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 19-FEB-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 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 29 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 as received from a medical assistant refers to multiple patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of GARDASIL 9, (lot# M023169 and expiry date 13-JUN-2018) (strength, dosing details, route and anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of 3 reports received from reporter source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash generalised
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 73 year old female patient. The medical history, concurrent conditions were unknown. On 10-OCT-2016, the patient was vaccinated with ZOSTAVAX lot # M026874, 19-JUL-2017, 0.65 ml. Concomitant therapies included TYLENOL, unspecified thyroid medication and other unspecified medications. On 11-OCT-2016, the patient had a small injection site, determined to be rash after receiving ZOSTAVAX that became widespread on the patient's body. It was unknown if patient put something on the rash for treatment that made the rash spiral out of control. No treatment was rendered for the event. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention (spoke with physician). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 18-AUG-2016, the patient was inadvertently vaccinated with M-M-R II at a partial dose of about 0.3 ml (subcutaneous, lot # and expiration date unknown). No adverse effect was reported. 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 18-MAY-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 three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 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: HPV4
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 GARDASIL (Lot Number: K009202, Expiry date: 17-DEC-2016) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was mot 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 04-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 three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 192 hours with the lowest recorded temperature of 29 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 04-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 three times. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 29 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber (also reported as nurse practitioner) concerning a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of VARIVAX (dose and route were not reported) lot # M005972 with expiration date 02-FEB-2016, which was stored at 8.6 Fahrenheit Degrees for 1 minute, 6.5 for 1 minute and 47 Fahrenheit Degrees for 1 hour and 40 minutes. The temperature excursion was detected with a data logger. There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several reports 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 08-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 three times. The total cumulative excursion time of the first time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 29 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: This spontaneous report was received from a nurse prescriber (also reported as nurse practitioner) concerning a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of M-M-R II (dose and route were not reported) lot # M000768 with expiration date 05-JAN-2018 and lot# K024825 with expiration date 02-DEC-2016, which was stored at 8.6 Fahrenheit Degrees for 1 minute, 6.5 for 1 minute and 47 Fahrenheit Degrees for 1 hour and 40 minutes. The temperature excursion was detected with a data logger. There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several reports from the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates the patients received unspecified number of doses of improperly stored GARDASIL. The nurse reported that the doses may have been given from the following lots: Lot # K011325 (expiry date: 08-APR-2017) and lot# K011562 (expiry date: 08-APR-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Flushing, Hyperhidrosis, Wheezing
Clinical narrative: Wheezing, sweats, flushing.
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-MAY-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 three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 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
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown dates, the patient were vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017; dose and route were unknown). The excursion temperature was 34.9 Fahrenheit degree for 22 hours. No data logger was involved. There was no previous temperature excursion. No product quality complaint (PQC) was involved. 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 multiple unspecified patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of M-M-R II, (lot#L012482 and expiry date 10-APR-2017) subcutaneously (strength, dosing details, anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of the 3 reports received from the reporter 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 licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (15 hours in 34F) doses of PNEUMOVAX 23 (lot # reported as M013504 with expiration date 06-MAY-2018, lot # L018503 with expiration date 16-MAR-2017; dose and route of administration were not reported). No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia, Syncope
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were unknown or GARDASIL 9 (dose, lot number and expiration date were unknown) (unspecified if the product was GARDASIL or GARDASIL 9). On an unknown date in September 2016, the patient experienced "syncope and hypo aesthesia". The outcome of the event was unknown. The causal relationship between the events and GARDASIL or GARDASIL 9 was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV, MMRV
Symptoms: No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant therapy were reported. No vaccines had been administered. The office manager reported product confusion with PEDVAXHIB and (Oka-Merck) PROQUAD. The cartons the vaccines were packed in had similar blue colors on the outside of the carton, which made it easy for them to get mistaken for the other and stored in the wrong place. No adverse effects were reported. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L051124, expiration date: 14-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates the patients received unspecified number of doses of improperly stored GARDASIL 9. The nurse reported that the doses may have been given from the following lots: Lot # L040054 (expiry date: 26-DEC-2017) and Lot# M007764 (expiry date: 30-JAN-2018). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (patient's mother) concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 03-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dosing details, lot# and expiry date were not reported). The patient received the second and third dose of GARDASIL 9 on 13-APR-2016 and 15-JUN-2016 respectively (inappropriate schedule of drug administration). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacy Intern referring to two unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On 12-OCT-2016, the patients were administered doses of PNEUMOVAX 23 syringes (lot number M020521 with expiration date 17-NOV-2017; dose was unknown) intramuscularly. On an unspecified date in October 2016, after administration, the patients experienced "redness, and swelling from the shoulder to the elbow on the arm, where PNEUMOVAX 23 was administered". Both the patients also experienced the area being "hot to touch". No treatment was given for the events. These symptoms lasted for an unspecified amount of time, and the current status of the unspecified patients was unknown. The pharmacy intern requested a lot check for this lot of PNEUMOVAX 23. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown multiple dates, the patients were vaccinated with a doses of VAQTA lot # M027879, expiration date 24-JAN-2018 (dose and route of administration were 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.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Developed hives on 10/24. Started cetirizine 10/25 and may need to take prednisone.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report was received from healthcare professional refers to a 1 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # M024680, expiry date: 18-MAY-2018), dose 1, subcutaneous and (Oka-Merck) PROQUAD (Lot # M029599, expiry date: 10-DEC-2017 (Overdose). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 23-MAY-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L044707 exp date 06-OCT-2018) (dose and route not reported). The temperature and time of excursion was 53 degrees C for 120 hours. 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: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection (dose was not reported) (Lot#: M000592, Expiry date: 12-OCT-2017) which was improperly stored. No adverse effects reported. The vaccine was stored at 16.4 C for 1.75 hours. No further information was provided. 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 a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 27-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 10 single DS, 0.5 mLVls 10SDV, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. The lowest temperature excursion was of 34 degrees Fahrenheit (F) for a total of 176 hours. No adverse effects were reported. The type of excursion was refrigerator and the vaccine status in excursion. Furthermore, 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: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route were unknown). On an unknown date after the patient received PNEUMOVAX 23, the patient stated that the injection site was red, very swollen and hard. The outcome of the events was reported as not recovered. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates between 24-SEP-2016 and 13-OCT_2016, the patients, inadvertently received an improperly stored doses of GARDASIL 9 (lot # reported as M021407, expiration date: 30-APR-2018) (doses and routes of administration were not provided). The administered doses of vaccine were exposed to a temperature of 35 Fahrenheit (F) degrees for 40 minutes. No previous temperature excursions were reported. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. 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 as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates between 24-SEP-2016 and 13-OCT-2016, the patients inadvertently received an improperly stored doses of ROTATEQ (lot # M019691, expiration date: 02-NOV-2017) orally, (doses were not provided). The administered doses of vaccine were exposed to a temperature of 35 Fahrenheit (F) degrees for 40 minutes. No previous temperature excursions were reported. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Information regarding concurrent conditions, medical history and concomitant medications of the patient were not reported. The patient was vaccinated with a total of 4 doses of GARDASIL 9 injection (dosing details, lot# and expiry date not known) on 22-MAY-2015, 21-JUL-2015, 18-DEC-2015 and 21-OCT-2016(Extra dose administered). No adverse symptoms were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route, lot number and expiry date were not reported). On an unknown date the patients experienced rash. The pharmacist found this information in an unspecified media report and in an unspecified lecture. Full patient demographics could not be provided. It was not specified how many patients developed the rash. The outcome of rash was unknown. The causality was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. In 2016, one month before the reporting date, the patient received 1st dose of BEXSERO. At the time of reporting, the patient returned to physician's (MD) office for receiving 2nd dose of BEXSERO. During office visit, the patient commented that the pain (specific to injection site) from the 1st dose had recently ceased. This case has been linked with case US2106153389, reported by the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048848 with expiration date on 09-AUG-2018, (route and anatomical location were not provided). The time frame was reported as 10 hours with a temperature between 0 degrees C and 1 degree C. A first excursion of 14 degrees C had occurred previously which lasted 2 hours on an unspecified date. The pharmacist reported no adverse effects. There was a data logger issue involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain. On and unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. One month prior from the time of reporting the patient received 1st dose of BEXSERO. The patient returned to doctor of medicine's office for the 2nd dose of BEXSERO. During visit to the office, the patient stated that the pain from the 1st dose had recently ceased. This case has been linked with the case US2016153388, reported by the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 10 patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose, dose# and route unknown). No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist via a public representative referring to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot number not provided). On an unknown date (a couple days after ZOSTAVAX administration), the patient went to his physician's office and received an unspecified steroid injection for an unspecified reaction. A few days after this appointment at the physician's office, the patient received a prescription for a methylprednisolone dose pack. The pharmacist did not know the cause of the patient's unspecified reaction. At the time of report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose, lot# and expiration date were not provided) in an unspecified arm. The reporter that was unsure if the vaccine was administered either by subcutaneous or intramuscular route. There were no concomitant medications reported. On an unknown date, the patient experienced injection site pain. No product quality complain was involved. At the reporting time, the outcome of the event of injection site pain was unknown. The reporter did not assessed the causality between the event of injection site pain and ZOSTAVAX. This is one of several reports 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 as received from a pharmacist refers to a unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M015930 with expiration date on 29-MAR-2019, (route and anatomical location were not provided). The time frame was reported as 10 hours with a temperature between 0 degrees C and 1 degree C. A first excursion of 14 degrees C had occurred previously which lasted 2 hours on an unspecified date. The pharmacist reported no adverse effects. There was a data logger issue involved. 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 29-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 three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 792 hours with the lowest recorded temperature of 29 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of ROTATEQ, (lot# L048854 and expiry date 31-AUG-2017) (strength, dosing details, route and anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of the 3 reports received from reporter source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Injection site haematoma
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient aged above 60 or more. Information on pertinent medical history and drug reactions/allergies were not reported. On 19-OCT-2016, the patient received a dose of ZOSTAVAX 19400 PFU (dosing details not reported). Concomitant medication included warfarin. On 19-OCT-2016 (reported as unknown time after receiving vaccine), the patient noted that his arm was bruised and had a melanoma at the injection site. The patient was treating the bruising with cold compress. The patient had sought medical attention. The reporter stated that a clinician was currently on the way to visit the patient at home and examine the arm. Bruising was still present at the time of reporting, five days later. Outcome of the event injection site hematoma was unknown. Causality of the events was not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M007764, expiration date 30-JAN-2018; dose and route of administration were not reported. There was no adverse effect reported. Administered doses of vaccines had been stored at the temperature of 0.5 degrees Celsius for 2 months and 8 days (date unspecified). A digital data logger was involved. There were no precious temperature excursions reported. There was no product quality complaint involved. 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-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 three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 96 hours with the lowest recorded temperature of 29 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a pharmacist referring to a currently 60 year old male patient with high blood pressure. Information regarding concomitant medication and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # M032139 with expiration date 02-OCT-2017, dose unknown, subcutaneous). It was reported that after the patient received the vaccine, he still experienced an outbreak of shingles (date unspecified) (vaccination failure). The patient didn't contact physician for medical attention. It was unknown if treatment was given for the events or if lab diagnostics studies were performed. The outcome of the events was unknown. The causality was not reported. 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 22-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 three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 29 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 pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M033086 with expiration date 06-MAY-2018, lot # M027552 with expiration date 04-FEB-2018, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates the patients received unspecified number of doses of improperly stored PEDVAXHIB. The nurse reported that the doses may have been given from the following lots: Lot # M014926 (expiry date: 17-FEB-2019), Lot # reported as M025194 (expiry date: 22-MAR-2019) and Lot# M007762 (expiry date: 07-DEC-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. 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 as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates the patients received unspecified number of doses of M-M-R II (incorrect product storage). The nurse reported that the doses may have been given from the following lot: Lot # L039551 (expiry date: 07-OCT-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # L025738, expiration date: 14-AUG-2017, dose and route of administration were not reported). This vaccine was exposed to a temperature excursion of 13 degree Celsius for a time frame of 168 hours (date unspecified). A Digital Data Logger was used. No adverse effects were reported. 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 an office manager concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, unspecified patients received doses of improperly stored ROTATEQ (lot # M031802, expiration date 09-NOV-2017). The storage detail was a temperature excursion for ROTATEQ at 50 F for 1 hour 12 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected since there is no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, unspecified patients received doses of improperly stored VARIVAX (lot # M004330, expiration date 26-JAN-2018) (lot # M027343, expiration date 01-JUN-2018) (dose and route unknown). The storage detail was a temperature excursion for VARIVAX at 6.1 F for 96 hours. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected since there is no consent to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, unspecified patients received doses of improperly stored Gardasil 9 (lot # M005714, expiration date 03-OCT-2017; dose and route unknown). The storage detail was a temperature excursion GARDASIL 9 at 50 F for 1 hour 12 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected since there is no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has ben received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU (lot # M001747 with expiration date 07-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU (lot # M001747 with expiration date 07-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Eye pain, Herpes zoster
Clinical narrative: This spontaneous report was received from a 76 years old female patient regarding herself. Patient had no medical history or drug reactions/allergies. On an unknown date in 1998, the patient received ZOSTAVAX 19400 PFU (dosing details not reported). Patient was not on any concomitant medications. The patient stated that she had been experiencing shingles like pain on and off since being vaccinated. The pain has been consistently in her right eye and has recently been on her stomach. No lab diagnostic tests were performed. The administrating physician was unknown. Patient did not receive any treatment for the events. Outcome of the event was reported as not recovered. Causality of the events was not reported. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant medications were reported. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of (M-M-R II) (lot numbers: M006544, Expiry date: 03-FEB-2018) (dosing regimen and frequency unknown). The administered vaccine underwent a temperature excursion at 49 F for a time frame of 7 hours 9 minutes. There was no previous temperature excursions. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. Patient's pertinent medical history was not known. It was reported that the patient had no drug reactions or allergies. On 17-OCT-2016, the patient was vaccinated with ZOSTAVAX (lot # M003486, expiry date: 27-MAR-2017), subcutaneously (dosing regimen unspecified). Concomitant therapies included gabapentin (manufacturer unknown), baclofen (manufacturer unknown), morphine sulfate (manufacturer unknown), oxycodone (manufacturer unknown) and AMBIEN. On 17-OCT-2016, the patient experienced redness at the injection site following vaccination with ZOSTAVAX. It was reported that the redness extended "high up on the arm". On 18-OCT-2016, the patient developed "blisters in a cluster in an area that was about 3 inches round". On an unknown date, the patient reported that her arm was "hot to the touch". The pharmacist requested for a lot check for the lot number provided. At the time of this report, the patient did not recover from the events of injection site erythema, skin warm and injection site vesicles. Causality assessment was not provided by the reporter. Additional information has been requested.