chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 21-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event 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 13-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two time. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event 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: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-MAY-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX "10 PK 0.5 ml SD-PFS LLokwTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at 1.11 Celsius Degrees for 88 hours and 0 Celsius Degrees or 40 hours. The type of excursion was refrigerator. No adverse effects 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: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-OCT-2016, the patient received improperly stored ZOSTAVAX 19400 PFU, lot# M028798 with expiry date: 18-AUG-2017 (dosing details not reported). No adverse effects reported. Temperature/time frame: 18 F for 48 hours. No previous excursions. No data logger involved. No product quality complaint involved. 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 06-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received PEDVAXHIB (Lot number: M010440, Expiry date: 09-DEC-2018) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. 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: This spontaneous report was received from an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M021407 and expiry date 30-APR-2018) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature excursion of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. 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 an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004544 and expiry date 18-OCT-2017) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature excursion of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, since 19-AUG-2016, the patients received improperly stored doses of PROQUAD (lot # M006105 with expiration date 01-AUG-2017, therapy type rHA; lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; lot # M012987, expiration date 12-SEP-2017, therapy type HSA; lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; lot # M021427 with expiration date 29-OCT-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant via a company representative concerning two 16 year old female patients. Concurrent condition, concomitant medication and medical history were not provided. Approximately in July 2016 (about three months ago), the patients were received the first dose of GARDASIL 9, (lot#, expiration date and dose were not reported) intramuscular. Approximately in September 2016 (about one month ago), the patients experienced fainted after each girl received the second dose of GARDASIL 9 (intramuscular; lot#, expiration date and dose were not reported). The patient did not seek medical attention. No treatment was given for the events. No lab test was performed. The outcome of fainted was reported as recovered. Additional information is not expected due to the reporter did not allow to be contacted.
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 patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ (dose and route were not reported) lot # M019690, expiry date: 02-NOV-2017 and lot # M019691, expiry date: 02-NOV-2017. The vaccine was exposed to a temperature frame of 34.9 Fahrenheit for 336 hours. A data logger was used to record the temperatures. No adverse effects were reported. No additional information was provided. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 14-OCT-2016 from a healthcare worker via a field representative. The healthcare worker reported that on an unspecified date, an unspecified patient (gender and age not reported) was "supposed to" received ZOSTAVAX however the patient "may have" received (Oka/Merck) VARIVAX by mistake. It was documented that the patient received a dose of (Oka/Merck) VARIVAX, however it could have been a dose of ZOSTAVAX and they just wrote it down incorrectly. Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. No further information was provided. Additional information is not expected as physician did not wish to be contacted.
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 24-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event 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 20-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was  136 hours with the lowest recorded temperature of 33 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 event was 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 registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (dose and route unknown, lot # M008589, expiration date: 16-FEB-2018). The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours (7 cycles). No adverse effects were reported. 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017. This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event was reported. This is one of several reports received from the same source. Addition 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 01-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event was reported. This is one of several report 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 15-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017. This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event was reported. This is one of several reports received from the same source. Addition 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 01-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017. This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event was reported. This is one of several reports received from the same source. Addition 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 16-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event was reported. This is one of several reports received from the same source. 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. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (incorrect product storage) (lot numbers: L039660, Expiry date: 04-FEB-2018; lot numbers: M000442, Expiry date: 31-MAR-2018; lot numbers: M023718, Expiry date: 09-AUG-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 1610USA012625, 1610USA012627 and 1610USA012628 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
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. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II (incorrect product storage) (lot numbers: L001336, Expiry date: 13-JAN-2017; lot numbers: L012482, Expiry date: 10-APR-2017; lot numbers: K021952, Expiry date: 10-NOV-2016; lot numbers: L012481, Expiry date: 10-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 1610USA012625, 1610USA012626 and 1610USA012628 via same reporter link. 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. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of VAQTA (lot numbers: M022924, Expiry date: 24-JAN-2018; lot numbers: M015290, Expiry date: 31-MAR-2018; lot numbers: M030598, Expiry date: 13-OCT-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 161USA012626, 1610USA012627 and 1610USA012628 via same reporter link. 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. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (lot numbers: M004542, Expiry date: 18-OCT-2017; lot numbers: M004726, Expiry date: 19-OCT-2017; lot numbers: L033545, Expiry date: 30-MAY-2017; lot numbers: L039141, Expiry date: 16-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 1610USA012625, 1610USA012626 and 1610USA012627 via same reporter link. 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 physician refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored dose of VARIVAX (dose and route were not reported), lot # M025867 and expiry date: 24-MAY-2018. There were no adverse symptoms reported. No further information was provided. There was no product quality complaint 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot numbers: L026602, Expiry date: 19-FEB-2017; lot numbers: L036301, Expiry date: 20-DEC-2017; lot numbers: M026306, Expiry date: 30-APR-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report was received from a Physician Assistant via company representative regarding a male patient of unknown age. Pertinent medical history, drug reactions and allergies and concomitant medications were unknown by the reporter. On 14-OCT-2016, the patient was vaccinated with PNEUMOVAX 23. Since an unknown date in October 2016, the patient was unable to move the arm where he received the injection. As of 18-OCT-2016, the outcome of the event was not resolved. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M025192 and expiry date 21-MAR-2019) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature excursion of of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patient were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2017 and lot # L007578 expiration date 05-MAR-2017 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperature and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degree for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30 SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported.  There were no data logger and no prior excursions. 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: Information has been received from a nurse referring to an unspecified number of unknown 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 PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown). It was reported that the vaccine was improperly stored at 51.2 Fahrenheit for 23 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received on 12-OCT-2016 from a pharmacist who reported that an unspecified female patient (presently 27 years old) who was vaccinated with VARIVAX (Date of vaccination, dose volume, lot number, expiration date were not reported) and MMR (Date of vaccination, dose volume, lot number, expiration date were not reported) "during her adolescence," (age not reported) recently had titers drawn which exhibited low levels for each of the components in those vaccines. The patient's medical history, concurrent conditions and concomitant medications were not reported. The call ended before any further adverse experience (AE) questions could be asked. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Rash, Skin disorder
Clinical narrative: This spontaneous report as received from a 87 years old female patient regarding herself. The patient's pertinent medical history reported as blood pressure. On an unknown date the patient was vaccinated with ZOSTAVAX, (lot, expiration date and dosing regiment were unknown) subcutaneously. Concomitant therapies included LIPITOR and blood thinner (unspecified). On an unknown date the patient experienced outbreak of shingles, rash, soreness, flaky skin, scalp irritation, and a headache. The patient sought medical attention with her physician. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: This spontaneous report as received from a 87 years old female patient regarding herself. The patient's pertinent medical history reported as blood pressure. On an unknown date the patient was vaccinated with ZOSTAVAX, (lot, expiration date and dosing regiment were unknown) subcutaneously. Concomitant therapies included LIPITOR and blood thinner (unspecified). On an unknown date the patient experienced outbreak of shingles, rash, soreness, flaky skin, scalp irritation, and a headache. The patient sought medical attention with her physician. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 15 year old female patient. No information on patient's pertinent medical history, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with the first dose of unidentified Merck HPV vaccine (unknown if GARDASIL or GARDASIL 9), dose, route, lot number and expiry date were not provided). The patient had no adverse effects after first dose. Approximately on 29-SEP-2016 (reported as 2 weeks before the time of this report), the patient was vaccinated with the second dose of unidentified Merck HPV vaccine. There were no concomitant medications. On an unspecified date in 2016 (reported as shortly after the injection), the patient experienced pain at the injection site. Approximately in October 2016 (reported as a week and a half after the second dose injection), the patient had swelling, warmth to the touch and an unspecified mass or knot at the injection site. The patient sought medical attention by an office visit with the physician and was prescribed ibuprofen. The primary reporter reported that all the symptoms listed above did not improve. The outcome of events was reported as not recovered. The causality between events and the vaccination with unidentified Merck HPV vaccine was not provided. 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 and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown multiple dates, the patients were vaccinated with an improperly stored doses of ROTATEQ, orally, lot # L046319, expiration date 28-SEP-2017 (dose was not reported). The administered doses of vaccines were exposed to a temperature of 9 Celsius degrees, for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the 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 pharmacist refers to 3 patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (dose and route were not reported), lot # M030140 and expiry date: 18-AUG-2017. There were no adverse events reported. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unknown 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 ROTATEQ (lot#, expiration date and dose were unknown; oral). It was reported that the vaccine was improperly stored at 51.2 Fahrenheit for 23 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event 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 06-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017. This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 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 event was reported. This is one of several reports received from the same source. Addition information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unknown 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 PEDVAXHIB (lot#, expiration date and dose were unknown; oral). It was reported that the vaccine was improperly stored at 51.2 Fahrenheit for 23 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unknown 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 M-M-R II (lot#, expiration date, dose and route were unknown). It was reported that the vaccine was improperly stored at 51.2 Fahrenheit for 23 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. 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: Information has been received from a nurse referring to an unspecified number of unknown 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 GARDASIL 9 (lot#, expiration date, dose and route were unknown). It was reported that the vaccine was improperly stored at 51.2 Fahrenheit for 23 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Onset swelling and redness at vaccine site the day after injection-treatment recommended ice, BENADRYL-Resolved without further treatment, within few days.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness
Clinical narrative: Pt was given Varicella vaccine to the left deltoid. It was suppose to be given subcutaneous. 3-4 minutes feeling dizzy, lightheaded around 10:45 am on 10/17/16.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema
Clinical narrative: Pt said she couldn't breath the night of flu shots.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea
Clinical narrative: Pt said she couldn't breath the night of flu shots.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: My arm started hurting the day after receiving the shot but felt better a week later.  Then nine (9) days after the shot I woke up and my arm was hurting even worse.  By the end of the weekend, I could not move my arm without assistance from the other arm.  On 10/3/2016 I went to the doctor and received a steroid shot and my arm felt better the next day but that only lasted one (1) day.  On 10/5/2016 it was hurting just as bad as it did that weekend.  I went to the orthopedic doctor on 10/7/2016 and had x-rays done and they notice that my bursa sack was completely deflated.  I have been going to physical therapy for three (3) weeks and have a follow up with my doctor or 11/18/2016.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Bursa disorder, Movement disorder, Pain in extremity
Clinical narrative: My arm started hurting the day after receiving the shot but felt better a week later.  Then nine (9) days after the shot I woke up and my arm was hurting even worse.  By the end of the weekend, I could not move my arm without assistance from the other arm.  On 10/3/2016 I went to the doctor and received a steroid shot and my arm felt better the next day but that only lasted one (1) day.  On 10/5/2016 it was hurting just as bad as it did that weekend.  I went to the orthopedic doctor on 10/7/2016 and had x-rays done and they notice that my bursa sack was completely deflated.  I have been going to physical therapy for three (3) weeks and have a follow up with my doctor or 11/18/2016.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Paraesthesia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 14-OCT-2016. This case involves a 74-year-old male patient who was vaccinated with a dose of FLUZONE HD batch number: UI679AA, expiration date: 09-Apr-2017 (dose, dose in series, route of administration were not reported), in left deltoid on 15-SEP-2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies, diabetes mellitus 2, hypertension, high cholesterol. Any other vaccinations within four weeks of vaccinations was reported as none. Other concomitant medications were not reported. On 16-SEP-2016, one day following the vaccination, the patient scabbing at the injection site. On 17-SEP-2016, two days following the vaccination (starting the next day), the patient had pain and itching at the injection site with bruising and pain that spread down the back of his left arm to the elbow at one point. It was reported that the patient required emergency room/doctor visit. Lab data was reported as none and corrective treatment was reported as Ibuprofen. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 14-OCT-2016. This case involves a 74-year-old male patient who was vaccinated with a dose of FLUZONE HD batch number: UI679AA, expiration date: 09-Apr-2017 (dose, dose in series, route of administration were not reported), in left deltoid on 15-SEP-2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies, diabetes mellitus 2, hypertension, high cholesterol. Any other vaccinations within four weeks of vaccinations was reported as none. Other concomitant medications were not reported. On 16-SEP-2016, one day following the vaccination, the patient scabbing at the injection site. On 17-SEP-2016, two days following the vaccination (starting the next day), the patient had pain and itching at the injection site with bruising and pain that spread down the back of his left arm to the elbow at one point. It was reported that the patient required emergency room/doctor visit. Lab data was reported as none and corrective treatment was reported as Ibuprofen. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Fall, Fear, Hyperventilation
Clinical narrative: Initial unsolicited report received from a physician on 13 October 2016. This case involves a 11 years old male patient who was vaccinated with a dose of ADACEL (batch number U5288AA, expiration date, dose in series, route of administration was not reported) at left arm, with a dose of MENACTRA (batch number U5187AA, expiry date 16 March 2017, dose in series, route of administration was not reported) at right arm and with a dose of GARDASIL 9 (manufacturer other, batch number M011117, dose in series, route of administration was not reported) at left arm on 10 October 2016 on 11:15 AM. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 October 2016 at 11:15 AM, immediately following the vaccination, patient got dizzy, stiff, pale, rolled his eyes, fell on exam table, scared and experienced hyperventilation. It was also reported that patient was healthy and seen for check up. Lab data and corrective treatment was not reported. On 10 October 2016, after 30 minutes of rest, patient recovered (got better) from events. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Initial unsolicited report received from a physician on 13 October 2016. This case involves a 11 years old male patient who was vaccinated with a dose of ADACEL (batch number U5288AA, expiration date, dose in series, route of administration was not reported) at left arm, with a dose of MENACTRA (batch number U5187AA, expiry date 16 March 2017, dose in series, route of administration was not reported) at right arm and with a dose of GARDASIL 9 (manufacturer other, batch number M011117, dose in series, route of administration was not reported) at left arm on 10 October 2016 on 11:15 AM. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 October 2016 at 11:15 AM, immediately following the vaccination, patient got dizzy, stiff, pale, rolled his eyes, fell on exam table, scared and experienced hyperventilation. It was also reported that patient was healthy and seen for check up. Lab data and corrective treatment was not reported. On 10 October 2016, after 30 minutes of rest, patient recovered (got better) from events. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Hyperventilation, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from a physician on 13 October 2016. This case involves a 11 years old male patient who was vaccinated with a dose of ADACEL (batch number U5288AA, expiration date, dose in series, route of administration was not reported) at left arm, with a dose of MENACTRA (batch number U5187AA, expiry date 16 March 2017, dose in series, route of administration was not reported) at right arm and with a dose of GARDASIL 9 (manufacturer other, batch number M011117, dose in series, route of administration was not reported) at left arm on 10 October 2016 on 11:15 AM. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 October 2016 at 11:15 AM, immediately following the vaccination, patient got dizzy, stiff, pale, rolled his eyes, fell on exam table, scared and experienced hyperventilation. It was also reported that patient was healthy and seen for check up. Lab data and corrective treatment was not reported. On 10 October 2016, after 30 minutes of rest, patient recovered (got better) from events. List of documents held by sender: none.