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 576 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1176 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified gender, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mL Vls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 384 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies no adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via company representatives and an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 408 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 384 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 696 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 2400 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 528 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 984 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1008 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 registered nurse refers to an unspecified number of patients of unknown age and gender. No information about the patients medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L032391, expiration date: 26-AUG-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. There was no adverse event reported. This is one of two 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 648 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 552 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The medical assistant reported that an unspecified number of doses of ROTATEQ (lot # L027070, expiration date: 30-APR-2017, dose was not reported, orally) were administered to the patients on unknown dates following a temperature excursion of 32.9F for 22 hours and 17 minutes. No adverse effects were reported for any patients receiving doses. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 07-MAY-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5mlSD-PFS LLokw Tip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1416 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-JAN-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 480 hours with the lowest recorded temperature 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 632 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-APR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 0 Fahrenheit degree. The total cumulative excursion time of the second time was 992 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 25-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlISD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 528 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 31-JUL-2015, the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II 0.5ml (recombinant human albumin (rHA), lot # K018990, expiration date 15-OCT-2016, 0.5 ml, route was unspecified). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 152 hours with the highest recorded temperature of -14 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the highest recorded temperature of -12 Fahrenheit degree. The total cumulative excursion time of the third time was 88 hours with the highest recorded temperature of -13 Fahrenheit degree. The storage criteria for this vaccine was refrigerator (R)/Freezer (F). The type of excursion for this vaccine was refrigerator (R). No adverse effects 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
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K014191, expiration date 10-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K014191, expiration date 21-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 112 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 03-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). The specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On 24-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 560 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-SEP-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 120 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 01-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (rHA, lot # L007577, expiration date 05-MAR-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JAN-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L0018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 368 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.